Essential Medicines 2008 - Indonesia

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1 Ind n
NATIONAL LIST of ESSENTIAL MEDICINES 2008
NATIONAL LIST of ESSENTIAL MEDICINES 2008
DEPARTEMEN KESEHATAN R.I.
MINISTRY of HEALTH REPUBLIC of INDONESIA

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Ministry of Health of The Republic of Indonesia. Cataloging in Publication Data. 615.1 Ind n Indonesia. Ministry of Health Republic of Indonesia. National list of essential medicines 2008.-Jakarta : Ministry of Health of The Republic of Indonesia, 2008. 1. Judul 1. DRUGS
CONTENT Page Foreword Content The decree of The Ministry of Health regarding National List of Essential Medicines 2008 Chapter I Chapter II Chapter III APPENDICES Appendix I Appendix II Changes of National List of Essential Medicines 2005 The Decree of Ministry of Health Number 239/MENKES/ SK/III/2008, 5 March 2008, regarding The Establishment of National Committee on Revision of The NLEM 2008 List of Participants of Technical Meetings and Plenary Session of National List of Essential Medicines 2008 Statement of Compliance Conflict of Interest Statement Assessment Form 88 100 INTRODUCTION National List of Essential Medicines 2008 Restricted Medicine List for Public Health Center 2008 i ii iii 1 19 63
Appendix III Appendix IV Appendix V Appendix VI Index
105 108 109 110 112
National List of Essential Medicines 2008
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THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA THE DECREE OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NUMBER : 791/MENKES/SK/VIII/2008 REGARDING THE NATIONAL LIST OF ESSENTIAL MEDICINES 2008 THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA Considers : a. in order to increase the quality of health services and to ensure the availability, equity, affordability of the essential medicines to the community at all levels, it is therefore, the National List of Essential Medicines should be revised; the National List of Essential Medicines which mentioned in the Decree of the Minister of Health No. 497/Menkes/SK/VII/2006 has to be revised according to progress of medical sciences, health technology, disease pattern and the health program respectively; Considering point (a) and (b), it is necessary to redetermine the National List of Essential Medicines by the Ministerial Decree; Law No. 23 year 1992 regarding Health (States Paper Year 1992 No. 100. Additional to States Paper No. 3495); Law No. 29 year 2004 regarding Medical Practice (State Paper year 2004 No. 116, Additional to State Papers of the Republic of Indonesia No. 4431); Law No. 32 year 2004 regarding the Regional Government Administration (State Paper year 2004 No. 125, Additional to State Paper No. 4437) as lastly changed by Regulation No. 12 year 2008 regarding the second changing on the Regulation No. 32 year 2004 regarding Regional Government (State Paper year 2008 No. 59, Additional State Paper No. 4844); Government Regulation No. 32 Year 1996 regarding Health Human Resource/ Health personnel (State Paper year 1996 No. 49, Additional to State paper No. 3637); Government Regulation No. 72 Year 1998 regarding the Security of the pharmaceutical product and Medical Devices (State Paper year 1998 No. 138, Additional to State Paper No. 3781); Government regulation No. 38 year 2007 regarding Division of governing administration of central government, Provincial Government, and local government in Municipality/District (State paper Year 2007 No. 82, Additional State Paper NO. 4737);
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c. Refers to : 1. 2.
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Presidential Regulation No. 9 year 2005 regarding the authority, function, Organizational Structure and duty of States Ministries of the Republic of Indonesia; Presidential Regulation No. 10 Year 2005 regarding Organization Unit and duty of the First Rank Officers of the States Ministries; The Regulation of Ministry of Health No. 085/Menkes/Per/I/ 1989 regarding the Compulsory of Generic products prescribing at public health facilities; The decree of the Minister of Health of the Republic of Indonesia no. 1575/Menkes/Per/XI/2005 regarding Organization and Management of the Ministry of Health as has been changed by the Regulation of the Minister of Health No. 1295/Menkes/Per/XII/2007; The decree of the Minister of Health No. 189/Menkes/SK/III/ 2006 regarding the National Medicines Policy; The decree of the Minister of Health No. 239/Menkes/SK/III/ 2008 regarding The Establishment of The National Committee on Revision of The National List of The Essential Medicines 2008. Has decided
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To Stipulate The First The Second The Third
: : : : THE DECREE OF THE MINISTER OF HEALTH REGARDING NATIONAL LIST OF ESSENTIAL MEDICINES 2008. The National List of Essential Medicines 2008 as mentioned in the first dictum is attached in the Appendix hereto. The National List of Essential Medicines (NLEM) is the list of the selected medicines that satisfy the priority health care needs of the population and are intended to be available within the context of functioning health systems. The implementation of NLEM is to increase the appropriateness, safety, rationalization of the medicine use and management and also increase the effectiveness and efficiency of the available budget in order to expand, to distribute evenly and to increase the quality of health services for all community levels. The implementation of NLEM should be consistent and continuously in level of Health Service Units. With approval of this decree, therefore the Decree of Minister of Health No. 497/Menkes/SK/VII/2006 regarding the National List of Essential Medicines 2005, hereby cancelled and believed not to be applicable any more.
The Fourth
The Fifth The Sixth
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The Seventh
This decree shall be effective as of the date of stipulation. Stipulated in : Jakarta On Date : August 21, 2008. Minister of Health
Dr. dr. SITI FADILAH SUPARI, Sp.JP (K)
FOREWORD
The National Medicines Policy (2006) mandates the enforcement to enhance the quality of health services; to ensure the availability of safe, efficacious and good quality medicines in sufficient amount and type, affordability and accessibility of medicine particularly essential medicine for the whole community, to be governments responsibility. Essential medicine is selected medicine that mostly needed for health service, including diagnosis, prevention, therapy and rehabilitation, which enforced to be provided in health care units, according to their function and level. This revisions renewal applied a new approach, whereas the process of addition and deletion preceded with re-evaluation of existing list of previous National List of Essential Medicines (NLEM) by The National Committee of NLEM, therefore there were deletion of obsolete medicines and addition of new medicines in consequence of science improvement. It needs the transparency of evaluating process which utilize scientific evidence and consider the pediatric formulation. NLEM revised regularly every three years; the last revision carried out in 2005. Current revision is conducted by The National Committee of NLEM, which legalized through The Decree of Minister of Health. Hopefully, by the prevailing of NLEM 2008, mandate of The National Medicines Policy could be applied better. A great thankfulness is given to all parties involved in the process of revision and formulation of NLEM 2008. Jakarta, August 2008 Director General Pharmaceutical Services and Medical Devices
Dra. Kustantinah, Apt. MAppSc. NIP. 140 100 965
CHAPTER I
INTRODUCTION
The concept of Essential Medicine in Indonesia was first introduced with the publication of The National List of Essential Medicines (NLEM) in 1978, followed by the National Medicines Policy document in 1983. The National List of Essential Medicines, named DOEN (NLEM) is revised periodically every 3-4 years. DOEN 2008 is a revised edition. The Governments commitment to do periodic revisions is a reputation of its own. In the year 2007, the World Health Organization (WHO) has carried out the first phase of Good Governance on Medicines (GGM) program in Indonesia by conducting a survey on transparency of five pharmaceutical functions. One of them is the selection process of essential medicines, which from the aspect of transparency process is valued to be insufficient. From the meeting of the 30th WHO Essential Medicine List in Sri Lanka (2007), it was reiterated that the importance of transparency of the selection process both by expert panel members who do revisions, revision process, and revision methods which have got to be more rely on evidence based medicine (EBM), and the importance of the conflict of interest statement from expert panel members. Recalling some of the above mentioned issues, this years (2008) revision has been geared into its betterment. Because of it, the revision process this time is rather different from the earlier revision process, some of these improvements are as follows: 1. 2. The selection of expert panel members has been tightly scrutinized, including valuation against conflict of interest. Since the beginning of discussion, program managers who use medicines in the environment of the Ministry of Health have been included, not only during the plenary meeting. This endeavor is hoped to be a re-learning process to the internal of the Ministry of Health to fully understand the concept of essential medicines. Besides the opinion and experiences of expert panel members in this revision team, the utilization of evidence based medicine (EBM) data are important considerations. The entire discussion process gives great attention to medicines for children, including its formulation. The WHO essential medicines list for children has been used as one of the guidelines. The siding with the individual rights of children is also shown by electing pediatricians into the expert panel that numbered to 4 (four) persons. Revision of the medicines list has been holistic and total, meaning weighing all medicines listed in the NLEM 2005 including notes which may no longer be deemed fit. Earlier revisions were more in the evaluation of medicines which are suggested to be added on in the previous list.
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Transparency is also displayed with descriptions of arguments why a medicine must be deleted or be added from the NLEM 2005, or even be change of dosage form.
A.
National Essential Medicines Essential medicines are chosen medicines which are most needed to cater to the diagnoses, prophylaxis, therapy, and rehabilitation, which are made available to the health service units in accordance to its functions and tiers. 1. Criteria of National Essential Medicines a. Selection Criteria Selection of essential medicines is based on these criteria: (1) (2) (3) (4) (5) (6) (7) Having got the most beneficial risk-benefit ratio. Guaranteed of quality, including stability and bio-availability. Practicality in storage and distribution. Practical in use and delivery, which are adjusted to man power and health services facilities. Advantageous in compliance and reception by patients. Having got the highest benefit-cost ratio based on direct and indirect expenses for the patient. If there is more than one choice which have the same therapeutic effects, then preference is made for: (8) medicines with effects which are known to have scientific data; medicines with pharmacokinetic data which are known to be most beneficial; medicines with better stability; easily obtainable; medicines that are most familiar. the compounded medicine is useful in the form of that combination only; combination medicines have got to show higher efficacy and safety than each individual component; ratio of the components of patent combination medicines are ratios which are fixed for a large number of patients who need those combination medicines; combination medicines have got to increase the benefit-cost ratio; combination antibiotics it must also prevent or lessen the occurrences of resistance or other disadvantageous effects.
Fixed combination medicines have to follow the following criteria: -
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Criteria of Additions and Deletions 1. When addition of new medicines are considered, the existing old medicines with the same indications which may be obsolete should be taken into account, unless there is a strong reason to keep both of them. Medicines used in special program(s) are suggested by the program manager and will be assessed by general EM selection criteria. In the revision process, the entire medicine list in the NLEM (2005) is evaluated by the National Revisions Committee. Deletion of medicines which are seen as no longer effective may here be decided upon or a substitution may be done when another better medicine has been available.
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Guidance on Evidence and Recommendation Proof of evidence and recommendations are adopted from the US Agency for Health Care Policy and Research. The type of study should rely on scientific data, such as depicted in the list below, but the recommendation should depend on the overall judgement of all available data. Testimonials are not considered for assessment. STATEMENTS OF EVIDENCE Ia Ib IIa IIb III IV Data are obtained from meta-analysis of randomized, controlled clinical trials. Data are obtained from at least one randomized, controlled clinical trial. Data are obtained from at least one non-randomized and well designed clinical trial. Data are obtained from at least one quasi-experiment of another type of study that is well designed. Data are obtained from descriptive study that is well designed, like comparative study, correlation study, and case study. Data are obtained from reports or opinion of expert panels.
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Application of Concept of Essential Medicines Essential medicines are the most basic medicines which are needed to cater for health services. If other than listed NLEM medicines are needed, a (Hospital) Formulary or another limited medicine list may be instituted. The NLEM may also be expanded into other documents as the needs arise.
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a.
National List of Essential Medicines (NLEM) National List of Essential Medicines consists of selected, most needed medicines and made to be available at health services units in accordance with its functionality and its levels. NLEM are a national minimum standard to health services. Implementation of NLEM is meant to increase the efficacy, safety, rational use, and medicine management which altogether increase efficiency of available cost, which in turn extends coverage and increase average quality of medicine prescriptions. Application of this National Essential Medicines Policy must be done consistently, and continuously at all levels of health services units. Medicine dosage-form and strength, such as tablets, syrups, injections, and other forms, unit strength, dose, and size of package indicated in the NLEM are binding, in order to create standards. Sizes of packaging for each health service unit are based on logistics efficiency while distribution is related with common usage.
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Therapeutic Guidelines Medication Guidelines should be systematically structured to help physicians to make a correct diagnosis and optimal medication for a certain kind of disease. Guidelines of medication should be suited for every level of health services units, such as guidelines in basic medication at Public Health Center and guidelines in diagnosis and therapy at local hospitals. Medication Guidelines consist of information about all kinds of diseases, especially sicknesses which are occurring frequently - with their respective complaints - and information about dosage form, unit strength, dose of medicines and length of time of medication.
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Hospital Formulary A hospital formulary is a list of medicines which have been agreed upon by key hospital physicians and their inherent (medicine) information which are used in the hospital concerned. A national hospital formulary is written by the Medicine and Therapeutic Committee based on NLEM and elaborated upon by taking into account other medicines proven effective which are needed by specialties in the concerned hospitals. The creation of a hospital formulary has to be based on therapeutic guidelines. The implementation of a hospital formulary must be monitored and its report be used to carry out evaluation and revision so as to keep up with advancements of scientific knowledge and medical science.
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Specialists Formulary Specialists formularies are books which are consist of comprehensive complete information on medicines needed by certain specialists of a hospital, to be used for patient care with special disease indications. Specialists formularies are written to increase compliance of hospital specialists towards their hospital formulary, that has been ranked very low until today. Certain
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specializations may have many sub-specializations, for example the field of obstetrics and gynecology as a specialization that has got many subspecializations, that special essential medicines list can be made for Obstetrics and Gynecology. The writings of a specialists formulary involve specialist professional association with its many sub-branches. With the involvement and active participation of specialists it is expected that they will feel that they are part of the association, so that rational medicine use can be positively applied. e. National Indonesian Medicine Information National medicine information consists of medicines which are on the market and are presented briefly, are relevant to physicians needs, pharmacists, and other health services workers. The National Indonesian Medicine Information is published by the Ministry of Health to guarantee objectivity, completeness, and unconfounding. Information on medicines that are covers indications, side-effects, dosages, how to use, and other important information which are most important for patients. The development of this book was based on more scientific data, related to benefits and actual medicine use. 3. Management and Medicine Use To improve rational medicine use, the use of essential medicines at health service units should follow treatment guidelines and proper medicine management be instituted. Effective medicine management is required to guarantee medicine availability in the right kinds and quantities while fulfilling quality standards. Important aspects of medicine management are as follows: Limitation of numbers and kinds of medicines based on an Essential Medicines List, using generic names, with a correct selection process; Bulk purchasing should be applied; Competitive, transparent purchases; Audit system and reporting from management report.
Application of Government Regulation Number 38 year 2007 on the coordination of the governance between the Central Government and the Provincial Government and other regional governments in order to synchronize its health management in the country. So, as with medicine management organizations, each state/city has got organizational structures and their own medicine management policies. This would open up basic differences in each state/city in carrying out medicine management. The cycle of medicine distribution is started at the time a medicine is delivered from the factory or distributor, and it ends at the time medicine consumption reports are handed in to the logistics unit. Effective medicine distribution should have a system design and sound management such as: constant medicine supply, taking care of the quality of medicines at the time of distribution process, minimizing medicines which are unused because of spoilage or being expired, with correct planning in accordance with each provinces medicine needs, use of inventory records which are accurate, rationalization of medicine depots, and supply of information to estimate medicine needs.
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With decentralization in place it is hoped that state government or city or provinces can sufficiently supply respective individual medicine needs. The central government, in this matter, the Ministry of Health only lends back-up support when state/city or province cannot fully supply the medicine needs. The NLEM is a base for planning and supply or logistics of medicines in local (district/province/city) and central government. Management and use of specialists medicines for certain situations, the government c.q. Directorate General of Pharmaceutical Services and Medical Devices, Ministry of Health can provide these through special channels (special access scheme) in accordance with The Decree of Minister of Health Number: 1379.A/Menkes/SK/XI/2002. 4. Communication, Information, and Education(CIE) CIE on essential medicines are a pre-requisite to improve the use of medicines and rational prescribing by health providers. CIE for health providers and the public in general to increase rational use of medicines and be maintained continuously should use the following links: a. b. c. d. Governmental organizations/private institutions. Related professional organization. Curriculum of education for health providers. Other possible channels.
Every listed medicine in NLEM must be accompanied by accurate information that is objective and understandable by health providers. This information covers indication, contraindication, dose, how to use, caution remarks, side-effects, medicine interaction, and dosage forms of preparations. 5. Research and Development Research and development should be done to support the selection process and improvement of the NLEM. Research and development are done in line with medical science and technology in the subjects of medicine, pharmacy, epidemiology, and education. The outcome or result of research and development are utilized as inputs in the revision process and improvement of NLEM periodically. 6. Monitoring and Evaluation Monitoring and evaluation are done to support the success of the application of the NLEM through mechanism and output evaluation of potential underlying problems and its effective solutions. This can be achieved through co-ordination, supervision, monitoring and evaluation of application of the NLEM by the Ministry of Health. Monitoring and evaluation are done gradually fitting to functions and levels. 7. NLEM Revisions NLEM has to be revised and perfected periodically. Revisions are not only for keeping up with the advancement of knowledge, but also for practical reasons in the use and dispensing which fits health providers and the health service facilities.
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Perfection of NLEM is done continuously with input of suggestions from health service units and health research, whether governmental or private, conveyed to the Directorate General of Pharmaceutical Services and Medical Devices, Ministry of Health, Republic of Indonesia. NLEM revisions are done periodically every 3 (three) years. 8. Quality Control Total medicine quality control covers the phases of product development, good manufacturing practices, monitoring of medicine quality in the distribution chain and their use, are important elements in applying the essential medicines concept. 9. Antibiotics Resistance Antibiotic resistance will increase, especially with first-line essential antibiotics, which are relatively inexpensive. This condition is dangerous, because ultimately the public will lose sensitive antibiotics that are potential in fighting infectious diseases which are newly occurring or recurring. The reason is because of irrational use of antibiotics by both of health providers or patients. In overcoming the problem of antibiotic resistance it takes the following efforts: a. b. Conducting surveillance of microbe resistance so that antibiotics resistance patterns are obtained. Surveillance of antibiotic use Surveillance of antibiotic use is done by research institutions, hospitals, and public health centers, province or district health offices and other health, education and research institutions. c. Containing antibiotic use by health providers by applying antibiotic prescription policy gradually, fitting to the conditions of patients and disease patterns, using first-choice antibiotics from the start, and reserving other antibiotics of subsequent choice for limited use. To provide communication, information and education towards all parties using antibiotics whether they be health workers, patients or the public in general about how to use antibiotics rationally and the danger, caused by irrational use of medicines.
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10. Donated Medicines Donations in the form of money or medicines from another country, private organizations, or other international bodies can support the public health services in a country that needs it. In its operation, medicines donation must fulfill the requirements as described in WHO Guidelines for Medicines Donations 1999. Health services being used must fulfill a certain existing applicable guidelines/standards. This guideline covers general principles about selection of medicines, quality of medicines, shelf life, packaging and labeling, information and management.
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Four main principles of donated medicines are: Donated medicines must provide maximum usefulness to recipient country. Understand the needs and respecting the authority of recipient country. Does not use double standards for the quality of donated medicines. Effective communication between donor country and recipient country.
Donated medicines are best received when they are in accordance with NLEM. In order for medicines supply and health logistics can help the operations of health workers, the types of medicines and health logistics must coincide with the disease patterns in Indonesia. For medicines which are not marketed in Indonesia acceptance must follow a special channel (special access scheme), in accordance with the existing applicable rule. B. Terminologies 1. Contents and Format of NLEM a. b. c. 2. The National Essential Medicine list is used as the basis for all units of (governmental) health services. One type if medicines can be used in several forms of preparations and one form of preparation can consist of a few dosage forms. In the NLEM, medicines are categorized according to class, subclass and sometimes sub-subclass therapy, which are in alphabetical order.
Nomenclature a. Medicine names are written according to the last edition of Indonesian Pharmacopoeia. If it does not appear in the Indonesian Pharmacopoeia then generic names are used. Medicines which are commonly used and do not have an INN (International Nonproprietary Name) are written with common names, for example oral rehydration salt. Combination medicines which do not have a generic name are given agreed names which are generic names for combinations and each is written with the effective ingredients, followed with dosage of each component. For some items which need a synonym are written within brackets.
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Explanatory Notes a. Keywords (1) Dosage Forms Dosage forms or preparations are forms of medicines according to the production process in the form of usage, for example: capsule, enteric coated tablet, intravenous injection etc. (2) Dosage strength Strength of preparation is the content or percentage of effective components in ready made preparations. For dosage strength in the form of salt or its esther, salt or esther are written down within brackets, for example ethambutol tablet 250 mg (hydrochloride). As for dosages of effective components, the names of salts or esther (which are written within brackets) would be priored by the word as, for example: chloroquine tablet 150 mg (as phosphate). (3) (4) Packaging Packaging is the smallest container that contains the medicine. Package Size Package Size is the total number of preparation units or the smallest container in one standard packaging, for example 100 vials. b. Other Notes (1) Information in restricted columns are meant for medicines with certain restrictive notes: (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (2) (3) (4) Monitoring of side-effects. Limitation of indications. Only for certain cases. Tight screening is required or medical expert considerations needed. Nature or medicine mechanism of action requires attention. Special treatment required. Special facilities needed. Combination with other medicine needed. Required for certain areas, like endemic areas. Uses in accordance with existing health program.
Writing of technical terms or foreign language words are written in italics. National Medicines Lists are medicine lists that are used by hospitals. NLEM for Public Health Center (primary health service units) in red colored paper.
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Abbreviations i.a. injection i.c. injection infiltr inj infusion sol inj i.m. injection IU i.v. injection liq p.v. injection rectal sol s.c. injection sacch sol supp : intraartherial injections : intracutaneous injection : infiltrated injection : infusion solution : injection : intramuscular injection : international unit : intravenous injection : liquid : paravertebral injection : rectal solution : subcutaneous injection : sacchets/bags/pouches : solution : suppository
C.
Renewal of Revision Process Discussions were not conducted only limited to incoming requests, but revaluating the whole NLEM of 2005. This was done because the list was only updated during previous years and some old medicines have become obsolete or new and better medicines have become available. Also some uses of older medicines have been renewed and some have made other restrictions. Expert teams and consultants work together in the discussion that is divided into several groups based on therapeutic class. Consultants are responsible for EBM data in accordance with his/her competence. Besides information from consultants and expert team, the secretariat supported fully with among others, information from Cochrane review and WHO Library. From this process, although EBM information is not always totally accepted, but discussions are no longer based on level-4 evidence or expert team opinion only. Understanding the concept of essential medicines has to be re-socialized. Seemingly, the understanding of the essential medicines is withering and explanation about this concept is appreciated. Essential Medicine is a floor not a ceiling (WHO TRS 946), it is a minimum for health care. A medicine is essential when you cant do without it. The difference of essential medicines and program medicines will result in the availability of a specific medicine. This problem is overcome by socialization and special policies by the Ministry of Health relating to essential medicines and program medicines. In the revision process, from the start it has been planned to give attention to medicines for children. This policy is not only meant for harmony with the global policy, but Indonesia is consistently aiming at decreasing mortality of babies and children, so that it needs this emphasis. The involvement of four pediatricians, give sufficient contributions for this problem. Also the involvement of the Directorate of Child Health and other directorates are very intensive. The addition of medicines for children with dosage forms especially for children, like carbamazepine, is provided in the form of syrup. In the final discussion of the Plenary Meeting it has been agreed that 78 medicines has been deleted from NLEM 2005 and 48 were added to the new list of 2008. Changes in formulations
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(forms of preparations, dosages, packaging) was agreed for 21 medicines. It was found that 33 medicines were given short notes as important to be provided or supplied by the government through ways fitting with the existing applicable policies. The total number of medicines in the NLEM 2008 is 323 medicine items. 1. Revision Process Revision processes started by sending letters to government health services institutions (hospital types A, B, C, public health center) as well as several chosen private parties, special programs in the Ministry of Health and professional organizations. Three months later, from 114 installations to whom letters were sent to, 25 had responded. From those responses three had no suggestion, 22 were responding with request for additions to the list, and there was no one responding to delete medicines from the old list. Although in the letter sent, it has been informed that suggestion has got to come together with supporting data and functions, only 10 installations were sending supporting data. Besides suggestions from the installations, the expert team and consultants, may give suggestions with supportive data. This process is a yardstick in carrying out the assessment, it is needed to build transparency process and accountability in the future. The process consists of creation of a committee, criteria of recruitment of expert team members, tasks and obligations of expert team members, revision processes, holding discussion meetings and socialization of NLEM. 2. Committee Members a. Organization (1) Organizational structure is a National Committee consisting of: (a) Expert team (b) Consultants (c) Program manager and (d) Operational Secretariat Membership of National Committee lasts until a next committee is formed for the next NLEM revision meeting. The Committee is legalized by the Minister of Health by a Decree wherein its duties are stated. Names of expert team members and selected consultants are indexed without titles, only differentiated into MDs, general practitioner, specialists, or pharmacists. Not all therapeutic classes need to be represented as a member or consultant in the Committee. If an expert in a special field is needed, he/she can be invited to become a resource person to give an expert opinion in the revision process. They will not become a part of the expert team and also do not take part in decision making. Duties of expert team members and consultants listed in the Ministerial Decree are:
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(3)
(4) (5)
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(a)
Expert Team members are evaluating medicines listed in NLEM 2005 and also evaluate suggested medicines which are applied for deletion or inclusion in the new list. Consultants are joining the discussions and may give scientific or practical inputs which may be needed to be useful to be taken into consideration by the expert team members. Expert team members and consultants together give technical/scientific justification to Ministry of Health through Directorate of Pharmaceutical Services and Medical Devices to accept the new NLEM 2008 nationally, while assisting the Directorate of Rational Medicine Use in practicing its concept.
(b)
(c)
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Program manager is a representative of a directorate in the Ministry of Health who owns special therapeutic programs and manages the logistics of medicines. The Operational Secretariat are Directorate of Rational Medicines Use, Directorate General of Pharmaceutical Services and Medical Devices.
(8) b.
The selection process of Expert Team and Consultants (1) Pre-requisites of Expert Team and Consultants (a) Have integrity and a high professional standard. (b) Expert team members and consultants are clinicians from several fields of specialization, Clinical Pharmacology, Dentistry, Pharmacists, physicians/health service units (public health center). (c) In order to get professional expert team members who are impartial, he or she must not represent professional associations, hospital departments, or other jobs which are potential in creating conflicts.
(d) Signing a letter of consent, acceptance and availability. (e) Willing to sign a conflict of interest statement. But somebody who has a conflict of interest can still be considered to become a member of the expert team, if integrity can be maintained. He/she may then not participate in a voting process. (2) Recruitment processes of Expert Team and Consultants: (a) The Secretariat sends a form of written availability and willingness, accompanied by his/her superior permission, 1 (one) month prior to the commencement of the Meeting. (b) He or she must submit the filled-in form 1 (one) week after receiving, together with a conflict of interest statement. (c) An acceptance and statement of willingness letter consists of: Explanation of job description of expert team. Schedule of material of discussion which have to be attended.
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Revision Methods a. Submission of medicines Revision processes is started by sending submission forms to several health service units (University Hospitals, Special Hospitals, chosen State Hospitals, Provincial Hospitals, Military/Police Hospitals, chosen Private Hospitals, Regional Hospitals, Public Health Center with beds). Provincial Health Units representative, public health center, and program managers (in the directorate of Ministry of Health). Submission Request Forms are sent 3 (three) months before the first Meeting. b. c. Compilation of Submissions Compiled submissions are categorized or grouped in therapeutic classes. Material of Revisions Material of Revisions are put in a matrix, which is put side by side with the WHO List 2007 and the latest NLEM 2005 edition. It is followed with the submitted medicines. Revised Materials will be handed to expert team members 1 (one) week before technical discussion meeting. Discussion Criteria Submissions to be discussed are suggestions which come with arguments and accompanied with scientific evidence. Methods of Revision Materials (1) Revision can be the whole assessment or one of the following processes: (a) Only assessment of submission requests. Deleting or accepting submissions. (b) Taking into account the whole NLEM and incoming requests. Deleting and adding essential medicines whether from requests or from expert team members and consultants opinion. Types of discussions meeting: (a) Preliminary Meeting consists of Information about the understanding of essential medicines (definitions, criteria, (approximate) number of essential medicines in NLEM etc). Implementation of NLEM (in relation with program medicines, guideline for procurement of PKD Medicines, DPHO- AsKes and others). NLEM Revision Procedure. Procedure in technical discussion (preparation of NLEM revision draft) and plenary meetings. Attendance: expert team, consultants, program managers, operational secretariat.
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(b) Technical discussion meetings Discussion meetings of the pro and contra whether to accept or refute a submission. Discussion on benefit-risk of additions or deletions of essential medicines which are on the old list. Putting in focus those medicines which are submitted, but were not included in the WHO list. These were specially scrutinized. Suggestion to put food supplements into NLEM will not be considered. If the Expert Team fails to make a decision on some choices, a resource person outside the expert team members will be invited. Attendance for the meeting are: o Expert team o Consultants o Related program managers of Ministry of Health o Related resource persons. Result of technical discussion meetings is NLEM revision draft.
(c)
Plenary Meeting Aims at making agreements, formalizing, and socializing revised draft of the NLEM. Meeting Chairman is the head of the expert team. Formalization of NLEM draft to become the new revision is the Directorate of Pharmaceutical Services and Medical Devices task or someone who is appointed by the institute. When the result of plenary meeting has been legalized it may not be altered, except editorial revisions. Plenary meeting members should be responsible as part of the decision making process and are also expected in the active participation to deploy the new NLEM. Plenary meeting attendees are: o Those who attended the preliminary meeting and technical discussions; o Medical Committees of University Hospitals, Military/Police Hospitals, chosen Private Hospitals and other hospitals and medal schools who submitted suggestions for revision; o Attendees from Faculty of Medicine o Attendees from Faculty of Pharmacy; o Attendees from School of Nursery; o Provincial Health Office submitting revision suggestion(s);
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o o
Professional organizations (IBI, IDI, PPNI, ISFI, specialists associations); Pharmaceutical Industries (BUMN and Pharmaceutical Wholesalers Association)
4.
Explanation of changes made Medicine changes made in NLEM 2008 whether generic names or their formulations, based on therapeutic classes are as follows: 1. Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Medicines, Medicines used to treat gout 1.1 Opioid Analgesics Sufentanyl in the form of citrate 50 mcg/ml, was taken out from the list, because of poor availability in the market. 1.2 Non-opioid Analgesics Methampyron i.m. inj. 250 mg/ml was taken out from the list for safety reason, where in the form of injection may cause anaphylactic shock. Suggestion to add ketoprofen supp. 100 mg and paracetamol supp. 120 mg and 240 mg were accepted, recalling that ketoprofen supp. is used for post-surgical patients who cannot yet receive oral medicine forms, while it is non-irritant to the stomach. While paracetamol supp. is needed to prevent febrile convulsion cases, post-surgery in children, in line with pediatric procedures. Availability and procurement of paracetamol supp., are limited to district level hospitals. 1.3 Anti-gout Colchicine tablets 500 mcg has been listed in NLEMs from the start. But with the availability of many NSAIDs, its efficacy is valued not much different from other NSAID medicines, while their safety is lower than colchicine. Thus colchicine was taken out from the list. The WHO Model List 2007 did not contain colchicines either. 2. Anesthetics 2.1 Local Anesthetics Lidocaine inj 5% + glucose 7.5% 2 ml amp was suggested to be added, especially for spinal anesthesia, in areas where bupivacaine are difficult to get. Besides, toxic effects against the heart is smaller. Lidocaine inj. 1% (HCl) + epinefrin 1 : 200,000 in packaging of 20 and 30 ml were deleted from the list, because the packaging is seen to be too large, so it would cause spoilage if not finished.
15
2.2
General Anesthetics and Oxygen Suggested liquid isoflurane liq. 3 3.5 % 250 ml are accepted, because of advantages to the heart and are used for patients with specific certain conditions. Midazolam inj. i.v. 1 mcg/ml and i.v. inj. 5 mg/ml are choice medicine for patients with fragile vital signs, as sedative, hypnotic, and pre-anaesthetics. While liquid enflurane ih., btl 250 ml was taken out of the list with the reason being less advantageous if compared with isoflurane and halothane. While Thiopental powder. inj. i.v. 1,000 mg/ml was taken out from the list because of safety consideration.
5.
Antiepileptic-Anticonvulsants Suggestion of addition in the dosage form of syrup and chewable tablet for pediatric patients are accepted. So, in this class were listed: fenitoin syrup 50 mcg/5 ml, carbamazepin 100 mg/ml bottle 120 ml, chewable tablets 100 mg. Phenobarbital tab 50 mg was added, because it was still effective and cheap.
6.
Anti-infective In several previous revisions of NLEMs, cephalosporines were always suggested to be added, but only this time the National Committee, gave way to cephazolin with limitation to special use of surgery prophylaxis inj. 1 g/vial. Cephazolin is a chosen medicine for surgery prophylaxis to prevent surgical wounds infection. The same thing happens to Ceftriaxone inj. 1 g/vial, that is a chosen medicine for meningitis and is used for resistant cases of typhoid fever with chloramphenicol and cyprofloxacin. The delay of entry of cephalosporine antiinfectives is caused by the fast growing anti-infective resistance in hospitals, especially. Expert team agreed to accept the inclusion of vancomycine inj. 500 mg to overcome MRSA (methicillin resistant S. aureus) infection, a serious nasocomial infection. Amphotericine*) inj. i.v. vial 50 mg was requested and accepted for inclusion, because it is the only systemic antifungal, mainly for pulmonary fungal infection. In the list it was marked *) that means needing special expertise in its use. For anti-amoebic diloxanide furoate tab 500 mg was included, recalling the importance of treatment of cysts that does not show physical symptoms. In the anti-malarial case arthesunate inj. i.v. 60 mg/ml was added, that was valued to be having better efficacy compared to artemether inj., although from the side of usage artemether is more practical for public health center (primary health service units). In the antiviral protease inhibitor group lopinavir were added because they were needed for HIV/AIDS, although their prices are higher. In anti-tuberculosis medicines, besides a few single medicines are provided, listed were some combination medicines for use by program needs. But in the case of dosage forms, it was left to program needs, whether they be in the form of FDC (fixed dose combination), or combipack. Single preparations are maintained for use in health services which are not yet able to carry out direct observed treatment shortcourse (DOTS) program.
16
8.
Antineoplastic, Immunosuppressive and Medicines used in Palliative Care Chlormetin and levamisol were taken out of the list, because they were no longer in use as anticancer medicines, because of their efficacy and safety. Addition of daunorubicin HCl powder inj. was suggested and accepted by expert team, as well as chlorambucil tablet 2 mg and melfalan tablet 2 mg. Daunorubicin is a main medication in Acute Lymphocyte Leukemia that is often found in children. Chlorambucil is low priced, registered in Indonesia and is in accordance with the WHO Model List. Melfalan is a cheap medicine and is needed in the treatment of multiple myeloma.
14.
Dental Medication and Oral Health From this therapeutic class many are evaluated as obsolete, even their uses are no longer being taught by Dental Schools, for example sulpha cones preparation and iodoform paste. There are some which are causing environmental damage, like the use of amalgam, because of that it is agreed upon that composite be used.
17.
Cardiovascular Medicines In this therapeutic category a few changes in subclass or deletions of medicines were applied because they are no longer in production and are no longer available in the market like procainamide, reserpine, quinidine. In the subclass of antiarrythmic added were amiodarone and digoxin. In the antihypertension class sodium nitroprusid inj. was added to be used for its specific efficacy in surgery needing hypotension technique and septic shock.
18.
Dermatological Medicines Many medicines were deleted because of obsolescence, for example gentian violet, liver oil ointment. These liquids like lotio kummerfeldi, if needed, can be entered into a hospital formulary. New additions which are accepted are permethrine as an antiscabicide that is less toxic to children, in place of Gamexan. Other addition is Liquor Veilli (diluted salicylic acid), a simple effective medicine for wet dermatitis.
20.
Electrolytes and Nutrients Oral rehydration salt in 1000 ml sacchets are deleted from the list, because the packaging is too large, inefficient to store and it does not maintain freshness for long time. Only 200 ml sachets are available. In the case of parenteral nutrition liquid namely liquid nutrients i.v. all of them were deleted from the list. The National Committee, especially expert team and consultants, are well aware of the importance of this preparation, but compositions which are available in the market vary and were too many, with uses which may be different.
17
For children use and neonates in this therapeutic class liquid nutrients were added: glucose 4% + NaCl 0.18% infusion, and sodium bicarbonate inj. 1.4% isotonic. 23. Psychotherapeutic Medicines Alprazolam was deleted because valued to be non-essential and tend to cause overuse and dependence. In subclass therapy antidepression and antimania it was suggested addition of fluoxetine, sertraline and paroxetine. Fluoxetine cap/tab10 mg and cap/tab 20 mg were accepted as choice medicines for category SSRI. In the antipsychotic subclass racemic methylphenidat addition was suggested in the form of regular release and extended release to be used for Attention Deficit Hyperactive Disorder (ADHD). Although evidence has not fully supported, but all these times it has been a choice medicine for ADHD. Addition of chlozapine was accepted because it is a selected medicine for other resistant antipsychotic medicines. This medicine is effective but it is necessary to watch for agranulocytosis side effect. Periodic leucocytes counts must be taken. 28. Ear treatment, Nose, and Throat Important changes took place in looking at ear treatment, nose, and throat. Experts considered that treatment of ear infection does not need to use antibiotics or corticosteroids. Other than that antibiotic preparations in the form of nose or ear drops are not listed in the WHO Model List. D. Socialization of NLEM 2008 In applying essential medicines concept, NLEM 2008 must be spread to health service facilities in the entire Indonesia. Socialization can be in the form of printed books which are delivered to all health service units and publicized in electronic form.
18
CHAPTER II NATIONAL LIST OF ESSENTIAL MEDICINES 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)
1.1 OPIOID ANALGESICS codeine fentanyl
DOSAGE FORM
RESTRICTION
1. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES, MEDICINES USED TO TREAT GOUT tablet 10 mg, bottle 250 tablets injection i.m./i.v. 0.05 mg/ml (citrate), box 5 ampoules @ 2 ml injection i.m./s.c./i.v. 10 mg/ml (HCl/sulfate), box 10 ampoules @ 1 ml tablet 10 mg (HCl/sulfate), bottle 30 tablets injection i.m./s.c./slow released i.v 50 mg/ml (HCl), box 10 ampoules @ 2 ml injection 5 mcg/ml (citrate), box 5 vials @ 10 ml Authority required : Anesthetist
morphine
pethidine
sufentanyl
1.2 NON-OPIOID ANALGESICS acetylsalicylic acid (acetosal) tablet 100 mg, box 10 blisters @10 tablets tablet 500 mg, box 10 blisters @10 tablets ibuprofen tablet 200 mg, bottle 100 tablets tablet 400 mg, bottle 100 tablets suppositoria 100 mg Restricted use : Post operative patients
ketoprofen
19

methampyrone paracetamol
DOSAGE FORM
tablet 500 mg, bottle 1000 tablets tablet 100 mg, bottle 1000 tablets tablet 500 mg, bottle 1000 tablets syrup 120 mg/5 ml,bottle 60 ml suppositoria 120 mg suppositoria 240 mg coated tablet 200 mg, bottle 100/1000 tablets
RESTRICTION
Restricted use : To reduce agranulocytosis
phenylbutazone
Restricted use : Only for acute arthritis, to be taken after meals, for one week and to be followed by other safer NSAID as needed.
sodium diclofenac
tablet 25 mg, box 10 stripes @ 10 tablets tablet 50 mg, box 10 stripes @ 10 tablets
1.3. MEDICINES USED TO TREAT GOUT allopurinol tablet 100 mg, bottle 100/1000 tablets Note : - Blocks uric acid production (in 35% of cases) - Not for acute attack
probenecid
tablet 500 mg, bottle 100/1000 Note : - Increases uric acid renal tablets excretion (in 65% of cases) - Dosage 2 X tablet, increase water intake - Not for acute attack
2. ANESTHETICS 2.1 LOCAL ANESTHETICS bupivacaine p.v. injection 0.50% (HCl), box 5 vials @ 20 ml injection 0.5% (HCl) + glukosa 7.5%, box 5 ampoules @ 4 ml Restricted use : Only for spinal anesthesia
20

ethyl chloride lidocaine
DOSAGE FORM
spray, bottle 100 ml infiltr injection 1% (HCl), box 100 amps @ 2 ml p.v. injection 2% (HCl), box 100 ampoules @ 2ml gel 2%, tube 10 g spray 4%, bottle 50 ml injection 5% + glukosa 7,5 %, ampoule 2 ml
RESTRICTION
Note : Air tight package
Restricted use : Only for spinal anesthesia
2.2 GENERAL ANESTHETICS and OXYGEN halothane isoflurane ketamine inhalation liquid, bottle 50/250 ml inhalation liquid, bottle 250 ml i.v. injection 10 mg/ml (as HCl), box 10 vial @ 20 ml i.v. injection 50 mg/ml (as HCl), box 10 vial @ 20 ml i.v. injection 1 mg/ml i.v .injection 5 mg/ml inhalation, gas in tube inhalation, gas in tube injection 10%, box 5 ampoules @ 20 ml i.v. powder for injection 500 mg/ampoule (as sodium salt) (for dissolved in 20 ml WFI), box 25 ampoules Restricted use : Only for special conditions
midazolam nitrous oxide oxygen propofol thiopental
2.3 MEDICINES USED FOR PREOPERATIVE MEDICATION PROCEDURES atropine injection 1 mg/ml (sulfate), box 50 ampoules @ 1 ml
21

diazepam
DOSAGE FORM
tablet 5 mg, bottle 1000 tablet injection 5 mg/ml, box 100 ampoules @ 2 ml i.m./s.k./i.v. injection 10 mg/ml (HCl/sulfate), box 10 ampoules @ 1 ml
RESTRICTION
morphine
3 ANTIALLERGICS and MEDICINES USED IN ANAPHYLAXIS chlorpheniramine tablet 4 mg ( maleate), bottle1000 tablets injection 5 mg/ml (maleate), box 100 ampoules @ 1 ml injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml i.m. injection 10 mg/ml (HCl), box 100 ampoules @ 1 ml s.c./i.m. injection 0,1% (HCl/bitartrate), box 100 ampoules @ 1 ml Note : - Drug of choice for anaphylactic reaction - Dosage 0,3 mg 0,5 mg i.m., may be repeated
dexamethasone
diphenhydramine epinephrine (adrenaline)
4. ANTIDOTES and OTHER SUBSTANCES USED IN POISONING 4.1 SPECIFIC atropine i.m./i.v./s.c injection 1 mg/ml (sulfate), box 10 ampoules @ 2 ml Restricted use : Caution on package: only for antidotes (large dose).
calcium folinic (leucovorin, Ca) tablet 1 mg, bottle 100 tablets tablet 15 mg, bottle 10 tablets injection 3 mg/ml, box 10 ampoules @ 1 ml calcium gluconate injection 100 mg/ml, box 24 ampoules @ 10 ml
22

deferoxamine
DOSAGE FORM
powder for injection 500 mg/ml (mesilate), box 10 vials @ 10 ml injection i.v. 10 mg/ml (as dihydrate), box 10 ampoules @ 10 ml injection 0.02 mg/ml (HCl), box 10 ampoules @ 2 ml injection 0.4 mg/ml (HCl), box 5 ampoules @ 2 ml i.m. injection 10 mg/ml, box 10 vials @ 5 ml tablet 500 mg, bottle 1000 tablets i.v. injection 25%, box 10 ampoules @10 ml
RESTRICTION
methylthioninium chloride (methylene blue) naloxone
protamine sulfate sodium bicarbonate sodium thiosulfate 4.2 NON-SPESIFIC active carbon apomorphine magnesium sulfate
activated powder, sacch 0.5 kg s.c. injection 5 mg/ml (HCl), box 10 ampoules @ 1 ml powder, sacch 30 g
5. ANTIEPILEPTICS ANTICONVULSANTS carbamazepine tablet 200 mg, bottle 100/1000 tablets chewable tablet 100 mg syrup 100 mg/5 ml, bottle 120 ml i.m./i.v. injection 5 mg/ml, box 100 ampoule @ 2 ml rectal sol 4 mg/ml, tube 2.5 ml i.v. injection 20%, ampoule 25 ml i.v. injection 40%, ampoule 25 ml
diazepam
magnesium sulfate
23

phenobarbital
DOSAGE FORM
tablet 30 mg, bottle 1000 tablets tablet 50 mg, bottle 1000 tablets tablet 100 mg, bottle 1000 tablets i.m injection 50 mg/ml, box 100 ampoules @ 2 ml i.v.injection 50 mg/ml (as sodium salt), box 100 ampoules @ 2 ml capsule 30 mg (as sodium salt), bottle 250 capsules capsule 100 mg (as sodium salt), bottle 250 capsules injection 50 mg/ml (as sodium salt), box 10 ampoules @ 2 ml syrup 50 mg/5 ml,bottle 120 ml tablet 250 mg (as sodium salt), bottle 50 tablets tablet 500 mg (as sodium salt), bottle 50 tablets syrup 250 mg/5 ml (as sodium salt), bottle 120 ml
RESTRICTION
phenytoin
valproate
6. ANTI-INFECTIVE MEDICINES 6.1 ANTHELMINTHICS 6.1.1 Intestinal Anthelminthics albendazole tablet 400 mg, box 5 stripes @ 6 tablets Note : - For strongiloides. - Pediatric dose : 20 mg/kgBW
mebendazole
tablet 100 mg, bottle 100 tablets syrup 100 mg/5 ml,bottle 30 ml
24

praziquantel pyrantel
DOSAGE FORM
scored tablet 300 mg, bottle 100/1000 tablets scored tablet 250 mg (pamoate), bottle 250 tablets suspension 125 mg/5 ml (pamoate), bottle 30 ml
RESTRICTION
6.1.2 Antifilarials diethylcarbamazine scored tablet 100 mg (citrate), bottle 1000 tablets Note : For endemic area
6.1.3 Antischistosomals praziquantel tablet 600 mg, bottle 100 tablets Restricted use : - Only for Central Sulawesi - Only for South Kalimantan, for Fasciolopsis buski treatment
6.2 ANTIBACTERIALS 6.2.1 Beta Lactam medicines amoxicillin trihydrate scored tablet 500 mg, box 10 stripes @ 10 tablets dry syrup 125 mg/5 ml, bottle 60 ml i.m./i.v. powder for injection 250 mg/vial (as sodium salt), box 10 vials i.m./i.v. powder for injection 500 mg/vial (as sodium salt), box 10 vials i.m. injection 1.2 millions IU/ml, box 25 vials @ 4 ml i.m. injection 2.4 millions IU/ml, box 25 vials @ 10 ml i.m./i.v. injection 10 millions IU/vial, box 25 vials
ampicillin
benzathine benzylpenicillin
benzylpenicillin crystal
25

cefazolin
DOSAGE FORM
powder for injection 1 g / vial, box 2 vials powder injection 1 g / vial, box 2 vials capsule 250 mg (as sodium salt), box 25 stripes @ 4 capsules scored tablet 500 mg (as sodium salt) syrup 62.5 mg/5 ml (as sodium salt), bottle 60 ml i.m./i.v. powder for injection 500 mg/vial (as sodium salt) (soluble in 5 ml WFI), box 20 vials tablet 500 mg (as potassium salt), bottle 1000 tablets tablet 250 mg (as potassium salt), box 10 stripes @ 10 tablets dry syrup 250 mg/5 ml (as potassium salt), bottle 60 ml powder for injection i.m. 3 millions IU/vial, box 100 vials powder for injection i.m. 1 million IU/vial, box 100 vials
RESTRICTION
Note : Prophylactics, to prevent operation wound infection
ceftriaxone dicloxacillin
phenoxymethylpenicillin (penicillin V)
procaine benzylpenicillin
6.2.2 Other antibacterials 6.2.2.1 Tetracycline doxycycline capsule 100 mg(hyclate/HCl), box 10 stripes @ 10 capsules Note : May be used for renal patients
26

oxytetracycline
DOSAGE FORM
i.v. injection 250 mg/3 ml (HCl), box 10 ampoules @ 3 ml i.v. injection 50 mg/ml (HCl), box 10 vials @ 10 ml capsule 250 mg (HCl), bottle 1000 capsules capsule 500 mg (HCl), box 10 stripes @ 10 capsules
RESTRICTION
tetracycline
6.2.2.2 Chloramphenicol chloramphenicol
capsule 250 mg, bottle 1000 capsules suspension 125 mg/5 ml (as palmitate), bottle 60 ml i.v. powder for injection 100 mg/ml (as succinate sodium), box 10 vials @ 10 ml
6.2.2.3 Sulfa-Trimethoprim NLEM co-trimoxazole I (adult) combination of : sulfamethoxazole 400 mg trimethoprim 80 mg NLEM co-trimoxazole II (paediatric) combination of: sulfamethoxazole 100 mg trimethoprim 20 mg NLEM co-trimoxazole III combination of : sulfamethoxazole 80 mg/ml trimethoprim 16 mg/ml sulfadiazine trimethoprim
tablet, box 10 stripes @ 10 tablets
tablet, bottle 100 tablets
i.v. injection, box 5 ampoules Note : @ 5 ml, box 5 vials @ 10 ml Minimized use
tablet 500 mg, bottle100 tablets scored tablet 200 mg, bottle 100 tablets
27

6.2.2.4 Macrolides clindamycin
DOSAGE FORM
RESTRICTION
injection 150 mg/ml (as phosphate), box 100 ampoules @ 2 ml capsule 250 mg (as stearate), bottle 100 capsules syrup 200 mg/5 ml (as ethyl succinate), bottle 60 ml
Note : Benefit for bone infections
erythromycin
6.2.2.5 Aminoglycosides gentamicin injection 10 mg/ml (as sulfate) @ 2 ml injection 40 mg/ml (as sulfate), box 10 ampoules @ 2 ml
6.2.2.6 Quinolones ciprofloxacin scored tablet 500 mg (as HCl), Caution : box 10 blister @ 10 tablets Not for fist line treatment on gram possitive bacteria infection powder injection 500 mg/vial, box 1 vial Restricted use : Benefit for MRSA infection
vancomycin
6.2.2.7 Specific Use metronidazole
tablet 250 mg, bottle 100/1000 tabs tablet 500 mg, bottle 100/1000 tabs suppositoria 500 mg, box 6 suppositoria infusion solution 5 mg/ml, bottle 100 ml tablet 500 mg, bottle 500 tablets Restricted use : Specific for ulcerative colitis
sulfasalazine
28

6.3.1 Antileprosy medicines clofazimine, micronized dapsone rifampicin
DOSAGE FORM
RESTRICTION
6.3 SPECIFIC ANTI-INFECTIVE MEDICINES oily capsule 100 mg, bottle 100 capsules scored tablet 100 mg, bottle 1000 tablets capsule 300 mg, box 10 stripes @ 10 capsules Restricted use : Only for tuberculosis and leprosy
6.3.2 Antituberculosis medicines ethambutol tablet 250 mg (HCl), bottle 100 tablets tablet 500 mg (HCl), bottle 100 tablets tablet 100 mg, bottle 1000 tablets tablet 300 mg, bottle 1000 tablets tablet 500 mg, bottle 100 tablets scored tablet 300 mg, box 10 stripes @10 tablets tablet 450 mg, box 10 stripes @10 tablets tablet 600 mg, box 10 stripes @10 tablets powder for injection 1000 mg/vial (as sulfate), box 100 vials caplet 150 mg; 75 mg tablet 150 mg; 50 mg Note : Dosage form and usage according to National Tuberculosis Program Restricted use : Only for tuberculosis and leprosy
isoniazid
pyrazinamide rifampicin
streptomycin
combination of : rifampicin isoniazid
29

combination of : rifampicin isoniazid ethambutol combination of : rifampicin isoniazid pyrazinamide combination of : rifampicin isoniazid pyrazinamide ethambutol
DOSAGE FORM
capl 150 mg tablet 150 mg tablet 400 mg capl 150 mg; 75 mg;450 mg tablet 75 mg; 50 mg; 300 mg tablet 400 mg; 150 mg; 500mg capl 150 mg; 450 mg tablet 75 mg; 300 mg tablet 400 mg; 500 mg tablet 275 mg; 250 mg; 500mg
RESTRICTION
Note : Dosage form and usage according to National tuberculosis program. Note : Dosage form and usage according to National tuberculosis program. Note : Dosage form and usage according to National tuberculosis program
6.3.3 Urinary Antiseptics NLEM co-trimoxazole I (adult) combination : sulfamethoxazole 400 mg trimethoprim 80 mg methenamine mandelate (hexamine mandelat) nitrofurantoine trimethoprim tablet, box 10 stripes @ 10 tablets
enteric coated tablet 500 mg, bottle 100/1000 tablets scored tablet 100 mg, bottle 100 tablets scored tablet 200 mg, bottle 100 tablets
6.4 ANTIFUNGAL MEDICINES 6.4.1 Systemic amphotericin ) griseofulvin, micronized i.v injection vial 50 mg/10 ml, vials @ 10 ml scored tablet 250 mg, bottle 100 tablets
Complementary list
30

ketoconazole
DOSAGE FORM
tablet 200 mg, bottle 100 tablet
RESTRICTION
Restricted use : Only for cronic mucocutaneous candidiasis, which are not responsive to nystatin and other fungicides, systemic mycosis infection (candidiasis, parakoksidioidomikosis etc)
nystatin
coated tablet 500,000 IU/tablet, bottle 100/1000 tablets suspension 100,000 IU/ml, bottle 12 ml
6.4.2. Topical NLEM antifungal medicines combination of: benzoic acid 6% salicylic acid 3% miconazole nystatin ointment, pot 30 g
powder,2% (nitrate),sacch 20 g cream, 2% (nitrate), tube 10g vaginal tablet 100,000 IU/tablet, box 10 stripes @10 tablets liquid 25%, bottle 30 ml
sodium thiosulfate
6.5 ANTIPROTOZOAL MEDICINES 6.5.1 Antiamoebic and antigiardiasis medicines diloxanide metronidazole tablet 500 mg (furoate) tablet 250 mg, bottle 100 tablets tablet 500 mg, bottle 100 tablets
31

6.5.2 Antimalarial medicines 6.5.2.1 For prophylaxis chloroquine
DOSAGE FORM
RESTRICTION
tablet 150 mg (as phosphate), bottle 1000 tablets
6.5.2.2 For curative treatment NLEM antimalarial medicines combination of : pyrimethamine 25 mg sulfadoxine 500 mg artemether artesunate combination of : artesunate 50 mg amodiaquin 200 mg chloroquine tablet, bottle 500 tablets Restricted use : For specific area which already resistent to chloroquin (decided by District Health Offices)
injection 80 mg/ml, box 6 ampoules @ 1 ml injection i.v./i.m. 60 mg/ml, box 8 vials @ 1 ml tablet, box 2 blisters @ 12 tablets (combipack) box 3 blisters @ 8 tablets tablet 150 mg(as phosphate), bottle 1000 tablets syrup 50 mg/5ml, bottle 60 ml tablet 15 mg (as phosphate), bottle 1000 tablets tablet 222 mg (bisulfate), bottle 1000 tablets i.v. injection 25% (as HCl), box 100 ampoules @ 2 ml Restricted use : Only for severe malaria
primaquine quinine
6.6 ANTIVIRAL MEDICINES 6.6.1 Antiherpes medicines aciclovir scored tablet 200 mg scored tablet 400 mg
32

6.6.2. Antiretrovirals
DOSAGE FORM
RESTRICTION
6.6.2.1. Nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (3TC) tablet 150 mg stavudine zidovudine tablet 30 mg, bottle 60 tablets tablet 40 mg, bottle 60 tablets tablet 300 mg, bottle 60 tablets tablet 100 mg, bottle 100 tablets syrup 50 mg/5 ml, bottle 10ml i.v. infusion solution 200 mg/10 ml
6.6.2.2 Non-nucleoside reverse transcriptase inhibitors (NNRTI) efavirenz tablet 200 mg, bottle 90 tablets tablet 600 mg, bottle 30 tablets nevirapine tablet 200 mg, box 6 blisters @ 10 tablets
6.6.2.3 Protease inhibitors lopinavir 7. ANTIMIGRAINE MEDICINES 7.1 FOR PROPHYLAXIS dihydroergotamine
tablet
tablet 2.5 mg (as mesilate), box 10 stripes @ 10 tablets scored tablet 40 mg (HCl) bottle 100 tablets
propranolol
7.2 FOR TREATMENT OF ACUTE ATTACK ergotamine tablet 1 mg (tartrate), bottle 100 tablets
33

combination of : ergotamine 1 mg caffeine 50 mg
DOSAGE FORM
tablet, box 30/100 tablets
RESTRICTION
8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES and MEDICINES USED IN PALLIATIVE CARE 8.1 HORMONES AND ANTIHORMONES medroxyprogesterone acetate tablet 250 mg, bottle 50 tablets injection 200 mg/ml, box 1 vial 2.5 ml tablet 20 mg (citrate), bottle 30 tablets soft capsule 40 mg (undecanoate), box 5 stripes @ 4 capsules
tamoxifen testosterone
8.2. IMMUNOSUPPRESSIVE MEDICINES azathioprine ciclosporin tablet 50 mg, bottle 100 tablets soft capsule 25 mg, bottle 50 capsules injection 50 mg/ml, box 10 ampoules @ 5 ml
8.3 CYTOTOXIC MEDICINES asparaginase powder for injection 10,000IU/vial, box 1 vial bleomycin powder for injection 15 mg/ampoule (as HCl), box 1 ampoule coated tablet 2 mg, bottle 100 tablets tablet 15 mg, bottle 10 tablets injection 3 mg/ml, box 5 ampoules @ 1/10 ml
busulfan calcium folinate (leucovorin, Ca)
34

chlorambucyl cyclophosphamide
DOSAGE FORM
tablet 2 mg coated tablet 50 mg, bottle 28 tablets i.v. powder injection 200 mg/vial, box 1 vial i.v. powder for injection 500 mg/vial, box 1 vial i.v. powder injection 1000 mg/vial, box 1 vial powder for injection 10 mg/vial, box 10 vial powder for injection 50 mg/vial, box 100 vial i.m./i.v./s.c powder injection 100 mg/vial, box 5 vials powder for injection 100 mg/vial, box 1 vial i.v. injection 0.5 mg/vial, box 1 vial 0.5 mg powder injection 20 mg/vial (HCl), box 1 vial @ 4 ml i.v. powder for injection 10 mg/vial (HCl), box 1 vial @ 5 ml i.v. powder for injection 50 mg/vial (HCl), box 1 vial @ 25 ml injection 20 mg/ml, box 10 ampoules @ 5 ml capsule 100 mg, bottle 10 capsules i.v. injection 50 mg/ml, box 10 ampoules @ 5 ml
RESTRICTION
cysplatin
cytarabine dacarbazine dactinomycin daunorubicin doxorubicin
etoposide
fluorouracyl
35

melphalan mercaptopurine methotrexate
DOSAGE FORM
tablet 2 mg tablet 50 mg, bottle 25 tablets tablet 2.5 mg (as sodium salt), bottle 100 tablets powder for injection 50 mg/vial (as sodium salt), box 1 vial i.v./i.m./i.t. powder for injection 5 mg/vial (as sodium salt), box 1 vial capsule 50 mg (as HCl), bottle 100 capsules powder for injection 10 mg/vial (sulfate), box 1 vial i.v. powder for injection 1 mg/vial (sulfate), box 1 vial
RESTRICTION
Note : Storage at 2-8oC
procarbazine vinblastine vincristine
Caution : - Not for intrathecal use - Storage at 2-8oC Restricted use : Palliative Care Hospital
8.4 MEDICINES FOR PALLIATIVE TREATMENT morphine tablet 10 mg (sulfate), bottle 30 tablets
9. ANTIPARKINSONISM MEDICINES NLEM antiparkinsonism tablet, bottle 100 tablets medicines combination of : benserazide 25 mg levodopa 100 mg trihexyphenidyl tablet 2 mg (HCl), bottle 250 tablets
10. MEDICINES AFFECTING THE BLOOD 10.1 ANTIANAEMIA MEDICINES cyanocobalamine injection 500 mcg/ml, box 100 ampoules @ 1 ml
36

fe (II) sulfate 7 H20
DOSAGE FORM
coated tablet 300 mg, bottle 1000 tablets syrup, bottle 60 ml drops, bottle tablet 1 mg, bottle 1000 tablets tablet 5 mg, bottle 1000 tablets
RESTRICTION
folic acid
10.2 MEDICINES AFFECTING COAGULATION heparin sodium phytomenadione (vitamin K1) i.v./s.c. injection 5000 IU/ml, box 1 vial 5 ml coated tablet 10 mg, bottle 1000 tablets injection 10 mg/ml, box 100 ampoules @ 1 ml i.m injection 2 mg/ml, ampoule 1 ml
Dose : - New born baby dose 1 mg - Premature baby dose 0,5 mg Authority required
protamine sulfate warfarin
injection 10 mg/ml, box 10 vial @ 5 ml tablet 2 mg (as sodium/ potassium salt), bottle 100 tablets
11. BLOOD PRODUCTS and PLASMA SUBSTITUTES 11.1 BLOOD PRODUCTS factor VIII (consentrate) powder for injection 250 IU/vial Authority required : Used for the treatment of + solvent 10 ml, box 1 vial haemophilia A Authority required : powder for injection 1000 IU/vial + solvent 25 ml, Used for the treatment of box 1 vial haemophilia B powder for injection 500 IU/vial + solvent 10 ml, box 1 vial
factor IX complex
37

protein plasma fraction
DOSAGE FORM
RESTRICTION
Authority required : Right procedures needed
11.2 PLASMA SUBSTITUTES and PLASMA EXPANDERS hydroxy ethyl starch infusion solution 6%, bottle 500 ml infusion solution 10%, bottle 500 ml infusion solution, bottle 500 ml Restricted use : - Only for special cases - Need special facility and skill - Various combination in market could be used
NLEM plasma substitutes combination of: polygeline (equivalent 0.63 g nitrogen) 17.5 g sodium chloride 4.25 g potassium chloride 0.19 g calcium (bound at polypeptide) 0.125 g pyrogen free sterile water to 500 ml 12. DIAGNOSTIC AGENTS
12.1 RADIOCONTRAST MEDIA 12.1.1 Angiography meglumine amidotrizoate 12.1.2 Billigraphy sodium iopodate injection 65%, box 1 vial @ 50 ml capsule 500 mg, bottle 6 capsules
12.1.3 Histerosalpingography meglumine sodium injection 76%, amidotrizoate box 1 ampoule 20 ml 12.1.4 Myelography iohexole
injection 240 mg I/ml, box 1 vial 10 ml injection 300 mg I/ml, box 1 vial 10 ml injection 350 mg I/ml, box 1 vial 20 ml
38

iopamidol
DOSAGE FORM
injection 0.408 g/ml, box 10 ampoule @ 10 ml injection 0.612 g/ml, box 10 ampoule @ 20 ml injection consist of 30.5 % iodium, box 1 ampoule @ 3 ml
RESTRICTION
iophendilate
12.1.5 Metabolism NLEM media contrast substance combination of : sodium bicarbonate 1.25 g simethicone 0.042 g barium sulfate granule, sacch, with anhydric acetic acid 10%
powder, sacch 200 g suspension 2.2%, bottle 250/450 ml suspension 55%, bottle 2 l suspension 65%, bottle 500 ml sol 59.7 %, bottle 120 ml
meglumine sodium amidotrizoate 12.1.6 Urograph iopamidole
injection 0.612 g/ml, box 10 ampoules @ 20 ml injection 0.755 g/ml, box 10 ampoules @ 20 ml i.v. injection 76%, box 1 ampoule @ 20 ml
meglumine sodium amidotrizoate 12.2 FUNCTION TEST 12.2.1 Renal sodium aminohypurate
i.v. injection 200 mg/ml, box 1 ampoule 10 ml
39

12.2.2 Liver sodium bromsulphtalein 12.2.3 Miscellaneous fluorescein
DOSAGE FORM
RESTRICTION
i.v. injection 5%, box 1 ampoule 3 ml
eye drops 1% (sodium salt), bottle 5 ml eye drops 2% (sodium salt), bottle 5 ml injection 10%, box 1 ampoule @ 5 ml injection 20%, box 1 ampoule @ 5 ml i.c. injection 1:10, box 1 vial 2 ml
12.3 SKIN TEST tuberculin protein purified derivative
13. ANTISEPTICS dan DISINFECTANTS 13.1 ANTISEPTICS chlorhexidine hydrogen peroxyde sol 5.0% (gluconate), bottle 2.5 l concentrate solution, bottle 1000 ml For diluted Storage : - Storage in glass bottle with glass cap, air tight, saved from light. - For diluted until 3%.
policresulen (metacresol sulphonate and methanal condensate) povidone-iodine 13.2 DISINFECTANTS calcium hypochlorite chlorine base compound ethanol 70%
liquid, bottle 10 ml / 50 ml
solution 10%, bottle 1000 ml
powder, sacch 20 g powder (for 0.1% sol), bottle 100 g sol, bottle 100 ml /1000 ml
Samijaga program
40

paraformaldehyde saponificated cresol 50% (lysol)
DOSAGE FORM
tablet 1 g, bottle 100 tablets sol 5%, bottle 1000 ml liquid, bottle 1000 ml
RESTRICTION
14. MEDICINES and DENTAL MATERIAL USED FOR ORAL HEALTH 14.1 MEDICINES USED FOR DENTAL and ORAL HEALTH, NLEM dental anesthetics combination of: lidocaine HCl 2% epinephrine 1 : 80,000 calcium hydroxide chlorhexidine chlorphenol camphor menthol ethyl chloride eugenol fluorine lidocaine injection, box 20/50/100 ampoules @ 2 ml
paste, box 2 tubes liquid 0,2% (gluconate) liquid, bottle 10 ml spray 0.05-0.2 ml, bottle 100 ml liquid, bottle 10 ml tablet 0.5 mg, bottle 100 tablets injection 2% (HCl), box 100 ampoules @ 2 ml paste 5% (HCl), tube 10 g spray 15% (HCl), bottle 60 ml suspension 100,000 UI/ml, bottle 12 ml concentrate liquid 5%, bottle 10 ml Note : For making dilutions Note : For making dilutions
nystatin sodium hypochlorite
14.2 DENTAL MATERIAL USED FOR ORAL HEALTH gelatin sponge cubicles 1x1x1 cm, tin 50 pcs
41

glass ionomer ART (Atraumatic Restorative Treatment) gutta percha points resin composite root canal filling surgical ginggival pack temporary filling 15. DIURETICS furosemide
DOSAGE FORM
powder bottle10 g sol, bottle 6 g (4.8 ml) cocoa butter 5 g box 120 sticks set paste, bottle set sol and powder, bottle 100 g
RESTRICTION
tablet 40 mg, bottle 250 tablets i.v./i.m. injection 10 mg/ml, box 25 ampoules @ 2 ml tablet 25 mg, bottle 1000 tablets infusion liquid 20%, bottle 500 ml tablet 25 mg, box 10 stripes @10 tablets tablet 100 mg, box 10 stripes @10 tablets
hydrochlorothiazide mannitol spironolactone
16. HORMONES, OTHER ENDOCRINE MEDICINES and CONTRACEPTIVES 16.1 ANTIDIURETIC HORMONES desmopressin vasopressin spray i.m./s.c. injection 20 IU/ml, box 10 ampoules @ 1 ml
42

16.2 ANTIDIABETIC 16.2.1 Oral Antidiabetic glibenclamide
DOSAGE FORM
RESTRICTION
tablet 2.5 mg, bottle 100 tablets tablet 5 mg, bottle 100 tablets tablet 5 mg, box 5 blisters @ 20 tablets tablet 500 mg, bottle 100 tablets
glipizide metformin
16.2.2 Injectable Antidiabetic intermediate insulin regular insulin regular insulin : intermediate insulin (30 : 70) injection 100 IU/ml, box 1 vial @ 10 ml injection 100 IU/ml, box 1 vial @ 10 ml injection 100 IU/ml, box 1 vial @ 10 ml
16.3 SEX HORMONE and FERTILITY RELATED MEDICINES 16.3.1 Androgens testosterone oil injection 200 mg/ml (enantate), box 1 vial @1 ml
16.3.2 Estrogens conjugated estrogens ethinylestradiol
tablet 0.625 mg, box stripes 28 tablets tablet 0.05 mg, bottle 100 tablets tablet 0.5 mg, bottle 100 tablets
16.3.3 Progestogens hydroxy progesterones i.m. injection 125 mg/ml, box 1 ampoule 2 ml
43

norethisterone 16.3.4 Contraceptives
DOSAGE FORM
tablet 5 mg, bottle 30 tablets
RESTRICTION
16.3.4.1 Oral Hormonal Contraceptives combination : pill levonorgestrel 150 mcg ethinylestradiol 30 mcg 16.3.4.2 Injectable Hormonal Contraceptives medroxyprogesterone depot injection 150 mg acetate 16.3.4.3 Intra-uterine Devices copper - containing device set / pcs 16.3.4.4 Implantable Contraceptives levonorgestrel implant 2 rods (3-4 years)
Note : According to National Family Planning Program coordinated by National Family Planning Coordination Board (BKKBN)
16.4 THYROID and ANTITHYROID HORMONES lugol solution bottle 30 ml propylthiouracyl thyroxine sodium scored tablet 100 mg, bottle 1000 tablets tablet 0.1 mg, bottle 50 tablets
Note : Dilute before use
16.5 CORTICOSTEROID HORMONES dexamethasone tablet 0.5 mg, bottle 1000 tablets injection 5 mg/ml (as sodium phosphate), box 100 ampoule @ 1 ml hydrocortisone tablet 10 mg powder for injection 100 mg/vial (sodium succinate), box 100 vial @ 2 ml tablet 5 mg, bottle 1000 tablets
prednisone
44

17.1 ANTI-ANGINAL MEDICINES atenolol diltiazem HCl isosorbide dinitrate nitroglycerine
DOSAGE FORM
RESTRICTION
17. CARDIOVASCULAR MEDICINES tablet 50 mg, box 10 stripes @ 10 tablets tablet 30 mg, box 10 stripes @ 10 tablets sublingual tablet 5 mg, bottle 60 tablets sublingual tablet 0.5 mg, bottle100/1000 tablets
17.2 ANTIARRHYTHMIC MEDICINES amiodarone tablet 200 mg, box 30 tablets injection 150 mg/3 ml, box 6 ampoule @ 3 ml digoxin tablet 0.0625 mg, bottle 100 tablets tablet 0.25 mg, bottle 100 tablets injection 0.25 mg/ml, box 1 ampoule @ 2 ml capsule 100 mg (phosphate), bottle 100 capsules injection 0.1% (as bitartrate), box 100 ampoules @ 1 ml i.v. injection 2% (HCl), box 100 ampoules @ 2 ml tablet 10 mg (HCl), bottle 100 tablets i.v. injection 1 mg/ml (HCl), box 10 ampoules @ 1ml Note : For intracardial or resusitation Pediatric dose : Tablet 0,0625 mg for pediatrics
disopyramide epinephrine (adrenaline) lidocaine propranolol
45

verapamil
DOSAGE FORM
tablet 40 mg (HCl), bottle 30 tablets injection 2.5 mg/ml (HCl), box 10 ampoules @ 2 ml
RESTRICTION
Special use : For supraventricular arrhythmia.
17.3 ANTIHYPERTENSIVE MEDICINES atenolol captopril tablet 50 mg, bottle 50 tablets scored tablet 12.5 mg, box 10 stripes @ 6 tablets scored tablet 25 mg, box 10 stripes @ 6 or 10 tablets i.m. injection 0.15 mg/ml (HCl), box 1 ampoule 1 ml tablet 25 mg, bottle 100 tablets tablet 5 mg, box 3 stripes @ 10 tablets tablet 10 mg, box 3 stripes @ 10 tablets tablet 20 mg, CD box 3 stripes @ 10 tablets coated tablet 250 mg, bottle 100 or 1000 tablets tablet 10 mg injection, vial Caution : - Not for pregnant women - Having cough side effect Note : For severe hypertension
clonidine ) hydrochlorothiazide lisinopril
methyldopa nifedipine sodium nitroprusside *)
17.4 PLATELET ANTIAGGREGATION acetylsalicylic acid (acetosal) tablet 80 mg, box 10 blisters @ 10 tablets
Complementary list
46

streptokinase
DOSAGE FORM
RESTRICTION
17.5 ANTI THROMBOTIC MEDICINES injection 750,000 IU/vial injection 1,500,000 IU/vial Restricted use : - Authority required - Need special facility and skill
17.6 MEDICINES USED IN HEART FAILURE captopril scored tablet 12.5 mg, box 10 stripes @10 scored tablets scored tablet 25 mg, box 10 stripes @ 10 scored tablets tablet 0.0625 mg, bottle 100 tablets tablet 0.25 mg, bottle 100 or 1000 tablets injection 0.25 mg/ml, box 1 ampoule @ 2 ml tablet 40 mg, box 20 stripes@ 10 tablets injection i.v./i.m. 10 mg/ml, box 25 ampoules @ 2 ml Caution : - Not for pregnant women - Having cough side effect
digoxin
Pediatric dose : Tablet 0,0625 mg for pediatrics
furosemide
17.7 MEDICINES USED for SHOCK ATTACK 17.7.1 Medicines used for Cardiogenic Shock dobutamine injection 50 mg/ml; vial 5 ml injection 25 mg/ml; ampoule 10 ml injection 40 mg/ml (HCl), box 5 ampoules @ 5 ml injection i.v. 0.1 % (as HCl/ bitartrate), box 100 ampoules @ 1 ml
dopamine epinephrine (adrenaline)
47
DOSAGE FORM
RESTRICTION
17.7.2 Medicines used for Anaesthetic Shock ephedrine injection 50 mg/ml (HCl), box 100 ampoules @ 1 ml norepinephrine injection 4 mg/ml, ampoule 2 ml
Note : Used as long acting vasopressor
17.8 LIPID-LOWERING AGENTS simvastatin scored tablet 10 mg, box 30 tablets
18. DERMATOLOGICAL MEDICINES 18.1 ANTIACNE MEDICINES retinoic acid cream 0.05%, tube 20 g
18.2 ANTI-INFECTIVE MEDICINES silver sulfadiazine NLEM anti-infective medicines combination of : bacitracin 500 IU/g polymixin B 10,000 IU/g cream 1%, pot 500 g ointment, tube 5 g Special use : Large area burn wounds
18.3 ANTIFUNGAL MEDICINES NLEM antifungal medicines combination of : benzoic acid 6% salicylic acid 3% miconazole ointment, pot 30 g Note : General antifungal ointment
powder 2% (nitrate), sacch 20 g cream 2% (nitrate), tube 10 g liquid 25%, bottle 30 ml
sodium thiosulfate
18.4 ANTI-INFLAMMATORY and ANTIPRURITIC MEDICINES betamethasone ointment 0.1% (as valerate), tube 5 g cream 0.1% (as valerate), tube 5 g
48

hydrocortisone liquor veilli (salicylic acid solution 0,1 %) combination of : salicylic acid 0.1 % boric acid 0.5 % glycerine 10 %
DOSAGE FORM
cream 2.5% (acetate), tube 5 g solution
RESTRICTION
Note : - Fresh prepared (r.p.= recentus paratus) - For wet dermatitis
18.5 SCABICIDES and PEDICULICIDES permethrin 2-4 ointment, combination of : salicylic acid 2% sulfur precipitate 4 % 18.6 CAUSTIC MEDICINES silver nitrate sol 20%, bottle 10 ml Note : For hypergranulation cream 5 %, tube ointment, pot 30 g
18.7 MEDICINES AFFECTING SKIN DIFFERENTIATION and PROLIFERATION coal tar podophyllum resin sol 5 %, bottle 100 ml alcoholic sol 25 %, bottle 30 ml Authority required : - Should be applicated by practitioners - Should be cleaned 1-4 hours after used, make sure that no residues - Only for severe thickening, causing danger of absorptions - Not for pregnant women because of terratogenic effect - Not for use by patients - Not for take away home
salicylic acid
ointment 2%, pot 30 g ointment 5%, pot 30 g ointment 10%, pot 30 g
49

urea 18.8 MISCELLANEOUS liquor carbonis detergents liquor faberi salicyl powder
DOSAGE FORM
cream 10 %, tube 40 g
RESTRICTION
suspension 2%, bottle 30 ml suspension 5%, bottle 30 ml liquid powder 2%, box 100 g
19. PERITONEAL DIALYSIS SOLUTIONS NLEM haemodialysis solution NLEM peritoneal dialysis solution sol, bottle 1 gallon infusion sol, 24 bottle @ 1000 ml
20. ELECTROLYTE, NUTRITION SOLUTIONS, and OTHERS 20.1 ORAL oral rehydration salts combination of : sodium chloride potassium chloride trisodium citrate dihydrate anhydric glucose potassium chloride powder, 100 sacch each sacch for 200 ml water - Drink slowly to prevent vomiting - 1 sacchet to be dissolved in 200 ml water
0.52 g 0.30 g 0.58 g 2.70 g
ready-to-dissolve tablet 300 mg, air tight tube 10 tablets tablet 500 mg, ottle 1000 tablets
- Dissolve before use - Storage in air tight container
sodium bicarbonate
20.2 PARENTERAL calcium gluconate darrow glucose ana (DG ana) dextrose
i.v. injection 10%, box 24 ampoules @ 10 ml infusion sol, bottle 500 ml infusion sol 5 %, bottle 500 ml
50

glucose
DOSAGE FORM
infusion sol 5%, bottle 500 ml infusion sol 10%, bottle 500 ml infusion sol 40%, bottle 25 ml infusion sol, bottle infusion sol 10%, bottle 100/500 ml infusion sol 20%, bottle 100/500 ml infusion sol 20 %, bottle 500 ml infusion sol, bottle 500 ml
RESTRICTION
half strength darrow glucose intralipid liquid
Restricted use : - Only for special cases - Need special facility and skill
mannitol NLEM nutritious solution combination of : glucose 5% sodium chloride 0.225 % nutritious solution combination of : glucose sodium chloride potassium chloride ringer lactate sodium bicarbonate
Note : For pediatric use
infusion sol, bottle 500 ml 4% 0.18 % i.v. injection 1 meq/ml, box 1 ampoule 10 ml infusion sol, bottle 500 ml i.v. injection 8.4%, bottle 25 ml injection 1.4% isotonik, bottle infusion sol 0,9%, bottle 500 ml infusion sol 3%, bottle 500 ml injection 15%, vial 50 ml Note : Need to check blood gas level Note : Need to check sodium level.
sodium chloride
20.3 MISCELLANEOUS water for injections
box, ampoule/vial @ 10 ml/20 ml
51
DOSAGE FORM
RESTRICTION
21. OPHTHALMOLOGICAL PREPARATION 21.1. LOCAL ANESTHETICS bupivacaine injection 0.5% (HCl), box 5 ampoules @ 20 ml tetracaine eye drops 0.5% (HCl), bottle 5 ml
21.2 ANTI-INFECTIVE AGENTS amphotericin eye ointment 3%, tube 3.5 g gentamicin idoxuridine oxytetracycline sulfacetamide eye ointment 0,3%, tube 3.5 g eye drops 0.3%, bottle 5 ml eye drops 0.1%, bottle 5 ml eye ointment 0.5%, tube 4 g eye ointment 1% (HCl), tube 3.5 g eye drops 15% (sodium), bottle 5 ml
21.3 ANTI-INFLAMMATORY AGENTS betamethasone eye drops 1 mg/ml (sodium), bottle 5 ml 21.4 MYDRIATICS atropine eye drops 0.5% (sulfate), bottle 5 ml eye drops 1% (sulfate), bottle 5 ml eye drops 2% (as hydro bromide), bottle 15 ml
homatropine
21.5 MIOTICS and ANTIGLAUCOMA MEDICINES acetazolamide tablet 250 mg, bottle 100 tablets i.m/i.v. powder for injection 500 mg/vial (as sodium salt), box 10 vials + 10 ampoules WFI @ 5 ml
52

pilocarpine
DOSAGE FORM
eye drops 2% (HCl/nitrate), bottle 5 ml eye drops 4% (HCl/nitrate), bottle 5 ml eye drops 0.25% (maleate), bottle 5 ml eye drops 0.5% (maleate), bottle 5 ml
RESTRICTION
timolol
21.6 MISCELLANEOUS combination of : hydroxypropyl methylcellulose 5 mg dextran (70) 1 mg glycerine 2 mg benzalkonium chloride 0.01% w/v sodium chromoglycate
sol 2%, bottle 5 ml
Note : For dry eyes syndrome
eye drops 2%, bottle 15 ml
22. OXYTOCICS and UTERIC RELAXANTS 22.1 OXYTOCICS methyl ergometrine coated tablet 0.125 mg (maleate), bottle 100 tablets injection 0.200 mg/ml, box 100 ampoules @ 1 ml injection 10 IU/ml, box 100 ampoules @ 1 ml
oxytocin
22.2 UTERIC RELAXANTS magnesium sulfate injection 20%, box 10 vials @ 20 ml injection 40%, box 10 vials @ 20 ml
53
DOSAGE FORM
RESTRICTION
23. PSYCHOTHERAPEUTIC MEDICINES 23.1 MEDICINES USED in GENERALIZED ANXIETY and SLEEP DISORDERS diazepam tablet 2 mg, bottle 1000 tablets tablet 5 mg, bottle 1000 tablets i.m. injection 5 mg/ml, box 100 ampoules @ 2 ml
23.2 MEDICINES USED in DEPRESSIVE DISORDERS amitriptyline coated tablet 25 mg (HCl), box 10 blisters @ 10 tablets fluoxetine capsule/tablet 10 mg, box 30 tablets capsule/tablet 20 mg, box 30 tablets tablet 200 mg, box 10 stripes @ 10 tablets Caution : - If possible, need to check blood concentration level - Safety windows is 0,8-1,2 mmol eq/l
lithium carbonate
23.3 MEDICINES USED for OBSESSIVE COMPULSIVE DISORDERS clomipramine tablet 25 mg (HCl), bottle 1000 tablets
23.4 MEDICINES USED in PSYCHOTIC DISORDERS chlorpromazine coated tablet 25 mg (HCl), bottle 1000 tablets coated tablet 100 mg (HCl), bottle 1000 tablets i.m. injection 25 mg/ml (HCl), box 100 ampoules @ 1 ml
54

clozapine )
DOSAGE FORM
tablet 25 mg, box 50 tablets tablet 50 mg, box 50 tablets
RESTRICTION
Caution : - Need to check blood leucocyte regularly (agranulocytosis) - Drug of choice in psychotic disorder treatment which already resistent to other antipsychotics.
fluphenazine
tablet 2.5 mg (HCl), bottle 100 tablets i.m. injection 25 mg/ml (decanoate), box 10 vials @ 1 ml tablet 0.5 mg, bottle 100/1000 tablets tablet 1.5 mg, bottle 100/1000 tablets tablet 2 mg, box 100 tablets tablet 5 mg, bottle 100/1000 tablets drops 2 mg/ml, bottle 15 ml/100 ml i.m. injection 2 mg/ml (HCl) box 5 ampoules @ 1 ml i.m. injection 5 mg/ml (HCl) box 5 ampoules @ 1 ml injection 50 mg/ml (as decanoate) box 5 ampoules @ 1 ml (long acting) tablet 1 mg, box 5 stripes @ 10 tablets tablet 2 mg, box 5 stripes @ 10 tablets Note : Second generation antipsychotic
haloperidol
risperidone
23.5. MEDICINES USED for ADHD Authority required : (dl) methylphenidate*) regular release tablet 10 mg, box 30 tablets Need special skill extended release tablet 20 mg, box 30 tablets
Complementary list
55
DOSAGE FORM
RESTRICTION
24. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) and CHOLINESTERASE INHIBITORS 24.1 NEUROMUSCULAR INHIBITORS atracurium injection 25 mg/2,5 ml, ampoule 2.5 ml rocuronium succinylcholine i.v injection 10 mg/ml; vial 5 ml powder i.v./i.m. injection 100 mg/ vial (chloride), box 10 vials Authority required : - Restricted use (only for special cases) - Need special facillities and skill
24.2 MEDICINES USED for MIASTENIA GRAVIS injection 0.5 mg/ml (methyl neostigmine ) sulfate), box 50 ampoules @ 1 ml pyridostigmine tablet 60 mg (bromide), box 10 stripes/blisters @ 10 tablets
25. GASTROINTESTINAL MEDICINES 25.1 ANTACIDS and OTHER ANTIULCER MEDICINES NLEM antacid I chewable tablet, bottle 1000 combination of: tablets aluminium hydroxide 200 mg magnesium hydroxide 200 mg NLEM antacid II combination of : aluminium hydroxide 200 mg/5 ml magnesium hydroxide 200 mg/5 ml suspension, bottle 60 ml
Complementary list
56

ranitidine
DOSAGE FORM
tablet 150 mg, box 3 stripes @10 tablets
RESTRICTION
25.2 ANTIEMETIC MEDICINES chlorpromazine coated tablet 25 mg (HCl), bottle 1000 tablets i.m. injection 25 mg/ml (HCl), box 100 ampoules @ 1 ml i.m injection 5 mg/ml (HCl), box 100 ampoules @ 2 ml tablet 50 mg, bottle 1000 tablets tablet 10 mg (as HCl), bottle 100 tablets injection 5 mg/ml (as HCl), box 10 ampoules @ 2 ml syrup 5 mg/5 ml, bottle 50 ml drops 0.1 mg/drop, bottle 10 ml Note : - Adult dose : - 1 tablet - Use - 1 hour before meals to get better efficacy
dimenhydrinate
metoclopramide
25.3 ANTIHAEMORRHOID MEDICINES NLEM antihaemorrhoid combination of : bismuth subgallate 150 mg hexachlorophene 2.5 mg lidocaine 10 mg zinc oxide 120 mg supp to 2 g suppositoria, box 100 supps
25.4 ANTISPASMODIC MEDICINES atropine tablet 1 mg (sulfate), tin 100 tablets i.m./i.v./s.c. injection 0.25 mg/ml (sulfate), box 100 ampoules @ 1 ml i.m./i.v./s.c. injection 1 mg/ml (sulfate), box 50 ampoules @ 1 ml
57

belladonna extract
DOSAGE FORM
tablet 10 mg, bottle 100/1000 tablets
RESTRICTION
25.5 MEDICINES USED IN DIARRHOEA powder, 100 sacchs, oral rehydration salts each sacch for 200 ml of combination of : sodium chloride 0.52 g water potassium chloride 0.30 g trisodium citrate dihydrate 0.58 g anhydric glucose 2.70 g 25.6 CATARTIC MEDICINES bisacodyl
- Drink slowly to prevent vomitting - 1 sachet to be dissolved in 200 ml of water
suppositoria 5 mg, box 6 suppositoria suppositoria 10 mg, box 6 suppositoria liquid, bottle 100 ml
glycerine
25.7 ANTI-INFLAMMATORY MEDICINES sulfasalazine tablet 500 mg, box 10 stripes @ 10 tablets 26. MEDICINES ACTING ON RESPIRATORY TRACT 26.1 ANTIASTHMATIC aminophylline scored tablet 200 mg, bottle 1000 tablets injection 24 mg/ml, box 100 ampoules @10 ml aerosol 100 mcg/puff, canister 15 ml aerosol 200 mcg/puff, canister 15 ml tablet 0.5 mg, bottle 1000 tablets i.v. injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml
budesonide
dexamethasone
58

ephedrine epinephrine (adrenaline)
DOSAGE FORM
tablet 25 mg (HCl), bottle 1000 tablets injection 0.1 % (as HCl/bitartrate), box 100 ampoules @ 1 ml tablet 2 mg (as sulfate), bottle 100/1000 tablets tablet 4 mg (as sulfate), bottle 100/1000 tablets ih liquid 0.5 % , bottle 10 ml ih/aerosol 100 mcg/dose (as sulfate), tube 200/400 doses injection 50 mcg/ml (as sulfate), box 100 ampoules @ 1 ml respirator liquid for nebulizer 2.5 mg/2.5 ml NaCl, box 4x5 nebules
RESTRICTION
salbutamol
Note : For intermittent inhalation and first accute attack.
26.2 ANTITUSSIVES codeine dextromethorphan
tablet 10 ml (HCl/phosphate), bottle 250 tablets tablet 15 mg (HBr), bottle 1000 tablets syrup 10 mg/5 ml (HBr), bottle 60 ml
26.3 EXPECTORANT glyceryl guaiacolate
syrup 25 mg/5 ml,bottle 60 ml tablet 100 mg, bottle 1000 tablets liquid, bottle 200 ml concentrate liquid, bottle 1000 ml
obat batuk hitam (OBH)
59

27. IMMUNOLOGICALS
DOSAGE FORM
RESTRICTION
27.1 SERA and IMMUNOGLOBULINS antitetanus immunoglobulin (human) antidiphtheria sera (A.D.S) i.m. injection 500 IU, vial i.m. injection 10,000 IU/vial, box 10 vials @ 5 ml i.m. injection 20,000 IU/vial, box 10 vials @ 10 ml i.m. injection 100 IU/ml, box 10 vial @ 20 ml Note : - Storage at 2-8 C Note : - Storage at 2-8 C
antirabies sera
Indication : - For post-exposure treatment in rabies area - Storage at 2-8 C
antitetanus sera (A.T.S)
Note : for prophylaxis : i.m. injection 1500 IU/ampoule, - Storage at 2-8 C box 10 ampoules @ 1 ml for curative treatment : i.m./i.v. injection 10,000 IU/ampoule, box 10 ampoules @ 2 ml i.m./i.v injection 20,000 IU/vial, box 10 vials@ 4 ml injection i.m., box 10 vial @ 10 ml i.m./i.v. injection, box 10 vial @ 5 ml Note : - Storage at 2-8 C Note : - Only for specific area - Storage at 2-8 C.
immunoglobulin sera snake antivenom sera snake antivenom special for snake from outside papua snake antivenom special for papua snake 27.2 VACCINES BCG vaccine
i.c. injection, box 5 ampoules @ 2 ml i.c. injection, box 5 ampoules @ 4 ml
Note : - Storage below 5 C
60

diphtheria, pertusis and tetanus adsorbed vaccine (DPT) hepatitis B vaccine (recombinant) measles vaccine poliomyelitis vaccine rabies vaccine (human)
DOSAGE FORM
i.m injection, box 10 vial @ 5 ml injection 20 mcg/ml, box 1 vial 0.5; 1 ml s.c injection, box 10 vials (10 doses) @ 5 ml drops, box vial 10/20 doses s.k./i.c. powder for injection, box 7 vial @ 1 dose + 7 ampoules solvent @ 2 ml booster : box 5 ampoules @ 1 dose + 5 ampoules solvent @ 4 ml i.m.injection, box 1 vial 5 ml i.m. injection, box 10 vial @ 5 ml
RESTRICTION
Note : - Storage at 2-8 C Note : - Storage at 2-8 C Note : - Storage at 2-8 C Note : - Storage at 2-8 C Indication : - Storage at 2-8 C - Used for pre-exposure and post-exposure treatment in rabies area Note : - Storage at 2-8 C Note : - Storage at 2-8 C
tetanus adsorbed vaccine (tetanus adsorbed toxoid) tetanus and diphteria adsorbed vaccine (TD)
28. MEDICINES USED FOR EAR, NOSE and THROAT carboglycerine ear drops 10 %, bottle 5 ml hydrogen peroxide concentrate liquid, bottle 1000 ml Note : - Storage in glass bottle with glass cap, air tight, save from light - For making dilution until 3%
lidocaine oxymetazoline
spray liquid 4% (HCl), bottle 50 ml nasal drops 0.025% (HCl), bottle 15 ml nasal drops 0.050 % (HCl), bottle 10 ml
61
DOSAGE FORM
RESTRICTION
29. VITAMINS and MINERALS ascorbic acid tablet 50 mg, bottle 1000 tablets calcium gluconate calcium lactate ergocalciferol injection 100 mg/ml, box 24 ampoules @ 10 ml tablet 500 mg, bottle 1000 tablets capsule 50,000 IU, bottle 100 capsules suspension 10.000 IU/ml, bottle 60 ml soft capsule 200 mg, bottle 1500 capsules tablet 100 mg tablet 10 mg (HCl), bottle1000 tablets tablet 25 mg (HCl), bottle 1000 tablets tablet 5000 IU, bottle 1000 tablets soft capsule 50,000 IU, bottle 50 capsules soft capsule 100,000 IU, bottle 50 capsules soft capsule 200,000 IU (as palmitate), bottle 50 capsules tablet 50 mg (HCl), bottle 1000 tablets tablet, bottle 1000 tablets Note : Therapeutic use for hypocalcemia (seldom needed in tropical countries)
iodine nicotinamide pyridoxine
retinol
thiamine vitamin B complex
62
CHAPTER III RESTRICTED MEDICINE LIST FOR PUBLIC HEALTH CENTER 2008
1.1 OPIOID ANALGESICS pethidine
DOSAGE FORM
RESTRICTION
1. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES, MEDICINES USED TO TREAT GOUT injection i.m./s.c./slow released i.v 50 mg/ml (HCl), box 10 ampoules @ 2 ml Authority required : Used only for nursing Public Health Center (PHC)
1.2 NON-OPIOID ANALGESICS acetylsalicylic acid (acetosal) tablet 100 mg, box 10 blisters@10 tablets tablet 500 mg, box 10 blisters@10 tablets ibuprofen tablet 200 mg, bottle 100 tablets tablet 400 mg, bottle 100 tablets tablet 500 mg, bottle 1000 tablets tablet 100 mg, bottle 1000 tablets tablet 500 mg, bottle 1000 tablets syrup 120 mg/5 ml,bottle 60 ml suppositoria 120 mg suppositoria 240 mg tablet 25 mg, box 10 stripes @ 10 tablets tablet 50 mg, box 10 stripes @ 10 tablets Restricted use : To reduce agranulocytosis
methampyrone paracetamol
sodium diclofenac
63

allopurinol
DOSAGE FORM
RESTRICTION
1.3. MEDICINES USED TO TREAT GOUT tablet 100 mg, bottle 100/1000 tablets Note : - Blocks uric acid production (in 35% of cases) - Not for acute attack Note : - Increases uric acid renal excretion (in 35% patients) - Dosage 2 X tablet, increase water intake - Not for acute attack
probenecid
tablet 500 mg, bottle 100/1000 tablets
2. ANESTHETICS 2.1 LOCAL ANESTHETICS ethyl chloride lidocaine spray, bottle 100 ml infiltr injection 1% (HCl), box 100 amps @ 2 ml p.v. injection 2% (HCl), box 100 ampoules @ 2ml gel 2%, tube 10 g spray 4%, bottle 50 ml Note : Air tight package
2.2 GENERAL ANESTHETICS and OXYGEN ketamine i.v. injection 10 mg/ml (as HCl), box 10 vial @ 20 ml i.v. injection 50 mg/ml (as HCl), box 10 vial @ 20 ml inhalation, gas in tube i.v. powder for injection 500 mg/ampoule (as sodium salt) (for dissolved in 20 ml WFI), box 25 ampoules Authority required : Used only for nursing PHC Authority required : Used only for nursing PHC
oxygen thiopental
2.3 MEDICINES USED FOR PREOPERATIVE MEDICATION PROCEDURES atropine

injection 1 mg/ml (sulfate), box 50 ampoules @ 1 ml
64

diazepam
DOSAGE FORM
tablet 5 mg, bottle 1000 tablet injection 5 mg/ml, box 100 ampoules @ 2 ml i.m./s.k./i.v. injection 10 mg/ml (HCl/sulfate), box 10 ampoules @ 1 ml
RESTRICTION
morphine
3. ANTIALLERGICS and MEDICINES USED IN ANAPHYLAXIS chlorpheniramine tablet 4 mg ( maleate), bottle1000 tablets injection 5 mg/ml (maleate), box 100 ampoules @ 1 ml injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml i.m. injection 10 mg/ml (HCl), box 100 ampoules @ 1 ml s.c./i.m. injection 0,1% (HCl/bitartrate), box 100 ampoules @ 1 ml Note : - Drug of choice for anaphylactic reaction - Dosage 0,3 mg 0,5 mg i.m. may be repeated
dexamethasone
diphenhydramine epinephrine (adrenaline)
4. ANTIDOTES and OTHER SUBSTANCES USED IN POISONING 4.1 SPECIFIC atropine i.m./i.v./s.c injection 1 mg/ml (sulfate), box 10 ampoules @ 2 ml Restricted use : - Caution on package: only for antidotes (large dose) - Used only for nursing PHC
calcium folinic (leucovorin, Ca) tablet 1 mg, bottle 100 tablets sodium bicarbonate sodium thiosulfate tablet 500 mg, bottle 1000 tablets i.v. injection 25%, box 10 ampoules @ 10 ml
65

4.2 NON-SPESIFIC active carbon magnesium sulfate
DOSAGE FORM
activated powder, sacch 0,5 kg powder, sacch 30 g
RESTRICTION
5. ANTIEPILEPTICS ANTICONVULSANTS diazepam i.m./i.v. injection 5 mg/ml, box 100 ampoules @ 2 ml rectal sol 4 mg/ml, tube 2,5 ml phenobarbital tablet 30 mg, bottle 1000 tablets tablet 50 mg, bottle 1000 tablets tablet 100 mg, bottle 1000 tablets i.m injection 50 mg/ml, box 100 ampoules @ 2 ml i.v.injection 50 mg/ml (as sodium salt), box 100 ampoules @ 2 ml capsule 30 mg (as sodium salt), bottle 250 capsules capsule 100 mg (as sodium salt), bottle 250 capsules injection 50 mg/ml (as sodium salt), box 10 ampoules @ 2 ml Restricted used : Specific for continued treatment for patient who referred back to PHC
phenytoin
6. ANTI-INFECTIVE MEDICINES 6.1 ANTHELMINTHICS 6.1.1 Intestinal Anthelminthics mebendazole tablet 100 mg, bottle 100 tablets syrup 100 mg/5 ml, bottle 30 ml pyrantel scored tablet 250 mg (pamoate), bottle 250 tablets suspension 125 mg/5 ml (pamoate), bottle 30 ml
66

6.1.2 Antifilarials diethylcarbamazine
DOSAGE FORM
RESTRICTION
scored tablet 100 mg (citrate), bottle 1000 tablets
Note : For endemic area
6.2 ANTIBACTERIALS 6.2.1 Beta lactam medicines amoxicillin trihydrate scored tablet 500 mg, box 10 stripes @ 10 tablets dry syrup 125 mg/5 ml, bottle 60 ml i.m./i.v. powder for injection 250 mg/vial (as sodium salt), box 10 vials i.m./i.v. powder for injection 500 mg/vial (as sodium salt), box 10 vials i.m. injection 1,2 millions IU/ml, box 25 vials @ 4 ml i.m. injection 2.4 millions IU/ml, box 25 vials @ 10 ml i.m./i.v. injection 10 millions IU/vial, box 25 vials tablet 500 mg (as potassium salt), bottle 1000 tablets tablet 250 mg (as potassium salt), box 10 stripes @ 10 tablets dry syrup 250 mg/5 ml (as potassium salt), bottle 60 ml powder for injection i.m. 3 millions IU/vial, box 100 vials powder for injection i.m. 1 million IU/vial, box 100 vials Restricted used : Not used for severe infection
ampicillin
benzathine benzylpenicillin
benzylpenicillin crystal phenoxymethylpenicillin (penicillin V)
procaine benzylpenicillin
67

6.2.2 Other antibacterials 6.2.2.1 Tetracycline oxytetracycline
DOSAGE FORM
RESTRICTION
i.v. injection 250 mg/3 ml (HCl), box 10 ampoules @ 3 ml i.v. injection 50 mg/ml (HCl), box 10 vials @ 10 ml capsule 250 mg (HCl), bottle 1000 capsules capsule 500 mg (HCl), box 10 stripes @ 10 capsules
tetracycline
6.2.2.2 Chloramphenicol chloramphenicol
capsule 250 mg, bottle 1000 capsules suspension 125 mg/5 ml (as palmitate), bottle 60 ml
6.2.2.3 Sulfa-Trimethoprim NLEM co-trimoxazole I (adult) combination of : sulfamethoxazole 400 mg trimethoprim 80 mg NLEM co-trimoxazole II (paediatric) combination of: sulfamethoxazole 100 mg trimethoprim 20 mg sulfadiazine trimethoprim 6.2.2.4 Macrolides erythromycin tablet, box 10 stripes @ 10 tablets
tablet, bottle 100 tablets
tablet 500 mg, bottle100 tablets scored tablet 200 mg, bottle 100 tablets capsule 250 mg (as stearate), bottle 100 capsules syrup 200 mg/5 ml (as ethyl succinate), bottle 60 ml
68

6.2.2.7 Specific Use metronidazole
DOSAGE FORM
RESTRICTION
tablet 250 mg, bottle 100/1000 tabs tablet 500 mg, bottle 100/1000 tabs
6.3 SPECIFIC ANTI-INFECTIVE MEDICINES 6.3.1 Antileprosy medicines clofazimine, micronized dapsone oily capsule 100 mg, bottle 100 capsules scored tablet 100 mg, bottle 1000 tablets
6.3.2 Antituberculosis medicines ethambutol tablet 250 mg (HCl), bottle 100 tablets tablet 500 mg (HCl), bottle 100 tablets tablet 100 mg, bottle 1000 tablets tablet 300 mg, bottle 1000 tablets tablet 500 mg, bottle 100 tablets scored tablet 300 mg, box 10 stripes @10 tablets tablet 450 mg, box 10 stripes @10 tablets tablet 600 mg, box 10 stripes @10 tablets powder for injection 1000 mg/vial (as sulfate), box 100 vials Restricted use : Only for tuberculosis and leprosy
isoniazid
pyrazinamide rifampicin
streptomycin
Note : Special packaging
69

combination of : rifampicin isoniazid combination of : rifampicin isoniazid ethambutol combination of : rifampicin isoniazid pyrazinamide combination of : rifampicin isoniazid pyrazinamide ethambutol
DOSAGE FORM
caplet 150 mg; 75 mg tablet 150 mg; 50 mg
RESTRICTION
Note : Dosage form and usage according to National Tuberculosis Program Note : Dosage form and usage according to National tuberculosis program. Note : Dosage form and usage according to National tuberculosis program. Note : Dosage form and usage according to National tuberculosis program.
capl 150 mg tablet 150 mg tablet 400 mg capl 150 mg; 75 mg;450 mg tablet 75 mg; 50 mg; 300 mg tablet 400 mg; 150 mg; 500mg capl 150 mg; 450 mg tablet 75 mg; 300 mg tablet 400 mg; 500 mg tablet 275 mg; 250 mg; 500mg
6.3.3 Urinary Antiseptics NLEM co-trimoxazole I (adult) combination : sulfamethoxazole 400 mg trimethoprim 80 mg nitrofurantoine trimethoprim tablet, box 10 stripes @ 10 tablets
scored tablet 100 mg, bottle 100 tablets scored tablet 200 mg, bottle 100 tablets
6.4 ANTIFUNGAL MEDICINES 6.4.1 Systemic griseofulvin, micronized nystatin scored tablet 250 mg, bottle 100 scored tablets coated tablet 500,000 IU/tablet, bottle 100/1000 tablets suspension 100,000 IU/ml, bottle 12 ml
70

6.4.2. Topical NLEM antifungal medicines combination of: benzoic acid 6% salicylic acid 3% nystatin
DOSAGE FORM
RESTRICTION
ointment, pot 30 g
vaginal tablet 100,000 IU/tablet, box 10 stripes @ 10 tablets
6.5 ANTIPROTOZOAL MEDICINES 6.5.1 Antiamoebic and antigiardiasis medicines metronidazole tablet 250 mg, bottle 100 tablets tablet 500 mg, bottle 100 tablets
6.5.2 Antimalarial medicines 6.5.2.1 For prophylaxis chloroquine tablet 150 mg(as phosphate), bottle 1000 tablets
6.5.2.2 For curative treatment NLEM antimalarial medicines combination of : pyrimethamine 25 mg sulfadoxine 500 mg tablet, bottle 500 tablets Restricted use : For specific area which already resistent to chloroquine (decided by District/Municipality Health Offices)
artemether artesunate
injection 80 mg/ml, box 6 ampoules @ 1 ml injection i.v./i.m. 60 mg/ml, box 8 vials @ 1 ml
71

combination of : artesunate 50 mg amodiaquin 200 mg chloroquine
DOSAGE FORM
tablet, box 2 blisters @ 12 tablets (combipack) box 3 blisters @ 8 tablets tablet 150 mg(as phosphate), bottle 1000 tablets syrup 50 mg/5ml, bottle 60 ml tablet 15 mg (as phosphate), bottle 1000 tablets tablet 222 mg (bisulfate), bottle 1000 tablets i.v. injection 25% (as HCl), box 100 ampoules @ 2 ml
RESTRICTION
primaquine quinine
Restricted use : - Only for severe malaria - Used only for nursing PHC
7. ANTIMIGRAINE MEDICINES 7.1 FOR PROPHYLAXIS dihydroergotamine tablet 2.5 mg (as mesilate), box 10 stripes@ 10 tablets
7.2 FOR TREATMENT OF ACUTE ATTACK ergotamine tablet 1 mg (tartrate), bottle 100 tablets combination of : ergotamine 1 mg caffeine 50 mg tablet, box 30/100 tablets
9. ANTIPARKINSONISM MEDICINES NLEM antiparkinsonism tablet, bottle 100 tablets medicines combination of : benserazide 25 mg levodopa 100 mg trihexyphenidyl tablet 2 mg (HCl), bottle 250 tablets
Authority required : Parkinsonism diagnostic has to be ensured
Authority required : Parkinsonism diagnostic has to be ensured
72

10.1 ANTIANAEMIA MEDICINES cyanocobalamine (vitamin B12) fe (II) sulfate 7 H20
DOSAGE FORM
RESTRICTION
10. MEDICINES AFFECTING THE BLOOD
injection 500 mcg/ml, box 100 ampoules @ 1 ml coated tablet 300 mg, bottle 1000 tablets syrup, bottle 60 ml drops, bottle tablet 1 mg, bottle 1000 tablets tablet 5 mg, bottle 1000 tablets
folic acid
10.2 MEDICINES AFFECTING COAGULATION phytomenadione (vitamin K1) coated tablet 10 mg, bottle 1000 tablets injection 10 mg/ml, box 100 ampoules @ 1 ml i.m injection 2 mg/ml, ampoule 1 ml
Dose : - New born baby dose 1 mg - Premature baby dose 0,5 mg
12. DIAGNOSTIC AGENTS 12.2 FUNCTION TEST 12.2.3 Miscellaneous fluorescein eye drops 1% (sodium salt), bottle 5 ml eye drops 2% (sodium salt), bottle 5 ml injection 10%, box 1 ampoule @ 5 ml injection 20%, box 1 ampoule @ 5 ml i.c. injection 1:10, box 1 vial 2 ml
12.3 SKIN TEST tuberculin protein (purified derivative)

73

13.1 ANTISEPTICS hydrogen peroxyde
DOSAGE FORM
RESTRICTION
13. ANTISEPTICS dan DISINFECTANTS concentrate solution, bottle 1000 ml Storage : - Storage in glass bottle with glass cap, air tight, saved from light - For diluted until 3%
povidone-iodine 13.2 DISINFECTANTS calcium hypochlorite ethanol 70% paraformaldehyde saponificated cresol 50% (lysol)
sol 10%, bottle 1000 ml
powder, sacch 20 g sol, bottle 100 ml /1000 ml tablet 1 g, bottle 100 tablets sol 5%, bottle 1000 ml liquid, bottle 1000 ml
Samijaga program
14. MEDICINES and DENTAL MATERIAL USED FOR ORAL HEALTH 14.1 MEDICINES USED FOR DENTAL and ORAL HEALTH, NLEM dental anesthetics combination of: lidocaine HCl 2% epinephrine 1 : 80,000 calcium hydroxide chlorphenol camphor menthol ethyl chloride eugenol fluorine injection, box 20/50/100 ampoules @ 2 ml
paste, box 2 tubes liquid, bottle 10 ml spray 0,05-0,2 ml, bottle 100 ml liquid, bottle 10 ml tablet 0,5 mg, bottle 100 tablets Authority required : For PHC in specific area Note : Air tight package
74

lidocaine
DOSAGE FORM
injection 2% (HCl), box 100 ampoules @ 2 ml paste 5% (HCl), tube 10 g spray 15% (HCl), bottle 60 ml suspension 100.000 UI/ml, bottle 12 ml
RESTRICTION
nystatin
14.2 DENTAL MATERIAL USED FOR ORAL HEALTH gelatin sponge cubicles 1x1x1 cm, tin 50 pcs glass ionomer ART (Atraumatic Restorative Treatment) gutta percha points resin composite root canal filling temporary filling 15. DIURETICS furosemide powder bottle10 g sol, bottle 6 g (4,8 ml) cocoa butter 5 g box 120 sticks set paste, bottle sol and powder, bottle 100 g
tablet 40 mg, bottle 250 tablets i.v./i.m. injection 10 mg/ml, box 25 ampoules @ 2 ml
16. HORMONES, OTHER ENDOCRINE MEDICINES and CONTRACEPTIVES 16.2 ANTIDIABETIC 16.2.1 Oral Antidiabetic glibenclamide tablet 2,5 mg, bottle 100 tablets tablet 5 mg, bottle 100 tablets tablet 500 mg, bottle 100 tablets
metformin
75

16.3.4 Contraceptives
DOSAGE FORM
RESTRICTION
16.3 SEX HORMONE and FERTILITY RELATED MEDICINES Note : According to National Family Planning Program coordinated by BKKBN
16.3.4.1 Oral Hormonal Contraceptives combination : levonorgestrel ethinylestradiol pill 150 mcg 30 mcg
16.3.4.2 Injectable Hormonal Contraceptives medroxyprogesterone acetate depot injection 150 mg
16.3.4.3 Intra-uterine Devices Copper - containing device set / pcs 16.4 THYROID and ANTITHYROID HORMONES lugol solution bottle 30 ml propylthiouracyl scored tablet 100 mg, bottle 1000 tablets
Note : Dilute before use
16.5 CORTICOSTEROID HORMONES dexamethasone tablet 0,5 mg, bottle 1000 tablets injection 5 mg/ml (as sodium phosphate), box 100 ampoule @ 1 ml tablet 10 mg powder for injection 100 mg/vial (sodium succinate), box 100 vial @ 2 ml tablet 5 mg, bottle 1000 tablets Note : Second line used after dexamethasone
hydrocortisone
prednisone
76

17.1 ANTI-ANGINAL MEDICINES atenolol isosorbide dinitrate
DOSAGE FORM
RESTRICTION
17. CARDIOVASCULAR MEDICINES tablet 50 mg, box 10 stripes @ 10 tablets sublingual tablet 5 mg, bottle 60 tablets
17.2 ANTIARRHYTHMIC MEDICINES propranolol tablet 10 mg (HCl), bottle 100 tablets i.v. injection 1 mg/ml (HCl), box 10 ampoules @ 1ml 17.3 ANTIHYPERTENSIVE MEDICINES captopril scored tablet 12.5 mg, box 10 stripes @ 6 tablets scored tablet 25 mg, box 10 stripes @ 6 or 10 tablets tablet 25 mg, bottle 100 tablets Caution : - Not for pregnant women - Having cough side effect
hydrochlorothiazide
17.4 PLATELET ANTIAGGREGATION acetylsalicylic acid (acetosal) tablet 80 mg, box 10 blisters @ 10 tablets
17.6 MEDICINES USED IN HEART FAILURE captopril scored tablet 12.5 mg, box 10 stripes @ 10 scored tablets scored tablet 25 mg, box 10 stripes @ 10 scored tablets tablet 0.0625 mg, bottle 100 tablets tablet 0.25 mg, bottle 100 or 1000 tablets injection 0.25 mg/ml, box 1 ampoule @ 2 ml Caution : - Not for pregnant women - Having cough side effect Pediatric dose : Tablet 0,0625 mg for pediatrics
digoxin
77

furosemide
DOSAGE FORM
tablet 40 mg, box 20 stripes @ 10 tablets injection i.v./i.m. 10 mg/ml, box 25 ampoules @ 2 ml
RESTRICTION
17.7 MEDICINES USED for SHOCK ATTACK, 17.7.1 Medicines used for cardiogenic shock epinephrine (adrenaline) injection i.v. 0,1 % (as HCl/ bitartrate), box 100 ampoules @ 1 ml
17.8 LIPID-LOWERING AGENTS simvastatin scored tablet 10 mg, box 30 scored tablets
18. DERMATOLOGICAL MEDICINES 18.2 ANTI-INFECTIVE MEDICINES NLEM anti-infective medicines combination of : bacitracin 500 IU/g polymixin B 10,000 IU/g ointment, tube 5 g
18.3 ANTIFUNGAL MEDICINES NLEM antifungal medicines combination of : benzoic acid 6% salicylic acid 3% sodium thiosulfate ointment, pot 30 g Note : General antifungal ointment
liquid 25%, bottle 30 ml
18.4 ANTI-INFLAMMATORY and ANTIPRURITIC MEDICINES betamethasone ointment 0.1% (as valerate), tube 5 g cream 0.1% (as valerate), tube 5 g cream 2.5% (acetate), tube 5 g
hydrocortisone
78

2-4 ointment, combination of : salicylic acid 2% sulfur precipitate 4 % 18.6 CAUSTIC MEDICINES silver nitrate
DOSAGE FORM
RESTRICTION
18.5 SCABICIDES and PEDICULICIDES ointment, pot 30 g
sol 20%, bottle 10 ml
Note : For hypergranulation
18.7 MEDICINES AFFECTING SKIN DIFFERENTIATION and PROLIFERATION coal tar podophyllum resin sol 5 %, bottle 100 ml alcoholic sol 25 %, bottle 30 ml Authority required : - Should be applicated by practitioners - Should be cleaned 1-4 hours after used, make sure that no residues - Only for severe thickening, causing danger of absorptions - Not for pregnant women because of terratogenic effect - Not for use by patients - Not for take away home
salicylic acid
ointment 2%, pot 30 g ointment 5%, pot 30 g ointment 10%, pot 30 g
18.8 MISCELLANEOUS liquor carbonis detergents liquor faberi salicyl powder
suspension 2%, bottle 30 ml suspension 5%, bottle 30 ml liquid powder 2%, box 100 g
79

20.1 ORAL oral rehydration salts combination of : sodium chloride potassium chloride trisodium citrate dihydrate anhydric glucose sodium bicarbonate 20.2 PARENTERAL glucose
DOSAGE FORM
RESTRICTION
20. ELECTROLYTE, NUTRITION SOLUTIONS, and OTHERS powder, 100 sacch each sacch for 200 ml water - Drink slowly to prevent vomiting - 1 sacchet to be dissolved in 200 ml water
0.52 g 0.30 g 0.58 g 2.70 g
tablet 500 mg, bottle 1000 tablets infusion sol 5%, bottle 500 ml infusion sol 10%, bottle 500 ml infusion sol 40%, bottle 25 ml infusion sol, bottle 500 ml infusion sol 0.9%, bottle 500 ml infusion sol 3%, bottle 500 ml injection 15%, vial 50 ml Note : - Need to check sodium level - Used only for nursing PHC
ringer lactate sodium chloride
20.3 MISCELLANEOUS water for injections
box, ampoule/vial @ 10 ml/20 ml
21. OPHTHALMOLOGICAL PREPARATION 21.1. LOCAL ANESTHETICS tetracaine eye drops 0.5% (HCl), bottle 5 ml 21.2 ANTI-INFECTIVE AGENTS oxytetracycline sulfacetamide
eye ointment 1% (HCl), tube 3.5 g eye drops 15% (sodium), bottle 5 ml
80

21.4 MYDRIATICS atropine
DOSAGE FORM
RESTRICTION
eye drops 0.5% (sulfate), bottle 5 ml eye drops 1% (sulfate), bottle 5 ml
21.5 MIOTICS and ANTIGLAUCOMA MEDICINES pilocarpine eye drops 2% (HCl/nitrate), bottle 5 ml eye drops 4% (HCl/nitrate), bottle 5 ml 22. OXYTOCICS and UTERIC RELAXANTS 22.1 OXYTOCICS methyl ergometrine coated tablet 0.125 mg (maleate), bottle 100 tablets injection 0.200 mg/ml, box 100 ampoules @ 1 ml injection 10 IU/ml, box 100 ampoules @ 1 ml
oxytocin
23. PSYCHOTHERAPEUTIC MEDICINES 23.1 MEDICINES USED in GENERALIZED ANXIETY and SLEEP DISORDERS diazepam tablet 2 mg, bottle 1000 tablets tablet 5 mg, bottle 1000 tablets i.m. injection 5 mg/ml, box 100 ampoules @ 2 ml
23.2 MEDICINES USED in DEPRESSIVE DISORDERS amitriptyline coated tablet 25 mg (HCl), box 10 blisters@10 tablets 23.3 MEDICINES USED for OBSESSIVE COMPULSIVE DISORDERS clomipramine tablet 25 mg (HCl), bottle 1000 tablets
81
DOSAGE FORM
RESTRICTION
23.4 MEDICINES USED in PSYCHOTIC DISORDERS chlorpromazine coated tablet 25 mg (HCl), bottle 1000 tablets coated tablet 100 mg (HCl), bottle 1000 tablets i.m. injection 25 mg/ml (HCl), box 100 ampoules @ 1 ml haloperidol tablet 0.5 mg, bottle 100/1000 tablets tablet 1.5 mg, bottle 100/1000 tablets tablet 2 mg, box 100 tablets tablet 5 mg, bottle 100/1000 tablets drops 2 mg/ml, bottle 15 ml/100 ml i.m. injection 2 mg/ml (HCl), box 5 ampoules @ 1 ml i.m. injection 5 mg/ml (HCl), box 5 ampoules @ 1 ml injection 50 mg/ml (as decanoate), box 5 ampoules @ 1 ml (long acting) Note : - Second generation antipsychotic - Specific for PHC which integrated to mental health care
25. GASTROINTESTINAL MEDICINES 25.1 ANTACIDS and OTHER ANTIULCER MEDICINES chewable tablet, NLEM antacid I combination of: bottle 1000 tablets aluminium hydroxide 200 mg magnesium hydroxide 200 mg NLEM antacid II combination of : aluminium hydroxide 200 mg/5 ml magnesium hydroxide 200 mg/5 ml suspension, bottle 60 ml
82

25.2 ANTIEMETIC MEDICINES chlorpromazine
DOSAGE FORM
RESTRICTION
coated tablet 25 mg (HCl), bottle 1000 tablets i.m. injection 25 mg/ml (HCl), box 100 ampoules @ 1 ml i.m injection 5 mg/ml (HCl), box 100 ampoules @ 2 ml tablet 50 mg, bottle 1000 tablets Note : - Adult dose : - 1 tablet - Use - 1 hour before meals to get better efficacy
dimenhydrinate
25.3 ANTIHAEMORRHOID MEDICINES suppositoria, box 100 supp NLEM antihaemorrhoid combination of : bismuth subgallate 150 mg hexachlorophene 2.5mg lidocaine 10 mg zinc oxide 120 mg supp to 2 g 25.4 ANTISPASMODIC MEDICINES atropine tablet 1 mg (sulfate), tin 100 tablets i.m./i.v./s.c. injection 0.25 mg/ml (sulfate), box 100 ampoules @ 1 ml i.m./i.v./s.c. injection 1 mg/ml (sulfate), box 50 ampoules @ 1 ml belladonna extract tablet 10 mg, bottle 100/1000 tablets
25.5 MEDICINES USED IN DIARRHOEA powder, 100 sacchs, oral rehydration salts each sacch for 200 ml of combination of : water sodium chloride 0.52 g potassium chloride 0.30 g trisodium citrate dihydrate 0.58 g anhydric glucose 2.70 g
- Drink slowly to prevent vomiting - 1 sachet to be dissolved in 200 ml of water
83

25.6 CATARTIC MEDICINES glycerine
DOSAGE FORM
RESTRICTION
liquid, bottle 100 ml
26. MEDICINES ACTING ON RESPIRATORY TRACT 26.1 ANTIASTHMATIC dexamethasone tablet 0.5 mg, bottle 1000 tablets i.v. injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml tablet 25 mg (HCl), bottle 1000 tablets injection 0.1 % (as HCl/bitartrate), box 100 ampoules @ 1 ml tablet 2 mg (as sulfate), bottle 100/1000 tablets tablet 4 mg (as sulfate), bottle 100/1000 tablets
ephedrine epinephrine (adrenaline)
salbutamol
26.2 ANTITUSSIVES codeine dextromethorphan
tablet 10 mg (HCl/phosphate), bottle 250 tablets tablet 15 mg (HBr), bottle 1000 tablets syrup 10 mg/5 ml (HBr), bottle 60 ml
26.3 EXPECTORANT glyceryl guaiacolate
syrup 25 mg/5 ml,bottle 60 ml tablet 100 mg, bottle 1000 tablets liquid, bottle 200 ml concentrate liquid, bottle 1000 ml
obat batuk hitam (OBH)
84

27. IMMUNOLOGICALS
DOSAGE FORM
RESTRICTION
27.1 SERA and IMMUNOGLOBULINS antidiphtheria sera (A.D.S) i.m. injection 10,000 IU/vial, box 10 vials @ 5 ml i.m. injection 20.000 IU/vial, box 10 vials @ 10 ml i.m. injection 100 IU/ml, box 10 vial @ 20 ml Note : - Storage at 2-8 C
antirabies sera
Indication : - For post-exposure treatment in rabies area - Storage at 2-8 C Note : - Storage at 2-8 C
antitetanus sera (A.T.S)
for prophylaxis : i.m. injection 1500 IU/ampoule box 10 ampoules @ 1 ml for curative treatment : i.m./i.v. injection 10,000 IU/ampoule, box 10 ampoules @ 2 ml i.m./i.v injection 20,000 IU/vial, box 10 vials@ 4 ml i.m./i.v. injection, box 10 vial @ 5 ml
snake antivenom sera snake antivenom special for snake from outside papua snake antivenom special for papua snake 27.2 VACCINES BCG vaccine
Note : - Only for specific area - Storage at 2-8 C.
i.c. injection, box 5 ampoules @ 2 ml i.c. injection, box 5 ampoules @ 4 ml i.m injection, box 10 vial @ 5 ml injection 20 mcg/ml, box 1 vial 0.5; 1 ml
Note : - Storage below 5 C
diphtheria, pertusis and tetanus adsorbed vaccine (DPT) hepatitis B vaccine (recombinant)
Note : - Storage at 2-8 C Note : - Storage at 2-8 C
85

measles vaccine poliomyelitis vaccine rabies vaccine (human)
DOSAGE FORM
s.c. injection, box 10 vials (10 doses) @ 5 ml drops, box vial 10/20 doses s.c./i.c. powder for injection, box 7 vial @ 1 dose + 7 ampoules solvent @ 2 ml booster : box 5 ampoules @ 1 dose + 5 ampoules solvent @ 4 ml i.m. injection, box 1 vial 5 ml i.m. injection, box 10 vial @ 5 ml
RESTRICTION
Note : - Storage at 2-8 C Note : - Storage at 2-8 C Indication : - Storage at 2-8 C - Use for pre-exposure and post-exposure treatment in rabies area Note : - Storage at 2-8 C Note : - Storage at 2-8 C
tetanus adsorbed vaccine (tetanus adsorbed toxoid) tetanus and diphteria adsorbed vaccine (TD)
28. MEDICINES USED FOR EAR, NOSE and THROAT carboglycerine ear drops 10 %, bottle 5 ml 29. VITAMINS and MINERALS ascorbic acid tablet 50 mg, bottle 1000 tablets calcium lactate pyridoxine tablet 500 mg, bottle 1000 tablets tablet 10 mg (HCl), bottle1000 tablets tablet 25 mg (HCl), bottle 1000 tablets tablet 5000 IU, bottle 1000 tablets soft capsule 50,000 IU, bottle 50 capsules soft capsule 100,000 IU, bottle 50 capsules soft capsule 200,000 IU (as palmitate), bottle 50 capsules
retinol
86

thiamine vitamin B complex
DOSAGE FORM
tablet 50 mg (HCl), bottle 1000 tablets tablet, bottle 1000 tablets
RESTRICTION
Minister of Health
Dr. dr. SITI FADILAH SUPARI, SpJP (K)
87
CHANGES OF NLEM 2005

ADDITION (+), DELETION (-), CHANGE OF DOSAGE FORM
Moved to other therapeutic subclass
NO
GENERIC NAME (INN)

acetazolamide
DOSAGE FORM
tablet 250 mg, bottle 100 tablets i.m/i.v. powder for injection, 500 mg/vial (as sodium salt), box 10 vials + 10 ampoules water for injection @ 5 ml activated powder, sacch 0.5 kg tablet 0.25 mg, box 10 stripes @ 10 tablets tablet 0.5 mg, box 10 stripes @ 10 tablets tablet 5 mg (HCl), bottle 100 tablets tablet 200 mg, box 30 tablets injection 150 mg/3 ml, box 6 ampoules @ 3 ml i.v injection vial 50 mg/10 ml, vials @ 10 ml
2 3
active carbon alprazolam
Change of generic name
4 5
amiloride amiodarone
6 7 8 9 10
amphotericin *)
+ + + +
antitetanus i.m. injection 500 UI, vial immunoglobulin (human) artesunate atracurium benzoil peroxyde i.v/i.m injection 60 mg/ml, box 8 vials @ 1 ml injection 25 mg/2,5 ml, ampoule 2,5 ml gel 2.5%, tube 5 g gel 5%, tube 5 g
National List of Essential Medicine 2008
88 88
NO
GENERIC NAME (INN)

benzylpenicilin betamethasone bupivacaine carbamazepine cefazolin ceftriaxone chlorambucyl chloramphenicol chlorhexidine chlorhexidine chlormethine clomiphen clomipramine clozapine )
DOSAGE FORM

+ + + + + + +
11 12 13 14 15 16 17 18 19 20 21 22 23 24
eye ointment 1.000 IU/g, tube 5 g eye drop 1 mg/ml (sodium), bottle 5 ml infiltrate injection 0.25% (HCl), box 5 vial @ 20 ml chewable tablet 100 mg syrup 100 mg/5 ml, bottle 120 ml powder for injection 1 g / vial, box 2 vials powder injection 1 g / vial, box 2 vials tablet 2 mg ear drop 3 %, bottle 5 ml sol 1.5 % (gluconate), bottle 2.5 l sol 4.0 % (gluconate), bottle 2.5 l sol 5.0% (gluconate), bottle 2.5 l powder injection 10 mg/vial (HCl), box 1 vial tablet 50 mg (citrate), bottle 10 tablets tablet 10 mg (HCl), bottle 250 tablets tablet 25 mg, box 50 tablets tablet 50 mg, box 50 tablets
Complementary list
89 89
NO
GENERIC NAME (INN)

codeine
DOSAGE FORM

Change of dosage strength and packaging +
25
tablet 10 mg (phosphate), bottle 250 tablet tablet 500 mcg, box 3 stripes @ 10 tablets tablet, box 30/100 tablets 1 mg 50 mg capsule
26 27
colchicine combination of: ergotamine caffeine
28
combination of: extr. apii herba 92 mg extr. ortosiphonis folium 28 mg compound thymi syrup copper containing device daunorubicin desmopressin devitalization paste (non arsen) dextran 70 dextrose diethylcarbamazine digoxin
29 30 31 32 33 34 35 36 37
liquid, bottle 100 ml set / pcs powder injection 20 mg/vial (HCl), box 1 vial @ 4 ml spray paste, bottle Infus sol 6%, bottle 500 ml infusion solution 5 %, bottle 500 ml scored tablet 100 mg (citrate), bottle 1000 tablet tablet 0.0625 mg, bottle 100 tablets tablet 0.25 mg, bottle 100 tablets injection 0.25 mg/ml; box 1 ampoule 2 ml
+ + Change of dosage form + Change of dosage strength +
90 90
NO
GENERIC NAME (INN)

diloxanide disodium edetate dobutamine
DOSAGE FORM

+ +
38 39 40
tablet 500 mg (furoate) eye drop 0.35%, bottle 5 ml injection 50 mg/ml, vial 5 ml injection 25 mg/ml, ampoule 10 ml injection i.v. 10 mg/ml (chloride), box 10 vial @ 10 ml tablet 200 mg, bottle 90 tablets tablet 600 mg, bottle 30 tablets inhalation liquid, bottle 250 ml solutio 0.1 %, bottle 300 ml powder, bottle 100 g capsule 250 mg, bottle 100/1000 capsules syrup 250 mg/5 ml, bottle 60 ml i.a./i.v. injection 1 ml consist of 0,96 ml (equivalent with 0.48 g iodine), box 1 ampoule 10 ml implant 1 rods (3 yrs) syrup, bottle 60 ml i.m./i.v. injection 0.05 mg/ml (citrate), box 5 ampoules @ 2 ml capsule/tablet 10 mg, box 30 tablets capsule/tablet 20 mg, box 30 tablets
41 42
edrofonium efavirenz
Change of therapeutic sub-class and dosage form
43 44 45
enflurane etacridine (rivanol) ethosuccimide
46
ethyl ester from oleum iodized papaveris (iodized oil) etonogestrel fe (II) sulfate 7H2O fentanyl
47 48 49
+ Change of packaging +
50
fluoxetine
91 91
NO
GENERIC NAME (INN)

framicetin gamexan gelatin spons gentian violet haloperidol
DOSAGE FORM

Change of salt form
51 52 53 54 55
sterile kassa 1% (sulfate), box 10 pieces cream 1%, bottle 30 ml layer 5 x 7 x 1 cm sol 1%, bottle 10 ml i.m. injection 2 mg/ml (HCl) box 5 ampoules @ 1 ml i.m. injection 5 mg/ml (HCl) box 5 ampoules @ 1 ml tablet 25 mg, bottle 1000 tablets tablet 10 mg cream 1% (acetate), tube 5 g eye drop 1%, bottle 5 ml injection 40 IU/ml, box 1 vial 10 ml injection 480 mg/ml, box 1 ampoule 10 ml paste inhalation liquid, bottle 250 ml injection 1mg/ml (HCl), box 1 ampoule 2 ml suppositoria 100 mg tablet 50 mg (HCl), box 4 bls @ 9 tablets
56 57 58 59 60 61 62 63 64 65 66
hydrochlorothiazide hydrocortisone hydrocortisone hydrocortisone acetate intermediate insulin iodine iodoform paste isoflurane isoprenaline ketoprofen levamisole
+ + + +
92 92
NO
GENERIC NAME (INN)

levertrane levonorgestrel levonorgestrel lidocaine lidocaine
DOSAGE FORM

+
67 68 69 70 71
ointment 5% pill 75 mcg, 150 mcg implant 6 rods (5 yrs) injection 5% + glucose 7.5 %, ampoule 2 ml injection 1% (HCl) + epinephrine 1 : 200,000, box 10 vials @ 30 ml injection 2% (HCl) + epinephrine 1 : 200,000, box 10 vials @ 20 ml liquor with menthol 0,1% liquor with menthol 0,5% solution
72 73
liquor faberi liquor veilli (salicylic acid solution 0.1 %) combination of : salicylic acid 0.1 % boric acid 0.5 % glycerine 10 % lisinopril
74
tablet 5 mg, box 3 stripes @ 10 tablets tablet 10 mg, box 3 stripes @ 10 tablets tablet 20 mg, box 3 stripes @ 10 tablets tablet 200 mg, box 10 stripes @ 10 tablets tablet liquid, packaging as needed
75 76 77
lithium carbonate lopinavir lotio kummerfeldi
Change of dosage strength +
93 93
NO
GENERIC NAME (INN)

mannitol melphalan meningococcus polysaccharide A + C vaccine methampyrone
DOSAGE FORM

+
78 79 80
infusion sol 20%, bottle 500 ml tablet 2 mg powder injection, box 10 vials @ 10 dosage + 10 ampoules solvent @ 5 ml i.m. injection 250 mg/ml, box 25 vials @ 10 ml box 100 ampoules @ 2 ml sol 2 %, bottle 5 ml
81
82
methyl cellulose, changed to be combination of hydroxypropyl methylcellulose 5 mg dextran (70) 1 mg glycerine 2 mg benzalkonium chloride 0.01% w/v (dl) methylphenidate )
Change of therapeutic subclass and the composition is written completely
83
regular release tablet 10 mg, box 30 tablets extended release tablet 20 mg, box 30 tablets tablet 4 mg, bottle 100 tablets syrup 5 mg/5 ml, bottle 50 ml drop 0.1 mg/drop, bottle 10 ml i.v. injection 1 mg/ml i.v. injection 5 mg/ml infusion sol, bottle 500 ml infusion sol, bottle 500 ml
84 85 86 87 88
methyl prednisolone metoclopramide midazolam NLEM nutritious solution I NLEM nutritious solution II
+ +
Complementary list
94 94
NO
GENERIC NAME (INN)
DOSAGE FORM

89 90 91 92
NLEM nutritious solution III infusion sel, bottle 500 ml NLEM nutritious solution IV infusion sel, bottle 500 ml NLEM nutritious solution V NLEM otic medicine combination of: neomycin sulfate 500 mg polymixin B sulfate 1.000.000 IU/100 ml neomycin nicotinamide norepinephrine infusion sel, bottle 500 ml ear drop, bottle 5 ml
93 94 95 96
tablet 500 mg, bottle 100 tablets tablet 100 mg injection 4 mg/ml, ampoule 2 ml
+ + +
nutritious solution infusion sol, bottle 500 ml combination of : glucose 4% sodium chloride 0.18 % oral rehydration salts pancuronium paracetamol patent blue V permethrin perphenazin powder, 100 sacch, each sacch for 1000 ml of water i.v. injection 2 mg/ml (bromide), box 10 ampoules @ 2 ml suppositoria 120 mg suppositoria 240 mg s.c. injection 2.5%, box 1 ampoule 2 ml cream 5%, tube tablet 4 mg (HCl), bottle 100/1000 tablets tablet 16 mg (HCl), bottle 100/1000 tablets
97 98 99 100 101 102
+ +
95 95
NO
GENERIC NAME (INN)

phenobarbital phenol liquid phenytoin phytomenadione piridostigmine policresulen (metacresol sulphonate & methanal condensate) prednisolon procainamide propranolol propyliodone propylthiouracyl propranolol protein plasma fraction (including fibrinogen) quinidine reserpin
DOSAGE FORM

+ + + Moved to other therapeutic class + Change of dosage strength Dosage form and strength are deleted
103 104 105 106 107 108
tablet 50 mg, bottle 1000 tablets bottle 10 ml syrup 50 mg/5 ml, bottle120 ml i.m injection 2mg/ml, ampoule 1 ml tablet 10 mg (bromide), box 10 stripes/bls @ 10 tablets liquid, bottle 10 ml / 50 ml
109 110 111 112 113 114 115 116 117
eye drop 0,5%, bottle 5 ml eye ointment 1%, tube 3,5 g injection 100 mg/ml (HCl) scored tablet 40 mg (HCl), bottle 100 tablets injection in oil 500-600 mg/ml, box 1 ampoule 20 ml tablet 100 mg, bottle 1000 tablets tablet 10 mg, box 100 tablets tablet 40 mg, box 100 tablets
tablet 200 mg (sulfate), bottle 100/1000 tablets tablet 0,10 mg, bottle 1000 tablets tablet 0,25 mg, bottle 1000 tablets
96 96
NO
GENERIC NAME (INN)

resin composite retinol set
DOSAGE FORM

+ +
118 119
tablet 5000 UI, bottle 50 tablet soft capsule 100,000 UI, bottle 50 soft capsules injection 100,000 IU/ ampoule, box 100 ampoules @ 1 ml oily injection 100,000 IU/ampoule (as palmitate), box 100 ampoules @ 2 ml injection 40 IU/ml, box 1 vial 10 ml injection 100 IU/ml, box 1 vial 10 ml i.v. injection 10 mg/ml, vial 5 ml powder 65 - 75%, bottle 1 oz sol 40%, bottle 10 ml injection 1,4% isotonic cream 20 mg/g, tube 5 g injection, vial tablet 30 mg, bottle 60 tablets tablet 40 mg, bottle 60 tablets iv/i.m powder injection 500 mg/vial (chloride), box 10 vial injection 50 mcg/ml (citrate), box 5 vial @ 5 ml
120
retinol
121 122 123 124 125 126 127 128 129
regular insulin regular insulin : intermediate insulin (30 : 70) rocuronium silver amalgam silver nitrate sodium bicarbonate sodium fucidic sodium nitroprusside *) stavudin
+ + + + Change of therapeutic sub-class and dosage form Change of generic name
130 131
succinyl choline sufentanyl
97 97
NO
GENERIC NAME (INN)

sulfonic preparation sulpirid
DOSAGE FORM

132 133
cones, bottle 100 butir capsule 50 mg, box 10 stripes @ 10 capsules tablet 200 mg, box 2 stripes @ 10 tablets iv/i.m powder injection 500 mg/vial (chlorida), box 10 vial injection 100 mg/ml, box 100 ampoules 1 ml i.v. powder for injection 500 mg/ampoule (as sodium salt) (for dissolved in 20 ml WFI), box 25 ampoules crystal, sacch eye drop 1%, bottle 5 ml i.c. injection 1:10, box 1 vial 25 ml tablet 250 mg (as sodium salt), bottle 50 tablets tablet 500 mg (as sodium salt), bottle 50 tablets syrup 250 mg/5 ml (as sodium salt), bottle 120 ml powder injection 500 mg/vial, box 1 vial powder injection 10 mg/vial (bromide), box 20 vials
134 135 136
suxamethonium thiamine thiopental
137 138 139 140
trichloracetic acid tropicamide tuberkulin protein (purified derivative) valproate
Change of dosage form and strength
141 142 143
vancomycin vecuronium warfarin
tablet 2 mg (potassium salt), bottle Change of dosage 100 tablets strength
98 98
NO
GENERIC NAME (INN)

zidovudine
DOSAGE FORM

Change of therapeutic sub-class and dosage form
144
tablet 100 mg, bottle 100 tablets
145
zinc phosphate cement
Powder and liquid, set 30 g bottle 1 set
99 99
THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA THE DECREE OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NUMBER: 239/MENKES/SK/III/2008 REGARDING THE ESTABLISHMENT OF NATIONAL COMMITTEE ON REVISION OF THE NATIONAL LIST OF ESSENTIAL MEDICINES 2008 THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA Considers : a. in order to enhance the quality of health services, the availability of a good quality, safe, effective and sufficient quantity of essential medicines is the responsibility of the government as authorized in the National Medicines Policy; as according to the point (a) above, it is necessary to support the implementation of rational use of medicines; as according to the progress of the medical sciences and health technology, disease pattern, health program and the improvement of public health status as a result of the currently health development, it is therefore, the National list of Essential Medicines should be revised; in order to revise the National List of Essential Medicines (NLEM), it is necessary to establish The National Committee On Revision of the National List of Essential Medicines 2008 by Ministerial decree. Law No. 23 year 1992 regarding Health (State Paper year 1992 No. 100, additional to State Paper No. 4431); Government Regulation No. 27 year 1998 regarding Safety of Pharmaceutical Products and Medical Devices (State Paper year 1998 No. 138, Additional to State Papers of the Republic of Indonesia No. 3781); Government Regulation No. 38 year 2007 regarding Division of Municipality/District Administrative (State of the Republic of Indonesian Paper year 2007 No. 82); The Regulation of the President of the Republic of Indonesia No. 9 year 2005 regarding the locality, duty, function, structure of the organization and the job description of the States Ministries of the Republic of Indonesia; The Regulation of the President of the Republic of Indonesia No. 10 year 2005 regarding Organization Unit and duty of the First Rank Officers of the States Ministries of the Republic of Indonesia; The Regulation of the Minister of Health of the Republic of Indonesia No. 1575/Menkes/Per/XI/2005 regarding the Organization and Ethical Task of the Health Department of the Republic of Indonesia; The Decree of the Minister of Health of the Republic of Indonesia No. 189/MENKES/SK/III/2006 regarding The National Medicines Policy.
b. c.
d.
Refers to
1. 2.
3. 4.
5. 6. 7.
100
To stipulate
The First The Second
: :
The Third The Fourth
: :
Has decided THE DECREE OF THE MINISTER OF HEALTH REGARDING THE ESTABLISMENT OF THE NATIONAL COMMITTEE ON REVISION OF THE NATIONAL LIST OF ESSENTIAL MECICINES 2008 To establish The National Committee on Revision of National List of Essential Medicines 2008 with organization structure as set forth in the appendix hereto; The responsibilities of National Committee of NLEM are as follows: a. The Steering Committee The Steering Committee is responsible to provide advice and direction of the revision according to prevailing laws and regulations; b. The Expert Team The Expert Team is responsible to evaluate the medicines in NLEM 2005 and to analyze the proposed medicines to be added to or deleted from the NLEM 2008. c. The Consultant The consultant is responsible to provide the technical support or scientific findings needed by the expert team. d. The Expert Team and The Consultant jointly provide the technical and the scientific support to the Ministry of Health vide Directorate General of Pharmaceutical Services and Medical Devices on implementing NLEM nationwide and to assist the Directorate of Rational Use of Medicine to execute its policy. e. The Members The Members are responsible to provide input needed for evaluation of NLEM 2005 and to analyze the proposed medicines to be added to or deleted from NLEM 2008. f. The Organizing Committee The Organizing Committee are responsible in recording, documentation and supplying the data, preparing the procedures and guidelines, and preparing the recommended draft of NLEM 2008, arranging the technical meetings and plenary session, preparing the draft documentations, and finalizing NLEM 2008 and its dissemination. The Revision of NLEM should be conducted during 2008; On implementing the duties of The National Committee of Revision of NLEM are responsible to the Ministry of Health vide Directorate General of Pharmaceutical Services and Medical Devices; and report the activities at least 1 (one) month after the termination of their task.
101
The Fifth The Sixth The Seventh
: : :
The duty period of The National Committee of Revision of NLEM started since the stipulation date of this decree and terminated at the end of 2008. The budget of The National Committee of Revision of NLEM and activities is under Annual National Budget of Directorate of Rational Use of Medicine in the year of 2008; This decree shall be effective as of the date of stipulation, and there will be reconsideration or amendment as required if there are shortcomings of mistakes in the stipulation. Stipulated in : Jakarta On Date : March 5, 2008. Minister of Health
Dr. dr. SITI FADILAH SUPARI, Sp.JP (K) Circulation to: 1. The Coordinator Minister of the Public Welfare 2. The Minister of Home Affair 3. The Head of National Planning and Development Board 4. The Head of National Agency of Drug and Food Control 5. The First Ranks officers in the Ministry of Health. 6. The Head of Province Health Office all over the Republic of Indonesia. 7. The Directors of all Teaching Hospitals and Vertical Hospitals within the Ministry of Health all over the Republic of Indonesia. 8. The Head of Municipality or District Health Office all over the Republic of Indonesia. 9. Whom it may concern, to be implemented as required.
102
APPENDIX : THE DECREE OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NUMBER : 239/MENKES/SK/III/2008 DATE : MARCH 5, 2008 THE ESTABLISHMENT OF NATIONAL COMMITTEE ON REVISION OF THE NATIONAL LIST OF ESSENTIAL MEDICINES 2008 Steering Committee : 1. Director General of Pharmaceutical Services and Medical Devices 2. Head of National Agency of Food and Drug Control 3. Director General of Medical Services 4. Director General of Diseases Control and Sanitation 5. Deputy 1 of National Agency of Food and Drug Control Head of Authority : Director General of Pharmaceutical Services and Medical devices Expert Team : Chairman Vice Chairman Members : Iwan Darmansjah (General Practitioner) : Rianto Setiabudy (General Practitioner) : 1. Abdul Muthalib (General Practitioner) 2. Asril Aminullah (General Practitioner) 3. Bambang Sudarmanto (Specialist) 4. Dede Gunawan (Specialist) 5. Djakaria (Specialist) 6. Gunawan (Specialist) 7. Hanafi Trisnohadi (Specialist) 8. Inge Sutanto (General Practitioner) 9. Nugroho Kampono (Specialist) 10. Omo Abdul Madjid (Specialist) 11. Robert Reverger (Specialist) 12. Sarwono Waspadji (specialist) 13. Silvia Desiree Fadiel (Dentist) 14. Sri Rezeki S. Hadinegoro (Specialist) : 1. 2. 3. 4. 5. 6. 7. 8. 9. Arini Setiawati ((Pharmacist) Atie W. Soekandar (General Practitioner) Engko Sosialine (Pharmacist) Irawan Mangunatmaja (Specialist) Iwan Dwiprahasto (General Practitioner) Kartono Muhammad (General Practitioner) Nani Sukasediati (Pharmacist) Pinky F. Riawan (General Practitioner) Sri Suryawati (Pharmacist)
Counsultant
103
Organizing Committee : Head : Director of Rational Use of Medicines Secretary : Zorni Fadia (General Practitioner) Seecretary I : Dita Novianti (Pharmacist) Members : 1. Secretary to Director General of Pharmaceutical Services and Medical devices 2. Director of Public Medicines and Medical Supply 3. Director of Maternal Health 4. Director of Child Health 5. Director of Direct Communicable Diseases Control 6. Director of Animal Sourced Diseases Elimination 7. Director of Non-Communicable Diseases 8. Director of Epidemiologic Surveillance, Immunization and Dimension Health 9. Head of Sub Directorate of Standardization and Technical Assistance, Rational Use Medicines Directorate 10. Head of Sub Directorate of Promotion, Rational Use Medicines Directorate Secretariat : 1. 2. 3. 4. 5. 6. Erie Gusnellyanti Liza Fetrisiani Prihadi Mulyono Anwar Wahyudi Nofiyanti Mulyati
Stipulated in : Jakarta On Date : March 5, 2008. Minister of Health
Dr. dr. SITI FADILAH SUPARI, Sp.JP (K)
104
LIST OF PARTICIPANTS OF TECHNICAL MEETINGS AND PLENARY SESSION NATIONAL LIST OF ESSENTIAL MEDICINES 2008
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43
Director General of Pharmaceutical Services and Medical Devices Head of National Agency of Food and Drug Control Director General of Medical Services Director General of Diseases Control and Sanitation Deputy I of National Agency of Food and Drug Control Secretary to Director General of Pharmaceutical Services and Medical Devices Director of Rational Use of Medicine Director of Public Medicines and Medical Supply Director of Maternal Health Director of Child Health Director of Direct Communicable Diseases Control Director of Non-Communicable Diseases Control Director of Animal Sourced Diseases Elimination Director of Epidemiologic Surveillance, Immunization and Dimension Health Director of Public Nutrition Director of Mental Health Services Director of Primary Medical Services Director of Specialist Medical Services Director of Public Hospital Dr. M Yunus Bengkulu Director of Public Hospital DR. M. Djamil Padang Director of Public Hospital Ulin Banjarmasin Director of National Public Hospital RS Cipto Mangunkusumo Director of Central Public Hospital Hasan Sadikin Bandung Director of Central Public Hospital Muh. Hussein Palembang Director of Public Hospital dr. Moewardi, Solo Director of Public Hospital dr. Sardjito, Yogyakarta Director of Central Public Hospital Wahidin Sudirohusodo, Makasar Director of Public Hospital Dr. Karyadi, Semarang Director of Public Cardiovascular Hospital Harapan Kita Director of Mental Hospital Cimahi Director of Provincial Public Hospital Wahidin Sudirohusodo Mojokerto-East Java Director of Provincial Public Hospital dr. Soetomo, Surabaya Director of Public Hospital Kab. Tangerang Director of Provincial Public Hospital Arifin Achmad, Pekanbaru Director of Central Public Hospital Sanglah - Denpasar Director of Siloam Karawaci Hospital, Banten Director of Sumber Waras Hospital, Jakarta Director of Husada Hospital, Jakarta Director of Public Hospital Yos Sudarso, Padang Director of PT. Indofarma Director of PT. Kimia Farma Director of PT. Phapros Health Directorate of National Army - POLRI
105
44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96
Head of Provincial Health Office in Nangroe Aceh Darusalam Head of Provincial Health Office in South Sulawesi Head of Provincial Health Office in DKI Jakarta Head of Provincial Health Office in West Java Head of Provincial Health Office in Central Java Head of Provincial Health Office in East Java Head of Provincial Health Office in West Kalimantan Head of Provincial Health Office in Central Kalimantan Head of Provincial Health Office in Western Southeast Nusa Tenggara Head of Provincial Health Office in Eastern Southeast Nusa Tenggara Head of Provincial Health Office in Papua Head of Provincial Health Office in Central Sulawesi Head of Provincial Health Office in North Sulawesi Head of Provincial Health Office in West Sumatera Head of Provincial Health Office in North Sumatera Head of District Health Office in Karang Anyar Head of District Health Office in Sleman Head of District Health Office in Surakarta Head of Public Health Center of Pajang, Surakarta Head of Public Health Center of Tebet, Jakarta Chairman of Indonesian Medical Doctors Association Chairman of Indonesian Midwives Association Chairman of Indonesian Pharmacologist Association Chairman of Indonesian Nursery Association Chairman of Indonesian Pharmacist Association Chairman of Indonesian Anesthesiologist and Reanimation Specialist Association Prof. dr. Iwan Darmansjah, SpFK. Prof. dr. Rianto Setiabudy, SpFK. Prof. dr. Abdul Muthalib, SpPD (K). Prof. dr. Djakaria, SpRad (K). Prof. dr. Nugroho Kampono, SpOG. Prof. Dr. dr. Hanafi Trisnohadi, SpKJ(K) Prof. Dr. dr. Inge Sutanto Prof. Dr. dr. Sarwono Waspadji, SpPD (K) Prof. Dr. dr. Sri Rezeki S. Hadinegoro,SpA (K) Prof. Dr. Arini Setiawati,PhD. Prof. dr. Iwan Dwiprahasto, M.MedSc, PhD. Prof. dr. Asril Aminullah, Sp.A (K) dr. Omo Abdul Madjid, SpOG. dr. Bambang Sudarmanto, Sp.A. dr. Dede Gunawan, SpS (K) dr. Robert Reverger, SpKJ (K) dr. Gunawan Darmansjah, SpAn. dr. Irawan Mangunatmadja , SpA.(K) drg. Silvia Desiree, SpKGA DR. Atie W. Soekandar, Sp.FK. DR. Sri Suryawati dr. Kartono Muhammad dr. Pinky F. Riawan Dra. Engko Sosialine, M. Biomed dr. Zorni Fadia dr. Abdullah Akhmad Dra. Detty Yuliati, Apt.
106
97 98 99 100 101 102 103 104 105 106 107 108 109
Dita Novianti, S.Si, Apt, MM Erie Gusnellyanti, S.Si, Apt. dr. Djentot Fibihanindyo Putro Dra. Dara Amelia, Apt. Dra. Ema Viaza, Apt. Rohayati Rahafat, S.Si, Apt. Drs. Suhata Awan Yurianto Suprihandoyo Prihadi Mulyono Anwar Wahyudi Nofiyanti Mulyati
-----------
107
STATEMENT OF COMPLIANCE CHAIRMAN/VICE CHAIRMAN/ EXPERT/CONSULTANT*)

I, as undersigned below Name Address : :
declare as follows: 1. Disposed to be the Chairman/Vice Chairman/Expert/Consultant*) of The National Committee of NLEM (National List of Essential Medicines) 2008. 2. Disposed to attend Technical Discussion Meeting of NLEM Revision. 3. Disposed to sign Conflict of Interest Statement.
Jakarta, .......................................
*) Strike out the unnecessary statement
108
CONFLICT OF INTEREST STATEMENT

Indonesian National Essential Medicines Committee (2008)
For the evaluation of the Selection of Essential Medicines an evaluation committee is needed that would guarantee that its members are impartial and free from conflicts of interest that would biased the outcome of their choice(s) of medicines. Therefore all individuals chosen as National Committee Members are required to sign a statement as below, as consented: 1. 2. 3. 4. 5. No direct family members, including self, have important positions in or have stakes in the drug business so as to bias his/her selection. Committee Members, including Chairman and Consultants, should not solicit or receive money or gratuities that clearly indicate a form of bribery. Committee Members should refrain from presenting faked data in the form of publications or statements of dubious nature. In its deliberations members should use their intellectual judgment, instead of stating mere opinions without support of scientific data. When in the discussion of a subject, a member feels that he/she might have a conflict of judgment, he/she must acknowledge the chairman of the nature of its possible conflict. In the case of a serious conflict of interest, he/she will not be allowed to participate in a voting procedure. Committee Members may not deliberately leak important confidential issues of decision to a third party.
6.
I, the undersigned below: Name: ......................................... Function: Chairman / Vice Chairman / Member / Consultant Declares that he/she understood the above statement and will obey the written rules above.
---------------------------------------Committee Member
---------------------Date
109
ASSESSMENT FORM APPLICATION FOR ADDITION / DELETION OF NATIONAL LIST OF ESSENTIAL MEDICINES 2008
NO
1 2 3 4 5 6 7 8 9 10 11 12 13 Summary Reason of deletion Public relation Comparation with similar medicine on the list Pharmacological characteristic Effectiveness evidence Safety evidence Benefit cost ratio Formulation The using of the medicine by international guidance Prevailing laws and regulatiuon which is supporting to delete the medicine Recommendation References
SUBJECT
110
RECAPITULATION OF APPLICATION FOR NLEM REVISION 2008

Application from Name of Institution : Address : Phone No/Facs :
CHANGE NO THERAPEUTIC CLASS GENERIC NAME (INN) DOSAGE PACKAGING FORM ADDITION DELETION SUPPORTING EBM *)
Explanation : *) Based on trusted literature / reference *) Enclose the related literature / reference
.200.. Stamp / signature
Name NIP.
_____
111

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615.

NATIONAL LIST of ESSENTIAL MEDICINES 2008

NATIONAL LIST of ESSENTIAL MEDICINES 2008

DEPARTEMEN KESEHATAN R.I.

MINISTRY of HEALTH REPUBLIC of INDONESIA

Appendix III Appendix IV Appendix V Appendix VI Index

105 108 109 110 112

National List of Essential Medicines 2008

National List of Essential Medicines 2008

To Stipulate The First The Second The Third

The Fifth The Sixth

National List of Essential Medicines 2008

Dr. dr. SITI FADILAH SUPARI, Sp.JP (K)

National List of Essential Medicines 2008

Dra. Kustantinah, Apt. MAppSc. NIP. 140 100 965

National List of Essential Medicines 2008

Fixed combination medicines have to follow the following criteria: -

CHAPTER II NATIONAL LIST OF ESSENTIAL MEDICINES 2008

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

Restricted use : Only for spinal anesthesia

midazolam nitrous oxide oxygen propofol thiopental

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

diphenhydramine epinephrine (adrenaline)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

methylthioninium chloride (methylene blue) naloxone

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

6.2.2.2 Chloramphenicol chloramphenicol

tablet, box 10 stripes @ 10 tablets

tablet, bottle 100 tablets

THERAPEUTIC CLASS, GENERIC NAME (INN)

Note : Benefit for bone infections

6.2.2.7 Specific Use metronidazole

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

combination of : rifampicin isoniazid

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

tablet 150 mg (as phosphate), bottle 1000 tablets

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

busulfan calcium folinate (leucovorin, Ca)

National List of Essential Medicines 2008

THERAPEUTIC CLASS, GENERIC NAME (INN)

cytarabine dacarbazine dactinomycin daunorubicin doxorubicin

National List of Essential Medicines 2008