Xatral (alfuzosin)

Main use Active ingredient Manufacturer

Enlarged prostate gland Alfuzosin hydrochloride Sanofi Aventis

How does it work?

Xatral tablets contain the active ingredient alfuzosin, which is a type of medicine called
an alpha-blocker. It works by blocking alpha receptors that are found in the muscle in the
prostate gland. (NB. Alfuzosin is also available without a brand name, ie as the generic
medicine.)

The prostate gland, which is found only in men, lies at the top of the tube connecting the
bladder to the outside (urethra). The prostate gland often enlarges with advancing age
(benign prostatic hyperplasia), pressing on the urethra and obstructing the flow of urine
from the bladder. This can cause various urinary symptoms, such as difficulty passing
urine.

Alfuzosin blocks alpha receptors in the muscle of the prostate gland, which causes the
muscle in the prostate to relax. This allows urine to flow freely past the prostate and
relieves the urinary symptoms.

What is it used for?

• Relieving the urinary symptoms of an enlarged prostate gland (benign prostatic
hyperplasia).

Warning!
• The first dose of this medicine may cause dizziness, light-headedness or fainting.
For this reason you should take the first dose, and preferably each dose, just
before retiring to bed at night. Take care when moving from lying down to sitting
or standing, particularly if you wake up in the night, until you know how this
medicine affects you. If you feel dizzy or light-headed at any time during
treatment, sit or lie down until the symptoms pass. Some people may find that
drinking alcohol makes dizziness worse.
• As this medicine may cause fatigue and dizziness, you should take care when
performing potentially hazardous activites, such as driving or operating
machinery, until you know how this medicine affects you and are sure you can
perform such activities safely.
• Your blood pressure should be monitored regularly during treatment with this
medicine.
 • If you are scheduled to have eye surgery for cataracts it is important to let your
eye specialist know if you are or have been taking this medicine. This is because
this type of medicine may make your pupil dilate poorly and the iris (the coloured
circular part of the eye) become floppy during the procedure. The specialist needs
to know if you have been taking this medicine so they can take appropriate
precautions with the medicines and techniques they use during the surgery. You
may be asked to stop taking this medicine for a period of time before cataract
surgery. Check with your doctor.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• Allergy to alpha-blocker medicines.
• Coronary artery disease or angina pectoris.
• People taking blood pressure lowering medication.

Not to be used in
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption (Xatral tablets contain lactose).
• People taking other alpha-blocker medicines.
• Severely decreased liver function.
• History of drops in blood pressure that cause dizziness when moving from a lying
down or sitting position to sitting or standing (postural hypotension).
• This medicine is not recommended for people who have ever fainted after passing
urine (micturition syncope).

This medicine should not be used if you are allergic to one or any of its ingredients.
Please inform your doctor or pharmacist if you have previously experienced such an
allergy.If you feel you have experienced an allergic reaction, stop using this medicine and
inform your doctor or pharmacist immediately.

Label warnings
• This medication may cause drowsiness. If affected do not drive or operate
machinery.

Side effects
Medicines and their possible side effects can affect individual people in different ways.
The following are some of the side effects that are known to be associated with this
medicine. Because a side effect is stated here, it does not mean that all people using this
medicine will experience that or any side effect.

• Feeling faint.
• Dizziness.
• Headache.
• Nausea.
• Abdominal pain.
• Weakness or loss of strength (asthenia).
• General feeling of being unwell (malaise).
• Balance problems involving the inner ear (vertigo).
• Drowsiness.
• Dry mouth.
• Diarrhoea.
• A drop in blood pressure that occurs when going from lying down to sitting or
standing, which results in dizziness and lightheadedness (postural hypotension).
• Fainting (syncope).
• Increased heart rate (tachycardia).
• Awareness of your heartbeat (palpitations).
• Chest pain.
• Flushing.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).
• Rash or itching.

The side effects listed above may not include all of the side effects reported by the drug's
manufacturer.For more information about any other possible risks associated with this
medicine, please read the information provided with the medicine or consult your doctor
or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking,
including those bought without a prescription and herbal medicines, before you start
treatment with this medicine. Similarly, check with your doctor or pharmacist before
taking any new medicines while taking this one, to ensure that the combination is safe.

If this medicine is taken with other medicines that can reduce blood pressure, this effect
may be enhanced, with an increased chance of dizziness or fainting. Other medicines that
may reduce blood pressure include the following:

• anaesthetics
• antipsychotics
• baclofen
• diuretics, eg furosemide
• medicines for high blood pressure (antihypertensives)
• nitrates, eg glyceryl trinitrate, isosorbide mononitrate, amyl nitrate (poppers)
 • other alpha-blockers, eg prazosin, doxazosin (this medicine must not be taken
with other alpha-blocker medicines)
• phosphodiesterase type 5 inhibitors for impotence, eg sildenafil, vardenafil,
tadalafil.

The following medicines may increase the blood level of alfuzosin and could therefore
increase the risk of side effects:

• itraconazole
• ketoconazole
• ritonavir.

Other medicines containing the same active ingredient

Besavar XL Xatral XL Zufal XL

Xatral® [SR tab]

Contents Alfuzosin HCl

Indications Treatment of functional symptoms of benign prostatic
hyperplasia (BPH). Xatral XL Adjuvant treatment to a
catheter in 1st episode of acute urinary retention (AUR)
related to BPH.
Dosage Xatral SR 1 tab morning & evening. Xatral XL BPH 1 tab
daily in the evening. Adjuvant treatment to a catheter in
1st episode of AUR related to BPH 1 tab once daily for 2-3
days during catheterisation & for 1 day after removal.
Overdosage For action to be taken in the event of accidental overdose ...
click to view
Administration Should be taken with food (Take w/ the same meal daily.
Swallow whole, do not chew/crush.).
Contraindications Orthostatic hypotension, hepatic insufficiency, severe renal
insufficiency, intestinal occlusion.
Special Renal or hepatic impairment, elderly. HTN; monitor BP
Precautions regularly. Coronary insufficiency; discontinue if angina re-
appears or worsens.
Adverse Drug More frequently: GI disturbances, lipothymic events &
Reactions headache. Less frequently: Dry mouth, tachycardia, chest
pain, asthenia, drowsiness, rash, pruritus & flushes.
Palpitation, orthostatic hypotension & edema.
Click to view ADR Monitoring Form
Drug Interactions Avoid combination w/ other α1-blockers. Antihypertensive
effect & risk of orthostatic hypotension increased w/
antihypertensive drugs. Use w/ general anesth could cause
profound hypotension (w/draw Xatral 24 hr before surgery).
Co-administration w/ potent CYP3A4 inhibitors may increase
serum conc.
Click here for more Interaction Checks
Pregnancy
Category (US
FDA) Category B: Either animal-reproduction studies have not
demonstrated a foetal risk but there are no controlled studies
in pregnant women or animal-reproduction studies have
shown an adverse effect (other than a decrease in fertility)
that was not confirmed in controlled studies in women in the
1st trimester (and there is no evidence of a risk in later
trimesters).
Storage For special storage condition to ensure optimal shelf-life of
medicine... click to view
Description For details on the chemical structure, and the excipient or
inactive compounds in the formulation... click to view
Mechanism of For Details of the mechanism of action, pharmacodynamics
Action and pharmacokinetics ... click to view
MIMS Class Drugs for Bladder & Prostate Disorders
ATC G04CA01 - Alfuzosin ; Belongs to the class of alpha-
Classification adrenoreceptor antagonists. Used in the treatment of benign
prostatic hypertrophy.
Poison Schedule POM
Packing/Presentation
Form Packing/Price Photo
Xatral SR tablet Xatral SR 5 mg x 56's ($77.5)

Xatral XL tablet Xatral XL 10 mg x 30's ($67)