Each sustained-release, film-coated tablet contains:
Alfuzosin hydrochloride …….........................…...............................………………………... 5 mg
Excipients …..................................................... q.s. ad to one sustained-release, film-coated tablet
Treatment of the functional symptoms of benign prostatic hypertrophy.
Dosage and method of administration
The tablet should be swallowed whole, without chewing.
1 tablet of XATRAL® SR 5 mg, morning and evening.
- Elderly subjects or hypertensive patients treated: as a systematic precaution, it is recommended
to initiate treatment with one tablet of XATRAL‚ SR 5 mg in the evening, and then increase the
dosage depending on the patient’s individual response, without exceeding the maximum dosage
of 1 tablet of XATRAL‚ SR 5 mg , morning and evening.
- Patients with liver failure: it is recommended to initiate treatment with one tablet of XATRAL®
2.5 mg per day, and then increase the dosage depending on the patient’s individual response,
without exceeding one tablet of XATRAL‚ 2.5 mg, twice daily.
This product must not be administered in the following cases:
- hypersensitivity to alfuzosin,
- orthostatic hypotension,
- severe liver failure (class C in the CHILD-PUGH classification).
Use of this product is generally inadvisable in combination with antihypertensive alpha-blockers
(see Drug Interactions).
Warnings and special precautions for use
In certain subjects, and particularly those being treated with antihypertensive agents, orthostatic
hypotension may occur during the hours following dosing, and may be accompanied by other
symptoms (dizziness feeling, fatigue, sweating).
Caution is recommended, particularly in elderly subjects.
These symptoms are usually transient, occur at the beginning of treatment and generally do not
prevent the pursuit of treatment. The patient should be informed as to the possible onset of these
Alfuzosin should not be prescribed as single-drug therapy in coronary patients. Specific treatment
for coronary insufficiency should be pursued. If angina pectoris recurs or worsens, alfuzosin
therapy should be discontinued.
Interactions with other drugs and other forms of interaction
+Antihypertensive alpha-blockers (prazosine, urapidil, minoxidil):
Enhancement of the hypotensive effect. Risk of severe orthostatic hypotension.
Combination to be taken into account
Increased antihypertensive effect and risk of orthostatic hypotension (additive effect).
Pregnancy and lactation
The therapeutic indication does not concern women.
The safety of alfuzosin during pregnancy and the passage of alfuzosin into breast milk are unknown.
Effects on ability to drive and use machines
Particular caution should be exercised by drivers and machine operators because of the risks of
orthostatic hypotension, particularly at the beginning of treatment with alfuzosin.
The adverse effects most commonly observed in patients treated with alfuzosin are the following:
- gastrointestinal disorders; nausea, gastric pain, diarrhoea;
- giddiness, dizziness feeling, malaise;
The following have been reported in rare cases:
- orthostatic hypotension,
- chest pain (see Warnings and special precautions for use);
- dry mouth;
- skin rashes;
In the event of overdose, the patient should be hospitalized and kept in supine position.
Standard treatment for hypotension should be implemented.
Because of its high protein binding level, alfuzosin is difficult to dialyze.
OTHER UROLOGICAL PRODUCTS/ALPHA-1 BLOCKER
(G04BX02: genitourinary system and sex hormones).
Alfuzosin is a quinazoline derivative, which is active when taken via the oral route. It is a selective
antagonist of post-synaptic, alpha- 1 adrenergic receptors. In vitro pharmacology studies have
confirmed the selectivity of alfuzosin for alpha- 1 adrenergic receptors situated in the prostate, the
bladder trigone and the urethra.
Through direct action on the smooth muscle of prostate tissue, alpha blockers reduce obstruction
downstream of the bladder. In vivo animal studies demonstrated that alfuzosin reduced urethral
pressure and thus resistance to the urinary flow during micturition. A study in conscious rats
demonstrates an effect on urethral pressure with a greater amplitude that the effect on blood
During placebo-controlled studies in patients suffering from benign prostatic hypertrophy, alfuzosin:
• significantly increased the urinary flow rate by on average 30% in patients with rate of
< 15 ml/second. This improvement was observed after the first dose;
• significantly reduced detrusor pressure and increased the volume, thus provoking the sensation
of a need to urinate;
• significantly reduced the residual urine volume.
These effects led to an improvement in irritative and obstructive urinary symptoms.
They had no deleterious effect on sexual function.
- Peak plasma concentrations are reached approximately 3 hours after dosing.
- The plasma elimination half-life is 8 hours.
- Bioavailability is usually reduced by approximately 15%, when compared with that of the 2.5 mg,
The pharmacokinetic profile is not modified by the concomitant consumption of food.
Alfuzosin undergoes marked metabolism in the liver, with excretion in the urine of only 11% of
the unchanged compound.
Most of the metabolites (which are inactive) are excreted in the feces (75 to 90%).
- In elderly subjects over the age of 75 years, alfuzosin is absorbed more rapidly and peak concentrations
are higher. Bioavailability may be increased, and a reduction in the volume of distribution may be
observed in certain patients. The elimination half-life remains unchanged.
- The elimination half-life is prolonged in patients with severe liver failure. Bioavailability is
increased when compared to that seen in healthy volunteers.
- In patients with kidney failure who do or do not require dialysis, the volume of distribution and
clearance of alfuzosin increase because of an elevation of the free fraction. Chronic or even severe
kidney failure (creatinine clearance between 15 and 40 ml/min) are not aggravated by alfuzosin.
- The pharmacokinetic profile of alfuzosin is not modified in the event of chronic heart failure.
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