Health and Prostate

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Drug Approvals

(British Approved Name Modified, US Adopted Name, rINN)

International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish): Alfutsosiinihydrokloridi; Alfuzosin Hidroklorur; Alfuzosine, chlorhydrate d’ Alfuzosin-hydrochlorid; Alfuzosinhydroklorid; Alfuzosini hydrochloridum; Alfuzozin-hidroklorid; Alfuzozino hidrochloridas; Hidrocloruro de alfuzosina; SL-77499-10; SL-77499 (alfuzosin).

Pharmacopoeias. In Europe.

European Pharmacopoeia, 6th ed. (Alfuzosin Hydrochloride). Awhite or almost white, slightly hygroscopic, crystalline powder. Freely soluble in water sparingly soluble in alcohol practically insoluble in dichlo-romethane. A 2% solution in water has apH of 4.0 to 5.5. Store in airtight containers. Protect from light.

Adverse Effects, Treatment, and Precautions

As for Prazosin Hydrochloride. Alfuzosin may be more selective for the urinary tract and vasodilator effects may be less frequent. It should be avoided in severe hepatic impairment, and doses may need to be reduced in mild to moderate hepatic impairment and in renal impairment (see below).

Incidence of adverse effects. In postmarketing surveillance involving 13 389 patients given alfuzosin 2.5 mg three times daily by mouth for benign prostatic hyperplasia, about 3.7% of patients failed to complete treatment because of adverse effects. These were mostly vasodilatory in nature (vertigo or dizziness, syncope or malaise, hypotension, and headache), and were more common in patients over 75 years of age and during the first week of treatment.

Surgical procedures. Alpha blockers, including alfuzosin, have been associated with intraoperative floppy iris syndrome in cataract surgery patients. For further details, see under Tamsu-losin, p.2197.

Interactions

As for Prazosin Hydrochloride. Potent inhibitors of the cytochrome P450 isoenzyme CYP3A4, such as ketoconazole, itraconazole, and ritonavir, may increase blood concentrations of alfuzosin.

Pharmacokinetics

Alfuzosin is readily absorbed after oral doses and peak plasma concentrations generally occur 0.5 to 3 hours after a dose bioavailability is about 64%. Absorption from modified-release preparations is improved if given with food. It is extensively metabolised in the liver, mainly by the cytochrome P450 isoenzyme CYP3A4, to inactive metabolites that are excreted primarily in faeces via the bile. Only about 11% of a dose is excreted unchanged in the urine. Alfuzosin has a plasma elimination half-life of 3 to 5 hours. It is 90% bound to plasma proteins.

Uses and Administration

Alfuzosin is an alpha₁-adrenoceptor blocker with actions similar to those of prazosin. It acts preferentially on receptors in the lower urinary tract and is therefore used in benign prostatic hyperplasia to relieve symptoms of urinary obstruction, including acute urinary retention.

Alfuzosin is given orally as the hydrochloride. Like other alpha₁-adrenoceptor blockers, it may cause collapse in some patients after the first dose, which should therefore be given just before bedtime to reduce the risk. Doses may need to be reduced in patients with hepatic or renal impairment (see below) the initial dose should also be reduced in the elderly.

In benign prostatic hyperplasia, the usual dose of alfuzosin hydrochloride is 2.5 mg three times daily, increased to 10 mg daily if necessary. In elderly patients, and those receiving treatment for hypertension, a lower initial dose of 2.5 mg twice daily should be considered. A modified-release preparation may also be used in a dose of 10 mg once daily after a meal.

In patients aged over 65 years catheterised for acute urinary retention associated with benign prostatic hyperplasia, a modified-release preparation may be given in a dose of 10 mg once daily after a meal for 3 to 4 days.

Administration in hepatic or renal impairment. In patients with mild to moderate hepatic impairment the initial dose of alfuzosin hydrochloride should be 2.5 mg daily, increased to 2.5 mg twice daily according to response modified-release preparations are not recommended.

In patients with renal impairment, 2.5 mg twice daily should be given initially, adjusted according to response. Although UK and US licensed product information advises caution with the use of modified-release preparations in severe renal impairment (creatinine clearance below 30 mL/minute), a study in patients with varying degrees of renal impairment (including severe) suggested that no dose reduction was necessary.

Preparations

Proprietary Preparations:

Argentina: Dalfaz UroXatral

Austria: Urion † Xatral

Belgium: Xatral

Brazil: Xatral

Canada: Xatral

Chile: UroXatral

Czech Republic: Alfuzostad Xatral

Denmark: Xatral Fin. Xatral

France: Urion Xatral

Germany: Urion UroXatral

Greece: Alfuprost Alfural Alfuzin Innosensitive Spedamyl Xatral

Hong Kong: Xatral

Hungary: Alfetim Alfuzostad

India: Flotral

Indonesia: Xatral

Ireland: Xatral

Israel: Xatral

Italy: Mittoval Xatral

Malaysia: Xatral

Mexico: Xatral

The Netherlands: Mittoval Urion UroXatral Xatral

Norway: Xatral

Philippines: Xatral

Poland: Alfuzostad Dalfaz

Portugal: Benestan

Russia: Dalfaz

South Africa: Xatral

Singapore Xatral

Spain: Alfetim † Benestan Unibenestan

Sweden: Xatral

Switzerland: Xatral

Thailand: Xatral

Turkey: Xatral

UK: Besavar Xatral

USA: UroXatral

Venezuela: Xatral.

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