Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
Alfuzosin Hydrochloride (UNII: 75046A1XTN) (Alfuzosin - UNII:90347YTW5F)
Stat Rx USA
Alfuzosin Hydrochloride
Alfuzosin Hydrochloride 10 mg
ORAL
PRESCRIPTION DRUG
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of hypertension. The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of Uroxatral is 50% lower under fasting conditions. Therefore, Uroxatral should be taken immediately after the same meal each day. The tablets should not be chewed or crushed. UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. UROXATRAL is contraindicated for use in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients. [see Clinical Pharmacology (12.3)]. UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased. [see
UROXATRAL is supplied as follows: UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep UROXATRAL out of reach of children.
New Drug Application
UROXATRAL - ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE STAT RX USA ---------- UROXATRAL (ALFUZOSIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE 1 INDICATIONS AND USAGE UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of hypertension. 2 DOSAGE AND ADMINISTRATION The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of Uroxatral is 50% lower under fasting conditions. Therefore, Uroxatral should be taken immediately after the same meal each day. The tablets should not be chewed or crushed. 3 DOSAGE FORMS AND STRENGTHS UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. 4 CONTRAINDICATIONS UROXATRAL is contraindicated for use in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients. _[see_ _Clinical Pharmacology (12.3)]._ UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased. _[see Clinical Pharmacology_ _(12.3)]_. UROXATRAL is contraindicated in patients known to be hypersensitive to alfuzosin hydrochloride or any component of UROXATRAL tablets. 5 WARNINGS AND PRECAUTIONS 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of UROXATRAL. As with other alpha-blockers, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. There may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL concomitantly with anti- hypertensive medication and nitrates. Care should be taken when UROXATRAL is administered to patie Soma hati kamili