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Uroxatral (Alfuzosin Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

Important Limitations of Use

UROXATRAL is not indicated for the treatment of hypertension.

UROXATRAL is not indicated for use in the pediatric population.

DOSAGE AND ADMINISTRATION

The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.

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.

HOW SUPPLIED/STORAGE AND HANDLING

UROXATRAL is supplied as follows:

Package NDC Number
Bottles of 100 0024-4200-10

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.

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