Source: FDA, National Drug Code (US) Revision Year: 2021
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
UROXATRAL is not indicated for the treatment of hypertension.
UROXATRAL is not indicated for use in the pediatric population.
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.
Should overdose of UROXATRAL lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP.
Protect from light and moisture.
Keep UROXATRAL out of reach of children.
Mfd. for: Concordia Pharmaceuticals
Distributed by: Amdipharm Limited, 17 Northwood House, Dublin 9, Ireland
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