RVP

Drug Catalog - Product Detail

ALFUZOSIN HCL ER TAB 10MG 90CT

NDC Mfr Size Str Form
57237-0114-90 RISING PHARMACEUTICALS 90 10MG TABLET
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Generic Name
ALFUZOSIN HYDROCHLORIDE
Substance Name
ALFUZOSIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA079060
Description
11 DESCRIPTION Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C 19 H 27 N 5 O 4 •HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: carbomer, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Alfuzosin Hydrochloride Extended-Release Tablets USP, 10 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ‘X’ on one side and ‘23’ on other side. Bottles of 90 NDC 57237-114-90 Bottles of 100 NDC 57237-114-01 Bottles of 500 NDC 57237-114-05 Store at 20° to 25°C (68° to 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 alfuzosin hydrochloride extended-release tablets out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed. 10 mg once daily with food and with the same meal each day. (2) Tablets should not be chewed or crushed (2 , 12.3)