Drug Catalog - Product Detail
ALFUZOSIN HCL ER TB 10MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47335-0956-88 | SUN PHARMACEUTICALS | 100 | 10MG | TABLET |
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Description
Description Each alfuzosin hydrochloride extended-release tablet contains 10 mg alfuzosin hydrochloride, USP as the active ingredient. Alfuzosin hydrochloride 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 C19H27N5O4•HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: chemical-structure The tablet also contains the following inactive ingredients: pregelatinized maize starch, hypromellose, hydroxypropyl cellulose, basic butylated methacrylate copolymer, colloidal silicon dioxide, magnesium stearate, and talc.
How Supplied
How Supplied Alfuzosin hydrochloride extended-release tablets 10 mg are available as white to off white, round shaped, biconvex, uncoated tablet debossed with ‘956’ on one side and plain on other side. Alfuzosin hydrochloride extended-release tablets are supplied as follows: Bottles of 30’s with Child Resistant Cap…....................NDC 47335-956-83 Bottles of 90’s with Child Resistant Cap…....................NDC 47335-956-81 Bottles of 100’s with Child Resistant Cap…..................NDC 47335-956-88 Bottles of 100’s with Non Child Resistant Cap…..........NDC 47335-956-08 Bottles of 1,000’s with Non Child Resistant Cap…........NDC 47335-956-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep alfuzosin hydrochloride extended-release tablets out of reach of children. Dispense in a tight, light-resistant container as defined in the USP.
Indications & Usage
Indications and Usage Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tabletsare not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.
Dosage and Administration
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.