Drug Catalog - Product Detail
NIFEDIPINE ER (CC) TB 30MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0677-05 | PAR PHARMACEUTICAL | 500 | 30MG | TABLET |
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Description
DESCRIPTION Nifedipine Extended-Release Tablets, USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine, USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain either 30 or 60 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate. The inert ingredients in the film coating are: hypromellose, polydextrose, polyethylene glycol 8000, triacetin, yellow iron oxide and titanium dioxide. Product meets USP dissolution test #6.
How Supplied
HOW SUPPLIED Nifedipine Extended-Release Tablets, USP are supplied as 30 mg and 60 mg round, biconvex, film-coated tablets which are 11 mm in diameter and 6 mm in height. The different strengths can be identified as follows: Strength Color Markings 30 mg Yellow Debossed “A” above “153” on one side and Plain on the other side 60 mg Yellow Debossed “A” above “151” on one side and Plain on the other side Nifedipine extended-release tablets, USP are supplied in: Strength NDC Code Bottles of 100 30 mg 49884-677-01 60 mg 49884-678-01 Bottles of 500 30 mg 49884-677-05 60 mg 49884-678-05 The tablets should be protected from light and moisture and stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Manufactured for: Par Pharmaceutical Companies Inc. Spring Valley, NY 10977 U.S.A. Issued: 09/2012 OS677-01-47-01 XX-XXXX
Indications & Usage
INDICATIONS AND USAGE Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage and Administration
DOSAGE AND ADMINISTRATION Dosage should be adjusted according to each patient’s needs. It is recommended that Nifedipine Extended-Release Tablets, USP be administered orally once daily on an empty stomach. Nifedipine extended-release tablets are an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7 to 14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended. If discontinuation of nifedipine extended-release tablets is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Coadministration of nifedipine with grapefruit juice is to be avoided (See CLINICAL PHARMACOLOGY and PRECAUTIONS ). Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended release dosage form has been prescribed.