Drug Catalog - Product Detail
NIFEDIPINE ER (CC) TB 30MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0105-10 | OCEANSIDE PHARMACEUTICALS | 100 | 30MG | TABLET |
PACKAGE FILES
Generic Name
NIFEDIPINE
Substance Name
NIFEDIPINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075269
Description
DESCRIPTION Nifedipine extended-release tablets 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. The molecular formula is C 17 H 18 N 2 O 6 and has the structural formula: Nifedipine 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 30 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4 (using first derivative UV spectrophotometry at 245 nm for sample analysis). Nifedipine Chemical Structure
How Supplied
HOW SUPPLIED Nifedipine Extended-Release Tablets, USP are supplied as 30 mg unscored, round film-coated tablets as follows: Strength Color Markings 30 mg Mustard yellow 30 mg unscored, round, film-coated tablets, engraved with "B" on one side and "30" on the other side. Nifedipine Extended-Release Tablets, USP are supplied in: Strength Quantity NDC Number 30 mg Bottles of 100 68682-105-10 30 mg Bottles of 300 68682-105-30 The tablets should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.
Indications & Usage
INDICATIONS AND USAGE Nifedipine extended-release tablets 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 tablet be administered orally once daily on an empty stomach. Nifedipine extended-release tablet is 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.