Drug Catalog - Product Detail
Nifedipine Tab ER 24HR 90 MG 100 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0107-10 | OCEANSIDE PHARMACEUTICALS | 100 | 90MG | TABLET |
PACKAGE FILES
Generic Name
NIFEDIPINE
Substance Name
NIFEDIPINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA076070
Description
DESCRIPTION Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. The product is provided as a general matrix tablet with a polymer coating. 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 90 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. Contains FD&C Yellow No. 5 (tartrazine) as a color additive. Nifedipine extended-release tablets meet USP Dissolution Test 7. Nifedipine Chemical Structure
How Supplied
HOW SUPPLIED Nifedipine Extended-Release Tablets, USP are supplied as 90 mg round film-coated tablets as follows: Strength Color Markings 90 mg Yellow 90 mg unscored, round, film-coated tablets, engraved with "B" on one side and "90" on the other side. Nifedipine Extended-Release Tablets, USP are supplied in: Strength NDC Code 90 mg Bottles of 100 68682-107-10 The tablets should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada Distributed by: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA 9495503 20001722 Rev. 06/2016
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.