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. The nifedipine extended-release tablet, USP is an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7-14 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 the nifedipine extended-release tablet is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended release dosage form has been prescribed.
Nifedipine extended-release tablets, USP are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:
NDC 68071-4411-3 BOTTLES OF 30
NDC 68071-4411-6 BOTTLES OF 60
NDC 68071-4411-9 BOTTLES OF 90
The tablets should be protected from light and moisture and stored at 20°-25°C (68°-77°F); [See USP Controlled Room
Dispense in tight, light-resistant containers.image6
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
Customer toll-free number: 1-877-748-1970
Novast Laboratories Ltd.
Nantong, China 226009
| NIFEDIPINE |
nifedipine tablet, extended release
|Labeler — NuCare Pharmaceuticals,Inc. (010632300)|
|NuCare Pharmaceuticals,Inc.||010632300||repack (68071-4411)|
Revised: 02/2022 NuCare Pharmaceuticals,Inc.
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