Nifedipine (Page 5 of 5)

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. 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.

Co-administration 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.

HOW SUPPLIED

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

Temperature].

Dispense in tight, light-resistant containers.

image6image6

SPL UNCLASSIFIED

Manufactured for:

Ingenus Pharmaceuticals, LLC

Orlando, FL 32839-6408

Customer toll-free number: 1-877-748-1970

Manufactured by:

Novast Laboratories Ltd.

Nantong, China 226009

Rx Only

I0086

Iss. 01/2017

Rev. A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP
(click image for full-size original)

NIFEDIPINE
nifedipine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4411(NDC:50742-621)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 60 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 3350
LECITHIN, SOYBEAN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Product Characteristics
Color pink Score no score
Shape ROUND Size 9mm
Flavor Imprint Code Novast;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4411-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68071-4411-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68071-4411-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202987 02/15/2017
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4411)

Revised: 02/2022 NuCare Pharmaceuticals,Inc.

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