Afeditab CR (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Afeditab® CR 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 Afeditab® CR 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 Afeditab® CR to assure that the extended-release dosage form has been prescribed.

HOW SUPPLIED

Product: 68151-4223

NDC: 68151-4223-0 1 TABLET, FILM COATED, EXTENDED RELEASE in a PACKAGE

Nifediac CC 30 mg tabs

Label ImageLabel Image
AFEDITAB CR nifedipine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-4223(NDC:0591-3193)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSES
FERRIC OXIDE RED
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
Product Characteristics
Color BROWN (brownish-red) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code ELN;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-4223-0 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075128 11/01/2002
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-4223)

Revised: 08/2016 Carilion Materials Management

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