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.
Afeditab® CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with ELN 30, and are supplied in bottles of 100 and 500.
Afeditab® CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with ELN 60, and are supplied in bottles of 100 and 500.
The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.
Watson Laboratories, Inc.
Corona, CA 92880 USA
Elan Pharma International Ltd.
Athlone, Co. Westmeath, Ireland
Rev. 09/07 CP0346D