ADALAT CC is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Dosage should be adjusted according to each patient's needs. It is recommended that ADALAT CC be administered orally once daily on an empty stomach. ADALAT CC 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 ADALAT CC 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 ADALAT CC to assure that the extended release dosage form has been prescribed.

ADALAT® CC Tablets are supplied in:

The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light- resistant containers.

Manufactured by: Bayer Pharmaceuticals Corporation, 400 Morgan Lane, West Haven, CT 06516. Made in Germany. Distributed by: Schering Corporation, Kenilworth, NJ 07033. ADALAT is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation. 10/04. FDA Rev date: 4/1/2005

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