Adalat CC (Nifedipine) - Indications and Dosage

INDICATION AND USAGE

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

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

ADALAT CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:

Strength	Color	Markings
30 mg	Pink	30 on one side and ADALAT CC on the other side
60 mg	Salmon	60 on one side and ADALAT CC on the other side
90 mg	Dark Red	90 on one side and ADALAT CC on the other side

ADALAT  CC Tablets are supplied in:

	Strength	NDC Code
Bottles of 100	30 mg	0085-1701-02
	60 mg	0085-1716-02
	90 mg	0085-1722-01
Unit Dose Packages of 100	30 mg	0085-1701-03
	60 mg	0085-1716-03
	90 mg	0085-1722-02
Bottles of 1000	30 mg	0085-1701-01
	60 mg	0085-1716-01

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 HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
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.

Rx Only

08935206, R.2
5/08

©2008 Bayer HealthCare Pharmaceuticals Inc.
Printed in U.S.A.