Nifediac (Nifedipine) - Indications and Dosage

INDICATIONS AND USAGE

Nifediac^™ CC extended-release tablets are 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 Nifediac^™ CC extended-release tablet be administered orally once daily on an empty stomach. Nifediac^™ CC extended-release tablet 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 Nifediac^™ CC extended-release tablets are necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Care should be taken when dispensing Nifediac^™ CC extended-release tablet to assure that the extended release dosage form has been prescribed.

Co-administration of nifedipine with grapefruit juice is to be avoided (See CLINICAL PHARMACOLOGY and PRECAUTIONS ).

HOW SUPPLIED

Nifediac^™ CC extended-release tablets are supplied as 30 mg round film coated tablets as follows:

Strength	Color	Markings
30 mg	Mustard yellow	30 mg unscored, round film coated tablets, engraved with "B" on one side and "30" on the other side.

Nifediac^™ CC Extended-release Tablets are supplied in:

	Strength	NDC Code
Bottles of 100	30 mg	0093-5272-01
Bottles of 300	30 mg	0093-5272-55
Bottles of 1000	30 mg	0093-5272-10

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

Manufactured by:
Biovail Corporation
Mississauga, ON, CANADA
L5N8M5

Manufactured for:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

LB0008-02
Rev. 10/03