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Nifediac (Nifedipine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Nifediac CC® Extended-release Tablets, USP 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 Tablets, USP be administered orally once daily on an empty stomach. Nifediac CC® Extended-release Tablets, USP 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 Nifediac CC® Extended-release Tablets, USP is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

Coadministration of nifedipine with grapefruit juice is to be avoided (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Care should be taken when dispensing Nifediac CC® Extended-release Tablets, USP to assure that the extended-release dosage form has been prescribed.

HOW SUPPLIED

Nifediac CC® Extended-release Tablets, USP are supplied as 90 mg round film coated tablets as follows:

Strength Color Markings
90 mg Yellow 90 mg unscored, round
film coated tablets,
engraved with “B” on
one side and “90” on
the other side.
Nifediac CC® Extended-release Tablets, USP are supplied in:

Bottles of 100
Strength
90 mg
NDC Code
0093-1023-01

The tablets should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

Manufactured In Canada By:
Biovail Corporation
Mississauga, ON CANADA
L5N 8M5

Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

LB0023-03 Rev. 07/09

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