April 29, 2017
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Afeditab CR

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Afeditab CR

AFEDITAB® CR
(nifedipine) Extended-Release Tablets

DRUG DESCRIPTION

Afeditab® CR is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2- nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula:

AFEDITAB® CR (Nifedipine) Structural Formula Illustration

Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3.

Afeditab® CR tablets contain either 30 mg or 60 mg of nifedipine for once-a-day oral administration.

Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate (60 mg), magnesium stearate, and microcrystalline cellulose (30 mg). The inert ingredients in the film coating are: hypromellose, iron oxide, polyethylene glycol, and titanium dioxide. The ingredients of the printing ink are: ammonium hydroxide, iron oxide black, isopropyl alcohol, nbutyl alcohol, propylene glycol and shellac.

Does not meet USP Drug Release Test.

Last reviewed on RxList: 2/22/2016
This monograph has been modified to include the generic and brand name in many instances.

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