CP0346B
Afeditab® CR
(Nifedipine Extended-Release Tablets)
Revised: July 2005
Rx only
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:
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: alcohol SDA, dehydrated alcohol, deionized water, iron oxide black, lecithin, shellac, simethicone, and 2 ethoxyethanol.
Does not meet USP Drug Release Test.
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