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ENABLEX®
(darifenacin) Extended-Release Tablets

DRUG DESCRIPTION

ENABLEX® (darifenacin) is an extended-release tablet which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.

Chemically, darifenacin hydrobromide is (S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C28H30N2O2.HBr.

The structural formula is

ENABLEX® (darifenacin) Structural Formula Illustration

Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5.

ENABLEX is a once-a-day extended-release tablet and contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hydroxypropyl methylcellulose (hypromellose), lactose monohydrate, magnesium stearate, titanium dioxide and triacetin. The 15-mg tablet also contains FD&C Yellow No. 6 Aluminum Lake.

Brand Name: Enablex
Generic Name: Darifenacin Extended-Release Tablets

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