Enablex (Darifenacin) - Description

ENABLEX ^®

(darifenacin)

Extended - release tablets

Rx only

Prescribing Information

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

      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.