SUMMARY
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLETS, USP Cv
Each tablet, for oral administration, contains:
Diphenxylate Hydrochloride
2.5 mg
(Warning-May be habit forming)
Atropine Sulfate..................................................................................... 0.025 mg
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride.
Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate.
A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.
diphenoxylate and atropine (diphenoxylate/atropine) is indicated for the following:
Diphenoxylate Hydrochloride and Atropine Sulfate tablets are effective as adjunctive therapy in the management of diarrhea.
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