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Diphenoxylate and Atropine (Diphenoxylate Hydrochloride / Atropine Sulfate) - Description

 


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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLETS, USP Cv

Rx Only

DESCRIPTION

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 and has the following structural formula:

Molecular formula C30H32N2O2•HCl                                        M.W. 489.05

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 and has the following structural formula:

Molecular formula (C17H23NO3)2•H2SO4•H2O                                        M.W. 694.83

A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.

In addition, each tablet contains the following inactive ingredients: lactose monohydrate, acacia, calcium stearate, methylcellulose, and corn starch.

Page last updated: 2008-01-23

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