Lomotil® Cv
(diphenoxylate hydrochloride
and atropine sulfate tablets, USP)
Tablets
(diphenoxylate hydrochloride
and atropine sulfate oral solution, USP)
Liquid
DESCRIPTION
Each Lomotil tablet and each 5 ml of Lomotil liquid for oral use contains:
diphenoxylate hydrochloride 2.5 mg
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:
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:
A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.
Inactive ingredients of Lomotil tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc. Inactive ingredients of Lomotil liquid include cherry flavor, citric acid, ethyl alcohol 15%, FD&C Yellow No. 6, glycerin, sodium phosphate, sorbitol, and water.
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