DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Post-LOE

atropine sulfate; diphenoxylate hydrochloride

R-Pharm US

ANDAORALTABLET

Approved

Dec 1978

Lifecycle

Post-LOE

Competitive Pressure

30/100

Data completeness

3/8 — Basic

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (atropine sulfate; diphenoxylate hydrochloride) by R-Pharm US is clinical pharmacology diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. Approved for older for: atropine is an anticholinergic agent indicated in adults, older for: cycloplegia () mydriasis () penalization of the healthy eye in the treatment of amblyopia () 1. First approved in 1978.

Drug data last refreshed 18h ago

Mechanism of Action

CLINICAL PHARMACOLOGY Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5-mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution…

Indications (2)

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.