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DIPHENOXYLATE Hydrochloride AND ATROPINE Sulfate Tablets, C-V (GREENSTONE LLC)

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DIPHENOXYLATE Hydrochloride AND ATROPINE Sulfate Tablets, C-V (GREENSTONE LLC) Quick Finder

INDICATIONS AND USAGE

Diphenoxylate hydrochloride and atropine sulfate is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

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DOSAGE AND ADMINISTRATION

Management of Diarrhea in Patients 13 Years of Age and Older

Diphenoxylate hydrochloride and atropine sulfate is recommended as adjunctive...

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CONTRAINDICATIONS

Diphenoxylate hydrochloride and atropine sulfate is contraindicated in:

  • Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS)...
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WARNINGS

Respiratory and/or CNS Depression in Pediatric Patients Less Than 6 Years of Age

Cases of severe respiratory depression and coma, leading to permanent brain...

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ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in labeling:

  • Respiratory and/or CNS depression (see WARNINGS)
  • ...
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DRUG ABUSE AND DEPENDENCE

Controlled substance

Diphenoxylate hydrochloride and atropine sulfate is classified as a Schedule V controlled substance by federal regulation...

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OVERDOSAGE

Diagnosis

Overdosage can be life-threatening. Symptoms of overdosage may include opioid and/or anticholinergic effects including respiratory depression,...

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DESCRIPTION

Each diphenoxylate hydrochloride and atropine sulfate tablet contains:

2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to...

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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...

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HOW SUPPLIED

Tablets — round, white, with SEARLE debossed on one side and 61 on the other side and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as...

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This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

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