Diphenoxylate Hydrochloride And Atropine Sulfate
Diphenoxylate Hydrochloride And Atropine Sulfate Prescribing Information
Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Diphenoxylate hydrochloride and atropine sulfate tablets are recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate tablets. The use of diphenoxylate hydrochloride and atropine sulfate tablets should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate tablets until appropriate corrective therapy has been indicated (
Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in:
- Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (seeWARNINGS).
- Patients with diarrhea associated with pseudomembranous enterocolitis (Clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (seeWARNINGS).
- Patients with known hypersensitivity to diphenoxylate or atropine.
- Patients with obstructive jaundice.
The following serious adverse reactions are described elsewhere in labeling:
- Respiratory and/or CNS depression (seeWARNINGS)
- Anticholinergic and opioid-toxicities, including atroponism (seeWARNINGSandPRECAUTIONS)
- Dehydration and electrolyte imbalance (seeWARNINGS)
- GI complications in patients with infectious diarrhea (seeWARNINGS)
- Toxic megacolon in patients with acute ulcerative colitis (seeWARNINGS)
At
The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes.
Alcohol
Alcohol may increase the CNS depressant effects of diphenoxylate hydrochloride and atropine sulfate tablets and may cause drowsiness (
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 0.01 mg of atropine).
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 diphenoxylate hydrochloride and atropine sulfate tablets include silicified microcrystalline cellulose, pregelatinized starch, and magnesium stearate.