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

ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in labeling:

  • Respiratory and/or CNS depression (see WARNINGS)
  • Anticholinergic and opioid-toxicities, including atroponism (see WARNINGS and PRECAUTIONS)
  • Dehydration and electrolyte imbalance (see WARNINGS)
  • GI Complications in patients with infectious diarrhea (see WARNINGS)
  • Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS)

At therapeutic doses of diphenoxylate hydrochloride and atropine sulfate, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency:

Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination

Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus

Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort

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.

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