(diphenoxylate HCl, atropine sulfate)

Prescribing Information
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ADVERSE REACTIONS

ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in labeling:

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

At therapeutic doses of Lomotil, 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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