Diphenoxylate

Side effects, and when to stop

The following serious adverse reactions are described elsewhere in labeling:

• Respiratory and/or CNS depression (see WARNINGS )
• Anticholinergic and opioid-toxicities, including atropinism (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 tablets, 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.

To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Who should not take it

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 (see WARNINGS ).
• Patients with diarrhea associated with pseudomembranous enterocolitis ( Clostridium difficile ) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS ).
• Patients with known hypersensitivity to diphenoxylate or atropine.
• Patients with obstructive jaundice.