Lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Lomotil is 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 Lomotil. The use of Lomotil should be accompanied by appropriate fluid and electrolyte therapy when indicated. If severe dehydration or electrolyte imbalance is present, do not administer Lomotil until appropriate corrective therapy has been indicated. See package insert for complete information.

The following serious adverse reactions are described elsewhere in labeling:
• Respiratory and/or CNS depression.
• Anticholinergic and opioid-toxicities, including atroponism.
• Dehydration and electrolyte imbalance.
• GI Complications in patients with infectious diarrhea.
• Toxic megacolon in patients with acute ulcerative colitis. See package insert for complete information.

Lomotil is 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.

Since a subtherapeutic dose of atropine has been added to Lomotil, consideration should be given to the development of adverse reactions associated with of atropine (see WARNINGS). Lomotil has caused atropinism (hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes), particularly in pediatric patients with Down’s syndrome. See package insert for complete information.