LOMOTIL

FDA label

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Renal Use with extreme caution in advanced hepatorenal disease (hepatic coma may be precipitated)

Hepatic Use with extreme caution in advanced hepatorenal disease and abnormal liver function (hepatic coma may be precipitated)

Clinical improvement of acute diarrhea usually within 48 hours; if no improvement of chronic diarrhea within 10 days at maximum dose, discontinue

Instructions

• Accompany with appropriate fluid and electrolyte therapy when indicated
• Withhold if severe dehydration or electrolyte imbalance until corrected
• Reduce dose after initial control of diarrhea
• May cause drowsiness/dizziness — avoid driving/machinery until effect known

Available strengths

• tab 2.5/0.025 mg
• sol 2.5/0.025 mg/5 mL

Contraindications

• Pediatric patients less than 6 years of age (risk of respiratory and CNS depression)
• Diarrhea associated with pseudomembranous enterocolitis (C. difficile) or other enterotoxin-producing bacteria (risk of GI complications, including sepsis)
• Obstructive jaundice

Cautions

• Respiratory/CNS depression in children <6 yr (coma, permanent brain damage, death)
• Anticholinergic and opioid toxicities (onset may be delayed up to 30 hours)
• Dehydration and electrolyte imbalance
• GI complications in infectious diarrhea; toxic megacolon in acute ulcerative colitis
• Atropinism (esp. in Down syndrome patients)
• Potentiates other CNS depressants and alcohol

Adverse reactions

• Numbness of extremities, euphoria, depression, malaise/lethargy, sedation/drowsiness, dizziness, headache
• Anaphylaxis/angioedema/urticaria, pruritus
• Megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort
• Atropine effects: hyperthermia, tachycardia, urinary retention, flushing, dry skin/mucous membranes

Pregnancy No adequate well-controlled studies; use only if anticipated benefit justifies potential risk to the fetus

Lactation Diphenoxylic acid may be excreted in breast milk and atropine is excreted in breast milk; exercise caution in nursing women