Generic Name and Formulations:
Diphenoxylate HCl 2.5mg, atropine sulfate 0.025mg; tabs.
Indications for LOMOTIL:
Adjunct therapy in the management of diarrhea.
≥13yrs: 2 tabs 4 times daily until diarrhea is controlled; max 20mg/day. Maintenance: 2 tabs daily. Discontinue if no improvement within 10 days after treatment with max dose.
<13yrs: not established.
Age <6yrs (risks of respiratory and/or CNS depression). Diarrhea associated with pseudomembranous enterocolitis or other enterotoxin-producing bacteria due to risk of GI complications (including sepsis). Obstructive jaundice.
Dehydration. Electrolyte imbalance. Acute ulcerative colitis; discontinue if toxic megacolon occurs. Hepatic or renal impairment. Drug abusers. Pregnancy. Nursing mothers.
Opioid + anticholinergic.
Avoid alcohol. Concomitant MAOIs may cause hypertensive crisis; avoid use. Potentiates sedation with alcohol or other CNS depressants (eg, barbiturates, benzodiazepines, sedatives/hypnotics, anxiolytics, tranquilizers, general anesthetics, antipsychotics, opioids, buspirone, antihistamines, muscle relaxants); monitor closely. May delay elimination of other drugs metabolized by CPY450.
Nausea, vomiting, abdominal discomfort, paralytic ileus, toxic megacolon, dizziness, drowsiness, headache, euphoria, tachycardia, numbness of extremities, pruritus, urticaria, angioneurotic edema, anticholinergic effects; respiratory depression (overdosage), atropinism (esp. in pediatrics with Down's syndrome).