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.
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.
Opioid + anticholinergic.
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).