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  • Lomotil
    (atropine sulfate/diphenoxylate hydrochloride)

    THERAPEUTIC CLASS

    Anticholinergic/opioid

    DEA CLASS

    CV

    INDICATIONS

    Adjunctive therapy for management of diarrhea.

    ADULT DOSAGE

    Adults: Initial: 2 tabs or 10mL qid. Titrate: Reduce dose after symptoms are controlled. Maint: 2 tabs or 10mL qd. Max: 20mg/day diphenoxylate. D/C if symptoms not controlled after 10 days at max dose of 20mg/day (diphenoxylate).

    PEDIATRIC DOSAGE

    Pediatrics: 2-12 Yrs: Initial: 0.3-0.4mg/kg/day of solution in four divided doses. Titrate: Reduce dose after symptoms are controlled. Maint: May be as low as 25% of initial dose. D/C if no improvement within 48 hrs.

    ADMINISTRATION

    Oral route. Plastic dropper should be used when measuring liquid for administration to children.

    HOW SUPPLIED

    (Diphenoxylate-Atropine) Sol: 2.5mg-0.025mg/5mL [60mL]; Tab: 2.5mg-0.025mg

    CONTRAINDICATIONS

    Obstructive jaundice, diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.

    WARNINGS/PRECAUTIONS

    Avoid in children <2 yrs. Overdosage may result in severe respiratory depression and coma, leading to brain damage or death. Avoid use with severe dehydration or electrolyte imbalance until corrective therapy is initiated. May induce toxic megacolon with acute ulcerative colitis; d/c if abdominal distention occurs or untoward symptoms develop. May cause intestinal fluid retention. Avoid with diarrhea associated with organisms that penetrate the intestinal mucosa, and with pseudomembranous enterocolitis. Extreme caution with advanced hepatorenal disease and liver dysfunction. Caution in pediatrics, especially with Down's syndrome.

    ADVERSE REACTIONS

    Numbness of extremities, dizziness, anaphylaxis, drowsiness, toxic megacolon, N/V, urticaria, pruritus, anorexia, pancreatitis, paralytic ileus, euphoria, malaise/lethargy.

    DRUG INTERACTIONS

    MAOIs may precipitate hypertensive crisis. (Diphenoxylate) May potentiate barbiturates, tranquilizers, and alcohol. Potential to prolong T1/2 of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.

    PREGNANCY AND LACTATION

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Diphenoxylate: Antidiarrheal. Atropine: Anticholinergic.

    PHARMACOKINETICS

    Absorption: (4 tabs): Cmax=163ng/mL; Tmax=2 hrs. Metabolism: Rapid and extensive metabolism through ester hydrolysis to diphenoxylic acid (major metabolite). Elimination: Urine (14%), feces (49%). T1/2=12-14 hrs (diphenoxylic acid).

    ASSESSMENT

    Assess for hypersensitivity, obstructive jaundice, diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria, severe dehydration, electrolyte imbalance, hepatic dysfunction, hepatorenal disease, ulcerative colitis, Down's syndrome, diarrhea (caused by Escherichia coli, Salmonella, Shigella), pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for severe dehydration, electrolyte imbalance, renal function, toxic megacolon in ulcerative colitis, abdominal distention, signs of atropinism, and other adverse reactions.

    PATIENT COUNSELING

    Instruct to take ud and not to exceed the recommended dosage. Inform of consequences of overdosage, including severe respiratory depression and coma, possibly leading to permanent brain damage or death. Instruct to exercise caution while operating machinery/driving. Advise to avoid alcohol and other CNS depressants. Advise to keep medicines out of reach of children. Inform patient that drowsiness or dizziness may occur.

    STORAGE

    Dispense liquids in original container.