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Loperamide/Simethicone

    DEA Class; OTC

    Common Brand Names; Imodium Multi-Symptom Relief

    • Antidiarrheals

    Antidiarrheal and antiflatulent combination product
    Approved for self-treatment of acute diarrhea accompanied by bloating, cramps, and gas
    Supratherapeutic doses of loperamide have been associated with serious, sometimes fatal, cardiac events

    Indicated for self-treatment of acute diarrhea accompanied by bloating, cramps, pressure or flatulence.

    Hypersensitivity, bloody diarrhea, high fever, infectious diarrhea, pseudomembranous colitis

    Patients in whom constipation must be avoided

    Abdominal pain without diarrhea

    Avoid use as primary therapy with acute dysentery (bloody stools and high fever, acute ulcerative colitis, bacterial enterocolitis [caused by Salmonella, Shigella, and Campylobacter), pseudomembranous colitis associated with antibiotic use)

    Age <2 years

    • Dizziness
    • Fatigue
    • Headache
    • Abdominal pain
    • Dry mouth
    • Nausea
    • Diarrhea
    • Vomiting
    • Pancreatitis

    Chewable tab should be chewed thoroughly before swallowing

    Pregnancy category: B (loperamide); C (simethicone)

    Lactation: Unknown if distributed in to breast milk, use caution

    Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

    Adults

    8 mg/24 hours PO loperamide; 500 mg/24 hours PO simethicone.

    Geriatric

    8 mg/24 hours PO loperamide; 500 mg/24 hours PO simethicone.

    Adolescents

    8 mg/24 hours PO loperamide; 500 mg/24 hours PO simethicone.

    Children

    12 years: 8 mg/24 hours PO loperamide; 500 mg/24 hours PO simethicone.
    9—11 years (60—95 pounds): 6 mg/24 hours PO loperamide; 375 mg/24 hours PO simethicone.
    6—8 years (48—59 pounds): 4 mg/24 hours PO loperamide; 250 mg/24 hours PO simethicone.
    < 6 years (<= 47 pounds): Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Loperamide hydrochloride/simethicone

    Imodium Multi-Symptom Relief/Loperamide Hydrochloride, Simethicone/Loperamide, Simethicone Oral Tab: 2-125mg