loperamide/simethicone (OTC)

Brand and Other Names:Imodium Multi-Symptom Relief
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Dosing & Uses

AdultPediatricGeriatric

Dosing Form & Strengths

loperamide/simethicone

tablet

  • 2mg/125mg

tablet, chewable

  • 2mg/125mg

Diarrhea/Flatulence

After each loose bowel movement: 2 tablets once initially, then 1 tab/dose with each subsequent loose stool up to 4 tab/day

Dosing Form & Strengths

loperamide/simethicone

tablet

  • 2mg/125mg

tablet, chewable

  • 2mg/125mg

Diarrhea/Flatulence

<6 years: Safety and efficacy not established

6-8 years: 1 tablet once initially, then one-half tablet/dose, up to 2 tablets/day

9-12 years: 1 tablet once initially, then one-half tablet/dose, up to 3 tablets/day

≥ 12 years: After each loose bowel movement: 2 tablets once initially, then 1 tab/dose with each subsequent loose stool up to 4 tab/day

Diarrhea/Flatulence

After each loose bowel movement: 2 tablets once initially, then 1 tab/dose with each subsequent loose stool up to 4 tab/day

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Interactions

Interaction Checker

and loperamide/simethicone

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            Adverse Effects

            Frequency Not Defined

            Dizziness

            Fatigue

            Headache

            Abdominal pain

            Dry mouth

            Nausea

            Diarrhea

            Vomiting

            Pancreatitis

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            Warnings

            Contraindications

            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

            Cautions

            Chewable tab should be chewed thoroughly before swallowing

            loperamide

            • May cause drowsiness or dizziness, which may impair physical abilities to operate heavy machinery or tasks requiring mental alertness
            • Hypersensitivity reactions reported, including anaphylaxis, rash, urticaria, and rare cases of Steven’s Johnson syndrome or toxic epidermal necrolysis
            • Discontinue if no improvement seen within 48 hr in patients with acute diarrhea, symptoms worsen, or abdominal swelling or bulging develops
            • Discontinue promptly if constipation, abdominal pain or distention, blood in stool, or ileus develops; do not use when peristalsis inhibition should be avoided (ie, due to potential for ileus, megacolon, or toxic megacolon)
            • Discontinue therapy if symptoms of abdominal distention occur in patients with AIDS; cases of toxic megacolon reported with infectious colitis, resulting from viral or bacterial pathogens
            • Use with caution in patients with hepatic impairment due to reduced first pass metabolism; monitor for signs of CNS toxicity
            • Use of higher than recommended doses or abuse of loperamide can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes, or other ventricular arrhythmias, syncope, and cardiac arrest; in cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects

            simethicone

            • Can cause false-negative gastric guaiac test
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            Pregnancy & Lactation

            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

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Slows intestinal motility by direct effects on circular & longitudinal muscle (loperamide); changes surface tension of gas bubbles, causing collapse of foam bubbles, thus allow easier passage (simethicone)

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