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loperamide/simethicone (Imodium Multi-Symptom Relief)

 

Classes: Antidiarrheals

Dosing and uses of Imodium Multi-Symptom Relief (loperamide-simethicone)

 

Adult dosage forms and 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

 

Pediatric dosage forms and 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

 

Geriatric dosage forms and strengths

 

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

 

Imodium Multi-Symptom Relief (loperamide-simethicone) adverse (side) effects

Frequency not defined

Dizziness

Fatigue

Headache

Abdominal pain

Dry mouth

Nausea

Diarrhea

Vomiting

Pancreatitis

 

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

 

Pregnancy and 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.

 

Pharmacology of Imodium Multi-Symptom Relief (loperamide-simethicone)

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)