Adult Dosing

Acute diarrhea associated with gas-related abdominal discomfort

• 2 TABS (loperamide 2 mg/simethicone 125 mg) after first loose stool, followed by 1 TABS after each subsequent loose stool
• Max: 4 TABS/day (loperamide 2 mg/simethicone 125 mg)

Note:

• Discontinue the therapy once loose stools have resolved

Pediatric Dosing

Acute diarrhea associated with gas-related abdominal discomfort

• 6-8 yrs (48-59 lb)
• 1 TABS (loperamide 2 mg/simethicone 125 mg) after first loose stool, followed by 1/2 TABS after each subsequent loose stool
• Max: 2 TABS/day

• 9-11 yrs (60-95 lb)
• 1 TABS (loperamide 2 mg/simethicone 125 mg) after first loose stool, followed by 1/2 TABS after each subsequent loose stool
• Max: 3 TABS/day

• 12 yrs
• 2 TABS (loperamide 2 mg/simethicone 125 mg) after first loose stool, followed by 1 TABS after each subsequent loose stool
• Max: 4 TABS/day

Note:

• Discontinue the therapy once loose stools have resolved

[Outline]

• Adult Dosing
• Pediatric Dosing

• Symptomatic control of acute, nonspecific diarrhea associated with gas-related abdominal discomfort

• Hypersensitivity to any of the ingredients of the product
• Abdominal pain without diarrhea
• As primary therapy in severe ulcerative colitis
• As primary therapy in Pseudomembranous colitis
• As primary therapy in bloody or infectious diarrhea
• Children >2 yrs

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised, dose adjustments not defined

See Supplemental Patient Information

• Administer appropriate fluid and electrolyte as fluid and electrolyte depletion often occur in patients who have diarrhea and loperamide/simethicone does not preclude the need for appropriate fluid and electrolyte therapy
• If symptoms get worse or diarrhea last for more than 2 days, abdominal swelling or buldiging occurs, discontinue the drug and provide immediate medical attention as these are the signs of serious condition
• Do not administer when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon
• Toxic megacolon has been reported in ADIS patients when treated infectious colitis with loperamide, hence use cautiously and stop the therapy at the earliest signs of abdominal distention
• Anaphylaxis reactions have been reported

Cautions: Use cautiously in

• Hepatic impairment
• AIDS patients
• Pediatric patients
• Fluid and electrolyte depletion

Supplemental Patient Information

• Advise patients to consult their physician if symptoms get worse or diarrhea last for more than 48 hrs

Pregnancy Category:C

Breastfeeding: Simethicone is not absorbed orally, hence cannot be transferred to breastmilk. It is also used safely in breastfed infants. No special precautions are required. Loperamide use during breastfeeding is unlikely to affect the infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 8 April 2011).

• CNS: Dizziness, drowsiness
• GI: Abdominal pain, abdominal distension or discomfort, constipation, nausea, vomiting, dry mouth, epigastric pain
• MISC: Fatigue

Loperamide

• Antiperistaltic; inhibits peristaltic activity by a direct effect on the circular and longitudinal muscles of the intestinal wall and affects water and electrolyte movement through intestine
• Metabolized by liver; CYP450: 2B6, 2C8, 2D6,3A4
• Excreted mainly in feces, urine
• Half-life: 10.8 hrs

Simethicone

• Antiflatulent; relieves flatulence by dispersing and preventing formation of mucus-surrounded gas pockets in GI tract
• Metabolism: Unknown
• Excreted unchanged in feces
• Half-life: Unknown

US Trade Name(s)

• Imodium Multi-Symptom Relief

US Availability

loperamide/simethicone (generic)

• OTC CHEW TABS: 2 mg/125 mg
• OTC TABS: 2 mg/125 mg

Imodium Multi-Symptom Relief (loperamide/simethicone)

• OTC CHEW TABS: 2 mg/125 mg
• OTC TABS: 2 mg/125 mg

Canadian Trade Name(s)

• Imodium Advanced Multi-Symptom

Canadian Availability

Imodium Advanced Multi-Symptom (loperamide/simethicone)

• OTC CHEW TABS: 2 mg/125 mg
• OTC TABS: 2 mg/125 mg

UK Trade Name(s)

• Imodium Plus

UK Availability

Imodium Plus (loperamide/simethicone)

• TABS: 2 mg/125 mg

Australian Trade Name(s)

• Imodium Advanced

Australian Availability

Imodium Advanced (loperamide/simethicone)

• OTC CHEW TABS: 2 mg/125 mg

[Outline]

Gastrointestinal

Antidiarrheal Combinations