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Drug Details

Imodium Plus Caplets GSL

• Drug Class Description
  Antipropulsive antidiarrheals - ATC code: A07D A53
• Generic Name
  simeticone, loperamide hydrochloride
• Presentation
  Tablet, uncoated White, capsule-shaped tablets debossed with “IMO” on one side, the other side is debossed with a line between “2”and “125”.
• Description
  Each tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone.
• Indications
  

  Imodium Plus Caplets are indicated for the symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years when acute diarrhoea is associated with gas-related abdominal discomfort including bloating, cramping or flatulence.

• Adult Dosage
  

  The tablets should be taken with liquid.

  Adults over 18 years:

  Take two caplets initially, followed by one caplet after every loose stool. Not more than 4 caplets should be taken in a day, limited to no more than 2 days.

  Use in renal impairment:

  No dosage adjustment is necessary in renal impairment.

  Hepatic impairment:

  Although no pharmacokinetic data are available in patients with hepatic insufficiency, Imodium Plus should be used with caution in such patients because of reduced first pass metabolism.

• Child Dosage
  

  Adolescents between 12 and 18 years:

  Take one caplet initially, followed by one caplet after every loose stool. Not more than 4 caplets should be taken in a day, limited to no more than 2 days.

  Use in children:

  Imodium Plus must not be used in children under 12 years.

• Elderly Dosage
  

  No dosage adjustments are required for the elderly.

• Contra Indications
  

  Imodium Plus must not be used in:

  • Children less than 12 years of age

  • Patients with a known hypersensitivity (allergy) to loperamide hydrochloride, simeticone or any of the excipients

  • Patients with acute dysentery, which is characterised by blood in stool and high fever

  • Patients with acute ulcerative colitis

  • Patients with pseudomembranous colitis associated with broad spectrum antibiotics

  • Patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter

  Imodium Plus should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. It must be discontinued promptly if constipation, ileus or abdominal distension develop.

• Special Precautions
  

  Treatment of diarrhoea with loperamide-simeticone is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate.

  In patients with (severe) diarrhoea, fluid and electrolyte depletion may occur. It is important that attention is paid to appropriate fluid and electrolyte replacement.

  If clinical improvement is not observed within 48 hours, the administration of Imodium Plus must be discontinued. Patients should be advised to consult their physician.

  Patients with AIDS treated with Imodium Plus for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

  Although no pharmacokinetic data are available in patients with hepatic impairment, Imodium Plus should be used with caution in such patients because of reduced first pass metabolism. This medicine must be used with caution in patients with hepatic impairment as it may result in a relative overdose leading to central nervous system (CNS) toxicity. Imodium Plus should be used under medical supervision in patients with severe hepatic dysfunction.

• Interactions
  

  Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase in loperamide plasma concentrations. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is given at recommended dosages, is unknown.

  The concomitant administration of loperamide (4 mg single dose) and itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4-fold increase in loperamide plasma concentrations. In the same study a CYP2C8 inhibitor, gemfibrozil, increased loperamide by approximately 2-fold. The combination of itraconazole and gemfibrozil resulted in a 4-fold increase in peak plasma levels of loperamide and a 13-fold increase in total plasma exposure. These increases were not associated with measured CNS effects, as measured by psychomotor tests (i.e. subjective drowsiness and the Digit Symbol Substitution Test).

  The concomitant administration of loperamide (16 mg single dose) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in loperamide plasma concentrations. This increase was not associated with increased pharmacodynamic effects as measured by pupillometry.

  Concomitant treatment with oral desmopressin resulted in a 3-fold increase of desmopressin plasma concentrations, presumably due to slower gastrointestinal motility.

  It is expected that drugs with similar pharmacological properties may potentiate loperamide's effect and that drugs that accelerate gastrointestinal transit may decrease its effect.

  Since simeticone is not absorbed from the gastrointestinal tract, no relevant interactions between simeticone and other drugs are expected.

• Adverse Drug Reactions
  

  The use of loperamide plus simeticone, in the treatment of the symptoms of diarrhoea, and gas-related abdominal discomfort associated with acute diarrhoeal illness, was studied in five placebo-controlled, and active-controlled, clinical trials involving 462 adults treated with loperamide plus simeticone. The most frequently reported Adverse Drug Reactions (ADRs) associated with the use of the drug in these clinical trials were nausea and dysgeusia, reported in 1.7% and 1.9% of patients, respectively, and were considered Common.

  Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of loperamide plus simeticone, or loperamide alone, from either clinical trial or post-marketing experiences. The displayed frequency categories use the following convention:

  Very common ( 1/10); Common ( 1/100 to < 1/10); Uncommon ( 1/1,000 to < 1/100); Rare ( 1/10,000 to < 1/1,000); Very rare (< 1/10,000), Not known (cannot be estimated from the available data)

  System Organ Class	Adverse Reactions
  	Frequency
  	Common	Uncommon	Unknown
  Immune system disorders			Hypersensitivity including: Anaphylactic Shock, Anaphylactoid Reaction
  Nervous System Disorders		Somnolence	Loss of consciousness, Depressed level of consciousness, Dizziness
  Gastrointestinal disorders	Nausea, Dysgeusia	Constipation	Megacolon, including Toxic Megacolon; Ileus; Abdominal Pain; Vomiting; Abdominal Distension; Dyspepsia; Flatulence
  Skin and subcutaneous tissue disorders		Rash	Angioedema, Urticaria, Pruritus
  Renal and urinary disorders			Urinary Retention