Imodium

Loperamide Hydrochloride 2mg - 4 Capsules

Imodium Indications

Imodium is indicated for:

• The control and symptomatic treatment of acute nonspecific diarrhoea, and of chronic diarrhoea.
• Reducing the volume of discharge in patients with ileostomies, colostomies, and other intestinal resections.

Imodium Dosage and Administration

Acute Diarrhoea: The recommended initial dose of Imodium in adults is two capsules or caplets or tablets (4 mg) followed by one capsule or caplet or tablet (2 mg) after each unformed stool. Daily dose should not exceed eight capsules or caplets or tablets (16 mg). Clinical improvement is usually observed within 48 hours.

Chronic Diarrhoea and Reduction in Volume of Discharge of Intestinal Resections: The recommended initial dose of Imodium is two capsules or caplets or tablets (4 mg) followed by one capsule or caplet or tablet (2 mg) after each unformed stool until diarrhoea is controlled, after which dosage of Imodium should be reduced to meet individual requirements. When the optimal maintenance daily dosage has thus been established, this amount can then be administered as a single dose or in two or three divided doses.

The average daily maintenance dosage in clinical trials was two to four capsules (4-8 mg). A dosage of five capsules (10 mg) was rarely exceeded. A temporary exacerbation of diarrhoea was controlled by increasing the Ioperamide dosage to achieve further control followed by titration back to the established maintenance dose.

Imodium Contraindications

Imodium is contraindicated in patients with known hypersensitivity to Ioperamide or to any of the excipients.

Imodium should not be used as the primary therapy:

• in patients with acute dysentery, which is characterised by blood in stools and high fever;
• in patients with acute ulcerative colitis;
• in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter;
• in patients with pseudomembranous colitis associated with the use of broad-spectum antibiotics.

In general, Imodium 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. Imodium must be discontinued promptly when constipation, abdominal distension or ileus develop.

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

Imodium is contraindicated in children under the age of 12 years.

Imodium Precautions

Fluid and electrolyte depletion may occur in patients who have diarrhoea. The use of Imodium does not preclude the administration of appropriate fluid and electrolyte therapy.

In acute diarrhoea, if clinical improvement is not observed in 48 hours, the administration of Imodium should be discontinued and patients should be advised to consult their physician.

Use in Pregnancy: Category B3. Safe use of Imodium during pregnancy has not been established. Reproduction studies performed in rats and rabbits with high doses did not demonstrate evidence of impaired fertility or harm to the offspring due to Ioperamide hydrochloride. Higher doses impaired maternal and neonate survival, but even higher doses did not demonstrate teratogenicity. Such experience cannot exclude the possibility of damage to the foetus. Imodium should be used in pregnant women only if the potential benefit justifies the risk to the foetus.

Use in Lactation: There is little information on the excretion of Imodium in human milk, but as small amounts of the drug are detectable in the milk of nursing mothers, the use of Imodium is not recommended in breast feeding subjects. In a peri- and postnatal study, Ioperamide administered to female rats at dosage of 40mg/kg indicated a possible adverse effect of lactation as evidenced in a decreased pup-survival rate.

Abuse and Dependence: Physical dependence to Imodium in humans has not been observed. However, studies in monkeys demonstrated that Ioperamide hydrochloride at high dose produced symptoms of physical dependence of the morphine type.

Use in patients with hepatic impairment: Imodium should be used with caution in patients with hepatic insufficiency because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of central nervous system (CNS) toxicity.

Use in patients with renal impairment: since the majority of the drug is metabolised, and the metabolites or the unchanged drug is excreted in the faeces, dose adjustments in patients with a kidney disorder are not required.

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

Effects on ability to drive and use machinery: Tiredness, dizziness or drowsiness may occur in the setting of diarrhoeal syndromes treated with loperamide. Therefore it is advisable to use caution when driving a car or operating machinery.

Anticholinergic Effects: In vitro studies have demonstrated anti-cholinergic properties. Hence, caution should be used in patients with glaucoma, urinary bladder neck obstruction, pyloric obstruction, significant gastric retention, or intestinal stasis.

Imodium Interactions with other drugs

Effect of loperamide hydrochloride on other drugs: Although the pharmacological effect of Ioperamide hydrochloride is not associated with a central action, patients with concomitant administration of tranquillisers or alcohol should be carefully observed.

Other drugs that affect loperamide hydrochloride theoretical interactions: Consideration should always be given with new drugs as to possible interaction with monoamine oxidase inhibitors. Theoretically, the combination of Imodium with monoamine oxidase inhibitors (which are also inhibitors of liver microsomal enzymes) may potentiate the action of Ioperamide by blocking its metabolic pathway.

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 2-3 fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is given at recommended dosages (2 mg, up to 16 mg maximum daily dose), is unknown.

Delivery Time: 7-14 Days