Loperamide 2mg - diarrhea medication 15 capsules

Use in the elderly: No dose adjustment is necessary.

Renal impairment: No dose adjustment is necessary for patients with renal impairment.

Hepatic impairment: Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide Aurobindo should be used with caution in these patients due to reduced first-pass metabolism.

Warnings

Treatment of diarrhea with loperamide is only symptomatic. If appropriate, specific treatment should be administered whenever an underlying etiology can be determined. In acute diarrhea, the priority is the prevention or reversal of fluid and electrolyte depletion. This is particularly important in patients with hepatic impairment. is particularly important in young children and frail and elderly patients with acute diarrhea.

The use of loperamide hydrochloride does not preclude the administration of electrolyte replacement therapy. Since persistent diarrhea may be an indicator of potentially more serious conditions, loperamide hydrochloride should not be used for prolonged periods until the underlying cause of the diarrhea has been investigated.

Loperamide hydrochloride should be used with caution when the liver function required for drug metabolism is imperfect (e.g., in cases of severe liver disease), as this could result in relative overdose leading to CNS toxicity.

AIDS patients treated with loperamide hydrochloride for diarrhea should discontinue therapy at the first sign of abdominal distension. Isolated cases of toxic megacolon have been reported in AIDS patients with infectious colitis caused by both bacterial and viral pathogens treated with loperamide hydrochloride.

When no clinical changes in acute diarrhea are observed within 48 hours, loperamide administration should be discontinued and patients should be advised to consult their physician. Treatment with loperamide should be discontinued immediately if constipation, abdominal distension, or subileus develops.

Cardiac events, including QT prolongation, QRS prolongation, and torsades de pointes, have been reported in association with overdose.

Overdose may unmask Brugada syndrome. Patients should not exceed the recommended dose and/or recommended duration of therapy. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed.

When it is necessary to avoid inhibition of peristalsis due to a possible risk of significant sequelae including ileus, megacolon, toxic megacolon and some poisonings in particular:

• Children under 12 years of age
• When ileus or constipation are present and when abdominal distension develops
• In patients with acute ulcerative colitis
• In patients with enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter
• In patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics spectrum.

Loperamide Aurobindo should not be used alone in acute dysentery, which is characterised by blood in the stool and high body temperature.

Undesirable effects

Overdose

Pregnancy and breastfeeding

Pregnancy: Limited data are available on the use of loperamide in pregnant women. In one of two epidemiological studies, the use of loperamide during early pregnancy suggested a possible moderate increase in the risk of hypospadias, however, no increased risk of major malformations could be identified. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Safety in human pregnancy has not been established, although animal studies have not indicated that loperamide hydrochloride has teratogenic or embryotoxic properties. If possible, the use of loperamide should be avoided during the first trimester of pregnancy, however, it can be used during the second and third trimesters.

Breastfeeding: Small amounts of loperamide may appear in breast milk. Therefore, this medicine is not recommended during breastfeeding. Pregnant or breastfeeding women should therefore be advised to consult their doctor for appropriate treatment.

Fertility: Only high doses of loperamide hydrochloride have affected female fertility in non-clinical studies (see section 5.3).

Format

15 capsules