LOPERAMIDE HYDROCHLORIDE

Posology Acute Diarrhoea Adults and Children over 12 years:

Two tablets (4mg) initially, followed by one tablet (2mg) after every loose stool. The maximum dose should not exceed six tablets (12mg). Patients taking loperamide for acute diarrhoea should consult their doctor if symptoms persist for more than 48 hours.

Symptomatic Treatment of Acute Episodes of Diarrhoea Associated with Irritable Bowel Syndrome in Adults aged 18 years and over Two tablets (4mg) to be taken initially, followed by one tablet (2mg) after every loose stool, or as previously advised by the doctor.

The maximum daily dose should not exceed six tablets (12mg). Patients taking loperamide to control episodes of IBS should consult their doctor if improvement is not observed within 48 hours, if the pattern of their symptoms change or if repeated episodes of diarrhoea continue for more than two weeks.

Paediatric Population:

Loperamide is contraindicated in children less than 12 years of age. Elderly No dose adjustment is required for the elderly. Renal Impairment No dose adjustment is required for patients with renal impairment. 4 ‘Special warnings and precautions for use’).

Method of administration Oral use. The tablets should be taken with liquid.

Adults and children aged ≥12 years:

The safety of loperamide hydrochloride was evaluated in 3076 adults and children aged ≥12 years who participated in 31 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of acute diarrhoea.

Of these, 26 trials were in acute diarrhoea (N=2755) and 5 trials were in chronic diarrhoea (N=321). 1%). e. 2%). Table 1 displays ADRs that have been reported with the use of loperamide hydrochloride from either clinical trial (in acute or chronic diarrhoea or both) or post-marketing experience.

The 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); and very rare (<1/10,000). 4), Abdominal distension acute pancreatitis Skin and subcutaneous tissue disorders Rash Bullous eruptiona (including Stevens- Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme), Urticaria, Pruritus, Angioedema Renal and urinary disorders Urinary retention Adverse Reaction System Organ Class Common Uncommon Rare Not known General disorders and administration site conditions Fatigue A number of the adverse reactions reported during the clinical investigations and post-marketing experience with loperamide hydrochloride are frequent symptoms of the underlying diarrhoeal syndrome (for example abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence).

These symptoms are often difficult to distinguish from undesirable drug effects. Paediatric population The safety of loperamide hydrochloride was evaluated in 607 patients aged 10 days to 13 years, who participated in 13 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of acute diarrhoea.

In patients with diarrhoea, especially young children, fluid and electrolyte depletion may occur. Use of loperamide does not preclude the administration of appropriate fluid and electrolyte replacement therapy. Treatment of diarrhoea with loperamide is only symptomatic.

Since persistent diarrhoea can be an indicator of potentially more serious conditions, loperamide should not be used for prolonged periods of time and the underlying cause of the diarrhoea should be investigated if clinical improvement is not observed within 48 hours of initiating treatment.

Whenever the underlying etiology can be determined, specific treatment should be given when appropriate. g. in cases of severe hepatic disturbance), as this might result in a relative overdose leading to CNS toxicity. Loperamide must be discontinued promptly when constipation, abdominal distension or ileus develop.

Patients with AIDS treated with loperamide 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.

Cardiac events including QT interval and QRS complex prolongation, torsades de pointes have been reported in association with overdose. 9). Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Caution is needed in patients with a history of drug abuse. Loperamide is an opioid and addiction is observed with opioids as a class.

1. In children under 12 years of age. When inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon, in particular: When ileus, constipation or abdominal distention develop, 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-spectrum antibiotics.

Loperamide should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures.