LOPERAMIDE

For oral administration. The capsules should be taken with liquid. Acute diarrhoea Adults and Children 8-17 years The initial dose is 2 capsules (4 mg) for adults and 1 capsule (2 mg) for children; followed by 1 capsule (2 mg) after every subsequent loose stool.

The maximum dose is 8 capsules (16 mg) daily for adults; in children it must be related to the body weight (3 capsules/20 kg) but should not exceed a maximum of 8 capsules per day. Chronic Diarrhoea Adults The initial dose is 2 capsules (4 mg) daily; this initial dose should be adjusted until 1-2 solid stools a day are obtained, which is usually achieved with a maintenance dose of 1-6 capsules (2 mg-12 mg) daily.

Tolerance has not been observed and therefore subsequent dosage adjustment should be unnecessary. The maximum dose is 8 capsules (16 mg) daily. Paediatric Populations Children 2-8 years The capsule form of loperamide is not recommended in children of this age.

A syrup is commercially available. Children Under 2 Years Loperamide HCl should not be used in children under 2 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).

Adults and children aged ≥12 years The safety of loperamide HCl was evaluated in 2755 adults and children aged ≥12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide HCl used for the treatment of acute diarrhoea.

1%). List of adverse reactions Table 1 displays ADRs that have been reported with the use of loperamide HCl from either clinical trial (acute diarrhoea) 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); very rare (<1/10,000); unknown (cannot be estimated from the available data).

Table 1:

Adverse Drug Reactions IndicationSystem Organ Class Common Uncommon Rare Unknown a: Inclusion of this term is based on post-marketing reports for loperamide HCl. As the process for determining post marketing ADRs did not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with loperamide HCl (acute and chronic), including trials in children ≤ 12 years (N=3683).

4 Special Warnings and Special Precautions for use. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal Immune System Disorders Hypersensitivity reactiona Anaphylactic reaction (including Anaphylactic shock)a Anaphylactoid reactiona Nervous System Disorders Headache Dizziness Somnolencea Loss of consciousnessa Stupora Depressed level of consciousnessa Hypertoniaa Coordination abnormalitya Eye Disorders Miosisa Gastrointestinal Disorders Constipation Nausea Flatulence Abdominal pain Abdominal discomfort Dry mouth Abdominal pain upper Vomiting Dyspepsiaa Ileusa (including paralytic ileus) Megacolona (including toxic megacolonb) Abdominal distension Acute pancreatitis Skin and Subcutaneous Tissue Disorders Rash Bullous eruptiona (including Stevens-Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme) Angioedemaa Urticariaa Pruritusa Renal and Urinary Disorders Urinary retentiona General Disorders and Administration Site Conditions Fatiguea product is important.

Treatment of diarrhoea with loperamide HCl is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. In patients with diarrhoea, especially in children, fluid and electrolyte depletion may occur.

The use of loperamide HCl does not preclude the need for appropriate fluid and electrolyte replacement therapy, which is essential in such patients. Loperamide HCl should not be given to children aged 2 to 6 years without medical prescription and supervision.

Since persistent diarrhoea can be an indicator of potentially more serious conditions, loperamide hydrochloride should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated. In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of loperamide HCl should be discontinued and patients should be advised to consult their physician.

Patients with AIDS treated with loperamide HCl 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 HCl.

Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide HCl should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of central nervous system (CNS) toxicity.

Cardiac events including QT interval and QRS complex prolongation and 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.

Caution is needed in patients with a history of drug abuse. 9). Loperamide is an opioid with low bioavailability and limited potential to penetrate the blood brain barrier at therapeutic doses. However, addiction is observed with opioids as a class.

1. • Not to be used in children under 12 years of age. • Loperamide HCl should not be used: • 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-spectrum antibiotics.

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