Loperamide hydrochloride

SOURCE SCOPE: the SPC fetched is 'Boots Diarrhoea Relief 2 mg Capsules (P and GSL)', an over-the-counter product; the pharmacy/GSL indications and duration limits below reflect that. Second indication - symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over, following initial diagnosis by a doctor: 4 mg (two capsules) initially, followed by 2 mg (one capsule) after every loose stool, or as previously advised by the doctor; maximum daily dose must not exceed 12 mg (6 capsules); the patient should consult their doctor if new symptoms develop, if symptoms worsen, or if symptoms have not improved over two weeks. Duration: in acute diarrhoea, if symptoms persist for more than 24 hours consult a doctor, and if clinical improvement is not observed within 48 hours loperamide should be discontinued and the patient advised to consult their physician, since persistent diarrhoea can indicate a more serious condition. Should not be used for prolonged periods until an underlying cause for persistent diarrhoea has been investigated and diagnosed by a doctor. Fluid and electrolyte replacement is the most important measure in patients with diarrhoea, especially children and frail or elderly patients. Children under 12 years: loperamide capsules should not be used (also listed as a contraindication) - consult a children's formulary. Elderly: no dose adjustment required. Renal impairment: no dose adjustment required. Hepatic impairment: no pharmacokinetic data available, but use with caution because of reduced first-pass metabolism, which may result in a relative overdose leading to CNS toxicity. Cardiac events including QT interval and QRS complex prolongation and torsade de pointes have been reported in association with overdose, some with a fatal outcome, and overdose can unmask existing Brugada syndrome - patients should not exceed the recommended dose or duration of treatment. Caution in patients with a history of drug abuse; abuse and misuse of loperamide have been described. Patients with AIDS treated for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. Contains lactose monohydrate and Ponceau 4R (E124), which can cause allergic-type reactions including asthma.