Cozaar approved for use in children

Children with hypertension may now be treated with the angiotensin II receptor antagonist Cozaar (losartan) following a change to the product's licence.

The antihypertensive effect of Cozaar in children was established in a clinical study involving 177 hypertensive patients aged six to 16 years with a body weight in excess of 20 kg and a glomerular filtration rate of at least 30 ml/min/1.73m2.

Using a dose of 25 mg or 50 mg once daily in children weighing between 20 kg and 50 kg, and a dose of 50 mg or 100 mg once daily in children weighing over 50 kg, losartan was shown to lower trough blood pressure in a dose-dependent manner.

Cozaar is not recommended for use in children weighing less than 20kg. In line with the clinical study, the revised Summary of Product Characteristics recommends a dose of 25mg once daily (maximum 50mg) in children weighing 20-50kg and 50mg once daily (maximum 100mg) in children weighing more than 50kg.

In adults Cozaar is also indicated for the reduction in risk of stroke in hypertensive patients with left ventricular hypertrophy and for renal protection in adults with type II diabetes with nephropathy.

Further information: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Herts, EN11 9BU. Tel: 01992 467272.

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