The experience of simvastatin in pre-pubertal children is limited. Adjustments should be made at intervals of 4 weeks or more. Doses should be individualized according to the recommended goal of therapy as recommended by the paediatric treatment recommendations (see sections 4.4 and 5.1). The recommended dosing range is 10-40 mg/day the maximum recommended dose is 40 mg/day. Children and adolescents should be placed on a standard cholesterol-lowering diet before simvastatin treatment initiation this diet should be continued during simvastatin treatment. In patients with severe renal insufficiency (creatinine clearance < 30 ml/min), doses above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.įor children and adolescents (boys Tanner Stage II and above and girls who are at least one year post menarche, 10-17 years of age) with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10 mg once a day in the evening. No modification of dosages should be necessary in patients with moderate renal impairment. In patients taking amiodarone, amlodipine, verapamil or diltiazem, or products containing elbasvir or grazoprevir concomitantly with Simvastatin, the dose of Simvastatin should not exceed 20 mg/day. In patients taking Simvastatin concomitantly with fibrates, other than gemfibrozil (see section 4.3) or fenofibrate, the dose of Simvastatin should not exceed 10 mg/day. Dosing should occur either > 2 hours before or > 4 hours after administration of a bile acid sequestrant. Simvastatin is effective alone or in combination with bile acid sequestrants. Adjustments of dosage, if required, should be made as specified above. Drug therapy can be initiated simultaneously with diet and exercise. The usual dose of Simvastatin is 20 to 40 mg/day given as a single dose in the evening in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia). In patients taking lomitapide concomitantly with Simvastatin, the dose of simvastain must not exceed 40 mg/day (see sections 4.3, 4.4 and 4.5). LDL-apheresis) in these patients or if such treatments are unavailable. Homozygous familial hypercholesterolaemiaīased on the results of a controlled clinical study, the recommended simvastatin dose is 40 mg/day in the evening Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. Patients who require a large reduction in LDL-C (more than 45%) may be started at 20-40-mg/ day given as a single dose in the evening. The usual starting dose is 10-20 mg/day given as a single dose in the evening. The patient should be placed on a standard cholesterol-lowering diet, and should continue with this diet during treatment with Simvastatin. The 80 mg dose is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see sections 4.4 and 5.1). Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The dosage range is 5-80 mg/day given orally as a single dose in the evening. Date of first authorisation/renewal of the authorisation 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.4.4 Special warnings and precautions for use.4.2 Posology and method of administration.Show table of contents Hide table of contents
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