Active Ingredient: Simvastatin
Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 40 milligrams simvastatin, once daily at evening. The maximum allowed total dose is 80 milligrams simvastatin daily.
The dose range is 5-80 mg/day of simvastatin given orally as a single dose in the evening. Adjustments of dose, 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 80 mg dose is only recommended in patients with severe hypercholesterolaemia and at 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.
Based on the results of a controlled clinical study, the recommended starting dose is simvastatin 40 mg/day in the evening. Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
In patients taking lomitapide concomitantly with simvastatin, the dose of simvastatin must not exceed 40 mg/day.
It can be administered as a single dose in the evening.
For:
Oral, between 10 milligrams simvastatin and 40 milligrams simvastatin, once daily at evening. The maximum allowed total dose is 40 milligrams simvastatin daily.
For children and adolescents (boys Tanner Stage II and above and girls who are at least one year post-menarche, 10–years of age) with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10 mg once a day in the evening. Children and adolescents should be placed on a standard cholesterol-lowering diet before simvastatin treatment initiation; this diet should be continued during simvastatin treatment.
The recommended dosing range is 10–40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualised according to the recommended goal of therapy as recommended by the paediatric treatment recommendations. Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited.
It can be administered as a single dose in the evening.
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