Indications
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet.
Treatment of homozygous familial hypercholesterolaemia.
Treatment of hypertriglyceridemia.
Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus.
Contraindications
Known hypersensitivity to any of the active substance or excipients.
Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and lactation.
Compositon/Ingredients
Simvastatin 10mg
Dosage and administration
Hypercholesterolaemia: Start with 10 – 20 mg/day. Patients with LDL-C more than 45 % may start at 20 – 40 mg/day.
Homozygous familial hypercholesterolaemia: Start with 40 mg/day. In patients taking lomitapide concomitantly with simvastatin, the maximum dose of simvastatin is 40 mg/day.
Cardiovascular prevention: The usual dose is 20 to 40 mg/day in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia).
Concomitant therapy: Taking concomitantly with fibrates (gemfibrozil, fenofibrate), verapamil, diltiazem, dronedarone, the maximum dose of simvastatin is 10 mg/day. Taking concomitantly with amiodarone, amlodipine, verapamil, diltiazem, ranolazine, the maximum dose of simvastatin is 20 mg/day.
Moderate renal impairment, elderly: No dosage adjustment is necessary.
Children and adolescents with heterozygous familial hypercholesterolaemia, the starting dose is 10 mg once a day in the evening; the maximum recommended dose is 40 mg/day. The experience of simvastatin in prepubertal children is limited.
Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day.
Precaution
Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease, renal impairment, hypothyroidism, history of muscular disorders, in elderly.
Safety and efficacy of simvastatin have not been evaluated in prepubertal girls or in children younger than 10 years of age.
If muscular pain, weakness or cramps occur, CK levels should be measured.
Simvastatin therapy should be temporarily withheld or discontinued in any patients with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Driving/ operating machinery.
Storage
Store at temperature below 30°C, protect from light.
