Simvastatin STELLA 10 mg

Rx

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.

Dosage:

• 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.

Usage:

Simvastatin STELLA 10 mg is administered orally, as a single dose in the evening.

• Known hypersensitivity to any of the active substance or excipients.
• Active liver disease or unexplained persistent elevations of serum transaminases.
• Pregnancy and lactation.

Rare: Anaemia; headache, paresthesia, dizziness, peripheral neuropathy; constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis; hepatitis/jaundice; rash, pruritus, alopecia…

• 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.
• Patients should be aware of how they react to drug before driving or operating machinery.