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Simvastatin STELLA 10 mg
Rx

Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus.

Pack size Box of 30 tablets
Shelf-life 24 months
Composition Simvastatin
Dosage forms and strengths Film-coated tablet: 10 mg
Product code :

PRESCRIBING INFORMATION

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.
  • Driving/ operating machinery.