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Simvastatin STELLA 20 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: 20 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), the maximum dose of simvastatin is 10 mg/day. Taking concomitantly with amiodarone, amlodipine, verapamil, diltiazem, the maximum dose of simvastatin is 20 mg/day.
  • Moderate renal impairment, elderly: No dosage adjustment is necessary.
  • Paediatric population: Doses should be individualized according to the recommended goal of therapy as recommended by the paediatric treatment recommendations.

Usage:

Simvastatin STELLA 20 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.
  • Concomitant administration of potent CYP3A4 inhibitors, gemfibrozil, ciclosporin, or danazol.
  • In patients with homozygous familial hypercholesterolaemia, concomitant administration of lomitapide with doses > 40 mg simvastatin.

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

  • Risk of myopathy/rhabdomyolysis.
  • Caution with elderly, female gender, renal impairment, uncontrolled hypothyroidism, history of muscular disorders.
  • If muscular pain, weakness or cramps occur, creatin kinase levels should be measured.
  • If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
  • This medicine should not be used in patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • Driving/ operating machinery.