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Rosuvastatin STELLA 10 mg
Rx

Rosuvastatin reduces total cholesterol (total-C), LDL-cholesterol, apolipoprotein B, and non HDL-C (total cholesterol minus HDL-C) in patients with homozygous and heterozygous familial hypercholesterolemia (FH), nonfamilial forms of hypercholesterolemia, and mixed dyslipidemia. Rosuvastatin also reduces triglyceride and produces increases in HDL-cholesterol.

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

PRESCRIBING INFORMATION

Indications

  • The management of hyperlipidaemias, including primary hypercholesterolaemia (type IIa), mixed dyslipidaemia (type IIb), and hypertriglycericaemia (type IV).
  • The treatment for homozygous familial hypercholesterolaemia.

Dosage

  • Continue on diet during treatment. The usual initial dose is 5 – 10 mg once daily, increased dose at intervals of 4 weeks, if necessary, maximum 20 mg once daily.
  • Severe hypercholesterolaemia: 40 mg once daily.
  • The elderly patients, Asians, and those at risk of myopathy: The initial dose of 5 mg.
  • Patients receiving ciclosporin: Maximum of 5 mg once daily.
  • Patients receiving gemfibrozil or ritonavir-boosted lopinavir: Maximum of 10 mg once daily.
  • The patients with marked hypercholesterolaemia, such as those with homozygous familial hypercholesterolaemia: Start with 20 mg once daily.
  • Renal impairment (ClCr 30 – 60 mL/ minute): 5 mg once daily, maximum 20 mg once daily.
  • Concomitant with atazanavir, atazanavir/ ritonavir and lopinavir/ ritonavir: Maximum 10 mg once daily.

Usage

  • Administered orally as a single dose at any time of day, with or without food.
  • Hypersensitivity to any of the ingredients.
  • Active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal.
  • Severe renal impairment (ClCr < 30 mL/minute).
  • Myopathy.
  • During pregnancy and lactation and women of childbearing potential not using appropriate contraceptive measures.
  • Diabetes mellitus, increased blood sugar, increases in glycosylated hemoglobin (HbA1c).
  • Headache, dizziness.
  • Constipation, nausea, abdominal pain.
  • Myalgia.
  • Asthenia, cognitive impairment.
  • Caution in patients with: renal impairment; hypothyroidism; personal/familial history of hereditary muscular disorders; previous history of muscular toxicity with a statin/fibrate, previous history of liver disease and/or where substantial quantities of alcohol are consumed; in elderly > 70 years with the presence of other predisposing factors for rhabdomyolysis.
  • If serum creatine kinase concentrations become markedly elevated or if myopathy is diagnosed/suspected: discontinue rosuvastatin.
  • Dosage reduction for patients receiving 40 mg of rosuvastatin daily who have unexplained persistent proteinuria.
  • 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.