Indications
- The management of hyperlipidaemias, including primary hypercholesterolaemia (type IIa), mixed dyslipidaemia (type IIb), and hypertriglycericaemia (type IV).
- The treatment for homozygous familial hypercholesterolaemia.
Contraindications
- 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.
Dosage and administration
- Continue on diet during treatment. The usual initial dose is 5 – 10mg once daily, increased dose at intervals of 4 weeks, if necessary, maximum 20 mg once daily.
- Severe hypercholesterolaemia: 40mg once daily.
- The elderly patients, Asians, and those at risk of myopathy: The initial dose of 5mg.
- Patients receiving ciclosporin: Maximum of 5mg once daily.
- Patients receiving gemfibrozil or ritonavir-boosted lopinavir: Maximum of 10mg once daily.
- The patients with marked hypercholesterolaemia, such as those with homozygous familial hypercholesterolaemia: Start with 20mg once daily.
- Renal impairment (ClCr 30 – 60mL/ minute): 5mg once daily, maximum 20mg once daily.
- Concomitant with atazanavir, atazanavir/ ritonavir and lopinavir/ ritonavir: Maximum 10mg once daily.
Precaution
- 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.
Storage
Store at temperature below 30°C, protect from light.
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