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 components of the product. 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.
Compositon/Ingredients
Rosuvastatin 10mg
Dosage and administration
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 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 40mg of rosuvastatin daily who have unexplained persistent proteinuria.
Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Driving/operating machinery.
Storage
Store at temperature below 30°C, protect from light.
