CRESTOR-40 (Rosuvastatin Calcium-40)
Composition: Rosuvastatin (as calcium) 10mg, 20mg and 40mg tablets.
Presentation: Film-coated tablets.
Class: HMG-CoA reductase inhibitor.
Indications: Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (eg, exercise , weight reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate.
Dosage: The recommended start dose is 10mg once daily. A dose adjustment to 20mg can be made after four weeks. A doubling of this dose to 40mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk who do not achieve their treatment goal on 20mg and in whom routine follow-up will be performed.
Major cautions and contra-indications: Rosuvastatin is contraindicated in: active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding three times the upper limit of normal; severe renal impairment (creatinine clearance5 times upper limit of normal). Rosuvastatin should not be used in any patient with acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. While taking rosuvastatin, patients should be asked to report inexplicable muscle pain, weakness or cramps immediately. Use of rosuvastatin in combination with gemfibrozil is not recommended.
Side effects: Common (>1 per cent,