Full Prescribing Info
Rosuvastatin calcium.
Each film-coated tablet contains: ROSUVASTATIN (as Calcium) 10 mg.
Each film-coated tablet contains: ROSUVASTATIN (as Calcium) 20 mg.
Rosuvastatin is a hypolipidaemic agent; it is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA reductase), the rate determining enzyme for cholesterol synthesis. HMG-CoA reductase inhibitors (sometimes called "statins") reduce total cholesterol, low-density lipoprotein (LDL)-cholesterol, and very-low-density lipoprotein (VLDL)-cholesterol concentrations in plasma. They also tend to reduce triglycerides and to increase high-density lipoprotein (HDL)-cholesterol concentrations. They are considered to exert their hypocholesterolaemic action by stimulating and increase in LDL-receptors on hepatocyte membranes thereby increasing the clearance of LDL from the circulation.
Pharmacology: Pharmacokinetics: Rosuvastatin is incompletely absorbed from the gastrointestinal tract, with a bioavailability of about 20%. Peak plasma concentrations are achieved about 5 hours after an oral dose. It is about 90% bound to plasma proteins. The plasma elimination half-life of rosuvastatin is about 19 hours. About 90% of an oral dose of rosuvastatin is excreted in the faeces, including absorbed and non-absorbed drug, and the remainder is excreted in the urine; about 5% of a dose is excreted unchanged in urine.
Rosuvastatin is used, in conjunction with dietary modification, in the treatment of hypercholesterolemia particularly in type IIa, and IIb hyperlipoproteinemias as adjunct therapy. HMG-COA reductase inhibitors can be effective in patients with homozygous familial hypercholesterolaemia who have some functional LDL-receptors. It may also be given prophylactically as an adjunct to diet in hypercholesterolaemic patients with ischaemic heart disease.
Dosage/Direction for Use
Rosuvastatin is given in an initial dose of 5 to 10 mg or as prescribed by the physician. Increased if necessary after not less than 4 weeks to 20 mg once daily; increased after a further 4 weeks to 40 mg only in severe hypercholesterolemia with high cardiovascular risk and under specialist supervision. Maximum of 20 mg daily with concomitant ciclosporin or fibrate.
Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria and angioedema have been reported.
Special Precautions
Rosuvastatin should not be given to patients with acute liver disease or unexplained persistent raised serum-aminotransferase concentrations. It should be avoided during pregnancy since there is a possibility that it could interfere with fetal sterol synthesis; there have been a few reports of congenital abnormalities associated with HMG-CoA reductase inhibitors. It should be discontinued if marked increases in serum aminotransferase or creatinine phosphokinase concentrations occur.
Use In Pregnancy & Lactation
It should be avoided during pregnancy since there is a possibility that it could interfere with fetal sterol synthesis; there have been a few reports of congenital abnormalities associated with HMG-CoA reductase inhibitors.
Adverse Reactions
The most common adverse effects of therapy with Rosuvastatin and other HMG-CoA reductase inhibitors are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision and dysgeusia. Reversible increases in serum-aminotransferase concentrations may occur and liver function should be monitored. Myopathy, characterized by myalgia and muscle weakness and associated with increased creatinine phosphokinase concentrations, has been reported, especially in patients taking Rosuvastatin concurrently with immunosuppressive drugs, fibric acid derivatives or nicotinic acid. Rarely, rhabdomyolysis with acute renal failure may develop.
Drug Interactions
Rosuvastatin undergoes limited metabolism, principally by the cytochrome P450 isoenzyme CYP2C9, and may not have the same interactions with enzyme inhibitors as simvastatin. However, increased rosuvastatin plasma concentrations have been reported with ciclosporins and, to a lesser extent, with gemfibrozil, and such combinations should be avoided.
Store at temperatures not exceeding 30°C.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
FC tab 10 mg x 30's. 20 mg x 30's.
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