Rosuvastatin is a selective, potent and competitive inhibitor of HMG-CoA reductase effective in lowering low density lipoprotein (LDL) cholesterol and triglycerides. It produces its lipid modifying effects in two ways; firstly it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL and secondly it inhibits the hepatic synthesis of very low density lipoprotein (VLDL), which reduces the total number of VLDL & LDL particles.
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb) or homozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures; prevention of cardiovascular events in patients at high risk of a first cardiovascular event.
Hypercholesterolaemia: Initially 5-10 mg once daily increased if necessary at intervals of at least 4 weeks to 20 mg once daily. Severe Hypercholesterolaemia: Increased after further 4 weeks to 40 mg daily only. Elderly: Initially 5 mg once daily. Patient of Asian Origin: Initially 5 mg once daily increased if necessary to maximum 20 mg daily. Concomitant with Fibrate: Initially 5 mg once daily increased if necessary to maximum 20 mg daily.
Prevention of Cardiovascular Events: 20 mg once daily.
Hypersensitivity to any component of Ruvastin. Patients with active liver disease or with unexplained elevations in transaminase.
Use in pregnancy: The safety in pregnant women has not been established.
Use in lactation: It is not known whether Rosuvastatin is excreted in human milk.
Use in children: The safety and effectiveness in pediatric patients have not been established.
Use in pregnancy: The safety in pregnant women has not been established.
Use in lactation: It is not known whether Rosuvastatin is excreted in human milk.
Rosuvastatin is generally well tolerated. The common adverse effects are headache, myalgia, asthenia, constipation, dizziness and abdominal pain. It may rarely cause myositis, rhabdomyolysis, pancreatitis and hypersensitivity reaction.
Erythromycin: Co-administration of erythromycin with rosuvastatin decreased AUC and Cmax of rosuvastatin.
Itraconazole: Itraconazole increases the AUC of rosuvastatin.
Fluconazole: Co-administration of fluconazole with rosuvastatin increases the AUC of rosuvastatin.
Warfarin: The pharmacokinetics of warfarin is not significantly affected following co-administration with rosuvastatin.
Cyclosporin: Co-administration of rosuvastatin with cyclosporin resulted in no significant changes in cyclosporin plasma concentration.
Gemfibrozil: Concomitant use of rosuvastatin and gemfibrozil resulted in a 2-fold increase in Cmax and AUC(0-t).
Antacid: The simultaneous dosing of rosuvastatin with an antacid suspension containing aluminium and magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%.
There are no clinically significant interactions with an oral contraceptive, digoxin, fenofibrate, antihypertensive agents, antidiabetic agents and hormone replacement therapy.
Store below 30°C. Protect from light.
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
FC tab 5 mg x 3 x 10's. 10 mg x 2 x 10's.
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