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Ruvastin

Rosuvastatin Calcium

Rosuvastatin is a selective, potent and competitive inhibitor of HMG-CoA reductase effective in lowering 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 VLDL, which reduces the total number of VLDL & LDL particles.

Product Details

Presentation

Ruvastin-5 Tablet: Each tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 5 mg.
Ruvastin-10 Tablet: Each tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 10 mg.

Pharmacology

Rosuvastatin is a selective, potent and competitive inhibitor of HMG-CoA reductase effective in lowering 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 VLDL, which reduces the total number of VLDL & LDL particles.

Indication

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.

Dosage & Administration

Hypercholesterolaemia, initially 5-10 mg once daily increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily only in severe hypercholesterolaemia; elderly initially 5 mg once daily; patient of asian origin, initially 5 mg once daily increased if necessary to max. 20 mg daily. Initially 5 mg once daily with concomitant fibrate increased if necessary to max. 20 mg daily. Prevention of cardiovascular events, 20 mg once daily.

Contraindications

Rosuvastatin is contraindicated in patients with hypersensitivity to any component of this product. It is also contraindicated in patients with active liver disease or with unexplained elevations in transaminase.

Side effects

Rosuvastatin is generally well tolerated. The common side effects are headache, myalgia, asthenia, constipation, dizziness and abdominal pain. It may rarely cause myositis, rhabdomyolysis, pancreatitis and hypersensitivity reaction.

Drug interaction

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 two-fold increase in C max 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.

Use in special groups

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.

Packing

Ruvastin-5 Tablet: Each box contains 30's tablets in Alu-Alu blister pack.
Ruvastin-10 Tablet: Each box contains 30's tablets in Alu-Alu blister pack.

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