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Presentation

\nRocovas : Each tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 5 mg. \nRocovas : Each tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 10 mg. \n \n

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Description

\nRosuvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. \n \n

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Indications

\nRosuvastatin is indicated for- primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb), or homozygousfamilial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures. \n \n

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Dosage & Administration

\nDose range: 5-40 mg once daily. Initially 5-10 mg once daily increased if necessary at intervals of at least 4 weeks to 20 mg once daily. Daily dose can be increased after further 4 weeks to 40 mg only in severe hypercholesterolaemia with high cardiovascular risk and under specialist supervision. Elderly initially 5 mg once daily. \nHoFH: Starting dose 20 mg. \nIn pediatric patients 10 to 17 years of age with HeFH, the usual dose range is 5-20 mg/day; doses greater than 20 mg have not been studied in this patient population. \nUse 40 mg dose only for patients not reaching LDL-C goal with 20 mg \nRosuvastatin can be taken with or without food, at any time of day. \n \n

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Side Effects

\nRosuvastatin is generally well tolerated. The adverse events seen with Rosuvastatin are generally mild and transient. Most commonly occurring side-effects are headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain. Uncommonly pruritus, rash and urticaria may occur. Myopathy (including myositis), hypersensitivity reactions (including angioedema), rhabdomyolysis, pancreatitis etc are the rarely occurring side-effects of Rosuvastatin. \n \n

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Precautions

\nSkeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment, and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness. Rosuvastatin can be discontinued if signs or symptoms appear. \nLiver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Liver enzymes should be monitored before and during treatment. \n \n

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Use in Pregnancy & Lactation

\nRosuvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus. Because of the potential for adverse reactions in nursing infants, women taking Rosuvastatin should not breast-feed. \n \n

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Drug Interaction

\nRemarkable drug interactions of Rosuvastatin are- \nCyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily. \nGemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily. \nLopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily. \nCoumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy. \nConcomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects. \n \nUse in special population \nAge and sex: There was no clinically relevant effect of age or sex on the pharmacokinetics of Rosuvastatin in adults. \nRace: Pharmacokinetic studies show an increase in exposure in Asian subjects compared with Caucasians. \nPregnancy and lactation: The safety of rosuvastatin during pregnancy and whilst breast feeding has not been established. \nSevere renal impairment (not on hemodialysis): Starting dose is 5 mg, not to exceed 10 mg \n \n

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Over Dose

\nThere is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Haemodialysis is unlikely to be of benefit. \n \n

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Commercial Pack

\nRocovas 5 Tablet: Each commercial box contains 3 blister strip of 10 tablets \nRocovas 10 Tablet: Each commercial box contains 1 blister strip of 10 tablets \n \n