Ruvastin (Rosuvastatin) is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, it inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
Ruvastin-5 Tablet: Each film coated tablet contains Rosuvastatin Calcium USP equivalent to Rosuvastatin 5 mg.
Ruvastin-10 Tablet: Each film coated tablet contains Rosuvastatin Calcium USP equivalent to Rosuvastatin 5 mg.
Ruvastin-20 Tablet: Each film coated tablet contains Rosuvastatin Calcium USP equivalent to Rosuvastatin 20 mg.
Ruvastin (Rosuvastatin) is an HMG Co-A reductase inhibitor indicated for:
Adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C.
Pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy.
Pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, nonHDL-C, and ApoB as an adjunct to diet, either alone or with other lipid-lowering treatments.
Adult patients with hypertriglyceridemia as an adjunct to diet.
Adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet.
Adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.
Slowing the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C as an adjunct to diet.
Risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors.
General Dosing Information: The dose range for Ruvastin in adults is 5-40 mg once daily. The usual starting dose is 10 to 20 mg daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg/day.
Pediatric Dosing: In heterozygous familial hypercholesterolemia, the recommended dose range is 5 to 10 mg orally once daily in patients 8 to less than 10 years of age, and 5 to 20 mg orally once daily in patients 10 to 17 years of age. In homozygous familial hypercholesterolemia, the recommended dose is 20 mg orally once daily in patients 7 to 17 years of age. Dosing in Asian Patients: In Asian patients, consider initiation of rosuvastatin with 5 mg once daily dose due to increased rosuvastatin plasma concentrations.
Rosuvastatin is contraindicated in patients with known hypersensitivity (e.g. rash, pruritus, urticaria, and angioedema) to any component of this product. It is also contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels
Rosuvastatin is generally well tolerated. The following serious adverse reactions may occur: rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis); liver enzyme abnormalities. The most common adverse reactions that led to treatment discontinuation are myalgia, abdominal pain, nausea, headache, asthenia, and nausea.
Cyclosporine: Cyclosporine increase rosuvastatin’s exposure (AUC) to 7-fold. Therefore, in patients taking cyclosporine, the dose of rosuvastatin should not exceed 5 mg once daily. Gemfibrozil: Gemfibrozil significantly increased rosuvastatin exposure. If used together, the dose of rosuvastatin should not exceed 10 mg once daily. Protease Inhibitors: Coadministration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure. Caution should be exercised when rosuvastatin is co-administered with protease inhibitors (e.g. simeprevir, combinations of atazanavir/ritonavir, lopinavir/ritonavir, fosamprenavir/ritonavir etc). Coumarin Anticoagulatns: Rosuvastatin significantly increased INR (International normalized ratio) in patients receiving coumarin anticoagulants. Therefore, caution should be exercised when coumarin anticoagulants are given in conjunction with rosuvastatin. Niacin: The risk of skeletal muscle effects may be enhanced when rosuvastatin is used in combination with lipid- modifying doses (?1 g/day) of niacin; caution should be used when prescribing with rosuvastatin. Fenofibrate: Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concomitant use of fenofibrates, caution should be used when prescribing fenofibrates with rosuvastatin. Colchicine: Cases of myopathy, including rhabdomyolys, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing rosuvastatin with colchicin.
Use in Pregnancy: Rosuvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin during pregnancy.
Use in lactation: Rosuvastatin use is contraindicated during breastfeeding.
Geriatric Use: Elderly patients are at higher risk of myopathy and rosuvastatin should be prescribed with caution in the elderly.
Renal Impairment: Rosuvastatin exposure is not influenced by mild to moderate renal impairment (CLcr ?30 mL/min/1.73 m2). Exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (CL<30 mL/min/1.73 m2) who are not receiving hemodialysis and dose adjustment is required.
Hepatic Impairment: Rosuvastatin is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. Chronic alcohol liver disease is known to increase rosuvastatin exposure; Rosuvastatin should be used with caution in these patients.
There 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. Hemodialysis does not significantly enhance clearance of rosuvastatin.
Store below 300 C in a dry place, protect from light. Keep out of the reach of children.
Ruvastin-5 Tablet: Each box contains 30 tablets in Alu-Alu blister pack.
Ruvastin-10 Tablet: Each box contains 30 tablets in Alu-Alu blister pack.
Ruvastin-20 Tablet: Each box contains 10 tablets in Alu-Alu blister pack.
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