RosuTMÂ 5 Tablet: Each film coated tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 5 mg.
RosuTMÂ 10 Tablet: Each film coated tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 10 mg.
RosuTMÂ 20 Tablet: Each film coated tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 20 mg.
Dosage and administration:
General Dosing Information:The dose range for Rosuvastatin is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg. Rosuvastatin can be administered as a single dose at any time of day, with or without food. When initiating Rosuvastatin therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosuvastatin starting dose should first be utilized, and only then titrated according to the patient\’s response and individualized goal of therapy. After initiation or upon titration of Rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. The 40 mg dose of Rosuvastatin should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose. Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age): The usual dose range of Rosuvastatin is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more. Homozygous Familial Hypercholesterolemia: The recommended starting dose of Rosuvastatin is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels. Dosage in Asian Patients: Initiation of Rosuvastatin therapy with 5 mg once daily should be considered for Asian patients Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir: In patients taking Cyclosporine, the dose of Rosuvastatin should be limited to 5 mg once daily. In patients taking a combination of Lopinavir and Ritonavir or Atazanavir and Ritonavir, the dose of Rosuvastatin should be limited to 10 mg once daily. Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rosuvastatin is used in combination with Niacin or Fenofibrate; a reduction in Rosuvastatin dosage should be considered in this setting. Combination therapy with Gemfibrozil should be avoided because of an increase in Rosuvastatin exposure with concomitant use; if Rosuvastatin is used in combination with Gemfibrozil, the dose of Rosuvastatin should be limited to 10 mg once daily. Dosage in Patients with Severe Renal Impairment: For patients with severe renal impairment (CLcr < 30 mL/min/1.73 m²) not on hemodialysis, dosing of Rosuvastatin should be started at 5 mg once daily and not exceed 10 mg once daily.
Side effect:
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were myalgia, constipation, asthenia, abdominal pain, and nausea.
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