Rosugen 5 mg Tablet 10 pcs

127130

Quantity: 1
SKU: T2M2544

Indications

Rosugen tablet is indicated for:
  • Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non HDL-C and TG levels and to increase HDL-C.
  • Patients with hypertriglyceredemia as an adjunct to diet.
  • Patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet.
  • 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.
  • Pediatric patients 10 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.
    • Risk reduction of Myocardial Infarction (MI), stroke and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors.

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Dosage & Administration

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.

Very High Cholesterol and High Risk of Ml or Stroke: 40 mg once daily.

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.

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