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Rosuvastatin calcium equivalent to..............20 mg Rosuvastatin
Excipients q.s to...............................................................1 tablet

Dosage form: Film coated tablets

Packaging: Box of 3 blisters x 10 film coated tablets
                    Box of 10 blisters x 10 film coated tablets

Hyperlipidemia and mixed Dyslipidemia
Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH)
Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Homozygous Familial Hypercholesterolemia
Slowing of the Progression of Atherosclerosis
Primary Prevention of Cardiovascular Disease

Dosage & Administration:
- 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.

- 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). 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.

- Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir: In patients taking cyclosporine, the dose of Rosuvastatin should be limited to 5 mg once. 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.

- 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.

Contraindications: please read carefully the leaflet before using.

Storage: Store at controlled room temperature, 20-25ºC (68-77ºF). Protect from moisture and light.