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DEVASTIN 10mg


Composition: 
Rosuvastatin calcium equivalent to ........10 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

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

Dosage and 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.

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