Information about ROSUVA
Composition:

Rosuva Tablets for oral administration contain: 5, 10, 20, or 40 mg of Rosuvastatin.

Indications and usage:

Rosuva is indicated:

As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Type IIa and IIb).

As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);

To reduce LDL-C, total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments or if such treatments are unavailable.

Dosage and administration:

The patient should be placed on a standard cholesterol-lowering diet before receiving Rosuva and should continue on this diet during treatment.

Rosuva can be administered as a single dose at any time of day, with or without food.

- Hypercholesterolemia (Heterozygous Familial and Nonfamilial)and Mixed Dyslipidemia (Fredrickson Type lla and lib):

The dose range for Rosuva is 5 to 40 mg once daily.

Therapy with Rosuva should be individualized according to goal of therapy and response.

The usual recommended starting dose of Rosuva is 10 mg once daily.

Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy.

For patients with marked hypercholesterolemia (LDL-C > 190mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered.

After initiation and/or upon titration of Rosuva, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

- Homozygous Familial Hypercholesterolemia:

The recommended starting dose of Rosuva is 20 mg once daily in those patients.

The maximum recommended daily dose is 40 mg.

Rosuva should be used in these patients as an adjunct to other lipid-lowering treatments or if such treatments are unavailable.

Response to therapy should be estimated from pre-apheresis LDL-C levels.

- Patients Taking Cyclosporine:

In patients taking cyclosporine, therapy should be limited to Rosuva 5 mg once daily .

- Concomitant Lipid-Lowering Therapy

The effect of Rosuva on LDL-C and total-C may be enhanced when used in combination with a bile acid binding resin.

If Rosuva is used in combination with gemfibrozil, the dose of Rosuva should be limited to 10 mg once daily .

- Dosage in Patients With Renal Insufficiency:

No modification of dosage is necessary for patients with mild to moderate renal insufficiency.

For patients with severe renal impairment (CLcr<30 mL/min/1.73 m2) not on hemodialysis, dosing of Rosuva should be started at 5 mg once daily and not to exceed 10 mg once daily.

Package:

Packs of 30 Tablets.