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RUX

Rosuvastatin

Composition

Each film coated tablet contains:

Rosuvastatin (as calcium salt) 5 mg
Excipiets q.s.

Rosuvastatin (as calcium salt) 10 mg
Excipiets q.s.

Rosuvastatin (as calcium salt) 20 mg
Excipients q.s.

Presentations

RUX 5 mg: 30 coated tablets pack
RUX 10 mg: 30 and 60 coated tablets packs
RUX 20 mg: 30 coated tablets pack

Indications

Rosuvastatin is indicated for the treatment of:

Adults:

1. Primary hyperlipidemia and mixed dyslipidemia

Rosuvastatin is indicated as adjunctive therapy to diet to reduce elevated total cholesterol (TC), LDL-C, ApoB, non-HDL cholesterol and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

2. Hypertriglyceridemia

Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of patients with hypertriglyceridemia.

3. Type III familial hyperlipoproteinemia.

Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of patients with Type III familial hyperlipoproteinemia (a genetic disease characterized by hypertriglyceridemia, hypercholesterolemia, and the presence of cholesterol-rich, very low density lipoproteins in plasma).

4. Homozygous familial hypercholesterolemia

Rosuvastatin is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable to reduce LDL-C, total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

5. Generalized atherosclerosis

Rosuvastatin is indicated as adjunctive therapy to diet to slow atherosclerosis progression in adult patients with the aim of reducing total-C and LDL-C.

Pediatrics

1. Treatment of heterozygous familial hypercholesterolemia (HeFH)

It is indicated in 10 to 17-year-old pediatric patients for the treatment of heterozygous familial hypercholesterolemia (HeFH) as a supplement to diet to reduce Total-C, LDL-C and ApoB levels in male and female adolescents (at least one year after menarche). Drug treatment should be started after failing to achieve expected results with a diet therapy, and where laboratory tests show: LDL-C >190 mg/dL, or >160 mg/dL plus family history of early cardiovascular disease (CVD) or two or more cardiovascular risk factors.