Rosuvastatin Calcium Tablets 5mg, 10mg, 20mg, 40mg Oral Medications

Rosuvastatin Calcium Tablets 5mg, 10mg, 20mg, 40mg Oral Medications

Product : Rosuvastatin Calcium Tablets

Specification : 5mg, 10mg, 20mg, 40mg

Standard : In - house

Packing : 7’s/blister

Description :

Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.

Rosuvastatin calcium Tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and other inactive ingredients.

Indications and Usage :

1.1 Hyperlipidemia and Mixed Dyslipidemia

ROSUVASTATIN CALCIUM TABLETS is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL‑C, and triglycerides and to increase HDL‑C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH)

Adjunct to diet to reduce Total‑C, LDL‑C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10‑17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL‑C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.

1.2 Hypertriglyceridemia

ROSUVASTATIN CALCIUM TABLETS is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

1.3 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)

ROSUVASTATIN CALCIUM TABLETS is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

1.4 Homozygous Familial Hypercholesterolemia

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

1.5 Slowing of the Progression of Atherosclerosis

ROSUVASTATIN CALCIUM TABLETS is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total‑C and LDL‑C to target levels.

1.6 Primary Prevention of Cardiovascular Disease

In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL‑C, smoking, or a family history of premature coronary heart disease, ROSUVASTATIN CALCIUM TABLETS is indicated to:

reduce the risk of stroke

reduce the risk of myocardial infarction

reduce the risk of arterial revascularization procedures

1.7 Limitations of Use

Rosuvastatin Calcium Tablets has not been studied in Fredrickson Type I and V dyslipidemias.