rosuvastatin calcium tablet film coated

1 INDICATIONS AND USAGE Rosuvastatin Tablets, USP is an HMG Co-A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.3) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5) Limitations of use (1.8) : Rosuvastatin Tablets, USP have not been studied in Fredrickson Type I and V dyslipidemias. Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia Rosuvastatin Tablets, USP are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin Tablets, USP are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with homozygous familial hypercholesterolemia Rosuvastatin Tablets, USP are 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. 1.8 Limitations of Use Rosuvastatin Tablets, USP have not been studied in Fredrickson Type I and V dyslipidemias.

sunshine lake pharma co., ltd.

FDA Reported Adverse Reactions
[1] drug ineffective    [2] nausea    [3] fatigue    [4] off label use    [5] diarrhoea    [6] dyspnoea    [7] pain    [8] headache    [9] vomiting    [10] dizziness