• The dose range for Rosuvastatin Tablets in adults is 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.
• The maximum Rosuvastatin Tablets dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg.
• Rosuvastatin Tablets can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole.
• When initiating Rosuvastatin Tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosuvastatin Tablets 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 Tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

Rosuvastatin Tablets are contraindicated in the following conditions:

• Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with Rosuvastatin Tablets .
• Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
• Pregnancy
• Lactation: Limited data indicate that Rosuvastatin Tablets are present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require Rosuvastatin Tablets treatment should not breastfeed their infants.

Skeletal Muscle Effects

Rosuvastatin Tablets should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age≥65 years, inadequately treated hypothyroidism, renal impairment).

Immune-Mediated Necrotizing Myopathy

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.

Liver Enzyme Abnormalities

It is recommended that liver enzyme tests be performed before the initiation of Rosuvastatin Tablets, and if signs or symptoms of liver injury occur.

• Myalgia
• Constipation
• Asthenia
• Abdominal Pain
• Nausea

Store at room temperature.

ROVAS 5: 10×15’s
ROVAS 10: 10×15’s
ROVAS 20: 5x1x14’s