Manufacturer
APOTEX INC
Registraction Number
-MAL19920197AZ
A 30-tablet pack containing rosuvastatin calcium.
Apo-Rosuvastatin 10mg Tablets are indicated for:
Primary hypercholesterolemia and mixed dyslipidemia (including Fredrickson types IIa and IIb) as an adjunct to diet when response to diet and exercise is inadequate.
Homozygous familial hypercholesterolemia, either alone or as an adjunct to diet and other lipid-lowering treatments (e.g., LDL apheresis).
Primary prevention of cardiovascular disease to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures.
Reduction of total cholesterol, LDL-C, and apo B levels in children and adolescents aged 10–17 years as an adjunct to diet.
Dosage: The recommended starting dose is 5 or 10 mg once daily. The choice of starting dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions.
Administration:
Swallow the tablet whole with a full glass of water.
It can be taken at any time of day, with or without food.
Monitoring:
Regular monitoring of lipid levels is recommended to assess the effectiveness of the therapy.
Liver function tests should be performed before and during treatment.
Precautions:
Use with caution in patients with a history of liver disease or those who consume substantial quantities of alcohol.
Discontinue treatment if there is a marked increase in serum transaminases or if myopathy is suspected.
Use with caution in patients of Asian descent due to increased plasma concentrations.
Contraindications:
Hypersensitivity to rosuvastatin or any of its components.
Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and lactation.
Malaysia
