Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
Pregnancy & Lactation
Precautions & Warnings
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment