Dosage Form: Tablet.
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
HMG-CoA reductase is the rate-limiting enzyme that transforms 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase. Rosuvastatin has two mechanisms for altering lipid levels. To begin, it boosts the amount of hepatic LDL receptors on the cell surface, which improves LDL absorption and degradation. Second, Rosuvastatin decreases the total quantity of VLDL and LDL particles by inhibiting VLDL formation in the liver.
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.
Route of administration: Orally.
The significant drug interaction for rosuvastatin are
- Cyclosporine: combined use will increase rosuvastatin exposure. The dose of rosuvastatin should be limited to 5 mg once a day.
- Gemfibrosil: Conjoint use should be avoided. If used together, the dose of rosuvastatin should be limited to 10 mg once a day.
- Lopinavir / Ritonavir or Atazanavir / Ritonavir: Combination use will increase rosuvastatin exposure. The dose of rosuvastatin should be 10 mg once a day.
- Coumarin anticoagulant: the combination extends the international normalized ratio (INR). Before starting rosuvastatin, a stable INR should be achieved. The INR should be monitored frequently until stabilized after starting or changing rosuvastatin therapy.
- Concomitant lipid lowering therapy: Use with fibrates and niacin products may increase the risk of effects on skeletal muscle.
- If you have a known hypersensitivity to any of the product’s ingredients, you should avoid taking rosuvastatin.
- Unexplained chronic rises in hepatic transaminase values are a sign of liver illness.
- Women who are pregnant or may become pregnant
- Mothers who are breastfeeding
Rosuvastatin is well tolerated by most people. Headache, myalgia, constipation, asthenia, stomach pain, and nausea were the most common side effects linked to Rosuvastatin.
Pregnancy & Lactation:
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Precautions & Warnings:
Effects on skeletal muscle (e.g., myopathy and rhabdomyolysis): Usage of the 40 mg dose, advanced age (>65 years), hypothyroidism, renal impairment, and use of cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or certain other lipid-lowering medicines all enhance the risks. Patients should be encouraged to report any unexplained muscle discomfort, soreness, or weakness as soon as possible. If indications or symptoms arise, rosuvastatin can be stopped.
Abnormalities in liver enzymes and monitoring: Hepatic transaminases might be persistently elevated.
Before and during treatment, liver enzymes should be checked.
Other Anti-anginal & Anti-ischaemic drugs, Statins
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Manufactured by: UniMed UniHealth Pharmaceuticals Limited