Dosage Form: Tablet.
- Heterozygous Hypercholesterolemia is treated with rosuvastatin (Familial and Non familial)
- Hypercholesterolemia Homozygous (Familial)
- Dyslipidemia (Mixed) (Fredrickson Type IIa and IIb)
- Primary cardiovascular disease prevention
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
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.
Rosuvastatin can be taken at any time of day, with or without food.
Route of administration: Orally.
Exceptional sedate intelligent of Rosuvastatin are- Cyclosporine: Combination increments Rosuvastatin introduction. Rosuvastatin measurements ought to be constrained to 5 mg once daily. Gemfibrosil: Combination ought to be maintained a strategic distance from. On the off chance that utilized together, Rosuvastatin measurements ought to be constrained to 10 mg once daily. Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increments Rosuvastatin introduction. Rosuvastatin measurements ought to be to 10 mg once daily. Coumarin anticoagulants: Combination draws out universal normalized proportion (INR). Steady INR ought to be accomplished earlier to beginning Rosuvastatin. INR ought to be checked as often as possible until steady upon start or modification of Rosuvastatin therapy. Concomitant lipid-lowering treatments: Utilize with fibrates and niacin items may increment the hazard of skeletal muscle impacts.
If you have a known hypersensitivity to any of the product’s ingredients, you should avoid taking rosuvastatin.
Unexplained persistent elevations in hepatic transaminase levels are a sign of liver disease.
Women who are pregnant or may become pregnant
Mothers who are breastfeeding
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
Pregnancy & Lactation:
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
Precautions & Warnings:
Skeletal muscle impacts (e.g., myopathy and rhabdomyolysis): Dangers increment with utilize of 40 mg dosage, progressed age (>65 year), hypothyroidism, renal impedance and combination utilize with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients ought to be exhorted to instantly report unexplained muscle torment, delicacy or shortcoming. Rosuvastatin can be ceased in the event that signs or side effects appear. Liver protein variations from the norm and observing: Tireless rises in hepatic transaminases can happen.
Other Anti-anginal & Anti-ischaemic drugs, Statins
Protect from light and moisture by storing below 30°C. Keep the medicine out of children’s reach.
Manufactured by: Eskayef Pharmaceuticals Ltd.