Description and Composition of Statinor
Statinor contains as its active pharmaceutical ingredient, Rosuvastatin calcium; a synthetic lipid agent for oral administration. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-COA to mevalonate, an early and rate limiting step in the synthesis of cholesterol. Statinor comes in different dosage strengths which includes 5 mg, 10 mg, 20 mg and 40 mg.
Indications and uses of Statinor
Hyperlipidemia and Mixed Dyslipidemia
Rosuvastatin is indicated as adjunctive therapy to diet to reduce elevated LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.
Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH):
Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10-17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia):
Rosuvastatin is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Homozygous Familial Hypercholesterolemia:
Rosuvastatin is indicated as adjunctive therapy to other lipid-loweringt treatment (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C. Total-C and ApoB in adult patients with homozygous familial hypercholesterolemia.
Slowing of the Progression of Atherosclerosis
Rosuvastatin is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
Primary Prevention of Cardiovascular Disease:
In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age 2 50 years old in men and 2 60 years old in women, hsCRP 22 mg/l, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, Rosuvastatin is indicated to:
reduce the risk of stroke reduce the risk of myocardial infarction reduce the risk of arterial revascularization procedures.
Limitations of Use of Statinor
Statinor has not been studied in Fredrickson Type I and V dyslipidemias.
Dosage and Administration of Statinor
The recommended starting dose of Statinor is 5-10 mg once daily. The dose may be increased if necessary at intervals of at least 4 weeks to 20 mg once daily. The dose may be increased after further 4 weeks to 40 mg twice daily only in severe hypercholesterolemia with high cardiovascular risk and under specialist supervision. Dose in elderly patients: Initially 5 mg once daily.
In pediatric patients 10 to 17 years of age with HeFH, the usual dose range is 5-20 mg/day; doses greater than 20 mg have not been studied this patient population.
Contraindication of Statinor
Patients with a known hypersensitivity to any component of this product. It is contraindicated in patient with active liver disease.
Women who are pregnant or may become pregnant:
Rosuvastatin may cause fetal harm when administered to pregnant women.
Because another drug in this class passes into breast milk it is advised not to nurse their infants while taking this drug
Adverse Reactions of Statinor
- Rhabdomyolysis with myoglobinuria and acute renal failure,
- myopathy (including myositis),
- liver enzyme abnormalities
- abdominal pain,
- headache and
Statinor Use in Pregnancy and Lactation
Pregnancy category X.
Statinor is not recommended to use in pregnancy and lactation.
High Risk Group
Skeletal Muscle Effects:
Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
Concomitant Use of Antacids:
When taking Rosuvastatin with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after Rosuvastatin administration
If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy.
It is recommended that liver enzymes be checked before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Drug Interaction with Statinor
- Cyclosporine significantly increased Rosuvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to Rosuvastatin 5 mg once daily.
- Rosuvastatin significant increased INR in patients receiving coumarin anticoagulants. In patients taking coumarin Rosuvastatin concomitantly, INR should be determined before starting Rosuvastatin and frequently enough during early therapy to ensure that no significant alteration of INR occurs.
- The risk of skeletal muscle effects may be enhanced when Rosuvastatin is used in combination with niacin; dosage should be considered in this setting. The benefit of further alterations in lipid levels by the combined use of Rosuvastatin with fibrates should be carefully weighed against the potential risks of this combination
Keep out of the reach of children. Keep in a dry place, below 30°C. Protect from light.