Rosuvastatin tablets are indicated for:

• Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total cholesterol, LDL-C, ApoB, non-HDL-C, and triglycerides (TG), and to increase HDL-C.
• Patients with hypertriglyceridemia as an adjunct to dietary therapy.
• Patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet.
• Patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total cholesterol, and ApoB levels.
• Slowing the progression of atherosclerosis as part of a lipid-lowering treatment strategy.
• Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia (HeFH) to reduce total cholesterol, LDL-C, and ApoB after inadequate response to diet therapy.
• Reduction of the risk of myocardial infarction (MI), stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease (CHD) but with multiple risk factors.

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the key enzyme responsible for converting 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. It exerts its lipid-lowering effects through two primary mechanisms. Firstly, it increases the number of LDL receptors on hepatocyte surfaces, thereby enhancing the uptake and breakdown of LDL. Secondly, it reduces hepatic production of very low-density lipoprotein (VLDL), leading to a decrease in the total number of VLDL and LDL particles.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age): The usual dose range of Rosuvastatin is 5–20 mg per day; the maximum recommended dose is 20 mg/day (doses above 20 mg have not been studied in this group). Doses should be tailored according to treatment goals, with adjustments made at intervals of 4 weeks or longer.

Very High Cholesterol and High Risk of MI or Stroke: 40 mg once daily.

Homozygous Familial Hypercholesterolemia: The recommended starting dose of Rosuvastatin is 20 mg once daily. Response to treatment should be evaluated based on LDL-C levels before apheresis.

Dosage in Asian Patients: Consider initiating Rosuvastatin at 5 mg once daily in Asian patients.

Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir: In patients receiving Cyclosporine, limit Rosuvastatin to 5 mg once daily. In those taking Lopinavir/Ritonavir or Atazanavir/Ritonavir, the dose should not exceed 10 mg once daily.

Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may increase when Rosuvastatin is used with Niacin or Fenofibrate; dose reduction should be considered. Combination with Gemfibrozil should be avoided due to increased Rosuvastatin exposure; if unavoidable, limit the dose to 10 mg once daily.

Dosage in Patients with Severe Renal Impairment: For patients with severe renal impairment (ClCr <30 mL/min/1.73 m²) not on hemodialysis, initiate Rosuvastatin at 5 mg once daily and do not exceed 10 mg once daily.

Significant drug interactions of Rosuvastatin include:

• Cyclosporine: Increases Rosuvastatin exposure; limit the dose to 5 mg once daily.
• Gemfibrozil: Concomitant use should be avoided. If necessary, limit Rosuvastatin to 10 mg once daily.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir: These combinations increase Rosuvastatin exposure; the dose should not exceed 10 mg once daily.
• Coumarin anticoagulants: May increase INR. Ensure stable INR before initiating Rosuvastatin and monitor frequently after starting or adjusting therapy.
• Concomitant lipid-lowering therapies: Use with fibrates or niacin may increase the risk of skeletal muscle-related adverse effects.

Rosuvastatin is contraindicated in patients with:

• Known hypersensitivity to any component of the product
• Active liver disease, including unexplained persistent elevations in hepatic transaminases
• Pregnancy or women who may become pregnant
• Breastfeeding mothers

Rosuvastatin is generally well tolerated. The most commonly reported adverse reactions associated with its use include headache, myalgia, constipation, asthenia, abdominal pain, and nausea.

Rosuvastatin should be used in women of childbearing potential only when they are highly unlikely to become pregnant and have been informed of the potential risks. If pregnancy occurs during treatment, the drug should be discontinued immediately. It is not known whether Rosuvastatin is excreted in human milk; however, small amounts of similar drugs in this class have been detected in breast milk.

Rosuvastatin should be prescribed with caution in patients with risk factors for myopathy, such as advanced age (>65 years), untreated hypothyroidism, or renal impairment. The risk of myopathy may increase when used with other lipid-lowering agents (e.g., fibrates, niacin), or with drugs such as gemfibrozil, cyclosporine, lopinavir/ritonavir, or atazanavir/ritonavir. Therapy should be discontinued if significantly elevated creatine kinase levels occur or if myopathy is suspected or diagnosed. Treatment should also be temporarily withheld in patients with acute or serious conditions that may predispose to renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, or uncontrolled seizures). Liver function tests are recommended before starting therapy, at 12 weeks after initiation or dose escalation, and periodically (e.g., semiannually) thereafter.

There is no specific antidote for Rosuvastatin overdose. In case of overdose, patients should receive symptomatic and supportive treatment as required. Hemodialysis is unlikely to significantly enhance the elimination of Rosuvastatin.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Keep below 30°C temperature, protected from light and moisture. Keep out of the reach of children.