Rosutin 5

Indications

Rosutin is prescribed for:

• Primary Hyperlipidemia and Mixed Dyslipidemia: Used alongside dietary changes to lower elevated levels of total cholesterol (total-C), LDL cholesterol (LDL-C), ApoB, non-HDL cholesterol (non-HDL-C), and triglycerides (TG), while increasing HDL cholesterol (HDL-C).
• Hypertriglyceridemia: Utilized as an adjunct to diet for managing high triglyceride levels.
• Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): Administered with diet to manage this condition.
• Homozygous Familial Hypercholesterolemia (HoFH): Aimed at reducing LDL-C, total-C, and ApoB levels.
• Atherosclerosis Progression: Helps slow the progression of atherosclerosis when used with diet to lower total-C and LDL-C.
• Pediatric Patients (10-17 years) with Heterozygous Familial Hypercholesterolemia (HeFH): Prescribed to lower elevated total-C, LDL-C, and ApoB levels after diet therapy proves inadequate.
• Cardiovascular Risk Reduction: Reduces the risk of myocardial infarction (MI), stroke, and the need for arterial revascularization in patients with multiple risk factors but no evident coronary heart disease (CHD).

Pharmacology

Rosuvastatin is a potent, selective inhibitor of HMG-CoA reductase, the key enzyme in cholesterol production. It works in two main ways:

1. Enhancing LDL Uptake: Increases the number of LDL receptors in the liver, promoting the breakdown of LDL cholesterol.
2. Reducing VLDL Production: Inhibits the liver’s production of VLDL, thus lowering the overall levels of VLDL and LDL particles in the bloodstream.

Dosage & Administration

• Pediatric Patients (10-17 years): Typical dose is 5-20 mg daily, with a maximum of 20 mg daily. Adjust according to therapy goals and evaluate every 4 weeks or more.
• Very High Cholesterol or High Risk of MI/Stroke: Recommended dose is 40 mg daily.
• Homozygous Familial Hypercholesterolemia: Start with 20 mg daily, adjusting based on preapheresis LDL-C levels.
• Asian Patients: Begin with 5 mg daily.
• Cyclosporine Users: Limit Rosuvastatin to 5 mg daily.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir Users: Limit Rosuvastatin to 10 mg daily.
• With Other Lipid-Lowering Therapies: Consider reducing the dose with niacin or fenofibrate due to increased risk of muscle effects. Avoid gemfibrozil; if combined, limit Rosuvastatin to 10 mg daily.
• Severe Renal Impairment: Start with 5 mg daily and do not exceed 10 mg daily.

Interaction

Rosutin may interact with the following:

• Cyclosporine: Increases Rosutin exposure; limit dose to 5 mg daily.
• Gemfibrozil: Avoid combination; if used, limit Rosutin to 10 mg daily.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir: Increases Rosutin exposure; limit dose to 10 mg daily.
• Coumarin Anticoagulants: May prolong INR; monitor INR levels regularly.
• Other Lipid-Lowering Agents: Increased risk of muscle effects when combined with fibrates and niacin.

Contraindications

Rosutin should not be used in individuals with:

• Known hypersensitivity to its components
• Liver disease or unexplained persistent liver enzyme elevations
• Pregnancy or women who may become pregnant
• Nursing mothers

Side Effects

Rosutin is generally well tolerated. Common side effects include headache, muscle pain (myalgia), constipation, fatigue, abdominal pain, and nausea.

Pregnancy & Lactation

Rosuvastatin should be used in women of childbearing age only if they are unlikely to conceive. Discontinue if pregnancy occurs. The drug’s presence in breast milk is unknown, though similar drugs may be excreted in milk.

Precautions & Warnings

Prescribe Rosutin cautiously to individuals with risk factors for muscle problems (e.g., older age, untreated hypothyroidism, renal impairment). Monitor for signs of myopathy and consider dose adjustments or discontinuation in cases of elevated creatinine kinase levels or severe conditions that could lead to renal failure. Regular liver enzyme tests are recommended before starting therapy and periodically thereafter.

Overdose Effects

In case of overdose, provide symptomatic and supportive treatment. Hemodialysis is not effective in significantly clearing Rosutin.

Therapeutic Class

Rosutin falls under Other Anti-anginal & Anti-ischemic Drugs, Statins.

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.