Rosetor

Indications

Rosetor Tablets are prescribed for:

• Primary Hyperlipidemia and Mixed Dyslipidemia: Used alongside a proper diet to lower elevated Total Cholesterol (Total-C), LDL Cholesterol (LDL-C), ApoB, Non-HDL Cholesterol, and Triglycerides (TG) while improving HDL Cholesterol (HDL-C).
• Hypertriglyceridemia: As an adjunct to diet for effective triglyceride control.
• Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): Complementary to dietary adjustments.

Please use this medication under the supervision of a registered physician.

Pharmacology

Rosuvastatin, the active ingredient in Rosetor, is a potent and selective inhibitor of HMG-CoA reductase. This enzyme is critical in the cholesterol synthesis pathway, converting HMG-CoA to mevalonate, a precursor of cholesterol. Rosuvastatin lowers lipid levels by:

1. Increasing Hepatic LDL Receptors: This enhances LDL uptake and breakdown.
2. Inhibiting VLDL Synthesis: Reducing the number of VLDL and LDL particles.

Dosage & Administration

Pediatric Patients (10-17 years):

• Heterozygous Familial Hypercholesterolemia:
  Usual dose: 5-20 mg/day. Maximum: 20 mg/day.
  Adjust doses every 4 weeks based on treatment goals.

Adults:

• High Cholesterol or Elevated Risk of Stroke/MI:
  Standard dose: 40 mg once daily.
• Homozygous Familial Hypercholesterolemia:
  Starting dose: 20 mg daily. Adjust based on LDL-C levels before apheresis.

Special Populations:

• Asian Patients: Start at 5 mg/day.
• Severe Renal Impairment: Begin with 5 mg/day; do not exceed 10 mg/day.
• Cyclosporine Users: Limit dose to 5 mg/day.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir Users: Limit dose to 10 mg/day.

For best results, consult your doctor to tailor the dosage based on your condition.

Interactions

Key interactions to note when using Rosetor:

• Cyclosporine: Increases Rosetor levels; limit dose to 5 mg/day.
• Gemfibrozil: Avoid concurrent use; if necessary, limit Rosetor to 10 mg/day.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir: Limit dose to 10 mg/day.
• Coumarin Anticoagulants: May prolong INR. Monitor INR levels frequently.
• Fibrates or Niacin: May heighten the risk of muscle-related side effects.

Contraindications

Do not use Rosetor if you have:

• Hypersensitivity to any component.
• Active liver disease or unexplained elevated liver enzymes.
• Pregnancy or are breastfeeding.

Side Effects

Rosetor is generally well-tolerated, but some common side effects may include:

• Headache
• Muscle pain (myalgia)
• Constipation
• Abdominal discomfort
• Nausea

Pregnancy & Lactation

Rosuvastatin is contraindicated during pregnancy and breastfeeding. If a woman becomes pregnant while taking this medication, it should be discontinued immediately.

Precautions & Warnings

Exercise caution in patients predisposed to myopathy, including those:

• Aged over 65 years.
• With untreated hypothyroidism or severe renal impairment.

Concurrent use with certain drugs like fibrates, gemfibrozil, or cyclosporine may increase the risk of muscle damage. If myopathy or elevated creatinine kinase levels occur, discontinue use immediately.

Overdose Management

In case of overdose, treatment should be symptomatic and supportive. Hemodialysis has limited effectiveness in clearing Rosuvastatin.

Therapeutic Class

Statins, Anti-anginal & Anti-Ischaemic Drugs.

Storage

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