Rozavel 10 | 1 Strip

✔️ Pharmacology

Rosuvastatin is a selective, competitive HMG-CoA reductase inhibitor. This enzyme converts HMG-CoA to mevalonate, a cholesterol precursor. Rosuvastatin works by increasing hepatic LDL receptors to boost LDL uptake and breakdown, and by reducing hepatic VLDL production, thereby lowering total VLDL and LDL particles.

✔️ Dosage & Administration

• Pediatric HeFH (10–17 years): 5–20 mg/day; max 20 mg/day. Adjust every ≥4 weeks.
• Very high cholesterol/high MI/stroke risk: 40 mg once daily.
• HoFH: Start at 20 mg once daily; assess using pre-apheresis LDL-C.
• Asian patients: Consider starting at 5 mg once daily.
• With cyclosporine: Limit to 5 mg/day.
• With lopinavir/ritonavir or atazanavir/ritonavir: Limit to 10 mg/day.
• With fibrates or niacin: Consider lowering dose due to myopathy risk.
• With gemfibrozil: Avoid; if used, limit to 10 mg/day.
• Severe renal impairment (ClCr <30 mL/min, not on dialysis): Start at 5 mg/day; max 10 mg/day.

✔️ Drug Interactions

• Cyclosporine: Increases rosuvastatin exposure; limit to 5 mg/day.
• Gemfibrozil: Avoid; if used, limit to 10 mg/day.
• Lopinavir/ritonavir, atazanavir/ritonavir: Increases exposure; limit to 10 mg/day.
• Coumarin anticoagulants: May prolong INR; monitor closely.
• Other lipid-lowering agents (fibrates, niacin): May raise myopathy risk.

✔️ Side Effects

Commonly mild: headache, muscle pain, constipation, weakness, abdominal discomfort, nausea.

✔️ Contraindications:

• Hypersensitivity to rosuvastatin or components
• Active liver disease or unexplained persistent transaminase elevations
• Pregnancy and breastfeeding

✔️ Pregnancy & Lactation

Use only if pregnancy is extremely unlikely and risks are discussed. Discontinue immediately if pregnancy occurs. Unknown if excreted in breast milk; avoid during breastfeeding.

✔️ Precautions & Warnings

• Higher myopathy risk in patients >65 years, with untreated hypothyroidism, or renal impairment.
• Increased risk with fibrates, niacin, gemfibrozil, cyclosporine, lopinavir/ritonavir, or atazanavir/ritonavir.
• Discontinue if creatinine kinase is markedly elevated or myopathy is suspected.
• Temporarily stop in acute serious conditions that could predispose to renal failure from rhabdomyolysis.
• Check liver enzymes before treatment, 12 weeks after starting/increasing dose, and periodically thereafter.

✔️

No specific antidote; treat symptoms supportively. Hemodialysis is not effective in clearing rosuvastatin.

✔️ Storage:

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