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Primary hyperlipidemia and mixed dyslipidemia: reduces elevated total cholesterol, LDL-C, ApoB, non-HDL-C, and triglycerides, and increases HDL-C (as a diet adjunct).
- Hypertriglyceridemia: as a diet adjunct.
- Primary dysbetalipoproteinemia (Type III hyperlipoproteinemia): as a diet adjunct.
- Homozygous familial hypercholesterolemia (HoFH): lowers LDL-C, total cholesterol, and ApoB.
- Slows atherosclerosis progression by lowering total cholesterol and LDL-C (as a diet adjunct).
- Pediatric heterozygous familial hypercholesterolemia (ages 10–17) after failed dietary therapy.
- Reduces risk of myocardial infarction, stroke, and arterial revascularization in patients without clinical CHD but with multiple risk factors.
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বাহিরে
✅ Description:
Rozavel 10 mg Tablet is used to lower high cholesterol by reducing LDL (“bad” cholesterol) and triglycerides, while helping increase HDL (“good” cholesterol). It is prescribed alongside a healthy diet and regular exercise. It is generally safe, but may occasionally cause diarrhea, gas, or stomach upset—taking it with food may help. Seek medical advice if you experience fatigue, muscle weakness, or muscle pain. Liver function tests are often done before and during treatment, and you should inform your doctor if you notice signs of liver problems (e.g., abdominal pain, dark urine, yellowing of skin/eyes). Caution is advised if you have kidney disease, liver disease, or diabetes, as the medicine may raise blood sugar levels. Rozavel should not be used during pregnancy, breastfeeding, or if planning a pregnancy.
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✔️ 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.
⚠️Disclaimer:
At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.
