Rosvin
Generic Name
Rosuvastatin
Manufacturer
Popular Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rosvin 10 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Rosuvastatin is an HMG-CoA reductase inhibitor (statin) used to lower high cholesterol and triglyceride levels. It is also used to reduce the risk of heart attack, stroke, and certain heart complications in patients with or without coronary heart disease.
Uses & Indications
Dosage
Adults
Initial dose typically 10 mg once daily. May be adjusted up to 40 mg once daily depending on patient response and lipid goals. Take with or without food.
Elderly
No dosage adjustment required for elderly patients, but caution should be exercised, especially for patients >70 years. Initiate with a 5 mg dose.
Renal_impairment
For patients with severe renal impairment (CrCl <30 mL/min) not on hemodialysis, the starting dose is 5 mg once daily, and should not exceed 10 mg once daily.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole with a glass of water. Do not crush or chew.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition leads to a reduction in hepatic cholesterol synthesis and an increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL. It also reduces VLDL and triglyceride synthesis.
Pharmacokinetics
Onset
Cholesterol-lowering effect seen within 1 week; maximum effect by 2-4 weeks.
Excretion
Primarily excreted in feces (approximately 90%) unchanged, with a small portion excreted in urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% bioavailability after oral administration. Peak plasma concentrations reached within 3-5 hours.
Metabolism
Limited metabolism, primarily by CYP2C9 (10%), not extensively metabolized by CYP450.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Severe renal impairment (CrCl <30 mL/min) in patients not on hemodialysis when co-administered with cyclosporine
Drug Interactions
Niacin
Increased risk of muscle-related adverse events.
Warfarin
May enhance anticoagulant effect; monitor INR.
Colchicine
Increased risk of myopathy.
Gemfibrozil
Increases rosuvastatin exposure; use with caution, limit rosuvastatin dose.
Cyclosporine
Significant increase in rosuvastatin exposure; avoid co-administration or limit rosuvastatin dose.
Erythromycin
Decreases rosuvastatin exposure.
Protease inhibitors (e.g., Atazanavir/Ritonavir)
Significantly increases rosuvastatin exposure; adjust rosuvastatin dose.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Severe renal impairment (CrCl <30 mL/min) in patients not on hemodialysis when co-administered with cyclosporine
Drug Interactions
Niacin
Increased risk of muscle-related adverse events.
Warfarin
May enhance anticoagulant effect; monitor INR.
Colchicine
Increased risk of myopathy.
Gemfibrozil
Increases rosuvastatin exposure; use with caution, limit rosuvastatin dose.
Cyclosporine
Significant increase in rosuvastatin exposure; avoid co-administration or limit rosuvastatin dose.
Erythromycin
Decreases rosuvastatin exposure.
Protease inhibitors (e.g., Atazanavir/Ritonavir)
Significantly increases rosuvastatin exposure; adjust rosuvastatin dose.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
FDA approved (Generic widely available)
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Key clinical trials include JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) and METEOR (Measuring Effects on intima media Thickness: An Evaluation Of Rosuvastatin) which demonstrated its efficacy in cardiovascular risk reduction and progression of atherosclerosis.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiation of therapy and periodically thereafter.
- Creatine Kinase (CK) levels should be measured before initiating treatment and if muscle symptoms develop.
Doctor Notes
- Counsel patients on the importance of adherence to diet and exercise in conjunction with medication.
- Emphasize reporting any muscle pain or weakness promptly.
- Monitor LFTs at baseline and as clinically indicated.
Patient Guidelines
- Take Rosuvastatin exactly as prescribed by your doctor.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Continue with a cholesterol-lowering diet and exercise program as advised by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rosuvastatin is generally not expected to affect the ability to drive or operate machinery. However, patients should be aware of possible adverse effects like dizziness, which may affect these activities.
Lifestyle Advice
- Adopt a healthy, low-fat diet.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Avoid smoking and limit alcohol consumption.
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