Rosunor
Generic Name
Rosuvastatin
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosunor 10 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Rosunor 10 mg Tablet contains Rosuvastatin, which is used to lower high cholesterol and triglyceride levels in the blood. It helps prevent heart attacks, strokes, and other cardiovascular problems.
Uses & Indications
Dosage
Adults
Initial dose 5 mg or 10 mg once daily. Max 40 mg once daily.
Elderly
Starting dose of 5 mg is recommended for patients >70 years. No other dosage adjustment needed.
Renal_impairment
For severe renal impairment (CrCl <30 mL/min), initial dose 5 mg once daily, max 10 mg once daily. No dose adjustment for mild to moderate impairment.
How to Take
Rosunor 10 mg Tablet should be taken orally, once daily, with or without food. It can be taken at any time of the day, but consistency is recommended (e.g., always at bedtime). Swallow the tablet whole with water.
Mechanism of Action
Rosuvastatin is an HMG-CoA reductase inhibitor. It selectively and competitively inhibits the enzyme HMG-CoA reductase, which is responsible for cholesterol synthesis in the liver. This leads to a decrease in hepatic cholesterol, which upregulates the number of LDL receptors on the hepatocyte surface, enhancing uptake and catabolism of LDL. It also inhibits hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 1 week, with maximum effect by 2-4 weeks.
Excretion
Approximately 90% excreted unchanged in feces (biliary excretion), with the remaining 10% excreted in urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absorbed from the gastrointestinal tract, with peak plasma concentrations occurring 3-5 hours post-oral administration.
Metabolism
Limited metabolism, primarily by CYP2C9 (minor), not extensively metabolized by CYP450 system. Main metabolite is N-desmethyl rosuvastatin, which has about half the HMG-CoA reductase inhibitory activity of the parent drug.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Severe renal impairment (CrCl <30 mL/min)
- Pregnancy and lactation
- Concomitant use with cyclosporine
Drug Interactions
Warfarin
May enhance anticoagulant effect; INR monitoring recommended.
Gemfibrozil
Increases Rosuvastatin exposure; avoid concomitant use or limit Rosuvastatin dose to 10 mg/day.
Cyclosporine
Significantly increases Rosuvastatin exposure; concomitant use is contraindicated.
Erythromycin
Decreases Rosuvastatin exposure.
Oral contraceptives
Increases estrogen and progestin levels.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Rosuvastatin overdose. In case of overdose, initiate symptomatic and supportive measures. Liver function tests and CK levels should be monitored. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosunor 10 mg Tablet is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraceptive measures during treatment. If pregnancy occurs, stop the medication immediately.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Severe renal impairment (CrCl <30 mL/min)
- Pregnancy and lactation
- Concomitant use with cyclosporine
Drug Interactions
Warfarin
May enhance anticoagulant effect; INR monitoring recommended.
Gemfibrozil
Increases Rosuvastatin exposure; avoid concomitant use or limit Rosuvastatin dose to 10 mg/day.
Cyclosporine
Significantly increases Rosuvastatin exposure; concomitant use is contraindicated.
Erythromycin
Decreases Rosuvastatin exposure.
Oral contraceptives
Increases estrogen and progestin levels.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Rosuvastatin overdose. In case of overdose, initiate symptomatic and supportive measures. Liver function tests and CK levels should be monitored. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosunor 10 mg Tablet is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraceptive measures during treatment. If pregnancy occurs, stop the medication immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent (generic available)
WHO Essential Medicine
YesClinical Trials
Rosuvastatin has been extensively studied in numerous large-scale clinical trials (e.g., JUPITER, GALAXY program) demonstrating its efficacy in lowering LDL-C and reducing cardiovascular event risk.
Lab Monitoring
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be performed at baseline and periodically during treatment.
- Liver function tests (ALT/AST) should be performed at baseline and if clinically indicated.
- Creatine Kinase (CK) levels should be measured at baseline in patients at increased risk for myopathy and if muscle symptoms develop.
Doctor Notes
- Emphasize the importance of adherence to lifestyle modifications.
- Monitor LFTs at baseline and if symptomatic; routine periodic monitoring is generally not recommended unless clinically indicated.
- Advise patients to report any muscle symptoms promptly.
- Consider dose adjustment in patients with severe renal impairment or those taking interacting medications.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Continue with your cholesterol-lowering diet and exercise program.
- Do not stop taking Rosunor without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.
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
Rosunor 10 mg Tablet is generally not expected to affect the ability to drive or operate machinery. However, some patients may experience dizziness. If dizziness occurs, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain a healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity.
- Manage your weight to a healthy range.
- Quit smoking and limit alcohol consumption.
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