Rosugen
Generic Name
Rosuvastatin
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosugen 5 mg tablet | ৳ 13.00 | ৳ 130.00 |
Description
Overview of the medicine
Rosuvastatin is a statin medication used to lower high cholesterol and triglyceride levels. It helps reduce the risk of heart attack, stroke, and other cardiovascular problems.
Uses & Indications
Dosage
Adults
Initial dose is typically 5-10 mg orally once daily. Dose adjustments can be made at 2-4 week intervals based on lipid levels and treatment goals. Maximum dose is 40 mg once daily.
Elderly
No specific dose adjustment is generally required, but caution is advised with higher doses (>20 mg) in patients >70 years.
Renal_impairment
In patients with severe renal impairment (creatinine clearance <30 mL/min), the starting dose should be 5 mg once daily, and the maximum dose should not exceed 10 mg once daily.
How to Take
Take Rosugen tablet orally once daily, with or without food. It can be taken at any time of day, but it is often recommended to take it at the same time each day to maintain consistent blood levels.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme that plays a crucial role in cholesterol synthesis in the liver. By blocking this enzyme, it reduces the production of cholesterol, primarily low-density lipoprotein (LDL) cholesterol, often referred to as 'bad' cholesterol.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 1 week, maximal effect usually achieved within 2-4 weeks.
Excretion
Primarily excreted in feces (90%) as unchanged drug and metabolites; a small amount is excreted in urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absorbed orally; peak plasma concentrations reached in 3-5 hours.
Metabolism
Undergoes limited metabolism, primarily by CYP2C9 (approximately 10%).
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Hypersensitivity to rosuvastatin or any component of the formulation
- Severe renal impairment (CrCl <30 mL/min) at doses >10 mg
Drug Interactions
Warfarin
Potentiates the anticoagulant effect of warfarin; monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure; concurrent use should be avoided or limited.
Cyclosporine
Coadministration significantly increases rosuvastatin exposure; avoid or use 5 mg max.
Erythromycin
Decreases rosuvastatin plasma concentrations.
Protease inhibitors (e.g., Atazanavir/Ritonavir)
May significantly increase rosuvastatin exposure; dosage adjustment may be necessary.
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 antidote for rosuvastatin overdose. In case of overdose, symptomatic and supportive measures should be taken. Monitor liver function and CK levels.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Hypersensitivity to rosuvastatin or any component of the formulation
- Severe renal impairment (CrCl <30 mL/min) at doses >10 mg
Drug Interactions
Warfarin
Potentiates the anticoagulant effect of warfarin; monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure; concurrent use should be avoided or limited.
Cyclosporine
Coadministration significantly increases rosuvastatin exposure; avoid or use 5 mg max.
Erythromycin
Decreases rosuvastatin plasma concentrations.
Protease inhibitors (e.g., Atazanavir/Ritonavir)
May significantly increase rosuvastatin exposure; dosage adjustment may be necessary.
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 antidote for rosuvastatin overdose. In case of overdose, symptomatic and supportive measures should be taken. Monitor liver function and CK levels.
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
2 to 3 years from the date of manufacture, depending on manufacturer specifications.
Availability
Available in pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Off-patent
Clinical Trials
Rosuvastatin has been extensively studied in various clinical trials, including JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) and SATURN (Study of Coronary Atheroma by Intravascular Ultrasound with Rosuvastatin versus Atorvastatin). These trials demonstrated its efficacy in reducing cardiovascular events and atherosclerotic plaque progression.
Lab Monitoring
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) before initiation and periodically during treatment (e.g., 4-12 weeks after initiation or dose adjustment, then every 3-12 months)
- Liver function tests (ALT, AST) before initiation and periodically as clinically indicated; discontinue if transaminase levels persist at >3 times upper limit of normal.
- Creatine kinase (CK) levels should be measured if muscle pain, tenderness, or weakness occurs.
Doctor Notes
- Regularly monitor patient's lipid profile, liver function tests, and assess for muscle-related symptoms.
- Counsel patients on lifestyle modifications (diet, exercise) as these are critical adjuncts to pharmacotherapy.
- Discuss potential drug interactions, especially with cyclosporine, gemfibrozil, and warfarin.
- Advise female patients of childbearing potential about the contraindication during pregnancy and the need for effective contraception.
Patient Guidelines
- Take Rosugen exactly as prescribed by your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Follow a cholesterol-lowering diet and exercise program as advised by your healthcare provider.
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, if you experience dizziness or other side effects that could impair your concentration, you should avoid such activities.
Lifestyle Advice
- Adopt a heart-healthy diet low in saturated and trans fats, and cholesterol.
- Engage in regular physical activity for at least 30 minutes most days of the week.
- Maintain a healthy weight and quit smoking.
- Limit alcohol intake.
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