Rosugen
Generic Name
Rosuvastatin Calcium
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosugen 20 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Rosugen 20 mg tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglyceride levels, reducing the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
Initial dose 10-20 mg once daily, adjusted based on lipid levels, up to a maximum of 40 mg once daily.
Elderly
No dosage adjustment needed unless other risk factors are present (e.g., renal impairment).
Renal_impairment
Initial dose 5 mg once daily for patients with severe renal impairment (CrCl <30 mL/min). Doses greater than 20 mg are not recommended.
How to Take
Take orally once daily, with or without food, at any time of day, but it is best to take it at the same time each day.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. This leads to a decrease in hepatic cholesterol synthesis and an increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 1 week, maximal effect by 2-4 weeks.
Excretion
Primarily via feces (90%), with about 5% excreted in urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absorbed from the gastrointestinal tract; absolute bioavailability is about 20%.
Metabolism
Limited metabolism, primarily by CYP2C9; approximately 10% of the dose is metabolized.
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) at doses >20 mg
- Concomitant cyclosporine use
Drug Interactions
Warfarin
May enhance anticoagulant effect; monitor INR.
Gemfibrozil
Increases rosuvastatin exposure; limit rosuvastatin dose to 10 mg daily.
Cyclosporine
Significantly increases rosuvastatin exposure; co-administration is contraindicated.
Erythromycin
Decreases rosuvastatin exposure.
Antacids (aluminum and magnesium hydroxide)
Decreases rosuvastatin plasma concentration; take antacids 2 hours after rosuvastatin.
Protease Inhibitors (e.g., Ritonavir with Lopinavir)
Significantly increases rosuvastatin exposure; dose adjustment needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Treatment is symptomatic and supportive. Monitor liver function tests and CK levels.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception.
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) at doses >20 mg
- Concomitant cyclosporine use
Drug Interactions
Warfarin
May enhance anticoagulant effect; monitor INR.
Gemfibrozil
Increases rosuvastatin exposure; limit rosuvastatin dose to 10 mg daily.
Cyclosporine
Significantly increases rosuvastatin exposure; co-administration is contraindicated.
Erythromycin
Decreases rosuvastatin exposure.
Antacids (aluminum and magnesium hydroxide)
Decreases rosuvastatin plasma concentration; take antacids 2 hours after rosuvastatin.
Protease Inhibitors (e.g., Ritonavir with Lopinavir)
Significantly increases rosuvastatin exposure; dose adjustment needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Treatment is symptomatic and supportive. Monitor liver function tests and CK levels.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, check specific packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Generally off-patent in many countries, though specific formulations or combination therapies might still be patented.
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated Rosuvastatin's efficacy in lowering LDL-C and reducing cardiovascular event risk (e.g., JUPITER trial, AURORA trial).
Lab Monitoring
- Liver function tests (ALT, AST) before initiation and as clinically indicated
- Creatine Kinase (CK) levels before initiation in patients at risk for myopathy and if muscle symptoms develop
- Lipid panel (Total-C, LDL-C, HDL-C, Triglycerides) to monitor efficacy
Doctor Notes
- Monitor lipid profile regularly. Adjust dose based on patient response and tolerability.
- Educate patients on symptoms of myopathy and importance of reporting them.
- Consider genetic testing for SLCO1B1 polymorphisms in select high-risk patients.
Patient Guidelines
- Take as directed, do not stop without consulting your doctor.
- Maintain a healthy diet and regular exercise.
- Report any unexplained muscle pain, tenderness, or weakness immediately.
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose.
Driving Precautions
Rosuvastatin is generally not expected to affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery.
Lifestyle Advice
- Adopt a low-fat, low-cholesterol diet.
- Engage in regular physical activity.
- Quit smoking and limit alcohol intake.
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