Rosu
Generic Name
Rosuvastatin 40 mg Tablet
Manufacturer
Generic Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosu 40 mg tablet | ৳ 50.00 | ৳ 500.00 |
Description
Overview of the medicine
Rosuvastatin 40 mg Tablet is a lipid-lowering medication used to reduce high cholesterol and triglyceride levels, thereby lowering the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
The usual starting dose is 5 mg or 10 mg once daily. The 40 mg dose is reserved for patients with severe hypercholesterolemia and high cardiovascular risk who have not achieved their lipid goals on a 20 mg dose.
Elderly
No specific dose adjustment needed, but caution should be exercised.
Renal_impairment
For patients with severe renal impairment (creatinine clearance <30 mL/min/1.73m²), the 40 mg dose is contraindicated. Max dose for moderate impairment is 20 mg.
How to Take
Rosuvastatin tablets should be taken orally once daily, with or without food.
Mechanism of Action
It selectively inhibits HMG-CoA reductase, an enzyme in the liver that plays a key role in cholesterol synthesis. This leads to a decrease in LDL-C (bad cholesterol) and an increase in HDL-C (good cholesterol).
Pharmacokinetics
Onset
Lipid-lowering effects are evident within 1 week of therapy, with maximal effects usually achieved within 2-4 weeks.
Excretion
Approximately 90% of the administered dose is excreted unchanged in the feces, with the remaining 10% excreted in urine.
Half life
Elimination half-life is approximately 19 hours.
Absorption
Approximately 20% absolute bioavailability. Peak plasma concentrations are reached in 3-5 hours.
Metabolism
Limited metabolism, primarily by cytochrome P450 2C9 (CYP2C9).
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Severe renal impairment (creatinine clearance <30 mL/min/1.73m²).
- Myopathy.
- Concomitant cyclosporine.
- Pregnancy and lactation.
- Hypersensitivity to rosuvastatin or any component of the tablet.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin; INR monitoring is required.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; co-administration is contraindicated.
Gemfibrozil and other fibrates
May increase the risk of myopathy; co-administration should be avoided or used with caution.
Protease inhibitors (e.g., ritonavir-boosted lopinavir)
May significantly increase rosuvastatin exposure; dose adjustment may be necessary.
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, there is no specific treatment. Symptomatic and supportive measures should be employed. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosuvastatin is contraindicated in pregnancy and during lactation. Women of childbearing potential should use adequate contraceptive measures.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Severe renal impairment (creatinine clearance <30 mL/min/1.73m²).
- Myopathy.
- Concomitant cyclosporine.
- Pregnancy and lactation.
- Hypersensitivity to rosuvastatin or any component of the tablet.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin; INR monitoring is required.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; co-administration is contraindicated.
Gemfibrozil and other fibrates
May increase the risk of myopathy; co-administration should be avoided or used with caution.
Protease inhibitors (e.g., ritonavir-boosted lopinavir)
May significantly increase rosuvastatin exposure; dose adjustment may be necessary.
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, there is no specific treatment. Symptomatic and supportive measures should be employed. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosuvastatin is contraindicated in pregnancy and during lactation. Women of childbearing potential should use adequate contraceptive measures.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 2-3 years, as indicated on the pack
Availability
Available in pharmacies and hospitals
Approval Status
FDA approved; available with DGDA approval in Bangladesh
Patent Status
Off-patent, generic versions 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 the GALAXY program.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiation and periodically thereafter.
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be checked periodically to assess efficacy.
- Creatine kinase (CK) levels should be measured at baseline in patients with risk factors for myopathy and if muscle symptoms develop.
Doctor Notes
- Emphasize monitoring LFTs at baseline and periodically.
- Counsel patients on reporting any muscle pain or weakness promptly.
- Review potential drug interactions, especially with cyclosporine and fibrates.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, preferably at the same time each day.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Do not stop taking Rosuvastatin without consulting your doctor, even if you feel well.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rosuvastatin is not expected to impair the ability to drive or operate machinery. However, if you experience dizziness, use caution.
Lifestyle Advice
- Maintain a healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity as advised by your doctor.
- Achieve and maintain a healthy weight.
- Quit smoking and limit alcohol consumption.
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