Rosustat
Generic Name
Rosuvastatin
Manufacturer
Incepta Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosustat 5 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Rosuvastatin is a statin medication used to lower high cholesterol and triglycerides, reducing the risk of heart disease and stroke. It works by blocking an enzyme in the liver that produces cholesterol.
Uses & Indications
Dosage
Adults
Initial dose is typically 5 mg or 10 mg once daily. For patients requiring large reductions in LDL-C, a starting dose of 20 mg once daily may be considered. The maximum recommended dose is 40 mg once daily.
Elderly
For patients 70 years of age or older, a starting dose of 5 mg is recommended.
Renal_impairment
For patients with severe renal impairment (CrCl < 30 mL/min/1.73m²), a starting dose of 5 mg once daily is recommended, and the dose should not exceed 10 mg once daily.
How to Take
Take Rosustat-5 mg tablet orally once daily, with or without food. It is advisable to take the tablet at the same time each day for consistency.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme that catalyzes an early, rate-limiting step in cholesterol biosynthesis. This inhibition reduces cholesterol production in the liver, leading to an increase in LDL receptors on liver cells, enhancing the uptake and catabolism of LDL-C.
Pharmacokinetics
Onset
Significant lipid-lowering effects typically observed within 1 week; maximum effect seen in 2-4 weeks.
Excretion
Primarily excreted in feces (approximately 90%) and to a lesser extent in urine (approximately 10%).
Half life
Approximately 19 hours.
Absorption
Approximately 20% absorbed after oral administration. Peak plasma concentrations are reached about 3-5 hours post-dose.
Metabolism
Minimal metabolism (approximately 10%) by cytochrome P450 enzymes, primarily CYP2C9. Most of the drug remains unchanged.
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/1.73m²)
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin; INR should be monitored when starting or stopping rosuvastatin.
Gemfibrozil
Increases rosuvastatin exposure (about 2-fold); use with caution, maximum rosuvastatin dose 10 mg/day.
Cyclosporine
Coadministration significantly increases rosuvastatin exposure (up to 7-fold); contraindicated.
Erythromycin
May decrease rosuvastatin exposure.
Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
May significantly increase rosuvastatin exposure; dose adjustments and monitoring are required.
Storage
Store below 30°C in a dry and cool place, protected from light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Rosuvastatin overdose. In the event of an overdose, treatment should be symptomatic and supportive. Hemodialysis is not expected to be effective.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy (Pregnancy Category X) and lactation. It may cause fetal harm and is excreted in human milk, potentially harming a nursing infant. Women of childbearing potential should use adequate contraception.
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/1.73m²)
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin; INR should be monitored when starting or stopping rosuvastatin.
Gemfibrozil
Increases rosuvastatin exposure (about 2-fold); use with caution, maximum rosuvastatin dose 10 mg/day.
Cyclosporine
Coadministration significantly increases rosuvastatin exposure (up to 7-fold); contraindicated.
Erythromycin
May decrease rosuvastatin exposure.
Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
May significantly increase rosuvastatin exposure; dose adjustments and monitoring are required.
Storage
Store below 30°C in a dry and cool place, protected from light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Rosuvastatin overdose. In the event of an overdose, treatment should be symptomatic and supportive. Hemodialysis is not expected to be effective.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy (Pregnancy Category X) and lactation. It may cause fetal harm and is excreted in human milk, potentially harming a nursing infant. Women of childbearing potential should use adequate contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies, hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available
Clinical Trials
Rosuvastatin has been extensively studied in major clinical trials, including the JUPITER trial (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) and various studies in the GALAXY program, demonstrating its efficacy and safety in primary and secondary prevention of cardiovascular events.
Lab Monitoring
- Liver Function Tests (LFTs): Baseline and periodically as clinically indicated. Discontinue if transaminase levels persist at >3 times ULN.
- Creatine Kinase (CK) levels: Baseline and if muscle symptoms develop. Discontinue if CK levels are markedly elevated or rhabdomyolysis is diagnosed.
Doctor Notes
- Educate patients on the importance of adhering to diet and exercise in conjunction with medication.
- Monitor liver function tests (LFTs) at baseline and periodically as clinically appropriate. Discontinue if transaminase levels exceed 3 times the upper limit of normal.
- Assess for muscle pain, tenderness, or weakness. Check Creatine Kinase (CK) levels if myopathy is suspected or muscle symptoms develop. Discontinue if CK levels are significantly elevated or rhabdomyolysis is diagnosed.
- Advise female patients of childbearing potential about the contraindication in pregnancy and the need for effective contraception.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, usually once daily.
- 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.
- Do not become pregnant while taking this medication. Use effective contraception.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, 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 might impair concentration, exercise caution.
Lifestyle Advice
- Maintain a healthy diet low in saturated fat and cholesterol, as advised by your doctor or nutritionist.
- Engage in regular physical activity and maintain a healthy weight to further improve cholesterol levels and cardiovascular health.
- Avoid smoking and limit alcohol consumption.
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