Rosutin
Generic Name
Rosuvastatin
Manufacturer
Generic Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rosutin 20 mg tablet | ৳ 32.00 | ৳ 480.00 |
Description
Overview of the medicine
Rosutin 20 mg tablet contains Rosuvastatin, which belongs to a class of drugs called statins. It is used to lower high cholesterol and triglycerides in the blood, thereby reducing the risk of heart disease, stroke, and other cardiovascular problems.
Uses & Indications
Dosage
Adults
The usual starting dose is 5 mg or 10 mg once daily. For Rosutin 20 mg, it can be used for patients requiring a greater reduction in LDL-C or those who have not responded adequately to lower doses. Maximum dose is 40 mg once daily.
Elderly
No specific dose adjustment is required in elderly patients, but caution is advised in patients over 70 years.
Renal_impairment
For mild to moderate renal impairment, no dose adjustment is needed. For severe renal impairment (CrCl < 30 mL/min), starting dose should be 5 mg once daily and should not exceed 10 mg once daily.
How to Take
Take Rosutin 20 mg tablet orally once daily, with or without food. It is recommended to take it at the same time each day, preferably in the evening.
Mechanism of Action
Rosuvastatin works by inhibiting HMG-CoA reductase, an enzyme that plays a crucial role in cholesterol production in the liver. This inhibition reduces the amount of cholesterol produced, primarily lowering LDL ('bad') cholesterol and triglycerides, and increasing HDL ('good') cholesterol.
Pharmacokinetics
Onset
Significant lipid-lowering effects observed within 1 week, maximal effect usually achieved within 2-4 weeks.
Excretion
Excreted primarily in feces (approximately 90% as unchanged drug), with about 10% excreted in urine.
Half life
Elimination half-life is approximately 19 hours.
Absorption
Approximately 20% absorbed after oral administration; peak plasma concentrations reached in 3-5 hours.
Metabolism
Undergoes limited metabolism, primarily by CYP2C9; approximately 10% of dose is metabolized.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the tablet
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Severe renal impairment (CrCl < 30 mL/min) for doses above 10 mg
- Concomitant use with cyclosporine
Drug Interactions
Niacin
Increased risk of myopathy/rhabdomyolysis.
Warfarin
May enhance anticoagulant effect; monitor INR closely.
Colchicine
Increased risk of myopathy/rhabdomyolysis.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin dose to 10 mg daily.
Cyclosporine
Significantly increases rosuvastatin exposure; concomitant use is contraindicated.
Ritonavir/Lopinavir (HIV protease inhibitors)
Increases rosuvastatin exposure; dose adjustment required, maximum rosuvastatin 20 mg daily.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, there is no specific antidote. Treatment should be symptomatic and supportive. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. It can cause fetal harm and is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the tablet
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Severe renal impairment (CrCl < 30 mL/min) for doses above 10 mg
- Concomitant use with cyclosporine
Drug Interactions
Niacin
Increased risk of myopathy/rhabdomyolysis.
Warfarin
May enhance anticoagulant effect; monitor INR closely.
Colchicine
Increased risk of myopathy/rhabdomyolysis.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin dose to 10 mg daily.
Cyclosporine
Significantly increases rosuvastatin exposure; concomitant use is contraindicated.
Ritonavir/Lopinavir (HIV protease inhibitors)
Increases rosuvastatin exposure; dose adjustment required, maximum rosuvastatin 20 mg daily.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, there is no specific antidote. Treatment should be symptomatic and supportive. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. It can cause fetal harm and is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from the date of manufacture, depending on storage conditions.
Availability
Pharmacies
Approval Status
Approved (Generic)
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., JUPITER trial, AURORA trial) have demonstrated Rosuvastatin's efficacy in reducing LDL-C and preventing cardiovascular events across various patient populations.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiating treatment and periodically thereafter.
- Lipid panel (Total cholesterol, LDL-C, HDL-C, Triglycerides) should be monitored regularly to assess efficacy.
- Creatine Kinase (CK) levels should be measured if muscle pain or weakness develops.
Doctor Notes
- Emphasize the importance of consistent adherence to therapy and lifestyle modifications.
- Monitor liver function tests periodically, especially if transaminase levels increase or symptoms of liver injury develop.
- Counsel patients on reporting muscle symptoms promptly to assess for myopathy or rhabdomyolysis.
- Review potential drug interactions, particularly with cyclosporine, gemfibrozil, and certain HIV protease inhibitors.
Patient Guidelines
- Take exactly as prescribed by your doctor, usually once daily.
- Continue with your cholesterol-lowering diet and exercise program.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Avoid alcohol consumption or consume in moderation as it can increase the risk of liver problems.
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, some individuals may experience dizziness, so caution is advised until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet low in saturated and trans fats.
- Engage in regular physical activity (e.g., 30 minutes of moderate exercise most days of the week).
- Quit smoking and reduce alcohol intake.
- Manage stress effectively.
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Global Brand Names
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