Rosterol
Generic Name
Rosuvastatin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosterol 10 mg tablet | ৳ 20.08 | ৳ 200.77 |
Description
Overview of the medicine
Rosterol 10 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglycerides, and to reduce the risk of heart attack and stroke. It works by reducing the amount of cholesterol made by the liver.
Uses & Indications
Dosage
Adults
Initial dose 5-10 mg once daily, maximum 40 mg once daily. For Rosterol 10 mg, typically 10 mg once daily.
Elderly
No dose adjustment generally required, but caution with very high doses (e.g., 40 mg) due to increased risk of myopathy.
Renal_impairment
For severe renal impairment (CrCl < 30 mL/min), initial dose 5 mg once daily. Do not exceed 10 mg once daily.
How to Take
Take orally once daily, with or without food, at any time of day. It is generally recommended to take it at the same time each day to help remember.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes an early rate-limiting step in cholesterol biosynthesis. This results in an upregulation of LDL receptors on the surface of liver cells, leading to increased catabolism of LDL-C.
Pharmacokinetics
Onset
Lipid-lowering effects are evident within 1 week of therapy, with maximal effect by 2-4 weeks.
Excretion
Approximately 90% of a rosuvastatin dose is excreted unchanged in the feces, with the remaining 10% excreted in urine.
Half life
The elimination half-life of rosuvastatin is approximately 19 hours.
Absorption
Peak plasma concentrations are achieved in approximately 3-5 hours. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism, primarily by CYP2C9 (approximately 10% 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) with the 40 mg dose
- Concomitant use with cyclosporine
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin; INR monitoring recommended.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration if possible.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; contraindicated.
Antacids (aluminum and magnesium hydroxide)
Reduces rosuvastatin plasma concentration when taken concurrently.
Protease Inhibitors (e.g., Atazanavir/Ritonavir)
Increased rosuvastatin exposure; dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for rosuvastatin overdose. Management should be symptomatic and supportive, including monitoring of liver function and CK levels.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, treatment should be discontinued immediately.
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) with the 40 mg dose
- Concomitant use with cyclosporine
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin; INR monitoring recommended.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration if possible.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; contraindicated.
Antacids (aluminum and magnesium hydroxide)
Reduces rosuvastatin plasma concentration when taken concurrently.
Protease Inhibitors (e.g., Atazanavir/Ritonavir)
Increased rosuvastatin exposure; dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for rosuvastatin overdose. Management should be symptomatic and supportive, including monitoring of liver function and CK levels.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, treatment should be discontinued immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, specific to batch.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies like FDA, DGDA
Patent Status
Generally off-patent in many regions
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials, such as the JUPITER trial, have demonstrated Rosuvastatin's efficacy in reducing LDL-C and preventing major cardiovascular events in high-risk individuals without existing coronary artery disease.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiation and as clinically indicated.
- Lipid panel (fasting LDL-C, HDL-C, triglycerides) to assess efficacy and guide dose adjustments.
- Creatine Kinase (CK) levels should be measured if muscle symptoms (e.g., pain, tenderness, weakness) occur.
Doctor Notes
- Emphasize the importance of consistent medication adherence and lifestyle modifications.
- Monitor lipid profiles, LFTs, and CK levels as per guidelines.
- Counsel patients on muscle pain symptoms and the need for immediate reporting.
Patient Guidelines
- Take Rosterol exactly as prescribed by your doctor.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
- Report any unexplained muscle pain, tenderness, or weakness immediately to your doctor.
- Continue with a cholesterol-lowering diet and exercise program while taking this medication.
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 with your regular schedule. Do not double the dose.
Driving Precautions
Rosterol may cause dizziness in some individuals. Caution is advised when driving or operating machinery until you know how the medication affects you.
Lifestyle Advice
- Maintain a healthy diet low in saturated and trans fats and rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity, at least 30 minutes most days of the week.
- Avoid smoking and limit alcohol consumption to reduce cardiovascular risk.
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