Rolip
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 |
|---|---|---|
| rolip 10 mg tablet | ৳ 24.00 | ৳ 240.00 |
Description
Overview of the medicine
Rolip 10 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglyceride levels in the blood. It is effective in reducing the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
The usual starting dose is 5-10 mg once daily. Dosage adjustment should be made at 2 to 4-week intervals based on lipid levels and patient response. Maximum dose is 40 mg once daily.
Elderly
No specific dosage adjustment is required for patients over 70 years of age, but a 5 mg starting dose is recommended.
Renal_impairment
Mild to moderate renal impairment: No dosage adjustment. Severe renal impairment (CrCl < 30 mL/min): initiate with 5 mg, maximum 10 mg once daily. The 40 mg dose is contraindicated.
How to Take
Rolip Tablet can be taken orally once daily, with or without food, at any time of the day. It is advisable to take it at the same time each day to maintain consistent blood levels.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This results in a reduction in hepatic cholesterol synthesis and an increase in the number of hepatic LDL receptors, thereby enhancing uptake and catabolism of LDL.
Pharmacokinetics
Onset
Lipid-lowering effects are typically evident within 1 week of therapy, and 90% of the maximum response is usually achieved within 2 weeks. Maximum response is generally attained by 4 weeks.
Excretion
Approximately 90% of a rosuvastatin dose is excreted unchanged in the feces, with the remainder excreted in the urine. The biliary excretion is the predominant route for elimination.
Half life
The plasma elimination half-life of rosuvastatin is approximately 19 hours.
Absorption
Peak plasma concentrations are achieved approximately 3-5 hours after oral administration. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism, primarily by CYP2C9. The main metabolite, N-desmethyl rosuvastatin, has approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Severe renal impairment (creatinine clearance < 30 mL/min) for the 40 mg dose.
- Pregnancy and lactation.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin, increasing the risk of bleeding. INR monitoring is recommended.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin to 10 mg once daily.
Cyclosporine
Concomitant use with cyclosporine significantly increases rosuvastatin exposure; limit rosuvastatin to 5 mg once daily.
Erythromycin
May decrease rosuvastatin exposure.
Storage
Store in a cool, dry place below 30°C. Protect 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, the patient should be treated symptomatically and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rolip is contraindicated during pregnancy and breastfeeding. It can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should use adequate contraception during treatment.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Severe renal impairment (creatinine clearance < 30 mL/min) for the 40 mg dose.
- Pregnancy and lactation.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin, increasing the risk of bleeding. INR monitoring is recommended.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin to 10 mg once daily.
Cyclosporine
Concomitant use with cyclosporine significantly increases rosuvastatin exposure; limit rosuvastatin to 5 mg once daily.
Erythromycin
May decrease rosuvastatin exposure.
Storage
Store in a cool, dry place below 30°C. Protect 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, the patient should be treated symptomatically and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rolip is contraindicated during pregnancy and breastfeeding. It can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should use adequate contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the date of manufacture, depending on the manufacturer.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Rosuvastatin has been extensively studied in various large-scale clinical trials, such as the JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) and AURORA trial (A Study to Evaluate the Effect of Rosuvastatin on Major Cardiovascular Events in Patients on Hemodialysis), demonstrating its efficacy in lipid-lowering and cardiovascular risk reduction.
Lab Monitoring
- Lipid panel: Baseline and periodically (e.g., 4-12 weeks after initiation or dose titration, then every 3-12 months).
- Liver function tests (LFTs): Baseline and periodically, or if symptoms suggestive of liver injury develop.
- Creatine Kinase (CK) levels: Baseline before treatment in patients with predisposing factors for myopathy, and if muscle pain, tenderness, or weakness occurs.
Doctor Notes
- Regularly monitor lipid panel, liver function tests (LFTs), and Creatine Kinase (CK) levels as per clinical guidelines.
- Educate patients about the signs and symptoms of myopathy and rhabdomyolysis and advise them to report any such symptoms promptly.
- Consider dose adjustments or alternative therapies in patients with severe renal impairment or significant drug interactions.
- Emphasize the importance of lifestyle modifications (diet, exercise) as an adjunct to pharmacotherapy.
Patient Guidelines
- Take Rolip exactly as prescribed by your doctor, usually once daily.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise, to your doctor immediately.
- Maintain a cholesterol-lowering diet and exercise program as advised by your doctor while taking this medicine.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If you miss a dose of Rolip, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rolip is generally not expected to impair the ability to drive or operate machinery. However, some individuals may experience dizziness, which could affect concentration. If you experience dizziness, avoid driving or operating heavy machinery.
Lifestyle Advice
- Follow a diet low in saturated fat and cholesterol.
- Engage in regular physical activity.
- Avoid smoking and limit alcohol consumption.
- Manage stress effectively.
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