Rolip
Generic Name
Rosuvastatin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rolip 20 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Rolip (Rosuvastatin) is a lipid-lowering medication used to reduce high cholesterol and triglyceride levels in the blood, thereby lowering the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
Initial dose is typically 10-20 mg orally once daily. May be adjusted at 2-4 week intervals. Maximum recommended dose is 40 mg once daily.
Elderly
A starting dose of 5 mg is recommended for patients ≥70 years of age.
Renal_impairment
For severe renal impairment (CrCl <30 mL/min/1.73 m² not on hemodialysis), a starting dose of 5 mg once daily and a maximum dose of 10 mg once daily is recommended. No dose adjustment needed for mild to moderate renal impairment.
How to Take
Take orally once daily, with or without food, at any time of day. It is best to take it at the same time each day to help remember.
Mechanism of Action
Rosuvastatin competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the early, rate-limiting step in cholesterol biosynthesis. This inhibition reduces cholesterol production in the liver, leading to an upregulation of LDL receptors on hepatocyte surfaces, which increases the uptake and catabolism of LDL-C.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 1 week of therapy, with maximal effects usually achieved within 2-4 weeks.
Excretion
Approximately 90% of the dose is excreted unchanged in the feces, with the remaining excreted in urine.
Half life
Elimination half-life is approximately 19 hours.
Absorption
Approximately 20% absolute oral bioavailability. Peak plasma concentration achieved approximately 3-5 hours post-dose.
Metabolism
Limited metabolism, primarily by CYP2C9 and CYP2C19. Approximately 10% of rosuvastatin is metabolized.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Myopathy.
- Concomitant use of ciclosporin.
- Pregnancy and lactation.
- Women of childbearing potential not using appropriate contraception.
Drug Interactions
Warfarin
May increase International Normalized Ratio (INR); monitor INR closely.
Ciclosporin
Concomitant use significantly increases rosuvastatin exposure; contraindicated.
Erythromycin
Decreased rosuvastatin exposure.
Gemfibrozil and other Fibrates
Increased risk of myopathy and rhabdomyolysis; avoid concomitant use or use with caution at lowest effective dose.
Antacids (Aluminum and Magnesium Hydroxide)
Decreased rosuvastatin plasma concentration when administered concomitantly; take rosuvastatin at least 2 hours after antacid.
Protease Inhibitors (e.g., Ritonavir, Lopinavir/Ritonavir)
Significantly increased rosuvastatin exposure; dose adjustment or temporary discontinuation 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. In case of overdose, provide symptomatic and supportive measures. Monitor liver function and creatine kinase levels.
Pregnancy & Lactation
Rolip (Rosuvastatin) is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Myopathy.
- Concomitant use of ciclosporin.
- Pregnancy and lactation.
- Women of childbearing potential not using appropriate contraception.
Drug Interactions
Warfarin
May increase International Normalized Ratio (INR); monitor INR closely.
Ciclosporin
Concomitant use significantly increases rosuvastatin exposure; contraindicated.
Erythromycin
Decreased rosuvastatin exposure.
Gemfibrozil and other Fibrates
Increased risk of myopathy and rhabdomyolysis; avoid concomitant use or use with caution at lowest effective dose.
Antacids (Aluminum and Magnesium Hydroxide)
Decreased rosuvastatin plasma concentration when administered concomitantly; take rosuvastatin at least 2 hours after antacid.
Protease Inhibitors (e.g., Ritonavir, Lopinavir/Ritonavir)
Significantly increased rosuvastatin exposure; dose adjustment or temporary discontinuation 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. In case of overdose, provide symptomatic and supportive measures. Monitor liver function and creatine kinase levels.
Pregnancy & Lactation
Rolip (Rosuvastatin) is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, refer to the package for exact expiry date.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA and local regulatory bodies
Patent Status
Generally off-patent, but specific formulations might have patents.
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials, such as the JUPITER trial, have demonstrated rosuvastatin's efficacy in reducing LDL-C and its benefits in preventing major cardiovascular events in high-risk individuals.
Lab Monitoring
- Liver function tests (ALT, AST) before initiation and as clinically indicated or when symptoms suggest liver injury.
- Creatine Kinase (CK) levels should be measured before initiation in patients with predisposing factors for myopathy, and if muscle symptoms occur.
- Lipid panel (LDL-C, HDL-C, Total Cholesterol, Triglycerides) should be monitored periodically to assess efficacy.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) alongside pharmacotherapy for optimal lipid management.
- Counsel patients on potential muscle-related symptoms (myalgia, tenderness, weakness) and instruct them to report these promptly.
- Monitor liver function tests at baseline and as clinically indicated, especially if symptoms of liver injury develop.
- Be aware of significant drug interactions, particularly with ciclosporin, gemfibrozil, and certain protease inhibitors, which may require dose adjustment or alternative therapy.
Patient Guidelines
- Take Rolip exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Maintain a cholesterol-lowering diet and exercise program as advised by your healthcare provider.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Rolip (Rosuvastatin) is generally not expected to affect the ability to drive or operate machinery. However, dizziness has been reported as a side effect, so caution should be exercised until the individual's response to the drug is known.
Lifestyle Advice
- Follow a heart-healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity, at least 30 minutes most days of the week.
- Maintain a healthy weight to reduce the burden on your cardiovascular system.
- Quit smoking, as it significantly increases the risk of heart disease.
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