Rozenon
Generic Name
Rosuvastatin Calcium
Manufacturer
XYZ Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rozenon 10 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Rozenon 10 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglycerides, reducing the risk of cardiovascular diseases such as 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. Max dose 40 mg once daily. Doses should be individualized according to the patient's cholesterol levels and treatment goal.
Elderly
Starting dose of 5 mg is recommended for patients >70 years of age.
Renal_impairment
For patients with severe renal impairment (CrCl <30 mL/min), a starting dose of 5 mg once daily is recommended. A 40 mg dose is contraindicated.
How to Take
Rozenon 10 mg Tablet should be taken 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.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition leads to a decrease in hepatic cholesterol synthesis and up-regulation of LDL receptors on the cell surface, enhancing the uptake and catabolism of LDL-C from the circulation.
Pharmacokinetics
Onset
Cholesterol-lowering effect begins within 1 week, with 90% of maximum effect by 2 weeks.
Excretion
Primarily excreted unchanged in the feces (90%), with about 5% excreted in urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absorbed after oral administration, peak plasma concentration reached in 3-5 hours.
Metabolism
Minimal metabolism (approximately 10%), primarily by CYP2C9.
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 (CrCl <30 mL/min).
- Myopathy.
- Concomitant cyclosporine therapy.
- Pregnancy and lactation.
Drug Interactions
Niacin
Increased risk of muscle-related side effects.
Warfarin
May increase International Normalized Ratio (INR), requiring careful monitoring.
Gemfibrozil
Increases rosuvastatin exposure; co-administration is not recommended.
Cyclosporine
Concurrent use significantly increases rosuvastatin exposure; co-administration is contraindicated.
Protease Inhibitors (e.g., ritonavir, lopinavir)
May significantly increase rosuvastatin exposure; dose adjustment or alternative therapy may be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored.
Pregnancy & Lactation
Rozenon is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If a patient becomes pregnant while taking this drug, 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.
- Severe renal impairment (CrCl <30 mL/min).
- Myopathy.
- Concomitant cyclosporine therapy.
- Pregnancy and lactation.
Drug Interactions
Niacin
Increased risk of muscle-related side effects.
Warfarin
May increase International Normalized Ratio (INR), requiring careful monitoring.
Gemfibrozil
Increases rosuvastatin exposure; co-administration is not recommended.
Cyclosporine
Concurrent use significantly increases rosuvastatin exposure; co-administration is contraindicated.
Protease Inhibitors (e.g., ritonavir, lopinavir)
May significantly increase rosuvastatin exposure; dose adjustment or alternative therapy may be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored.
Pregnancy & Lactation
Rozenon is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If a patient becomes pregnant while taking this drug, treatment should be discontinued immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA, FDA and other international regulatory bodies
Patent Status
Patent expired (generic versions available)
Clinical Trials
Clinical trials such as JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) have demonstrated the efficacy of rosuvastatin in reducing cardiovascular events in patients with elevated hs-CRP but without hyperlipidemia.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiation of therapy and at clinically indicated intervals thereafter (e.g., at 12 weeks after initiation and after any dose increase, then periodically).
- Lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) should be monitored periodically to assess treatment response.
- Creatine Kinase (CK) levels should be measured before treatment if baseline levels are elevated, or if the patient reports muscle pain/weakness.
Doctor Notes
- Emphasize the importance of adherence to diet and exercise alongside medication for optimal lipid management.
- Regular monitoring of liver function tests (LFTs) and lipid profile is crucial. Evaluate muscle symptoms promptly with CK levels.
- Consider potential drug interactions, especially with cyclosporine, gemfibrozil, and protease inhibitors, and adjust dosage or choose alternatives accordingly.
Patient Guidelines
- Take Rozenon 10 mg Tablet exactly as prescribed by your doctor.
- Continue with your cholesterol-lowering diet and exercise program while taking this medication.
- Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Avoid excessive alcohol consumption while on this medication.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rozenon is generally not expected to impair the ability to drive or operate machinery. However, some patients may experience dizziness. If dizziness occurs, caution should be exercised.
Lifestyle Advice
- Maintain a healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity for at least 30 minutes most days of the week.
- Quit smoking and limit alcohol intake.
- Manage stress effectively to support overall cardiovascular health.
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