Rozavas
Generic Name
Rosuvastatin 5 mg
Manufacturer
General Pharmaceuticals Ltd. (Example)
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rozavas 5 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Rozavas 5 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglycerides, reducing the risk of heart disease and stroke. It works by reducing the amount of cholesterol made by the liver.
Uses & Indications
Dosage
Adults
Initial dose of 5 mg or 10 mg once daily. For patients requiring a larger reduction in LDL-C, a 20 mg initial dose may be considered. The 40 mg dose should be reserved for patients with severe hypercholesterolemia and high cardiovascular risk who do not achieve their treatment goal on 20 mg. Max dose 40 mg daily.
Elderly
No dosage adjustment is necessary. However, a 5 mg starting dose is recommended for patients ≥70 years of age.
Renal_impairment
For patients with moderate renal impairment (CrCl < 60 mL/min), a 5 mg starting dose is recommended. For severe renal impairment (CrCl < 30 mL/min), do not exceed 10 mg once daily.
How to Take
Take Rozavas 5 mg Tablet orally once daily, with or without food. It can be taken at any time of day, but it is often recommended to take it at the same time each day, preferably in the evening.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. This inhibition leads to a decrease in hepatic cholesterol synthesis and an increase in the number of LDL receptors on the hepatocyte surface, enhancing the uptake and catabolism of LDL. It also inhibits hepatic synthesis of VLDL, thereby reducing total cholesterol and triglyceride levels.
Pharmacokinetics
Onset
Lipid-lowering effects typically begin within 1 week, with maximal effect achieved by 2 to 4 weeks.
Excretion
Approximately 90% of the administered dose is excreted unchanged in the feces, with the remainder excreted in the urine. Biliary excretion is the major route of elimination.
Half life
The elimination half-life is approximately 19 hours.
Absorption
Absolute bioavailability is approximately 20%. Peak plasma concentrations occur 3 to 5 hours after oral administration. Absorption increases with dose.
Metabolism
Rosuvastatin undergoes limited metabolism, primarily by CYP2C9 to N-desmethyl rosuvastatin, which has approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound. About 10% of the active substance is metabolized.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, which may include unexplained persistent elevations of serum transaminase levels
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Myopathy
- Concomitant use of cyclosporine
- Pregnancy and lactation
Drug Interactions
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin dose to 10 mg daily.
Cyclosporine
Concomitant use is contraindicated due to significantly increased rosuvastatin exposure.
Erythromycin
May decrease rosuvastatin exposure.
Warfarin and other coumarin anticoagulants
May potentiate the anticoagulant effect, increasing INR; monitor INR closely.
Antacids (aluminum and magnesium hydroxide)
Co-administration results in decreased rosuvastatin plasma concentrations; administer antacids at least 2 hours after rosuvastatin.
Protease inhibitors (e.g., ritonavir, lopinavir)
May significantly increase rosuvastatin exposure; dosage adjustment recommended.
Storage
Store below 30°C in a dry place, away from direct 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. Hemodialysis is not expected to be of benefit.
Pregnancy & Lactation
Rozavas 5 mg Tablet is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraception during treatment. It is unknown whether rosuvastatin is excreted in human milk, but because of the potential for serious adverse reactions in nursing infants, women taking rosuvastatin should not breastfeed.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, which may include unexplained persistent elevations of serum transaminase levels
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Myopathy
- Concomitant use of cyclosporine
- Pregnancy and lactation
Drug Interactions
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin dose to 10 mg daily.
Cyclosporine
Concomitant use is contraindicated due to significantly increased rosuvastatin exposure.
Erythromycin
May decrease rosuvastatin exposure.
Warfarin and other coumarin anticoagulants
May potentiate the anticoagulant effect, increasing INR; monitor INR closely.
Antacids (aluminum and magnesium hydroxide)
Co-administration results in decreased rosuvastatin plasma concentrations; administer antacids at least 2 hours after rosuvastatin.
Protease inhibitors (e.g., ritonavir, lopinavir)
May significantly increase rosuvastatin exposure; dosage adjustment recommended.
Storage
Store below 30°C in a dry place, away from direct 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. Hemodialysis is not expected to be of benefit.
Pregnancy & Lactation
Rozavas 5 mg Tablet is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraception during treatment. It is unknown whether rosuvastatin is excreted in human milk, but because of the potential for serious adverse reactions in nursing infants, women taking rosuvastatin should not breastfeed.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, depending on storage conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies
Patent Status
Patent expired for generic versions
Clinical Trials
Rosuvastatin has been extensively studied in large-scale clinical trials (e.g., JUPITER, GALAXY Program) demonstrating its efficacy in reducing LDL-C and cardiovascular events across various patient populations, including those with elevated high-sensitivity C-reactive protein (hsCRP) but normal LDL-C.
Lab Monitoring
- Liver function tests (LFTs) should be performed at baseline and as clinically indicated thereafter.
- Lipid panel should be monitored regularly to assess treatment efficacy.
- Creatine Kinase (CK) levels should be measured if muscle symptoms (e.g., pain, tenderness, weakness) occur.
Doctor Notes
- Regularly monitor liver function tests (LFTs) and lipid profile for all patients.
- Advise patients to report muscle symptoms (pain, tenderness, weakness) promptly due to the risk of myopathy/rhabdomyolysis.
- Evaluate potential drug-drug interactions, especially with cyclosporine, gemfibrozil, and protease inhibitors. Adjust dose or avoid concomitant use as necessary.
Patient Guidelines
- Take Rozavas 5 mg Tablet 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 regular exercise program as advised by your doctor.
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 not expected to impair the ability to drive or operate machinery. However, patients should be aware that dizziness may occur.
Lifestyle Advice
- Follow a low-fat, low-cholesterol diet.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Quit smoking and limit alcohol intake.
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