Zuvas
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 |
|---|---|---|
| zuvas 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Rosuvastatin is an HMG-CoA reductase inhibitor (statin) used to lower high cholesterol and triglyceride levels, and to reduce the risk of cardiovascular events like heart attack and stroke.
Uses & Indications
Dosage
Adults
Initial dose is usually 5-10 mg once daily. Dose adjustments, if needed, should be made at intervals of 2-4 weeks. The usual maximum dose is 20 mg once daily. A 40 mg dose should only be considered for patients with severe hypercholesterolemia and high cardiovascular risk, who do not achieve their treatment goal on 20 mg.
Elderly
No dose adjustment is necessary for patients >70 years of age. However, a starting dose of 5 mg is recommended.
Renal_impairment
No dose adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment (CrCl < 30 mL/min/1.73m²), excluding those on hemodialysis, a starting dose of 5 mg once daily is recommended, and the dose should not exceed 10 mg once daily.
How to Take
Zuvas tablets can be taken at any time of day, with or without food. It is recommended to take the tablet at the same time each day to maintain consistent drug levels.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. This inhibition leads to a decrease in hepatic cholesterol synthesis and an increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL. It also reduces VLDL and triglyceride synthesis.
Pharmacokinetics
Onset
Lipid-lowering effects begin within 1 week, with 90% of maximum effect by 2 weeks.
Excretion
Approximately 90% is excreted in feces, the remainder in urine. Less than 10% is renally excreted as unchanged drug.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absolute bioavailability; peak plasma concentrations reached in 3-5 hours.
Metabolism
Limited, primarily by CYP2C9 (10%) and CYP2D6 (minor). About 90% of plasma radioactivity is accounted for by the parent drug.
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).
- Myopathy.
- Concomitant cyclosporine therapy.
- Pregnancy and lactation (Pregnancy Category X).
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin. INR should be monitored when rosuvastatin is initiated or stopped.
Gemfibrozil
Increases rosuvastatin exposure. Avoid concomitant use. If unavoidable, limit rosuvastatin to 10 mg once daily and monitor.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; contraindicated. If unavoidable, limit rosuvastatin to 5 mg once daily and monitor.
Fibrates (e.g., Fenofibrate)
Increased risk of myopathy/rhabdomyolysis. Dose of rosuvastatin should not exceed 20 mg when co-administered with fenofibrate.
Niacin (lipid-lowering doses)
Increased risk of muscle-related adverse events.
Protease Inhibitors (e.g., Ritonavir combined with Lopinavir/Atazanavir)
Significantly increases rosuvastatin exposure. Dose adjustment of rosuvastatin may be necessary; limit rosuvastatin to 10 mg once daily.
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 treatment for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy (Pregnancy Category X) and lactation. It may cause fetal harm. Women of childbearing potential should use effective contraception during treatment. It is unknown whether rosuvastatin is excreted in human milk.
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).
- Myopathy.
- Concomitant cyclosporine therapy.
- Pregnancy and lactation (Pregnancy Category X).
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin. INR should be monitored when rosuvastatin is initiated or stopped.
Gemfibrozil
Increases rosuvastatin exposure. Avoid concomitant use. If unavoidable, limit rosuvastatin to 10 mg once daily and monitor.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; contraindicated. If unavoidable, limit rosuvastatin to 5 mg once daily and monitor.
Fibrates (e.g., Fenofibrate)
Increased risk of myopathy/rhabdomyolysis. Dose of rosuvastatin should not exceed 20 mg when co-administered with fenofibrate.
Niacin (lipid-lowering doses)
Increased risk of muscle-related adverse events.
Protease Inhibitors (e.g., Ritonavir combined with Lopinavir/Atazanavir)
Significantly increases rosuvastatin exposure. Dose adjustment of rosuvastatin may be necessary; limit rosuvastatin to 10 mg once daily.
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 treatment for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy (Pregnancy Category X) and lactation. It may cause fetal harm. Women of childbearing potential should use effective contraception during treatment. It is unknown whether rosuvastatin is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent (generics available)
Clinical Trials
Numerous clinical trials (e.g., JUPITER, METEOR) have demonstrated rosuvastatin's efficacy in reducing LDL-C and cardiovascular events.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiation of rosuvastatin, and then as clinically indicated. If transaminase levels increase to >3 times the upper limit of normal, rosuvastatin should be discontinued.
- Creatine Kinase (CK) levels should be measured before initiation in patients with predisposing factors for myopathy and monitored if muscle symptoms develop.
Doctor Notes
- Emphasize importance of lifestyle modification along with medication.
- Monitor LFTs, especially at initiation and with dose escalation.
- Educate patients on symptoms of myopathy and rhabdomyolysis.
Patient Guidelines
- Take Rosuvastatin exactly as prescribed by your doctor.
- Do not stop taking Rosuvastatin without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness to your doctor immediately.
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 resume 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, some patients may experience dizziness, so caution should be advised.
Lifestyle Advice
- Maintain a healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity.
- Manage weight and avoid smoking.
- Limit alcohol consumption.
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