Xerova-EZ
Generic Name
Rosuvastatin + Ezetimibe
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xerova ez 20 mg tablet | ৳ 24.00 | ৳ 168.00 |
Description
Overview of the medicine
Xerova-EZ 20 mg Tablet is a combination medicine containing Rosuvastatin (a statin) and Ezetimibe (a cholesterol absorption inhibitor). It is used to lower high cholesterol levels in the blood, reducing the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
The usual starting dose is one Xerova-EZ 20 mg tablet once daily. The dose should be individualized based on lipid levels and patient response. Take with or without food.
Elderly
No specific dose adjustment is required in elderly patients. However, caution should be exercised, and dose titration may be appropriate.
Renal_impairment
For patients with moderate renal impairment (CrCl ≥ 30 to < 60 mL/min), the recommended starting dose of rosuvastatin is 5 mg once daily. For severe renal impairment (CrCl < 30 mL/min), Rosuvastatin is contraindicated. Ezetimibe does not require dose adjustment in mild to severe renal impairment.
How to Take
This medicine should be taken orally, once daily, with or without food. It is generally recommended to take it at the same time each day, preferably in the evening.
Mechanism of Action
Rosuvastatin works by inhibiting HMG-CoA reductase, an enzyme essential for cholesterol synthesis in the liver. Ezetimibe works by inhibiting the absorption of cholesterol from the small intestine.
Pharmacokinetics
Onset
Lipid-lowering effects within 1 week for Rosuvastatin, maximal effects typically within 2-4 weeks. Ezetimibe maximal effect within 2 weeks.
Excretion
Rosuvastatin: Approximately 90% excreted unchanged in feces. Ezetimibe: Excreted primarily in feces (approx. 78%) and urine (approx. 11%).
Half life
Rosuvastatin: Elimination half-life ~19 hours. Ezetimibe: Elimination half-life of active glucuronide ~22 hours.
Absorption
Rosuvastatin: Absolute bioavailability ~20%. Peak plasma concentration ~3-5 hours. Ezetimibe: Rapidly absorbed and extensively conjugated to its active phenolic glucuronide. Peak plasma concentration ~4-12 hours.
Metabolism
Rosuvastatin: Minimally metabolized, primarily by CYP2C9. Ezetimibe: Extensively metabolized in the small intestine and liver via glucuronide conjugation.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin, Ezetimibe, or any excipients of the product
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Severe renal impairment (CrCl < 30 mL/min) for Rosuvastatin
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin (increased INR).
Cyclosporine
Concomitant use with Rosuvastatin is contraindicated due to significantly increased Rosuvastatin exposure.
Gemfibrozil/Other Fibrates
Increased risk of myopathy/rhabdomyolysis.
Colestyramine or Colestipol
May decrease the absorption of Ezetimibe; administer Ezetimibe at least 2 hours before or 4 hours after these bile acid sequestrants.
Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Increased Rosuvastatin exposure; dose adjustment may be necessary or contraindicated.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive measures should be initiated. Rosuvastatin is not significantly dialyzable. Ezetimibe overdose has not resulted in adverse effects in clinical studies.
Pregnancy & Lactation
Contraindicated during pregnancy and breastfeeding. Statins can cause fetal harm. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin, Ezetimibe, or any excipients of the product
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Severe renal impairment (CrCl < 30 mL/min) for Rosuvastatin
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin (increased INR).
Cyclosporine
Concomitant use with Rosuvastatin is contraindicated due to significantly increased Rosuvastatin exposure.
Gemfibrozil/Other Fibrates
Increased risk of myopathy/rhabdomyolysis.
Colestyramine or Colestipol
May decrease the absorption of Ezetimibe; administer Ezetimibe at least 2 hours before or 4 hours after these bile acid sequestrants.
Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Increased Rosuvastatin exposure; dose adjustment may be necessary or contraindicated.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive measures should be initiated. Rosuvastatin is not significantly dialyzable. Ezetimibe overdose has not resulted in adverse effects in clinical studies.
Pregnancy & Lactation
Contraindicated during pregnancy and breastfeeding. Statins can cause fetal harm. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture. Refer to the packaging for the exact expiry date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA in Bangladesh)
Patent Status
Off-patent (for generic components, formulation patent may vary)
Clinical Trials
Clinical trials have demonstrated that co-administration of Rosuvastatin and Ezetimibe leads to greater reductions in LDL-C compared to monotherapy with either agent, with a good safety profile. These trials support its use in patients requiring more aggressive lipid-lowering.
Lab Monitoring
- Liver function tests (ALT, AST) should be performed before initiation of therapy and periodically thereafter or as clinically indicated.
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be checked before starting treatment and after 2-4 weeks to assess response and adjust dose.
- Creatine kinase (CK) levels should be measured if a patient presents with muscle pain, tenderness, or weakness.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) alongside pharmacotherapy.
- Monitor liver function tests (LFTs) and lipid profiles regularly. Consider CK levels if muscle symptoms arise.
- Counsel patients on potential adverse effects, especially muscle pain, and when to seek medical attention.
- Review concomitant medications for potential drug interactions, particularly with cyclosporine, fibrates, and warfarin.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Follow a cholesterol-lowering diet and engage in regular physical activity as advised.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- 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, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine is generally not expected to impair the ability to drive or operate machinery. However, if you experience dizziness or blurred vision, avoid such activities.
Lifestyle Advice
- Maintain a low-cholesterol and low-fat diet.
- Engage in regular moderate exercise.
- Quit smoking and limit alcohol consumption.
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