Xerova-EZ
Generic Name
Rosuvastatin + Ezetimibe (10 mg + 10 mg)
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xerova ez 10 mg tablet | ৳ 16.00 | ৳ 112.00 |
Description
Overview of the medicine
Xerova-EZ 10 mg Tablet is a combination medicine containing Rosuvastatin and Ezetimibe, used to lower high cholesterol levels in the blood. It works by reducing the production of cholesterol in the liver and decreasing the absorption of cholesterol from the intestine, thereby lowering LDL-C and total cholesterol.
Uses & Indications
Dosage
Adults
The usual starting dose is one Xerova-EZ 10 mg tablet orally once daily, with or without food. The dose should be individualized based on the patient's lipid levels and response to therapy.
Elderly
No dose adjustment is generally required for elderly patients. However, caution should be exercised in patients aged >70 years with predisposing factors for myopathy.
Renal_impairment
For patients with moderate renal impairment (CrCl ≥30 mL/min), no dose adjustment is needed. For severe renal impairment (CrCl <30 mL/min), rosuvastatin is contraindicated. Ezetimibe does not require dose adjustment in renal impairment.
How to Take
Take one tablet orally once daily, with or without food. Swallow the tablet whole with water. Do not crush, chew, or break the tablet.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme responsible for cholesterol synthesis in the liver. Ezetimibe inhibits the absorption of cholesterol from the small intestine by targeting the Niemann-Pick C1-Like 1 (NPC1L1) protein. The combination provides complementary actions to reduce cholesterol levels.
Pharmacokinetics
Onset
Cholesterol-lowering effects observed within 1-2 weeks, maximal effect typically within 4 weeks.
Excretion
Rosuvastatin: Primarily fecal (~90%) and about 10% renal. Ezetimibe: Primarily fecal (~78%) and about 11% renal.
Half life
Rosuvastatin: Approximately 19 hours. Ezetimibe (and its active glucuronide): Approximately 22 hours.
Absorption
Rosuvastatin: Absolute bioavailability of approximately 20%. Tmax 3-5 hours. Ezetimibe: Rapidly absorbed and extensively conjugated to ezetimibe-glucuronide. Tmax 4-12 hours.
Metabolism
Rosuvastatin: Limited, primarily by CYP2C9. Ezetimibe: Extensively metabolized in the small intestine and liver via glucuronide conjugation.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin, ezetimibe, or any component of the tablet.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Severe renal impairment (CrCl <30 mL/min).
- Myopathy.
- Concomitant administration with cyclosporine.
- Pregnancy and lactation.
Drug Interactions
Cyclosporine
Concomitant use is contraindicated due to significantly increased exposure to both rosuvastatin and ezetimibe.
Colestyramine
Decreases ezetimibe absorption; administer at least 4 hours after ezetimibe.
Gemfibrozil, other fibrates
Increased risk of myopathy/rhabdomyolysis. Dose adjustment or avoiding concomitant use may be necessary.
Warfarin, other anticoagulants
May potentiate anticoagulant effect, requiring close monitoring of INR.
Protease inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Increased rosuvastatin exposure; dose adjustment of rosuvastatin may be required.
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 overdose with Rosuvastatin or Ezetimibe. In the event of an overdose, symptomatic and supportive measures should be initiated. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Contraindicated during pregnancy (Category X for statins) and lactation due to potential harm to the fetus/infant. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin, ezetimibe, or any component of the tablet.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Severe renal impairment (CrCl <30 mL/min).
- Myopathy.
- Concomitant administration with cyclosporine.
- Pregnancy and lactation.
Drug Interactions
Cyclosporine
Concomitant use is contraindicated due to significantly increased exposure to both rosuvastatin and ezetimibe.
Colestyramine
Decreases ezetimibe absorption; administer at least 4 hours after ezetimibe.
Gemfibrozil, other fibrates
Increased risk of myopathy/rhabdomyolysis. Dose adjustment or avoiding concomitant use may be necessary.
Warfarin, other anticoagulants
May potentiate anticoagulant effect, requiring close monitoring of INR.
Protease inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Increased rosuvastatin exposure; dose adjustment of rosuvastatin may be required.
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 overdose with Rosuvastatin or Ezetimibe. In the event of an overdose, symptomatic and supportive measures should be initiated. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Contraindicated during pregnancy (Category X for statins) and lactation due to potential harm to the fetus/infant. Women of childbearing potential should use effective contraception.
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
Available in pharmacies nationwide
Approval Status
Approved by relevant regulatory authorities (e.g., DGDA, FDA)
Patent Status
Patents may exist for specific formulations or combination, but generics for individual components are off-patent.
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of rosuvastatin and ezetimibe combination in reducing LDL-C and cardiovascular risk in patients with hypercholesterolemia and high-risk conditions.
Lab Monitoring
- Liver function tests (ALT/AST) should be performed before initiating therapy and at regular intervals (e.g., 3 months, 6 months) thereafter, or as clinically indicated.
- Creatine Kinase (CK) levels should be measured if muscle symptoms occur. Fasting lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be monitored periodically.
Doctor Notes
- Crucial for patients to understand the importance of lifestyle modifications alongside medication.
- Regular monitoring of lipid profile and liver function is essential.
- Educate patients on symptoms of myopathy and the need for immediate reporting.
- Consider alternative lipid-lowering agents or dose adjustment in specific patient populations (e.g., severe renal impairment).
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, usually once daily.
- Continue to follow a cholesterol-lowering diet and exercise program while taking this medicine.
- Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Avoid consuming excessive alcohol 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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or lightheadedness, avoid driving or operating heavy machinery.
Lifestyle Advice
- Adopt a healthy diet low in saturated and trans fats.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Quit smoking.
- Limit alcohol consumption.
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