Medicine Information

Ezitor

Name: Ezitor
Brand: Ezitor
Rating: 4.5 (117 reviews)

Tablet20 mgLipid-lowering agent, Cholesterol absorption inhibitorATC: C10AX09

Generic Name

Ezetimibe

Manufacturer

Incepta Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
ezitor 20 mg tablet	৳ 22.00	৳ 220.00

Description

Overview of the medicine

Ezitor 20 mg Tablet contains Ezetimibe, a medication used to lower high cholesterol levels in the blood. It works by inhibiting the absorption of cholesterol from the small intestine. It is often used in combination with statins or as monotherapy when statins are not tolerated or are contraindicated.

Uses & Indications

Primary Hypercholesterolemia (heterozygous familial and non-familial) as adjunctive to diet:

- In combination with a HMG-CoA reductase inhibitor (statin), or

- As monotherapy when a statin is considered inappropriate or not tolerated.

Homozygous Familial Hypercholesterolemia (HoFH) as adjunctive to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Homozygous Sitosterolemia (Phytosterolemia) as adjunctive to diet.

Dosage

Adults

The recommended dosage of Ezitor 20 mg Tablet is one tablet (20 mg Ezetimibe) once daily, with or without food, at any time of the day. When co-administered with a statin, it can be taken at the same time as the statin.

Elderly

No dosage adjustment is required for elderly patients.

Renal_impairment

No dosage adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment (creatinine clearance < 30 mL/min), caution should be exercised as exposure to ezetimibe is increased.

How to Take

Ezitor 20 mg Tablet should be taken orally, once daily, with or without food. It can be taken at any time of the day. If taken with a statin or fenofibrate, both medications can be taken at the same time. If taken with a bile acid sequestrant (e.g., cholestyramine), Ezitor should be taken at least 2 hours before or 4 hours after the sequestrant.

Mechanism of Action

Ezetimibe selectively inhibits the absorption of cholesterol and related phytosterols in the small intestine. It localizes at the brush border of the small intestine and inhibits the Niemann-Pick C1-Like 1 (NPC1L1) protein, which is involved in cholesterol uptake. This leads to a reduction in the delivery of cholesterol from the intestine to the liver, resulting in decreased hepatic cholesterol stores and increased clearance of cholesterol from the blood.

Pharmacokinetics

Onset

Lipid-lowering effects typically begin within 2 weeks of initiation.

Excretion

Mainly excreted in feces (approximately 78% as ezetimibe and ezetimibe-glucuronide) and to a lesser extent in urine (approximately 11%).

Half life

Ezetimibe and ezetimibe-glucuronide have a prolonged half-life of approximately 22 hours, allowing for once-daily dosing.

Absorption

Rapidly absorbed after oral administration and extensively conjugated to a pharmacologically active glucuronide. Peak plasma concentrations are achieved within 4-12 hours for ezetimibe-glucuronide.

Metabolism

Primarily metabolized in the small intestine and liver via glucuronide conjugation to form ezetimibe-glucuronide (active metabolite). Minor oxidative metabolism also occurs.

Side Effects

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
When Ezitor is co-administered with a statin, refer to the prescribing information for that statin for its contraindications.
Co-administration of Ezitor with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and lactation (when co-administered with a statin).

Drug Interactions

Statins

Generally well-tolerated when co-administered. May increase the risk of myopathy/rhabdomyolysis, necessitating monitoring of liver function tests and muscle symptoms.

Cyclosporine

May increase exposure to ezetimibe, requiring caution and monitoring.

Fibrates (e.g., Gemfibrozil)

Co-administration with gemfibrozil may increase ezetimibe concentrations. Concurrent use with gemfibrozil is not recommended. Caution should be exercised with other fibrates.

Cholestyramine and other bile acid sequestrants

May decrease the absorption of Ezetimibe. Ezetimibe should be administered at least 2 hours before or 4 hours after a bile acid sequestrant.

Storage

Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.

Overdose

In the event of an overdose, symptomatic and supportive measures should be employed. No specific antidote is available. Ezetimibe is not dialyzable.

Pregnancy & Lactation

Pregnancy Category C. Studies in animals have shown reproductive toxicity. Ezitor 20 mg Tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ezetimibe is excreted in human milk; therefore, Ezitor is not recommended for use in nursing mothers.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets30 tablets

Shelf Life

Typically 2-3 years from the date of manufacture, refer to the package for exact date.

Availability

Available in pharmacies nationwide

Approval Status

Approved by regulatory authorities (e.g., DGDA)

Patent Status

Off-patent, generic versions available

Clinical Trials

Ezetimibe has been extensively studied in various clinical trials demonstrating its efficacy and safety in reducing LDL-C, both as monotherapy and in combination with statins. The IMPROVE-IT trial, for instance, showed a reduction in cardiovascular events when ezetimibe was added to simvastatin in high-risk patients.

Lab Monitoring

Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) to monitor treatment efficacy.
Liver function tests (ALT, AST) especially when co-administered with a statin, and at baseline and periodically thereafter or as clinically indicated.

Doctor Notes

Ezitor (Ezetimibe) 20 mg provides a higher dose than the standard 10mg monotherapy, possibly for specific conditions or when deemed necessary by the physician.
Consider combination therapy with a statin for patients who do not achieve target LDL-C levels with statin monotherapy or who require further LDL-C reduction.
Monitor liver function tests at baseline and as clinically indicated, especially in combination therapy.
Counsel patients on lifestyle modifications, including diet and exercise, as essential components of lipid management.

Patient Guidelines

Take Ezitor 20 mg Tablet exactly as prescribed by your doctor.
Continue with your cholesterol-lowering diet and exercise program while taking this medication.
Report any unusual muscle pain, tenderness, or weakness to your doctor immediately, especially if accompanied by fever or dark urine.
Do not stop taking Ezitor without consulting 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

Ezitor is not expected to impair the ability to drive or operate machinery. However, patients should be aware of possible side effects like dizziness or fatigue that could affect these abilities.

Lifestyle Advice

Maintain a heart-healthy diet low in saturated and trans fats and cholesterol.
Engage in regular physical activity (e.g., brisk walking, jogging) for at least 30 minutes most days of the week.
Manage your weight to a healthy range.
Avoid smoking and limit alcohol consumption.