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ezetrol ezetimibe tablets primary hypercholesterolemia 10mg

Description

 Indication & Scope

Ezetrol® Ezetimibe Tablets provides adjunctive therapy to diet for the reduction of elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia. It is also indicated for homozygous familial hypercholesterolemia and homozygous sitosterolemia.

  • Mechanism: Specifically inhibits the intestinal Niemann-Pick C1-Like 1 transporter protein, blocking the absorption of dietary and biliary cholesterol in the small intestine, thereby reducing systemic cholesterol levels without affecting fat-soluble vitamin absorption.
  • Drug class: Intestinal cholesterol absorption inhibitor, lipid-regulating agent.
  • Clinical use: Used alone or combined with statins for mild to moderate hyperlipidemia; applied for long-term lipid management to prevent atherosclerotic cardiovascular diseases.
Specification
Generic Name Ezetimibe Tablets
Brand Name Ezetrol®
Ingredient Ezetimibe
Dosage Form Tablets
Package 10mg*5 tablets/box;

10mg*10 tablets/box;

10mg*30 tablets/box

Conditions Treated Primary hypercholesterolemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia
Taboos Strict contraindication for individuals with hypersensitivity to ezetimibe or tablet excipients; contraindicated in active liver disease and unexplained persistent transaminase elevation
Place of origin 70 Tuas West Drive Singapore 638414
Prescription type Prescription-only
Storage Conditions Store at controlled room temperature of 20°C–25°C, protected from moisture and direct ultraviolet light
Manufacturer MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)
Registration Authority National Medical Products Administration (NMPA), China
Approval number HJ20160181
Approval Date Mar 25, 2025
Shelf Life 36 months

How to use ?

Recommended Dose: Standard adult dose is 10 mg administered once daily.

 

Time: Administration can be performed at any time throughout the day, independent of meal timing.

 

Instructions for use: Swallow the whole tablet with sufficient water; no dosage adjustment required for elderly patients and mild renal/hepatic impairment patients.

 

Interaction: Bile acid sequestrants reduce oral bioavailability; concomitant statin use enhances lipid-lowering efficacy and may slightly elevate liver enzyme levels; no significant interaction with fibrates.

 

Side effects:

1. Common adverse reactions include headache, mild diarrhea, abdominal distension and fatigue.

2. Rare reactions include transient hepatic enzyme elevation, myalgia and allergic rash.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What lipid disorders can Ezetimibe Tablets clinically manage?

Ezetimibe Tablets manage primary hypercholesterolemia, mixed hyperlipidemia and homozygous familial hypercholesterolemia to lower abnormal blood lipid indicators.

Does food intake affect the absorption and efficacy of Ezetimibe Tablets?

No influence of food intake on drug absorption and efficacy, allowing administration at any daily time point.

What storage environment ensures stable quality of Ezetimibe Tablets?

Controlled room temperature between 20°C and 25°C with moisture and light protection maintains stable drug quality.

What common mild adverse reactions may occur after regular administration of Ezetimibe Tablets?

Mild headache, diarrhea, abdominal discomfort and physical fatigue represent the most frequent mild adverse reactions.

Ezetrol® | Ezetimibe Tablets | Primary Hypercholesterol | DengYueRX

INN: Ezetimibe Tablets
Indications: Primary hypercholesterol
Dosage Form: Tablets
Strength: 10mg/tablet

Original price was: $16.13.Current price is: $13.71.

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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