Medication info

Ezentimibe Tablets 10 mg (Ezetimibe)

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
(주)유유제약
Appearance
White to off-white rectangular tablet
Packaging
10 tablets/PTP, 100 tablets/bottle
Approval status
Expired

MFDS item code 201902131 · Approved 2019.04.08

This product's status changed to Expired on 2024.04.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary and familial) and sitosterolemia
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, administered regardless of meals.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary and familial) and sitosterolemia

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used to treat various types of hyperlipidemia, including primary hypercholesterolemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It helps effectively reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B. Additionally, in patients with mixed hyperlipidemia, it may be co-administered with fenofibrate to help lower non-high-density lipoprotein cholesterol (non-HDL-C). This medication is used in conjunction with dietary management and can be combined with statins or other lipid-lowering therapies to enhance therapeutic effects if needed. In complex cases of hyperlipidemia, secondary causes should be identified and treated before using this medication. Therefore, this drug is effective in improving cholesterol levels and is used to reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, administered regardless of meals.

Precautions

This medication should not be used in patients who have hypersensitivity to any of its ingredients. Patients with active liver disease or persistent liver function abnormalities should be cautious as co-administration with certain lipid-lowering agents may worsen liver damage. Women who are pregnant or breastfeeding are prohibited from using this medication with certain lipid-lowering agents, and women who may become pregnant should consult a doctor. This medication is not recommended for patients with moderate to severe liver dysfunction. While generally safe, side effects such as headache, abdominal pain, diarrhea, fatigue, and myalgia may occur. If symptoms such as myalgia or muscle weakness occur, promptly inform healthcare personnel, and in severe cases, discontinuation of the medication may be required. Patients with severely impaired kidney function do not require dosage adjustment; however, those with reduced kidney function should be monitored closely. This medication may interact with other lipid-lowering agents or specific anticoagulants, so patients should inform healthcare personnel of any other medications they are taking. During pregnancy or breastfeeding, the potential risks and benefits of this medication should be carefully considered. Its use is not recommended in children under 6 years old, and it should be administered to children and adolescents over 6 years at the discretion of a physician. It may also be used in elderly patients, but caution is necessary as some may be more sensitive to the medication. In cases of overdose, seek immediate medical attention for appropriate treatment. This medication should be stored out of reach of children, and it is advised not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, cholecystitis, hepatitis, thrombocytopenia, pancreatitis, renal failure (kidney disease), liver dysfunction, renal impairment, renal damage, persistent elevation of liver aminotransferase levels, myopathy, rhabdomyolysis, severe edema

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • dizziness
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  • constipation
  • bloating
  • nausea
  • myalgia
  • headache
  • peripheral neuropathy
  • depression
  • cholelithiasis
  • cholecystitis
  • emesis
  • upper abdominal pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • rhinorrhea
  • limb pain
  • diabetes
  • hypoglycemia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and the temperature should be maintained between 1°C and 30°C at room temperature. Proper storage helps maintain the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White to off-white rectangular tablet

Package unit

10 tablets/PTP, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.