Medication info
Ezetimibe Tablet (Ezetimibe)

Ezetimibe Tablet (Ezetimibe)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
White to nearly white oblong tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201702555 · Approved 2017.05.24 · Insurance code 657805990

Summary

Main use
Improvement of hypercholesterolemia and sitosterolemia (dyslipidemia)
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily, administered regardless of meals. When co-administering with HMG-CoA reductase inhibitors, start the combination at the recommended initial dose of HMG-CoA reductase inhibitors, and if already on a high dose of HMG-CoA reductase inhibitors, maintain that dose while using this drug. In cases of co-administration with fenofibrate:

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and sitosterolemia (dyslipidemia)

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • low-density lipoprotein cholesterol
  • apolipoprotein B
  • mixed hyperlipidemia
  • non-high-density lipoprotein cholesterol
  • homozygous familial hypercholesterolemia
  • homozygous sitosterolemia
  • elevated sitosterol
  • campesterol
View approved original text

This medication is used to treat various types of dyslipidemia associated with hypercholesterolemia. In patients with primary hypercholesterolemia, this drug helps reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B levels and can be used alone or in combination with statins while following a diet. In patients with mixed hyperlipidemia, this drug can effectively lower non-high-density lipoprotein cholesterol (non-HDL-C) when combined with fenofibrate. In patients with homozygous familial hypercholesterolemia, this medication acts as an adjunct when other lipid-lowering therapies are insufficient, in conjunction with statins. Additionally, it is used to reduce elevated sitosterol levels in homozygous sitosterolemia. This drug, when administered alongside an appropriate diet, is effective in controlling blood lipid levels and reducing the risk of atherosclerotic vascular diseases.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily, administered regardless of meals. When co-administering with HMG-CoA reductase inhibitors, start the combination at the recommended initial dose of HMG-CoA reductase inhibitors, and if already on a high dose of HMG-CoA reductase inhibitors, maintain that dose while using this drug. In cases of co-administration with fenofibrate:

Precautions

This medication should not be used in patients with an allergic reaction to any of its components. Patients with active liver disease or those with persistently elevated liver enzyme levels in blood tests should not use this drug in combination with certain lipid-lowering agents (statin class medications). Pregnant or breastfeeding women should avoid using this drug in combination with statin class medications or fenofibrate. Patients with severely impaired liver function or gallbladder disease, or those with severe renal dysfunction should not take this medication in combination with fenofibrate. Additionally, since this drug contains lactose, it should not be used in patients with lactose intolerance or certain genetic metabolic disorders. Patients with moderate to severe liver dysfunction may experience increased exposure to this medication, leading to unexpected side effects, thus caution is advised. This medication is generally well tolerated, but side effects such as headache, abdominal pain, diarrhea, fatigue, joint pain, and muscle pain may occur. Regular liver function tests are necessary as liver enzyme levels can increase when this drug is used with statin class medications. If symptoms such as muscle pain or weakness occur, the physician should be informed immediately, and the medication should be discontinued if necessary. Renal function should also be monitored in patients with reduced kidney function, and dosage adjustments may be required according to the physician's instructions. This drug can interact with other medications; therefore, patients taking colestipol, fibrates, cyclosporine, anticoagulants, etc., should inform their physician or pharmacist. The use of this medication during pregnancy is restricted, and it should only be used when absolutely necessary, as its safety for the fetus has not been sufficiently confirmed. Breastfeeding women are advised to avoid using this medication, as it may be excreted into breast milk. This medication is not recommended for children under 6 years of age, and children over 6 years or adolescents should take it under a physician's direction. Elderly patients can generally use it safely, but caution is needed due to possible age-related sensitivity differences. In cases of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, elevated liver aminotransferase levels, hepatitis, thrombocytopenia, pancreatitis, severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS), severe cutaneous adverse reactions including polymorphic erythema (SCARs), drug-induced liver injury, renal failure, liver dysfunction, increased serum creatinine, hypertension

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • joint pain
  • back pain
  • cough
  • headache
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  • dizziness
  • constipation
  • bloating
  • nausea
  • muscle pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • splenomegaly
  • sweating
  • rash
  • itching

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage conditions will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White to nearly white oblong tablets

Package unit

30 tablets (10 tablets/PTP x 3)

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.