Medication info
Ezetimibe 10 mg Tablets (Ezetimibe)

Ezetimibe 10 mg Tablets (Ezetimibe)

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

MFDS item code 201902782 · Approved 2019.04.30 · Insurance code 669805380

Summary

Main use
Reduction of cholesterol in hypercholesterolemia and sitosterolemia and suppression of atherosclerosis risk
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, taken regardless of meals. When co-administered with HMG-CoA reductase inhibitors, it should be started at the recommended initial dose of HMG-CoA reductase inhibitors alongside this medication. If a high dose of HMG-CoA reductase inhibitors is already being administered, this medication can be combined without changing the dose of HMG-CoA reductase inhibitors.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia and sitosterolemia and suppression of atherosclerosis risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • homozygous sitosterolemia
View approved original text

This medication helps to lower cholesterol and other lipid levels in patients with primary hypercholesterolemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. In particular, it is used in conjunction with diet or with other lipid-lowering therapies to control total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, and other lipid levels. This medication is also used to manage lipid levels in patients at high risk for cardiovascular disease. It is important to identify and treat secondary causes such as diabetes and hypothyroidism before use, and to monitor treatment efficacy through regular lipid testing. Thus, this medication effectively improves various lipid abnormalities associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, taken regardless of meals. When co-administered with HMG-CoA reductase inhibitors, it should be started at the recommended initial dose of HMG-CoA reductase inhibitors alongside this medication. If a high dose of HMG-CoA reductase inhibitors is already being administered, this medication can be combined without changing the dose of HMG-CoA reductase inhibitors.

Precautions

This medication should not be used in patients allergic to specific ingredients. Patients with active liver disease or persistently elevated liver enzyme levels of unknown cause should not combine this medication with statins. It is safe for pregnant or nursing women not to take this medication in conjunction with statins or fenofibrate. Patients with severe liver dysfunction or gallbladder disease or severe kidney dysfunction should not take this medication with fenofibrate. This medication contains lactose, so it should not be taken by patients with lactose intolerance or certain genetic metabolic disorders. Patients with moderate to severe liver dysfunction may have increased exposure to this medication, so its use is not recommended. Generally, this medication is safe, but side effects such as headache, abdominal pain, diarrhea, fatigue, and muscle pain may occur, so caution is advised. If used in conjunction with statins, there is a possibility of elevated liver enzymes, so liver function tests should be performed regularly. If symptoms of muscle pain or weakness appear, inform a doctor immediately and discontinue use. Patients with severe kidney impairment may take this medication without dose adjustment, but those with decreased kidney function should be closely monitored according to a doctor's instructions. This medication may interact with other drugs, so caution is necessary when taken with cholestyramine, fibrates, cyclosporine, anticoagulants, etc. Women who are pregnant or of childbearing potential should consult a doctor before using this medication, and breastfeeding should also be avoided. Children under 6 years of age are recommended not to take this medication, while children and adolescents over 6 years should use it under medical guidance. Older adults can also take it, but some may be more sensitive to the medication, so caution is needed. In cases of overdose, there is no specific antidote, so appropriate treatment should be obtained 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, anaphylaxis, hepatitis, thrombocytopenia, pancreatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, severe skin reactions (SCARs), drug-induced liver injury, renal failure, severe edema, hypersensitivity

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • joint pain
  • low back pain
  • cough
  • chest pain
Show 29 more
  • dizziness
  • headache
  • constipation
  • abdominal distension
  • nausea
  • muscle pain
  • malaise
  • epigastric 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
  • phlegm
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • splenomegaly
  • sweating
  • itching

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is best to store the medication at room temperature between 1 degree and 30 degrees Celsius, away from extremes of heat or cold.

Appearance and packaging

Appearance

White to almost white rectangular 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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.