Medication info

Ezetu Tablets (Ezetimibe)

Prescription medicationApproval withdrawn
Ingredient · strength
Ezetimibe›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
White to almost white rectangular tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 201901272 · Approved 2019.02.28

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol and lipid levels in hypercholesterolemia and sitosterolemia to alleviate cardiovascular disease risk
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily, regardless of meals. When used in combination with HMG-CoA reductase inhibitors, it should be started at the recommended initial dose of the HMG-CoA reductase inhibitor together with this medication, and for patients already taking high doses of the HMG-CoA reductase inhibitor, the dosage of the HMG-CoA reductase inhibitor should be maintained while adding this medication.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Reduction of cholesterol and lipid levels in hypercholesterolemia and sitosterolemia to alleviate cardiovascular disease risk

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

This medication helps to reduce elevated total cholesterol and low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed hyperlipidemia. It can be used alone or in combination with other lipid-lowering agents alongside dietary therapy. It is also effective in reducing total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia, and may be used in conjunction with other treatments if necessary. In patients with homozygous familial sitosterolemia, it is used as an adjunct to lower plant sterol levels. It is important to identify other underlying diseases before administering this medication and to implement appropriate dietary adjustments and non-drug therapies. In summary, this medication is used to treat various forms of dyslipidemia associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily, regardless of meals. When used in combination with HMG-CoA reductase inhibitors, it should be started at the recommended initial dose of the HMG-CoA reductase inhibitor together with this medication, and for patients already taking high doses of the HMG-CoA reductase inhibitor, the dosage of the HMG-CoA reductase inhibitor should be maintained while adding this medication.

Precautions

This medication should not be used in patients who are allergic to certain components. Patients with liver dysfunction or persistently abnormal liver enzyme levels should not take this medication with other specific lipid-lowering agents. Women who are pregnant or nursing are prohibited from combining this medication with certain lipid-lowering agents, so consultation with a physician is necessary if required. The use of this medication is not recommended in patients with moderately or severely impaired liver function, and liver function should be monitored periodically. During treatment with this medication, side effects such as headache, abdominal pain, diarrhea, and fatigue may occur; if these symptoms persist or worsen, consult a physician. If symptoms of muscle pain or weakness arise, notify medical personnel immediately, and in severe cases, discontinuation of the medication may be necessary. Patients with impaired kidney function may take this medication, but caution is required when used in combination with other medications, and physician’s guidance should be followed. As there may be interactions with other medications, it is important to inform the healthcare provider of any current medications. Pregnant or nursing women should consider the potential risks of this medication before deciding to administer it, and women of childbearing potential should take care with contraception. The drug is not recommended for children under 6 years of age; from age 6 and above, it may be administered at the discretion of a physician. Older adults may also use this medication, but careful observation is needed due to possible differences in sensitivity with age. In case of overdose, seek medical attention immediately for appropriate treatment, and symptomatic relief measures may be necessary. Keep the medication out of reach of children and do not transfer it to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, anaphylaxis, hypersensitivity reactions, erythema multiforme, persistent elevation of aminotransferase levels (liver dysfunction), hepatitis, pancreatitis, thrombocytopenia, cholelithiasis, cholecystitis, gallbladder-related adverse reactions, rhabdomyolysis, myopathy, muscle weakness, severe edema, kidney failure, kidney injury, heart-related chest pain, cardiovascular issues (congestive heart failure, myocardial ischemia).

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • joint pain
  • back pain
  • cough
  • chest pain
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  • dizziness
  • constipation
  • bloating
  • nausea
  • elevated AST
  • elevated ALT
  • muscle pain
  • queasiness
  • chest pain
  • discomfort in the chest
  • edema
  • weakness
  • generalized edema
  • diabetic neuropathy
  • tremors
  • upper abdominal pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure.

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 tightly sealed container. It should be kept at a temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

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

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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.