Medication info
Ezirol Tablet (Ezetimibe)

Ezirol Tablet (Ezetimibe)

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

MFDS item code 201902285 · Approved 2019.04.15 · Insurance code 670608990

Summary

Main use
Reduction of cholesterol and lipid levels in primary hypercholesterolemia (familial, non-familial) and sitosterolemia to alleviate the risk of cardiovascular disease
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, taken regardless of meals. When administered in combination with HMG-CoA reductase inhibitors, for patients with primary hypercholesterolemia, treatment should be initiated with this drug at the recommended initial dose of the HMG-CoA reductase inhibitor, and if the patient is already on a high dose of the HMG-CoA reductase inhibitor, the dose of the HMG-CoA reductase inhibitor should be maintained while starting this medication.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Reduction of cholesterol and lipid levels in primary hypercholesterolemia (familial, non-familial) and sitosterolemia to alleviate the risk of cardiovascular disease

  • Primary hypercholesterolemia
  • dyslipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
  • decreased high-density lipoprotein cholesterol
  • increased triglycerides
View approved original text

This drug is used as an adjunct to dietary therapy to reduce cholesterol and apolipoprotein levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly effective in patients with heterozygous familial hypercholesterolemia and can be administered in combination with HMG-CoA reductase inhibitors or fenofibrate if necessary. In patients with homozygous familial hypercholesterolemia, it is used in combination with statins when other lipid-lowering treatments are inadequate or when monotherapy is not possible. Additionally, this drug is used as an adjunct in dietary therapy to lower plant sterol levels in patients with homozygous sitosterolemia. This medication should be used in conjunction with appropriate dietary measures and non-pharmacological approaches, and it is important to exclude and treat secondary causes of dyslipidemia if necessary. Thus, this drug effectively improves various forms of cholesterol and lipid abnormalities associated with dyslipidemia.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, taken regardless of meals. When administered in combination with HMG-CoA reductase inhibitors, for patients with primary hypercholesterolemia, treatment should be initiated with this drug at the recommended initial dose of the HMG-CoA reductase inhibitor, and if the patient is already on a high dose of the HMG-CoA reductase inhibitor, the dose of the HMG-CoA reductase inhibitor should be maintained while starting this medication.

Precautions

This medication should not be used by patients with allergies to specific ingredients. Patients with active liver disease or persistent liver dysfunction should not take this medication along with other specific lipid-lowering agents. Women who are pregnant or breastfeeding should use caution as concomitant use with certain lipid-lowering drugs is prohibited. This drug is not recommended for patients with moderate to severe liver impairment and should be used with caution in such cases. While taking this medication, symptoms such as headache, abdominal pain, diarrhea, fatigue, and myalgia may occur, and if unusual symptoms arise, consultation with a physician is advised. If symptoms such as myalgia or muscle weakness occur, medical professionals should be notified immediately, and medication may be discontinued if necessary. Patients with severe renal impairment do not require dosage adjustment for this drug, but it is important to periodically check renal function status. There may be interactions with other medications, so it is important to inform the physician if taking cholestyramine, fibrates, cyclosporine, anticoagulants, etc. Pregnant or breastfeeding women should carefully consider the potential risks and benefits of using this medication and avoid use if possible. This medication is not recommended for children under 6 years of age and should be administered to children and adolescents aged 6 years and over under the direction of a physician. Elderly patients can also use this drug, but careful observation should be exercised considering age-related sensitivity differences. When storing the medication, it should be kept out of reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions including erythema multiforme (SCARs), drug-induced liver injury, hepatitis, pancreatitis, renal failure, kidney damage, liver dysfunction, myopathy, rhabdomyolysis

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • dizziness
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  • fatigue
  • headache
  • constipation
  • bloating
  • nausea
  • myalgia
  • chest pain
  • chest discomfort
  • asthenia
  • generalized edema
  • diabetic neuropathy
  • tremors
  • upper abdominal pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastrium
  • burping
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is best to keep the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold places. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

White to nearly white rectangular tablet

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.