Medication info

Ezetimibe Tablets (Ezetimibe)

Prescription medicationExpired
Ingredient · strength
Ezetimibe›Strength being verified
Manufacturer / importer
(주)이든파마
Appearance
White to off-white elongated tablets
Packaging
10 tablets/PTP, 100 tablets/bottle
Approval status
Expired

MFDS item code 201803117 · Approved 2018.07.27

This product's status changed to Expired on 2023.07.27. 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 primary hypercholesterolemia (familial, non-familial) and sitosterolemia to mitigate the risk of cardiovascular disease
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, administered regardless of meals. When co-administered with HMG-CoA reductase inhibitors, it should be started at the recommended initial dose of the HMG-CoA reductase inhibitor, and if already on a high dose of the HMG-CoA reductase inhibitor, this medication should be added while maintaining the dose of the HMG-CoA reductase inhibitor. This medication is

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
View approved original text

This medication helps reduce elevated total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels in patients with primary hypercholesterolemia, mixed dyslipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It is effective when used alone or in combination with other lipid-lowering therapies along with dietary management. Particularly, it supports safe and systematic treatment for patients at high risk of atherosclerotic vascular diseases due to hypercholesterolemia. It is important to exclude secondary causes and conduct necessary tests before administering this medication; it should only be taken under the direction of a healthcare professional for effective lipid management. In summary, this medication is used to improve blood lipid levels and lower the risk of cardiovascular diseases in various types of hypercholesterolemia and sitosterolemia.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, administered regardless of meals. When co-administered with HMG-CoA reductase inhibitors, it should be started at the recommended initial dose of the HMG-CoA reductase inhibitor, and if already on a high dose of the HMG-CoA reductase inhibitor, this medication should be added while maintaining the dose of the HMG-CoA reductase inhibitor. This medication is

Precautions

This medication should not be used in patients who have had allergic reactions to any of its components. Patients with active liver disease or persistently elevated liver enzymes of unknown origin should avoid the combination of this medication with specific lipid-lowering agents. Women who are pregnant or nursing are prohibited from using this medication in combination with specific lipid-lowering agents, so women of childbearing age should consult a doctor before use. Patients with severely impaired liver function, gallbladder disease, or severe renal failure should not combine this medication with specific lipid-lowering agents. In patients with moderate to severe liver function impairment, increased exposure to this medication may occur, leading to unexpected side effects, so its use is not recommended in such cases. This medication is generally well tolerated, but side effects such as headache, abdominal pain, diarrhea, fatigue, joint pain, low back pain, cough, and others may occur; if unusual symptoms arise, consult a doctor. When used in combination with specific lipid-lowering agents, liver enzyme levels may rise, so regular liver function tests are necessary. Notify a doctor immediately if symptoms of muscle pain, muscle weakness, or myasthenia appear, and discontinue medication as needed. Patients with severely impaired renal function also require caution, especially when using this medication with specific lipid-lowering agents, and renal function should be closely monitored. This medication can interact with other drugs; special care should be taken when used with cholestyramine, fenofibrate, cyclosporine, anticoagulants, and others, as warranted by a doctor's instructions. The use of this medication is restricted during pregnancy or lactation, and it should be considered carefully for potential effects on the fetus or infant. Use in children under 6 years is not recommended, and in children or adolescents aged 6 and older, strict adherence to a physician's guidance is necessary. Elderly patients may exhibit particularly sensitive reactions, so caution is advised. In case of overdose, no specific antidote is available; treatment should be symptomatic, following doctor's instructions. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), hypersensitivity reactions (anaphylaxis, angioedema), liver dysfunction (hepatitis, elevated liver amino transferase levels, potential jaundice), myopathy, rhabdomyolysis, severe skin adverse reactions, renal failure, severe swelling or urination abnormalities, hypertension, serious neurological symptoms (may include dizziness, sensory disturbances), respiratory issues (difficulty breathing, potential breathing abnormalities accompanied by coughing)

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • joint pain
  • low back pain
  • cough
  • chest pain
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  • dizziness
  • headache
  • constipation
  • bloating
  • nausea
  • ALT elevation
  • AST elevation
  • muscle pain
  • vomiting
  • gastritis
  • dyspepsia
  • discomfort in the epigastric region
  • burping
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • chest discomfort
  • swelling
  • asthenia
  • generalized edema
  • diabetic neuropathy
  • tremors
  • upper abdominal pain
  • dry mouth
  • tinnitus

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

Storage

This medication should be stored in a tightly sealed container to protect from air and moisture. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White to off-white elongated tablets

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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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.