Medication info
Ezetimeb Tablet 10 mg (Ezetimibe)

Ezetimeb Tablet 10 mg (Ezetimibe)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
White to off-white rectangular tablet
Packaging
10 tablets/PTP, 100 tablets/bottle, 30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201802161 · Approved 2018.05.24 · Insurance code 662503940

Summary

Main use
Reduces cholesterol and lipid levels in patients with hypercholesterolemia (primary, familial) and sitosterolemia, thereby lowering the risk of cardiovascular disease.
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily, taken regardless of meals. When co-administering with HMG-CoA reductase inhibitors, start the combination at the recommended initial dose of HMG-CoA reductase inhibitor, and if already receiving a high dose of HMG-CoA reductase inhibitor, continue the dose of HMG-CoA reductase inhibitor while co-administering this medication. For use with fenofibrate, in patients with mixed hyperlipidemia, this medication is co-administered with 160 mg once daily or 200 mg once daily of fenofibrate (refer to the precautions for use 4. General precautions). Administration in patients with liver impairment: No dosage adjustment is necessary for patients with mild liver impairment; however, the administration of this medication is not recommended for patients with moderate to severe liver impairment (refer to precautions for use 2. Use with caution in the following patients). Administration in patients with renal impairment: No dosage adjustment is necessary for patients with renal impairment. Administration in elderly patients: No dosage adjustment is necessary when administering to elderly patients.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Reduces cholesterol and lipid levels in patients with hypercholesterolemia (primary, familial) and sitosterolemia, thereby lowering the risk of cardiovascular disease.

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

This medication helps lower blood cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia. It particularly reduces total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B levels, and may be used in conjunction with other lipid-lowering agents such as fenofibrate or statins. Additionally, it helps control cholesterol and phytosterol levels when administered alongside dietary therapy in patients with homozygous familial hypercholesterolemia and homozygous sitosterolemia. This medication is recommended to be used together with appropriate dietary therapy and especially when there is insufficient response to other non-drug interventions. Before use, it is important to exclude other causes of dyslipidemia and conduct necessary tests. This medication improves hypercholesterolemia and related blood lipid abnormalities.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily, taken regardless of meals. When co-administering with HMG-CoA reductase inhibitors, start the combination at the recommended initial dose of HMG-CoA reductase inhibitor, and if already receiving a high dose of HMG-CoA reductase inhibitor, continue the dose of HMG-CoA reductase inhibitor while co-administering this medication. For use with fenofibrate, in patients with mixed hyperlipidemia, this medication is co-administered with 160 mg once daily or 200 mg once daily of fenofibrate (refer to the precautions for use 4. General precautions). Administration in patients with liver impairment: No dosage adjustment is necessary for patients with mild liver impairment; however, the administration of this medication is not recommended for patients with moderate to severe liver impairment (refer to precautions for use 2. Use with caution in the following patients). Administration in patients with renal impairment: No dosage adjustment is necessary for patients with renal impairment. Administration in elderly patients: No dosage adjustment is necessary when administering to elderly patients.

Precautions

This medication should not be used in patients who are allergic to specific components. Patients with active liver disease or consistently elevated liver enzyme levels should not take this medication in conjunction with specific lipid-lowering agents. Pregnant or breastfeeding women should exercise caution as the concomitant use of this medication with specific lipid-lowering agents is prohibited. Patients with moderate to severe liver function impairment may have increased exposure to this medication, leading to unexpected side effects, and therefore should avoid its use. This medication is generally well tolerated, but side effects such as headache, abdominal pain, diarrhea, fatigue, and muscle pain may occur; any unusual symptoms should prompt consultation with a physician. If muscle pain, weakness, or discomfort occurs, immediate notification to healthcare professionals is necessary and discontinuation of the medication may be warranted in severe cases. Regular liver function tests are required, and if liver enzyme levels increase, it may be necessary to adjust the treatment plan. Patients with severely impaired kidney function also require caution, particularly with concurrent use of statins, requiring dosage adjustment and monitoring. This medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken. Pregnant or breastfeeding women must consult a physician before taking this medication, carefully considering potential risks and benefits. It is not recommended for children under 6 years of age, and for those aged 6 and older, it should be administered according to a doctor's instructions. Elderly patients may respond sensitively to this medication and should exercise caution. In case of overdose, there is no specific antidote, and treatment will be symptomatic. This medication should be stored out of the reach of children, and it is safe not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, hepatitis, thrombocytopenia, pancreatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), dyspnea, jaundice of skin or eyes, drug-induced liver injury, severe allergic reactions, severe skin adverse reactions, severe cutaneous adverse reactions (SCARs), drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, myopathy, severe swelling or

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • joint pain
  • lower back pain
  • cough
  • dizziness
Show 27 more
  • headache
  • fatigue
  • constipation
  • bloating
  • nausea
  • increased AST
  • increased ALT
  • muscle pain
  • queasiness
  • vomiting
  • gastritis
  • constipation
  • dry mouth
  • discomfort in the epigastric area
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • chest pain
  • discomfort in the chest
  • swelling
  • weakness
  • generalized edema
  • diabetic neuropathy
  • tremors
  • upper abdominal pain
  • palpitations

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy.

Appearance and packaging

Appearance

White to off-white rectangular tablet

Package unit

10 tablets/PTP, 100 tablets/bottle, 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.