Medication info
Ezemib Tablet (Ezetimibe)

Ezemib Tablet (Ezetimibe)

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

MFDS item code 201707298 · Approved 2017.09.28 · Insurance code 656004770

Summary

Main use
Improvement of hypercholesterolemia and sitosterolemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily, taken regardless of meals. When used in combination with HMG-CoA reductase inhibitors, the initial recommended dose of HMG-CoA reductase inhibitors should be used to initiate combination therapy with this medication. If the patient is already receiving a high dose of HMG-CoA reductase inhibitors, this medication should be administered while maintaining the dose of the specific agent. When used in combination with fenofibrate, the dosing regimen should include 160 mg once daily or 200 mg once daily (refer to precautions for general cautions 4).

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and sitosterolemia (total cholesterol, LDL-C, etc.)

  • 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 is used for patients with primary hypercholesterolemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It helps lower lipid levels such as total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B in conjunction with dietary therapy. Particularly, its effectiveness can be enhanced when used in combination with HMG-CoA reductase inhibitors or fenofibrate. In patients with homozygous familial hypercholesterolemia, it is used together with statins when other lipid-lowering treatments are ineffective. Additionally, it serves as an adjunct to reduce elevated sitosterol and campesterol levels in patients with homozygous sitosterolemia. Overall, this medication is used to improve various lipid abnormalities associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily, taken regardless of meals. When used in combination with HMG-CoA reductase inhibitors, the initial recommended dose of HMG-CoA reductase inhibitors should be used to initiate combination therapy with this medication. If the patient is already receiving a high dose of HMG-CoA reductase inhibitors, this medication should be administered while maintaining the dose of the specific agent. When used in combination with fenofibrate, the dosing regimen should include 160 mg once daily or 200 mg once daily (refer to precautions for general cautions 4).

Precautions

This medication should not be used in patients who are allergic to its components. Caution should be taken when used in conjunction with specific lipid-lowering agents (such as statins) in patients with severely impaired liver function or abnormal liver enzyme levels. Women who are pregnant or breastfeeding should not use this medication in combination with specific lipid-lowering agents. Caution is also needed when using this medication in patients with moderate to severe liver dysfunction, as the effects may differ from expectations. While this medication is generally safe, side effects such as fatigue, headache, abdominal pain, and diarrhea may occur, so consult a doctor if any unusual symptoms appear. If symptoms like muscle pain or weakness occur, notify a healthcare professional immediately, as medication may need to be discontinued in severe cases. Patients with severely impaired kidney function can use this medication, but caution is necessary depending on their condition. Since interactions may occur with other medications, it is crucial to inform your doctor of any concurrent medications. Use during pregnancy is not recommended, and consultation with a doctor is advised if planning to get pregnant or if already pregnant. During breastfeeding, caution should be exercised as this medication may be excreted in breast milk. It should not be used in children under 6 years of age, and children over 6 years should be administered under a doctor's guidance. Elderly patients can generally use this medication, but they should be monitored for different bodily reactions. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, skin and mucous membrane reactions (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), severe skin reactions (SCARs), drug-induced liver damage, rhabdomyolysis, myopathy, hepatitis, pancreatitis, renal failure (kidney disease)

Mild side effects

  • Headache
  • fatigue
  • abdominal pain
  • diarrhea
  • constipation
  • bloating
  • nausea
  • muscle pain
  • dizziness
  • sensory disturbances
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  • depression
  • chest pain
  • discomfort in the chest
  • edema
  • weakness
  • general edema
  • 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
  • myocardial ischemia
  • flushing
  • cough
  • phlegm
  • runny nose
  • limb pain
  • joint pain
  • diabetes
  • hypoglycemia
  • anemia
  • urticaria

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 is advisable to maintain storage temperatures between 1°C and 30°C. Proper storage can help preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

White to almost white oblong tablet

Package unit

30 tablets (10 tablets/PTP *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.