Medication info

New Ezytime Tablets (Ezetimibe)

Prescription medicationExpired
Ingredient · strength
Ezetimibe›Strength being verified
Manufacturer / importer
안국뉴팜(주)
Appearance
White to almost white oblong tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Expired

MFDS item code 201801083 · Approved 2018.03.08

This product's status changed to Expired on 2023.03.08. 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 (homozygous 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 a day, administered regardless of meals. When co-administered with HMG-CoA reductase inhibitors, treatment should be started at the recommended initial dose of the HMG-CoA reductase inhibitor alongside this medication, and if a high dose of HMG-CoA reductase inhibitor is already being administered, this medication should be combined while maintaining the dose of the HMG-CoA reductase inhibitor.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

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

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

This medication helps to reduce total cholesterol and low-density lipoprotein cholesterol (LDL-C), commonly known as bad cholesterol, in patients with primary hypercholesterolemia. It is also applicable to patients with mixed hyperlipidemia and is used in conjunction with dietary measures. For the treatment of homozygous familial hypercholesterolemia, it is administered as an adjunct to other lipid-lowering therapies. Additionally, it helps reduce plant sterol levels in patients with homozygous sitosterolemia. This medication is used together with dietary therapy and is suitable in cases where non-drug measures are insufficient. Overall, this medication effectively improves the treatment of hypercholesterolemia and related dyslipidemic conditions.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once a day, administered regardless of meals. When co-administered with HMG-CoA reductase inhibitors, treatment should be started at the recommended initial dose of the HMG-CoA reductase inhibitor alongside this medication, and if a high dose of HMG-CoA reductase inhibitor is already being administered, this medication should be combined while maintaining the dose of the HMG-CoA reductase inhibitor.

Precautions

This medication should not be used in patients who are hypersensitive to any of its components. It is advisable not to use this medication together with certain types of drugs in patients with active liver disease or in those with a persistently elevated serum aminotransferase level without explanation. For women who are pregnant or breastfeeding, the combined use of this medication with certain lipid-lowering agents is prohibited, and caution is necessary for women of childbearing potential. Patients with severe liver dysfunction, biliary disease, or severe renal impairment should avoid concurrent use with certain lipid-lowering agents. Patients with moderate to severe liver dysfunction should be cautious in using this medication, as increased exposure may cause unexpected side effects. This medication generally has good tolerability; however, side effects such as headache, abdominal pain, diarrhea, fatigue, and myalgia may occur, so any unusual symptoms should be discussed with a physician. When this medication is used concurrently with certain lipid-lowering agents, liver enzyme levels may increase, so routine regular liver function tests are necessary. If muscle-related symptoms such as myalgia or weakness occur, notify medical personnel immediately, and in severe cases, discontinuation of the medication may be considered. Patients with impaired kidney function can also use this medication; however, caution is necessary in cases of severe renal impairment, but dose adjustment is not required. This medication may interact with other drugs, so it is essential to inform healthcare providers about any other medications being taken. Due to insufficient safety data for this medication during pregnancy or breastfeeding, consultations should be made with a doctor if pregnancy is planned or if pregnant. Use in children under 6 years is not recommended, and children and adolescents aged 6 and older should use it under a physician's direction. Elderly patients may also use this medication, but some may be more sensitive to the drug, so their condition should be monitored closely. In cases of overdose, immediate consultation with healthcare personnel is necessary, and appropriate treatment should be provided if needed. This medication should be stored out of reach of children, and it is safer not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, hepatitis, pancreatitis, thrombocytopenia, liver dysfunction, renal failure, cholecystitis, cholelithiasis, persistent elevation of liver aminotransferase levels (over three times the normal upper limit), myopathy, rhabdomyolysis, systemic edema, edema, hypertension, renal failure

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • dizziness
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  • constipation
  • bloating
  • nausea
  • myalgia
  • chest pain
  • chest discomfort
  • weakness
  • headache
  • diabetic neuropathy
  • tremor
  • epigastric pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain
  • diabetes

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. It is recommended to store it at room temperature, between 1 to 30 degrees Celsius. This helps maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White to almost white oblong 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.