Medication info

Atev 10 mg (Ezetimibe)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
White to almost white oblong tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 201902771 · Approved 2019.04.30

This product's status changed to Approval withdrawn on 2023.09.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol in hypercholesterolemia and sitosterolemia and inhibition of atherosclerosis risk
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily and can be taken 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 along with this medication, and when already on a high dose of the HMG-CoA reductase inhibitor, it can be co-administered while maintaining the dose of the HMG-CoA reductase inhibitor.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia and sitosterolemia and inhibition of atherosclerosis risk

  • 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
  • hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to dietary therapy to lower total cholesterol, LDL cholesterol, and apolipoprotein B levels in patients with primary hypercholesterolemia and mixed hyperlipidemia. It also helps reduce blood cholesterol levels when used alone or in combination with other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia. It is also used to reduce blood sitosterol levels in patients with homozygous sitosterolemia, alongside diet. This medication is used in conjunction with an appropriate diet and is administered when improvements are difficult through other non-pharmacological measures. It is important to identify and treat secondary causes of the condition before administration and to base the treatment plan on lipid test results. Overall, this medication is used to manage blood lipid levels related to hyperlipidemia, improving vascular health.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily and can be taken 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 along with this medication, and when already on a high dose of the HMG-CoA reductase inhibitor, it can be co-administered while maintaining the dose of the HMG-CoA reductase inhibitor.

Precautions

This medication should not be used in patients who are allergic to any of its components. Patients with severe liver impairment or persistently elevated liver enzyme levels of unknown cause should not take this medication in conjunction with certain lipid-lowering agents. Pregnant or breastfeeding women should be careful, as the concurrent use of this medication with certain lipid-lowering agents is prohibited. Patients with moderate to severe liver impairment should be cautious as unexpected side effects may occur when taking this medication. During treatment with this medication, symptoms such as headache, abdominal pain, diarrhea, fatigue, and muscle pain may appear; if these abnormal symptoms persist, consult a doctor. If muscle pain or weakness occurs suddenly, inform a physician immediately, and in severe cases, the medication may need to be discontinued. This medication can increase liver enzyme levels, so regular liver function tests are important. Patients with severe renal impairment should also exercise caution when taking the medication and may need to adjust doses according to a doctor’s instructions. There may be interactions with other medications, so it is essential to inform healthcare providers of any medications being taken. Children, pregnant women, and elderly patients require special attention, and it is not recommended for children under 6 years of age. In the case of overdose, seek medical attention immediately for appropriate treatment. 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

Hives, severe swelling (edema), anaphylaxis, hypersensitivity reactions including rash and angioedema, erythema multiforme, hepatitis, thrombocytopenia, pancreatitis, cholelithiasis, cholecystitis, headache (if severe neurological symptoms like sudden and very severe headache or thunderclap headache occur), renal failure, rhabdomyolysis, myopathy, muscle pain (accompanied by unexplained muscle weakness or pain, with creatine phosphokinase levels exceeding upper normal limits)

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • joint pain
  • back pain
  • cough
  • dizziness
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  • constipation
  • bloating
  • nausea
  • muscle 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
  • hypoglycemia
  • anemia
  • splenomegaly
  • sweating
  • itching
  • conjunctivitis

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

Storage

This medication should be stored in a sealed container to prevent moisture ingress and at a temperature between 1 to 30 degrees Celsius for safety. Storing it this way will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

White to almost white oblong tablets

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.