Medication info

EasyTip Tablet (Ezetimibe)

Prescription medicationApproval withdrawn
Ingredient · strength
Ezetimibe›Strength being verified
Manufacturer / importer
대화제약(주)
Appearance
White to off-white rectangular tablet
Packaging
10 tablets/PTP, 100 tablets/bottle, 30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Approval withdrawn

MFDS item code 201902290 · Approved 2019.04.15

This product's status changed to Approval withdrawn on 2023.06.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Inhibition of cardiovascular disease risk by reducing cholesterol and lipid levels in patients with hypercholesterolemia (primary, familial) and sitosterolemia.
Who uses it
Adults
Adult dosage
The recommended dosage for this drug is 10 mg once daily, to be taken without regard to meals. In cases where it is taken in combination with HMG-CoA reductase inhibitors, it should be initiated at the recommended starting dose of the HMG-CoA reductase inhibitor while already receiving a high dose of the HMG-CoA reductase inhibitor; continue to administer this drug while maintaining the dose of the HMG-CoA reductase inhibitor.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Inhibition of cardiovascular disease risk by reducing cholesterol and lipid levels in patients with hypercholesterolemia (primary, familial) and sitosterolemia.

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

This drug is used to reduce elevated total cholesterol and low-density lipoprotein cholesterol, and apolipoprotein B levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It can be administered as an adjunct or alternative therapy to other lipid-lowering treatments specifically for patients with homozygous familial hypercholesterolemia and helps reduce plant sterol levels in patients with homozygous sitosterolemia. This drug is given in conjunction with dietary measures and sometimes combined with other lipid-modifying medications to enhance therapeutic efficacy. Before treatment, it is essential to confirm any secondary causes of dyslipidemia and treat them if necessary, along with regular lipid monitoring. These processes are effective in reducing the risk of atherosclerotic vascular disease and improving blood lipid levels.

Dosage and Administration

Adult dosage

The recommended dosage for this drug is 10 mg once daily, to be taken without regard to meals. In cases where it is taken in combination with HMG-CoA reductase inhibitors, it should be initiated at the recommended starting dose of the HMG-CoA reductase inhibitor while already receiving a high dose of the HMG-CoA reductase inhibitor; continue to administer this drug while maintaining the dose of the HMG-CoA reductase inhibitor.

Precautions

This drug should not be used in patients with hypersensitivity to its ingredients. Patients with active liver disease or persistently elevated liver enzyme levels without an obvious cause should not take this drug together with certain lipid-lowering agents. Women who are pregnant or breastfeeding should exercise caution as combination therapy with this drug and certain lipid-lowering agents is contraindicated. The use of this drug is not recommended in patients with moderate or severe liver dysfunction, and caution should be exercised when used in these patients. This drug is generally safe, but side effects such as headache, abdominal pain, diarrhea, and myalgia may occur, so if symptoms persist, consultation with a physician is necessary. Liver enzyme levels may increase when this drug is taken together with certain lipid-lowering agents; therefore, regular liver function tests are required. If symptoms such as muscle pain or weakness occur, medical personnel should be notified immediately, and medication should be discontinued if necessary. Patients with severe renal impairment also need to exercise caution; while dosage adjustment is not needed when used alone, care should be taken when used in combination. This drug may interact with other medications, so anyone currently taking medications must inform their healthcare provider. The safety of this drug during pregnancy has not been established, so women of childbearing potential should consult a doctor before use. Breastfeeding women should consider the benefits and risks of this drug, as it may be excreted in breast milk. It is not recommended for children under 6 years old, and children and adolescents exhibit a safety profile similar to that of adults. The elderly can generally use this drug safely, though monitoring is necessary for potential sensitive reactions. Serious side effects from overdose are rare, but one should visit a medical institution immediately if abnormal symptoms occur. This drug must be kept 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
  • angioedema
  • severe allergic reaction
  • hepatitis
  • liver abnormalities (jaundice)
  • renal failure
  • cholecystitis
  • cholelithiasis
Show 5 more
  • rhabdomyolysis
  • myopathy
  • thrombocytopenia
  • pancreatitis
  • severe edema or urinary disturbances

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • arthralgia
  • lower back pain
  • cough
  • chest pain
Show 27 more
  • dizziness
  • constipation
  • bloating
  • nausea
  • myalgia
  • upper respiratory infection
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • chest discomfort
  • asthenia
  • systemic edema
  • tremor
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum production
  • runny nose
  • limb pain
  • diabetes
  • low blood sugar

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

Storage

This drug should be stored in a closed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 1°C and 30°C. This storage method helps maintain the drug's efficacy over time.

Appearance and packaging

Appearance

White to off-white rectangular tablet

Package unit

10 tablets/PTP, 100 tablets/bottle, 30 tablets/box [(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.