Medication info
Ezetimibe Tablets 10 mg (Ezetimibe)

Ezetimibe Tablets 10 mg (Ezetimibe)

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

MFDS item code 201902917 · Approved 2019.05.08 · Insurance code 663607820

Summary

Main use
Reduction of cholesterol in hypercholesterolemia and sitosterolemia and inhibition of atherosclerosis risk
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily, taken without regard to meals. When co-administered with HMG-CoA reductase inhibitors, therapy should start at the recommended initial dose of HMG-CoA reductase inhibitors along with this medication, maintaining the HMG-CoA reductase inhibitor dose if the patient is already on a high dose. This medication

Ingredients

Manufacturer
한국프라임제약(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
  • risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps lower elevated total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia. It also effectively controls cholesterol levels in patients with homozygous familial hypercholesterolemia when used alone or in conjunction with other therapies. Additionally, it reduces phytosterol levels in patients with homozygous sitosterolemia, contributing to improved vascular health. This drug is commonly used in conjunction with dietary modifications and may enhance therapeutic effects when administered with other medications. It is crucial to identify other potential causes and conduct necessary tests before treatment. Overall, this medication is used to effectively improve various types of hypercholesterolemia and related diseases.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily, taken without regard to meals. When co-administered with HMG-CoA reductase inhibitors, therapy should start at the recommended initial dose of HMG-CoA reductase inhibitors along with this medication, maintaining the HMG-CoA reductase inhibitor dose if the patient is already on a high dose. This medication

Precautions

This medication should not be used by individuals with an allergy to any ingredients of this medication. Patients with liver function issues or significantly elevated liver enzyme levels should not take this medication in combination with certain other drugs. Women who are pregnant or breastfeeding are advised against using this medication in combination with specific lipid-lowering agents. Patients with severely impaired liver function, gallbladder diseases, or severe kidney dysfunction should not take this medication with specific drugs. Individuals with lactose intolerance or those genetically unable to digest lactose should not take this medication. The use of this medication is not recommended in patients with moderate to severe liver impairment. While this medication is generally considered safe, side effects such as headache, abdominal pain, diarrhea, fatigue, and muscle pain may occur. When taken in conjunction with other lipid-lowering agents, liver enzyme levels may increase, necessitating regular liver function tests. If muscle pain or weakness occurs, consultation with a physician should be sought immediately, and drug use should be discontinued if severe. Patients with severely impaired kidney function can use this medication without special dosage adjustments, but care should be taken for those with weakened renal function. There may be interactions when used with other medications, so any existing medications should be disclosed to a physician or pharmacist. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication. Women who are breastfeeding should exercise caution as this medication may be excreted in breast milk and could affect the infant. Children under 6 years of age are advised not to take this medication, while children and adolescents over 6 years should do so under physician's guidance. Elderly patients can generally use this medication, but care is needed due to age-related sensitivities. In case of overdose, there are no specific antidotes, and appropriate treatment should be provided based on symptoms. This medication should be kept out of reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, swelling, anaphylaxis, hypersensitivity reactions including rash and angioedema, hepatitis, thrombocytopenia, pancreatitis, severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), eosinophilia with systemic symptoms drug reaction (DRESS), severe skin reactions including polymorphic erythema, drug-induced liver injury, myopathy, rhabdomyolysis, liver function abnormalities (ALT,

Mild side effects

Headache, abdominal pain, diarrhea, fatigue, constipation, bloating, nausea, dizziness, paresthesia, depression, palpitations, flushing, cough, phlegm, runny nose, limb pain, joint pain, diabetes, hypoglycemia, anemia, splenomegaly, sweating, rash, itching, upper respiratory infection, conjunctival congestion, vomiting, gastritis, dry mouth, discomfort in the epigastric region, belching, gastrointestinal disturbances, gastroesophageal reflux disease, tongue disorders, increased creatine phosphokinase (CPK) in the blood.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is recommended to store it at room temperature between 1 and 30 degrees Celsius. Proper storage can maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

White to almost white oblong tablets

Package unit

30 tablets/box [(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.