Medication info
Ezitimibe 10/10 mg Tablet

Ezitimibe 10/10 mg Tablet

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle
Approval status
Active

MFDS item code 202100201 · Approved 2021.01.08 · Insurance code 652606960

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day. A starting dose of 10/10 mg or 10/20 mg is recommended. For patients requiring greater LDL-cholesterol reduction, the dosage can be adjusted. After starting treatment or adjusting the dosage, blood lipid levels should be checked with an interval of more than 2 weeks.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL-cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used for patients with primary hypercholesterolemia, especially heterozygous familial and non-familial or mixed dyslipidemia. It acts as an adjunct to diet, effectively reducing total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, while increasing HDL cholesterol levels. It can be applied to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, and is more effective when used alongside appropriate dietary measures. It is essential to identify and treat any secondary causes of dyslipidemia before starting treatment. Caution is advised as studies on some types of dyslipidemia are limited, and lipid levels should be monitored through periodic testing during treatment. This helps improve lipid levels in patients and enhances cardiovascular health.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day. A starting dose of 10/10 mg or 10/20 mg is recommended. For patients requiring greater LDL-cholesterol reduction, the dosage can be adjusted. After starting treatment or adjusting the dosage, blood lipid levels should be checked with an interval of more than 2 weeks.

Precautions

This medication may cause adverse muscle reactions, so if symptoms such as muscle pain, cramps, or weakness occur, consult a doctor immediately. Particularly serious myopathy or rhabdomyolysis may occur; therefore, patients with risk factors such as impaired kidney function, severe infections, hypotension, or post-major surgery should temporarily discontinue the drug or consult a physician. This medication may affect liver function, so liver function tests should be conducted regularly before and during treatment, and if symptoms of liver dysfunction (e.g., nausea, vomiting, fatigue) appear, notify the healthcare personnel immediately. This drug may increase the risk of side effects due to drug interactions if taken with certain other medications; thus, inform healthcare professionals of any other medications being taken. Pregnant women, those who may become pregnant, or nursing mothers should not take this medication, and women of childbearing age should use appropriate contraceptive methods while taking it. Elderly patients or those with a history of liver disease or muscle disorders need to exercise more caution when using this medication and should have dosage adjustments and monitoring according to their physician's instructions. Symptoms like dizziness or drowsiness may occur during treatment, so caution is advised when driving or operating machinery. In case of overdose, there is no specific antidote, so seek medical attention immediately for proper treatment, and check the condition through liver function tests and blood tests. Keep out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), generalized malaise, sudden and severe headache, thunderclap headache, seizure, confusion, vision disturbances, paralysis, urinary

Mild side effects

  • Decreased sensation
  • sensory abnormalities
  • hypertension
  • ALT increase
  • GGT increase
  • nasopharyngitis
  • cough
  • itching
  • dizziness
  • diabetes
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  • fatigue
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pain in the pharynx/larynx
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • sensory loss
  • taste disturbance
  • amnesia
  • speech

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

Storage

This medication should be stored in a sealed container to prevent air and moisture exposure. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle

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.