Medication info

Ezétimibe/Atorvastatin Calcium Tablet 10/40 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP X3)]
Approval status
Approval withdrawn

MFDS item code 202100180 · Approved 2021.01.08

This product's status changed to Approval withdrawn on 2025.08.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. The recommended initial dosage is 10/10 mg or 10/20 mg once daily. The dosage range is from 10/10 mg to 10/40 mg once daily. For patients requiring greater reduction of LDL cholesterol, the dosage can be adjusted. After starting treatment or adjusting the dosage, cholesterol levels should be monitored at intervals of at least 2 weeks, followed by dosage adjustments accordingly.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • apo B protein
  • triglycerides
  • non-HDL cholesterol
View approved original text

This medication is used to regulate cholesterol and triglyceride levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia. Specifically, it helps lower total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels, and increase good cholesterol, HDL cholesterol. This medication is administered in conjunction with a proper diet and is effective as an adjunct when there is insufficient response to diet and other non-drug treatments, rather than used alone. Before use, it is essential to identify and treat secondary causes of dyslipidemia such as thyroid disease or diabetes if necessary, and during treatment, consistent monitoring of cholesterol and triglyceride levels is required. This medication may help prevent cardiovascular disease, but since greater benefits have not been established compared to other medications, consultation with a physician is necessary. Overall, this medication improves blood lipid levels in patients with hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. The recommended initial dosage is 10/10 mg or 10/20 mg once daily. The dosage range is from 10/10 mg to 10/40 mg once daily. For patients requiring greater reduction of LDL cholesterol, the dosage can be adjusted. After starting treatment or adjusting the dosage, cholesterol levels should be monitored at intervals of at least 2 weeks, followed by dosage adjustments accordingly.

Precautions

This medication is primarily used for the treatment of hyperlipidemia and carries a risk of muscle abnormalities; therefore, if symptoms such as muscle pain or weakness occur, the patient should inform the physician immediately. Serious muscle disorders such as myopathy or rhabdomyolysis can rarely occur, particularly in patients with risk factors such as poor kidney function, liver disease, hypothyroidism, or elderly patients, who should consult with medical professionals before use. This medication may affect liver function, so liver function tests should be conducted before starting treatment, and liver function status should be monitored periodically during treatment. Pregnant or potentially pregnant women and nursing mothers should not take this medication, and women of childbearing age should use appropriate contraception. While taking this medication, interactions may occur with certain antibiotics, antivirals, antifungals, so those taking other medications must inform their doctor or pharmacist. Additionally, since this medication contains lactose, patients with lactose intolerance should not take it, and those with a history of alcohol abuse or liver disease should use it with caution. Neurological side effects like dizziness or headaches may occur, so caution is advised when driving or operating machinery. In case of overdose, there is no specific antidote, and appropriate treatment according to symptoms should be administered while monitoring liver function tests and muscle enzyme levels. The safety of this medication has not been established in children; therefore, it is not recommended, and elderly patients should be closely monitored for the risk of myopathy. This medication should be kept out of reach of children and should not be transferred 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 fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizure, disorientation, vision abnormalities, paralysis, urination changes

Mild side effects

  • Headache
  • decreased sensation
  • abnormal sensation
  • hypertension
  • increased ALT
  • increased GGT
  • nasopharyngitis
  • cough
  • itching
  • dizziness
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  • diabetes
  • fatigue
  • abdominal pain
  • diarrhea
  • constipation
  • nausea
  • vomiting
  • rash
  • hair loss
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • visual impairment
  • tinnitus
  • hearing loss
  • thrombocytopenia
  • anemia
  • erectile dysfunction
  • breast lump
  • skin lump
  • ingrown toenails
  • bronchiolitis
  • dental abscess
  • vestibular neuritis

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 or moisture, and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP X3)]

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.