Medication info
Atorvastatin and Ezetimibe Tablets 10/5 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Atorvastatin and Ezetimibe Tablets 10/5 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›5.4225mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
White oblong film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500454 · Approved 2025.02.28 · Insurance code 642906920

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/5mg to 10/80mg daily. An initial dose of 10/5mg, 10/10mg, or 10/20mg is recommended. For patients who require greater reduction of LDL-cholesterol, an initial dose of 10/40mg is recommended. After starting treatment or adjusting the dose, check blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL-cholesterol
View approved original text

This medication helps improve blood cholesterol and triglyceride levels in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and mixed dyslipidemia. It particularly reduces elevated total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol, while increasing HDL-cholesterol, known as good cholesterol, contributing to the prevention of cardiovascular diseases. It is used as an adjunct to diet for effectively managing blood lipids and maintaining health.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/5mg to 10/80mg daily. An initial dose of 10/5mg, 10/10mg, or 10/20mg is recommended. For patients who require greater reduction of LDL-cholesterol, an initial dose of 10/40mg is recommended. After starting treatment or adjusting the dose, check blood lipid levels at intervals of more than 2 weeks.

Precautions

This medication may pose a risk of serious muscle problems; therefore, if muscle pain or weakness suddenly appears, immediate consultation with a physician is necessary. Do not use this medication if you have impaired liver function or liver disease, and regular liver function tests must be conducted. Women who are pregnant, potentially pregnant, or breastfeeding should not take this medication. Patients who consume excessive alcohol or have a history of liver disease should use this medication with caution, as well as those prone to myopathy. Interactions may occur when taken with other medications, so it is essential to inform the prescribing physician or pharmacist of any other medications being taken. Some side effects such as dyspepsia, abdominal pain, diarrhea, headache, dizziness, myalgia, back pain, muscle cramps, eye pruritus, giant papillary conjunctivitis, keratitis, capsule opacity, blurred vision, COVID-19, nasopharyngitis, upper respiratory tract infections, chest pain, acne, uterine leiomyoma, skin abrasions, and ulnar fractures may appear in some patients; if unusual symptoms persist, consult healthcare professionals. Particularly elderly patients or those with impaired kidney function may experience muscle-related symptoms more frequently, necessitating increased caution. During treatment, it is crucial to regularly conduct blood tests and liver function tests to monitor health status. Additionally, it is important to maintain an appropriate diet and make lifestyle improvements while taking this medication, and if sudden muscle pain or weakness occurs, treatment should be halted and a physician should be consulted.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest discomfort
  • increased blood creatine phosphokinase
  • headache
  • visual disturbances
  • hematuria
  • generalized edema
  • liver abnormalities (jaundice)
  • hepatitis
Show 14 more
  • liver failure
  • severe muscle weakness
  • rhabdomyolysis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • erythema multiforme
  • anaphylaxis
  • thrombocytopenia
  • kidney failure
  • hernia
  • bradycardia
  • hypotension
  • intracranial aneurysm
  • restless legs syndrome

Mild side effects

  • Dry mouth
  • increased blood creatine phosphokinase
  • cough
  • oropharyngeal pain
  • abdominal discomfort
  • diarrhea
  • dyspepsia
  • nausea
  • dizziness
  • paresthesia
Show 18 more
  • syncope
  • tension headaches
  • myalgia
  • spinal pain
  • muscle spasm
  • eye itching
  • giant papillary conjunctivitis
  • keratitis
  • capsule opacity
  • blurred vision
  • COVID-19
  • nasopharyngitis
  • upper respiratory tract infections
  • chest pain
  • acne
  • uterine leiomyoma
  • skin abrasions
  • ulnar fractures

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

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.