Medication info
Ezetimibe/Atorvastatin Calcium Tablets 10/10 mg

Ezetimibe/Atorvastatin Calcium Tablets 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
White or off-white oblong film-coated tablet
Packaging
30 tablets/box[(10 tablets/Alu-Alu x 3)]
Approval status
Active

MFDS item code 202101426 · Approved 2021.02.18 · Insurance code 628801790

Summary

Main use
Improvement in lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily. The recommended initial doses are 10/10 mg or 10/20 mg once daily. For patients requiring a larger reduction in LDL cholesterol (greater than 55%), the recommended initial dose is 10/40 mg once daily. After starting treatment or adjusting the dose, lipid levels should be monitored at least every two weeks.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Improvement in lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular diseases caused by hypercholesterolemia
View approved original text

This medication helps lower elevated levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol while increasing good HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is especially used in patients with homozygous familial hypercholesterolemia as an adjunct or alternative to other therapies. This medication can be safely used alongside dietary therapy, and secondary causes such as diabetes and hypothyroidism should be checked and treated if necessary before use. Additionally, it is essential to regularly monitor treatment efficacy through blood lipid tests. This process contributes to reducing the risk of cardiovascular disease and effectively improving lipid levels. Therefore, this medication is used for the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily. The recommended initial doses are 10/10 mg or 10/20 mg once daily. For patients requiring a larger reduction in LDL cholesterol (greater than 55%), the recommended initial dose is 10/40 mg once daily. After starting treatment or adjusting the dose, lipid levels should be monitored at least every two weeks.

Precautions

This medication may cause muscle-related issues, including muscle pain or weakness. If severe muscle pain, muscle cramps, or muscle weakness occur, you should inform your doctor immediately, and if necessary, check muscle enzyme levels and discontinue the medication if abnormalities are confirmed. This medication may affect liver function, so liver function tests should be performed regularly before and during treatment. Patients with poor liver function or liver disease should not use this medication or should use it with caution. Pregnant women or women who may become pregnant should not take this medication, and appropriate contraception should be employed during treatment. It is also safe for breastfeeding women not to take this medication. Patients with decreased kidney function should use this medication cautiously, and those with a history of kidney disease should consult a doctor. Patients who consume excessive alcohol or have a history of liver disease need to be particularly cautious when taking this medication. This medication may interact with other drugs, so if you are currently taking any medication, be sure to inform your doctor or pharmacist. Dose adjustments or monitoring may be necessary, especially when taken with specific antibiotics, antiviral agents, antifungal agents, or immunosuppressants. Dizziness or fatigue may occur, so caution is advised when driving or operating machinery. This medication should be used carefully in children and the elderly, as the elderly may be at higher risk for muscle-related issues. In case of overdose, treat symptoms accordingly and monitor liver function and muscle enzyme levels. 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

  • Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • Severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, severe skin reactions
  • Shortness of breath or difficulty breathing, asthma attack, respiratory symptoms accompanied by coughing and fever
  • Yellowing of the skin or eyes (jaundice), generalized fatigue, liver abnormalities (jaundice)
  • Sudden and severe headache

Mild side effects

  • Muscle pain
  • abdominal pain
  • headache
  • dizziness
  • nausea
  • diarrhea
  • fatigue
  • cough
  • itching
  • rash
Show 26 more
  • urticaria
  • hair loss
  • anemia
  • thrombocytopenia
  • blurred vision
  • tinnitus
  • insomnia
  • nightmares
  • sensory abnormalities
  • muscle fatigue
  • joint pain
  • limb pain
  • muscle cramps
  • increased creatine kinase in the blood
  • hyperkalemia
  • hyperglycemia
  • hypoglycemia
  • lethargy
  • chest pain
  • chest discomfort
  • swelling
  • weakness
  • systemic edema
  • upper respiratory tract infection
  • bronchitis
  • sinusitis

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. The storage temperature should be kept between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablet

Package unit

30 tablets/box[(10 tablets/Alu-Alu 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

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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.