Medication info
Ezetimibe/Simvastatin Tablet 10/10

Ezetimibe/Simvastatin Tablet 10/10

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
A white to pale yellow, bidirectional convex, rectangular tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201603895 · Approved 2016.06.24 · Insurance code 640903250

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, with the generally recommended starting dosage being 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start with 10/10mg daily. After adjusting the dose, lipid levels should be checked with an interval of at least 4 weeks to modify the dosage.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular diseases due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps to lower total cholesterol, LDL-cholesterol, ApoB protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, while increasing HDL-cholesterol levels. It is especially used as an adjunct to other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia or used alone if other treatments are ineffective. This medication should be administered in conjunction with an appropriate diet and is used when dietary control alone is insufficient. Additionally, it is important to confirm and, if necessary, treat secondary causes of dyslipidemia, such as diabetes and hypothyroidism, before using this medication. Regular monitoring of lipid levels is recommended to evaluate the treatment effect, and treatment and evaluation are also advised for patients with acute coronary events. Overall, this medication is used to manage blood lipid levels and reduce cardiovascular risk.

How to take

Adult dose

This medication is taken once daily in the evening regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, with the generally recommended starting dosage being 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start with 10/10mg daily. After adjusting the dose, lipid levels should be checked with an interval of at least 4 weeks to modify the dosage.

Precautions

This medication can cause serious muscle disorders such as myopathy or rhabdomyolysis, so if muscle pain or weakness symptoms occur, you must notify your doctor immediately. This medication should not be administered to patients with certain liver conditions or abnormally high liver enzyme levels. Pregnant or nursing women should not take this medication, and women who could become pregnant must confirm their pregnancy status before use. This medication may increase the risk of side effects when taken with certain strong drugs, so consult your physician or pharmacist if you are taking other medications. Elderly patients or those with reduced kidney function require extra caution when taking this medication and should have regular blood tests to check liver and muscle health. If any muscle-related adverse symptoms appear, you should discontinue use immediately and consult healthcare professionals, especially since the risk of muscle side effects increases with higher dosages of this medication. While taking this medication, limit alcohol intake, and inform your doctor if there are changes in your health status. Also, this medication may not be suitable for patients with certain genetic metabolic disorders, so if you have a history of drug allergies or adverse reactions, be sure to inform your healthcare provider. This medication is only used in children with restrictions and should be taken in adolescents under medical supervision. Finally, when receiving a new prescription from another doctor while taking this medication, be sure to inform them that you are currently taking this medication.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • paleness
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
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  • yellowing of skin or eyes (jaundice)
  • extreme lethargy throughout the body
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • markedly reduced urine output
  • severe general edema
  • increased blood pressure
  • anaphylaxis

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, myalgia, limb pain, fatigue, nausea, abdominal pain, constipation, dyspepsia, flatulence, vomiting, pruritus, facial swelling, edema, thirst, increased creatine phosphokinase (CPK) levels, weight loss, dizziness, paresthesia, insomnia, sore throat, nocturia, hematuria, weakness, cataract progression, alopecia, gynecomastia, reduced libido, sexual dysfunction, anemia, HbA1c and fasting blood glucose

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A white to pale yellow, bidirectional convex, rectangular tablet

Package unit

30 tablets (10 tablets/PTPX3)

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.