Medication info
Ezetimibe/Simvastatin 10/20 mg Tablet

Ezetimibe/Simvastatin 10/20 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
알리코제약(주)
Appearance
White to off-white, double-convex, rectangular tablets
Packaging
30 tablets
Approval status
Active

MFDS item code 201600854 · Approved 2016.02.15 · Insurance code 656004120

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/40 mg daily, with the generally recommended initial dose being 10/20 mg daily. Patients for whom a reduction in LDL-cholesterol is less critical may start at 10/10 mg daily. In patients with homozygous familial hypercholesterolemia, the recommended dose is 10/40 mg daily, taken once in the evening.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

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

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

This medication is used as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, Apo B protein, and triglycerides in patients with primary hypercholesterolemia and mixed hyperlipidemia, while increasing HDL-cholesterol. It can be applied either in conjunction with other lipid-lowering therapies or as an alternative treatment for patients with homozygous familial hypercholesterolemia. This drug is used when dietary adjustments and non-drug treatments are insufficient, and secondary causes must be identified and managed before treatment. Additionally, it is applied with caution to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. Overall, this medication effectively helps improve blood lipid levels.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/40 mg daily, with the generally recommended initial dose being 10/20 mg daily. Patients for whom a reduction in LDL-cholesterol is less critical may start at 10/10 mg daily. In patients with homozygous familial hypercholesterolemia, the recommended dose is 10/40 mg daily, taken once in the evening.

Precautions

This medication is used to lower blood cholesterol levels. However, caution is needed as this medication can cause muscle issues. Especially if muscle pain or weakness occurs, inform the physician immediately. Additionally, this medication may affect liver function, so it should not be used in cases of liver disease or abnormal liver function tests. Women who are pregnant or breastfeeding should not take this medication, and women planning to become pregnant must consult a doctor. This medication may increase the risk of muscle disease when taken with specific antifungals, antibiotics, or antivirals; therefore, inform your doctor if you are taking these medications. Elderly patients or those with impaired kidney function also need to be cautious when taking this medication. During treatment, any unusual symptoms such as muscle pain, weakness, or darkening of urine should be reported to healthcare personnel immediately. This medication should not be administered to patients with certain genetic diseases. While taking this medication, it is advisable to perform regular blood tests to monitor liver function and muscle condition. It is safe to avoid foods or drinks that inhibit the CYP3A4 enzyme, such as grapefruit juice, when taking this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, rash, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS), severe edema, liver abnormalities (including hepatitis and jaundice), severe rash with high fever and skin peeling, severe allergic reactions, difficulty breathing, dyspnea, asthma attacks, severe skin reactions, thrombocytopenia,

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, myalgia, limb pain, fatigue, nausea, abdominal pain, constipation, dyspepsia, flatulence, gastritis, atrophic gastritis, mucus in stool, irritable bowel syndrome, sore throat, nocturia, hematuria, pruritus, alopecia, asthenia, paresthesia, dizziness, insomnia, nausea, vomiting, chest discomfort, increased serum creatine phosphokinase (CPK), weight loss

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 sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius at room temperature to safely maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

White to off-white, double-convex, rectangular tablets

Package unit

30 tablets

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.

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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.