Medication info

Ezetimibe/Simvastatin Tablets 10/20

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
White to pale white, biconvex, rectangular tablet
Packaging
30 tablets/PTP [(10 tablets/PTP X 3)]
Approval status
Approval withdrawn

MFDS item code 201906495 · Approved 2019.09.17

This product's status changed to Approval withdrawn on 2023.10.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Lipid-lowering effect for hypercholesterolemia (primary, familial) and mixed hyperlipidemia by reducing LDL cholesterol and increasing HDL cholesterol.
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 10/10mg to 10/40mg per day. The generally recommended initial dose is 10/20mg once daily. Patients with a lower need for LDL cholesterol reduction may start at 10/10mg per day. After initiation or dose adjustment, blood lipid levels should be checked at intervals of more than 4 weeks.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Lipid-lowering effect for hypercholesterolemia (primary, familial) and mixed hyperlipidemia by reducing LDL cholesterol and increasing HDL cholesterol.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure.
View approved original text

This medicine is used in conjunction with diet to lower total cholesterol, LDL cholesterol, ApoB protein, and triglycerides and to raise HDL cholesterol primarily in patients with primary hypercholesterolemia, familial and non-familial mixed hyperlipidemia. Additionally, it may be used alone in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments or when other treatments are ineffective. This drug must be used safely in patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia, considering multiple risk factors. Before administration, secondary causes of the disease should be identified and treated if necessary, and treatment decisions should be made based on lipid test results. This drug is used in conjunction with an appropriate diet that includes limiting saturated fats and cholesterol, and is administered when there is an inadequate response to diet or non-drug measures. This approach effectively improves the patient's 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 10/10mg to 10/40mg per day. The generally recommended initial dose is 10/20mg once daily. Patients with a lower need for LDL cholesterol reduction may start at 10/10mg per day. After initiation or dose adjustment, blood lipid levels should be checked at intervals of more than 4 weeks.

Precautions

This medication has the potential to cause muscle disorders such as myopathy or rhabdomyolysis. The risk may be increased when taken in high doses or with certain medications, so caution is required. Patients with allergies to any ingredients in this medication or severe liver dysfunction, as well as pregnant or breastfeeding women, should not take this drug. Additionally, this medication can affect liver function, so patients with liver disease should always consult a doctor before taking it. If unexplained muscle pain or weakness occurs during use, it should be reported to a doctor immediately. This drug can interact with other medications, so patients should inform their healthcare providers of any other medications they are currently taking. Particularly, taking it with drugs that inhibit the enzymes that metabolize this drug in the liver may increase the risk of side effects. Women who are planning to become pregnant or are of childbearing potential should consult a doctor before taking this drug and stop the medication immediately if pregnancy is confirmed. During breastfeeding, as this drug may be excreted in breast milk, it is advised to discontinue breastfeeding. Caution is needed in elderly patients and children as safety and effectiveness have not been sufficiently confirmed. Regular blood tests to monitor liver function and muscle-related indicators are recommended. There is no specific antidote in case of overdose, and symptomatic treatment will be provided based on the symptoms. It is also safe to limit the intake of certain foods such as grapefruit juice while taking this drug.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema and rash, pancreatitis, cholelithiasis, cholecystitis, anaphylaxis, erythema multiforme-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia, arthritis, urticaria, fever, chills, flushing, malaise, difficulty breathing, toxic epidermal necrolysis (Lyell's syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome).

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, myalgia, limb pain, fatigue, abdominal pain, nausea, constipation, dyspepsia, flatulence, pruritus, rash, pharyngitis, sinusitis, arthralgia, low back pain, cough, weakness, cataracts, elevated laboratory values (ALT, AST, creatine kinase, etc.), insomnia, dizziness, sensory disturbances, peripheral neuropathy, mental disorders, anxiety, sleeping disorders, depression, respiratory abnormalities, hair loss.

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

Storage

This medication should be stored tightly sealed to prevent exposure to air or moisture. It is also safe to store at room temperature, that is, between 1 degree and 30 degrees Celsius, avoiding extreme heat or cold.

Appearance and packaging

Appearance

White to pale white, biconvex, rectangular tablet

Package unit

30 tablets/PTP [(10 tablets/PTP 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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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.