Medication info

Evatoreum Tablet 10/20

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
White to off-white, biconvex, rectangular tablet
Packaging
30 tablets/Alu-Alu packaging (10 tablets/Alu-Alu x 3)
Approval status
Active

MFDS item code 201603654 · Approved 2016.06.21

Summary

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

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B
  • triglycerides
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B, and triglyceride levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, and to increase HDL cholesterol levels. It is also used in patients with homozygous familial hypercholesterolemia when other treatments are ineffective or as adjunctive treatment. It should be used in conjunction with appropriate dietary measures, such as restricting saturated fat and cholesterol intake, and consider the overall risk factors of the patient according to hyperlipidemia treatment guidelines. It is also important to check for other causes of dyslipidemia and treat them if necessary. This medication improves the risk of hypercholesterolemia and associated atherosclerotic vascular disease by controlling total cholesterol, LDL, HDL, and triglyceride levels.

How to take

Adult dose

This medication is administered once a day in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg once daily, with the generally recommended starting dose being 10/20mg once daily. Patients with less need for LDL cholesterol reduction may start with 10/10mg once daily. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of 4 weeks or more.

Precautions

This medication is used to lower blood cholesterol levels. Caution should be exercised as symptoms such as muscle pain or weakness may occur while taking this medication. Particularly, if there are severe muscle pain or weakness symptoms, the doctor should be informed immediately. This medication may affect liver function, so it should not be taken if there is liver disease or abnormally high liver enzyme levels. Women who are pregnant or breastfeeding should not take this medication, and women who are planning to become pregnant should consult a doctor before taking it. Additionally, this medication may pose an increased risk of muscle damage when taken with certain antifungals, antibiotics, immunosuppressants, etc., so patients should inform their doctor of any other medications being taken. Special caution is required for elderly patients or those with impaired kidney function. It is advisable to undergo regular blood tests during the course of treatment to monitor liver function and muscle status. In case of overdose, there is no specific antidote, and appropriate treatment will be provided according to symptoms. Finally, it is safe to avoid grapefruit juice or certain medications during the course of treatment with this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucosa of mouth/eyes, difficulty breathing or shortness of breath, asthma exacerbation, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • viral infection
  • pharyngitis
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  • sinusitis
  • joint pain
  • low back pain
  • cough
  • weakness
  • cataract
  • constipation
  • indigestion
  • flatulence
  • nausea
  • eczema
  • itching
  • rash
  • dizziness
  • sensory abnormality
  • depression
  • gallstones
  • cholecystitis
  • increased eosinophils
  • systemic drug reaction
  • erythema multiforme
  • alopecia
  • various skin changes
  • lichenoid drug eruption

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 sealed container. It is important to store it at room temperature, between 1 degrees and 30 degrees Celsius. This helps maintain the potency of the medication and prevents degradation.

Appearance and packaging

Appearance

White to off-white, biconvex, rectangular tablet

Package unit

30 tablets/Alu-Alu packaging (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.