Medication info
Ezitorin Tablet 10/20 mg

Ezitorin Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Biconvex rectangular tablets that are white to off-white.
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201601234 · Approved 2016.02.29 · Insurance code 663606960

Summary

Main use
Lipid improvement through reduction of LDL cholesterol and total cholesterol in primary hypercholesterolemia (familial and mixed types) and homozygous familial hypercholesterolemia.
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 10/10 mg to 10/40 mg per day, with a generally recommended starting dose of 10/20 mg per day. When a reduction in LDL cholesterol is less critical, treatment can start with 10/10 mg per day. After starting treatment or adjusting the dosage, check lipid levels in the blood after an interval of more than 4 weeks.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Lipid improvement through reduction of LDL cholesterol and total cholesterol in primary hypercholesterolemia (familial and mixed types) and homozygous familial hypercholesterolemia.

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

This medication helps to reduce total cholesterol, LDL cholesterol, Apo B protein, and triglycerides in patients with primary hypercholesterolemia, especially in patients with heterozygous familial and non-familial hypercholesterolemia, and mixed dyslipidemia, and to increase HDL cholesterol levels. It is also used to lower cholesterol levels in patients with homozygous familial hypercholesterolemia either alone or in conjunction with other treatments. Such treatment should be implemented alongside an appropriate diet, and it is used as an adjunct when diet alone is insufficient. It is important to determine if there are other secondary causes based on the patient's condition, and to monitor treatment progress through lipid profile testing. For patients with acute coronary events, treatment may begin after evaluating lipid levels at the time of admission. This medication is effectively used to reduce cardiovascular risks associated with hypercholesterolemia.

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 10/10 mg to 10/40 mg per day, with a generally recommended starting dose of 10/20 mg per day. When a reduction in LDL cholesterol is less critical, treatment can start with 10/10 mg per day. After starting treatment or adjusting the dosage, check lipid levels in the blood after an interval of more than 4 weeks.

Precautions

This medication can cause serious muscle-related side effects, such as myopathy and rhabdomyolysis, so if symptoms like muscle pain or weakness occur, consult a doctor immediately. This medication should not be used in individuals who are allergic to its components, have severe liver impairment, are pregnant or breastfeeding, or in combination with certain medications. Particularly in patients with unstable liver function or liver disease, this medication should be used cautiously, and regular liver function tests are required. This medication may interact with certain antifungal agents, antibiotics, immunosuppressants, and some cardiovascular drugs, increasing the risk of side effects, so patients must inform their doctor of any other medications they are taking. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy is confirmed, use should be discontinued immediately. This medication is used only restrictively in children and adolescents, and is not recommended for children under 10 years of age. In older adults, careful monitoring should be undertaken, particularly for muscle-related side effects and liver function abnormalities. During the use of this medication, if unexplained muscle pain, tenderness, muscle weakness, or signs of liver function abnormalities occur, consult medical personnel immediately for testing. In the event of overdose, no specific antidote is available, and general symptomatic treatment and supportive care are necessary. It is advisable to limit the intake of certain foods like grapefruit juice while taking this medication, and dose adjustments may be necessary when combined with other drugs according to a doctor's instructions. Regular blood tests to check liver function and muscle enzyme levels can help ensure the safe use of the 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 fever, blisters, skin shedding, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary complications.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • dyspepsia
  • flatulence
  • itching
  • rash
  • anaphylaxis
  • angioedema
  • fever
  • chills
  • lethargy
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • cataracts
  • dizziness
  • paresthesia
  • insomnia
  • depression
  • mental disorders
  • sleep disturbances
  • muscle cramps
  • joint pain
  • low back pain
  • tremor
  • facial imperfection.

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

Storage

Store this medication in a sealed container as it is sensitive to air and moisture. It is recommended to maintain a room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Biconvex rectangular tablets that are white to off-white.

Package unit

30 tablets (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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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.