Medication info
Itorin Tablet 10/10

Itorin Tablet 10/10

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
White to light yellow, bi-convex rectangular tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201601703 · Approved 2016.03.31 · Insurance code 671806050

Summary

Main use
Improvement of cholesterol and lipids in primary hypercholesterolemia (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 dose being 10/20mg per day. For patients requiring less reduction in LDL cholesterol, treatment may start at 10/10mg daily. Following initiation or dosage adjustment, lipid levels should be monitored at intervals of more than 4 weeks.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Improvement of cholesterol and lipids in primary hypercholesterolemia (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 reduce total cholesterol, LDL cholesterol, ApoB protein, and triglycerides while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia in conjunction with dietary therapy. It can also be used as an adjunctive or alternative treatment for patients with homozygous familial hypercholesterolemia. This drug is effective when combined with lipid-regulating medications and when non-drug treatments do not respond. Before administration, secondary causes, such as diabetes and hypothyroidism, should be identified and may require treatment. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be measured periodically for management. This medication is used to reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia.

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 dose being 10/20mg per day. For patients requiring less reduction in LDL cholesterol, treatment may start at 10/10mg daily. Following initiation or dosage adjustment, lipid levels should be monitored at intervals of more than 4 weeks.

Precautions

This medication is primarily used to lower blood cholesterol levels. However, care should be taken as muscle-related issues may arise while taking this medication. In particular, muscle pain or weakness may occur, and in severe cases, a condition called rhabdomyolysis may develop, so if these symptoms appear, inform your doctor immediately. This medication can affect liver function, and patients with liver disease or abnormally high liver enzyme levels should not take it. Pregnant or nursing women should not take this medication, and women who could become pregnant should consult a doctor before taking it. Additionally, taking this medication with certain other drugs may increase the risk of muscle damage, so be sure to inform healthcare professionals if you are taking other medications. Older adults or patients with impaired kidney function also require more careful management when taking this medication. Regular blood tests to check liver enzymes and muscle damage markers during treatment are recommended. If you experience unexplained muscle pain, tenderness, or weakness while taking this medication, consult your healthcare provider immediately. This medication is also not suitable for patients with certain genetic lactase deficiency, so those with the condition should avoid taking it. Finally, caution should be taken with the consumption of specific foods such as grapefruit juice while taking this medication, and consulting with a physician or pharmacist is important.

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 peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties with cough and fever, jaundice (skin or eyes turning yellow), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • indigestion
  • vomiting
  • dizziness
  • sensory disturbances
  • depression
  • gallstones
  • cholecystitis
  • skin and mucous membrane syndrome
  • eosinophilia
  • skin rash
  • alopecia
  • pruritus
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • cataracts
  • ocular muscle paralysis
  • anemia
  • weight loss
  • hematuria
  • nocturia
  • chest pain
  • chest discomfort
  • insomnia
  • blood creatine phosphokinase increase

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 also advisable to store it at room temperature, between 1 to 30 degrees Celsius, avoiding extreme temperatures.

Appearance and packaging

Appearance

White to light yellow, bi-convex rectangular tablet

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.