Medication info
Aitojet Tablet 10/40 mg

Aitojet Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP packaging (Alu-Alu)x3)]
Approval status
Active

MFDS item code 202101563 · Approved 2021.02.18

Summary

Main use
Reduction of LDL cholesterol and increase of HDL cholesterol in patients with hypercholesterolemia and dyslipidemia, thus inhibiting the risk of cardiovascular diseases
Who uses it
Adults
Adult dosage
This medication is administered once a day regardless of meals. The dosage should be adjusted according to the patient's baseline LDL cholesterol levels, treatment goals, and patient response. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day, and the recommended starting dose is 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction in LDL cholesterol, a starting dose of 10/40 mg per day is recommended.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Reduction of LDL cholesterol and increase of HDL cholesterol in patients with hypercholesterolemia and dyslipidemia, thus inhibiting the risk of cardiovascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
View approved original text

This drug is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, and to raise HDL cholesterol levels in patients with primary hypercholesterolemia, especially in heterozygous familial and non-familial patients. It is also administered as an adjunct in patients with homozygous familial hypercholesterolemia either alongside other lipid-lowering treatments or when other treatments are ineffective. This drug is used when appropriate dietary measures and non-pharmacological interventions are insufficient for patients with cardiovascular risk factors, and evaluation and treatment of secondary causes are necessary. Regular lipid testing before and during treatment is recommended to establish a safe and effective treatment plan. Thus, this drug helps reduce the risks associated with dyslipidemia and improve blood lipid status.

Dosage and Administration

Adult dosage

This medication is administered once a day regardless of meals. The dosage should be adjusted according to the patient's baseline LDL cholesterol levels, treatment goals, and patient response. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day, and the recommended starting dose is 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction in LDL cholesterol, a starting dose of 10/40 mg per day is recommended.

Precautions

This drug may affect the muscles, so if symptoms such as muscle pain, muscle weakness, or muscle cramps occur, it should be reported to a doctor immediately. Special caution is needed if severe muscle pain or muscle damage (rhabdomyolysis) occurs as this may lead to kidney problems. Furthermore, it may affect liver function, so liver function tests should be conducted before and during treatment, and medication should be stopped if there are any abnormal symptoms related to the liver. This drug is not administered to patients with certain liver diseases or those with abnormally high liver enzyme levels. Women who are pregnant or may become pregnant and breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraceptive methods while on medication. This drug may increase the risk of side effects when taken with certain medications, therefore it is essential to inform the doctor or pharmacist of any other medications being taken. Elderly patients or those with impaired kidney function should take this medication with extra caution, and dosage adjustments may be necessary. Dizziness or fatigue may occur, so attention should be paid when driving or operating machinery. In case of overdose, as there is no specific antidote, symptomatic treatment and monitoring of liver function and muscle enzyme levels are required. This drug is not recommended for children as safety and efficacy have not been sufficiently established. Finally, it is advisable to store this drug in a place out of reach of children and not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (skin or eyes turning yellow), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • nausea
  • diarrhea
  • joint pain
  • musculoskeletal pain
  • fatigue
  • headache
  • lethargy
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  • vascular neurogenic edema
  • facial swelling
  • cough
  • nosebleed
  • pharyngitis
  • sinusitis
  • bronchitis
  • rhinitis
  • upper respiratory tract infection
  • rash
  • itching
  • hair loss
  • hives
  • thrombocytopenia
  • anemia
  • tinnitus
  • visual disturbances
  • vomiting
  • cholelithiasis
  • cholecystitis
  • increased blood pressure
  • elevated serum creatinine
  • elevated blood urea
  • increased CPK

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

Storage

This drug may be sensitive to air or moisture, so it is important to store it in a tightly closed container. Also, when storing the medication, it should be kept at room temperature, which is between 1 to 30 degrees Celsius. This helps maintain the efficacy of the medication.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP packaging (Alu-Alu)x3)]

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.