Medication info

Qutojet Tablets 10/20 milligrams

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
주식회사큐엘파마
Appearance
White or whitish rectangular film-coated tablet
Packaging
TP packaging - 30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Expired

MFDS item code 202101816 · Approved 2021.02.24

This product's status changed to Expired on 2026.02.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in lipid levels by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. Patients requiring more LDL cholesterol reduction should start with 10/40 mg as the initial dose. After starting treatment or adjusting dosage, check blood lipid levels with intervals of at least 2 weeks to adjust the dose accordingly. In homozygous familial hypercholesterolemia, the recommended dosage is 10/40 mg or 10/80 mg daily. This medication acts as an adjunct to other lipid-lowering therapies (e.g., LDL-Apheresis) or is administered when other lipid-lowering therapies are ineffective.

Ingredients

Manufacturer
주식회사큐엘파마

Efficacy & effects

Improvement in lipid levels by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia

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

This medication is used as an adjunct to dietary therapy to lower high total cholesterol, LDL cholesterol, apolipoprotein B, triglyceride, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia while increasing levels of good cholesterol, HDL cholesterol. It can also be used when the effect of existing treatment is insufficient in patients with homozygous familial hypercholesterolemia, or in conjunction with other treatments. This medication is safely and effectively used for certain types of dyslipidemia, mainly prescribed to lower the risk of cardiovascular disease. It should be taken together with an appropriate diet, and prior to treatment, secondary causes such as diabetes and hypothyroidism should be identified and treated. Accurate assessment of blood lipid levels is important, particularly after an acute coronary event, to aid in planning appropriate treatment. Therefore, this medication is effectively used to improve dyslipidemia related to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. Patients requiring more LDL cholesterol reduction should start with 10/40 mg as the initial dose. After starting treatment or adjusting dosage, check blood lipid levels with intervals of at least 2 weeks to adjust the dose accordingly. In homozygous familial hypercholesterolemia, the recommended dosage is 10/40 mg or 10/80 mg daily. This medication acts as an adjunct to other lipid-lowering therapies (e.g., LDL-Apheresis) or is administered when other lipid-lowering therapies are ineffective.

Precautions

This medication poses the risk of serious muscle problems, so any sudden muscle pain or weakness should be reported to a doctor immediately. In particular, if there are risk factors such as severe infections, hypotension, major surgery or trauma, or metabolic disorders, the use of this medication should be temporarily suspended or stopped. Persons with allergies to this medication’s active ingredients or components, those with active liver disease, muscle disorders, pregnant or breastfeeding women should not take this medication. Additionally, when taken with certain other medications, its use may also be prohibited or require caution. Patients with poor liver function or alcohol addiction, elderly patients, and those with impaired kidney function should use this medication with caution and require regular monitoring. This medication may elevate liver enzyme levels, so liver health should be checked periodically; if any abnormal symptoms appear in the liver, intake should be discontinued immediately. Symptoms such as dizziness, muscle pain, abdominal pain, or fatigue may occur during use, so if these persist, consultation with a doctor is advised. This medication is not to be used in pregnant or breastfeeding women, and women of childbearing potential should use proper contraception while taking it. The safety and efficacy of this medication are not established in children, so it is not recommended for them. In case of overdose, there is no specific antidote, so treatment should be symptomatic, monitoring liver function and muscle condition. This medication may interact with other drugs, so if there are any other medications being taken, it is essential to inform a doctor or pharmacist. Caution is needed when driving or operating machinery due to potential dizziness. This medication should be stored out of reach of children and should not be transferred to another container.

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 the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory anomalies with cough and fever, yellowness of the skin or eyes (jaundice), profound lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
  • sinusitis
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  • flushing
  • dizziness
  • fatigue
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • loss of appetite
  • indigestion
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • sensory abnormalities
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • hives
  • skin rash
  • itching
  • hair loss
  • thrombocytopenia
  • hepatitis
  • bile

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, avoid very hot or very cold locations; it is safely stored at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

White or whitish rectangular film-coated tablet

Package unit

TP packaging - 30 tablets/box [(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.