Medication info

Qutoget Tablet 10/40 mg

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
주식회사큐엘파마
Appearance
White or off-white rectangular film-coated tablet
Packaging
PTP - 30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Expired

MFDS item code 202101817 · 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 of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosing range is 10/10 mg to 10/80 mg per day. The recommended initial dose is either 10/10 mg or 10/20 mg once daily. In cases where a greater reduction in LDL cholesterol (more than 55%) is required, the recommended initial dose is 10/40 mg once daily. After administration or dose adjustment, monitor lipid levels for more than 2 weeks.

Ingredients

Manufacturer
주식회사큐엘파마

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

  • 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 diet for lowering elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol and for raising HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, it can be administered in patients with homozygous familial hypercholesterolemia either in combination with or as an alternative to other lipid-lowering therapies. This drug helps to mitigate the risk of cardiovascular disease, and it is important to use it alongside an appropriate diet and lifestyle changes. To maximize therapeutic efficacy, it is also crucial to diagnose and manage secondary causes such as diabetes and hypothyroidism. Regular lipid testing is necessary to assess treatment progress, and special tests may be performed if needed. Therefore, this medication is effectively used to improve dyslipidemia and hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosing range is 10/10 mg to 10/80 mg per day. The recommended initial dose is either 10/10 mg or 10/20 mg once daily. In cases where a greater reduction in LDL cholesterol (more than 55%) is required, the recommended initial dose is 10/40 mg once daily. After administration or dose adjustment, monitor lipid levels for more than 2 weeks.

Precautions

Rare side effects include rhabdomyolysis, which can cause severe muscle damage. Therefore, if serious muscle pain or weakness occurs, you must inform your doctor immediately, and if necessary, discontinue the medication. Extra caution is needed particularly in cases of severe infection, hypotension, major surgery, or trauma that may increase the risk of decreased kidney function. This medication should not be taken by those with an allergy to the active ingredient or its components, those with severely impaired liver function, those with muscle disorders, pregnant or potentially pregnant women, lactating mothers, or those taking certain other medications. Individuals with a history of alcohol abuse or liver disease, those with compromised kidney function, those with hypothyroidism, the elderly, and those at high risk for myopathy should use this drug cautiously. Lung function may be affected, so regular liver function tests should be performed before and during treatment. When taken with other drugs that can increase the risk of myopathy, dose adjustments and caution are necessary, and it should be taken under a doctor's guidance. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should use appropriate contraception while taking it. Caution is needed when driving or operating machinery due to potential symptoms such as dizziness. This medication is not recommended for children as its safety in this population has not been established. In case of overdose, specific antidotes are not available, so treatment will depend on symptoms, along with monitoring liver function and muscle enzymes. Keep this medication out of the reach of children, and take care not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing, jaundice, sudden and severe headache, seizures, visual disturbances, paralysis, significantly decreased urine output, severe generalized swelling and increased blood pressure, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), immune-mediated necrotizing myopathy, rhabdomyolysis, liver failure, fulminant hepatitis, severe muscle weakness

Mild side effects

  • Muscle pain
  • abdominal pain
  • increased liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • lethargy
  • fatigue
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • perception disturbances

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

Storage

This medication should be stored in a tightly sealed container that protects it from air and moisture. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White or off-white rectangular film-coated tablet

Package unit

PTP - 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.