Medication info

Torzetor Tablets 10/10 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White or milky white oblong film-coated tablet
Packaging
30 tablets/box [10 tablets /Alu-Alu x3]
Approval status
Approval withdrawn

MFDS item code 202101524 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2024.09.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia and suppression of cardiovascular disease risk through HDL increase
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the recommended dose range is 10/10 mg to 10/80 mg daily, with an initial dose of 10/10 mg or 10/20 mg suggested. In patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg is recommended. Lipid levels should be checked after an interval of more than 2 weeks following administration.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia and suppression of cardiovascular disease risk through HDL increase

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • homozygous familial hypercholesterolemia
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels and increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia or when other treatments are not effective. This medication is administered alongside proper dietary regimen, and it is important to identify and treat secondary causes that can induce dyslipidemia, such as diabetes and hypothyroidism. Given the heightened risk of atherosclerotic vascular disease due to dyslipidemia, multiple risk factors should be considered, and for patients with acute coronary events, lipid levels should be measured early in the hospital to inform treatment. This medication is used adjunctively when dietary measures and other non-pharmacological interventions are insufficient, helping to improve lipid levels and reduce cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the recommended dose range is 10/10 mg to 10/80 mg daily, with an initial dose of 10/10 mg or 10/20 mg suggested. In patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg is recommended. Lipid levels should be checked after an interval of more than 2 weeks following administration.

Precautions

This medication can rarely cause a condition called rhabdomyolysis, which may lead to serious kidney problems due to muscle tissue damage. Therefore, if severe muscle disease symptoms manifest or if there are risk factors such as severe infection, hypotension, major surgery, trauma, severe metabolic disturbances, or uncontrolled seizures, the medication should be temporarily discontinued or stopped. This drug should not be used in patients with a history of allergies to its ingredients, severely impaired liver function, muscle disorders, pregnant women, or nursing mothers. Additionally, it should not be taken by patients with lactose intolerance or certain antiviral medications. Patients with a history of alcohol abuse, liver disease, moderate to severe liver dysfunction, impaired kidney function, hypothyroidism, family history of muscle disorders, and the elderly, who are at an increased risk of muscle disease, should use this medication carefully. Caution is also必要 when used in conjunction with other medications that can cause muscle toxicity. Patients should immediately inform their doctor if they experience symptoms such as myalgia, muscle weakness, fatigue, or fever during treatment, and blood tests should be performed if necessary to check for muscle damage. Liver function abnormalities may also occur, so regular liver function tests should be performed before and during treatment, and patients should inform their doctor immediately if they experience symptoms of hepatitis (nausea, vomiting, fatigue, etc.). This medication should not be used in pregnant or nursing women due to potential risks to the fetus and newborn, and fertile women should use appropriate contraception. It is not recommended for children as safety and efficacy have not been established. Caution is required for the elderly due to a higher risk of muscle disease, though specific dosage adjustments are not necessary. There is no specific antidote in case of overdose, so appropriate treatment and supportive care should be provided according to symptoms, with regular liver function and muscle-related tests. Caution should be taken while driving or operating machinery, as dizziness may occur during treatment. There are many potential drug interactions, so if other medications are being taken, it is advisable to consult with a doctor or pharmacist, particularly when used with certain antibiotics, antifungals, antivirals, immunosuppressants, etc.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention.

Mild side effects

  • Myalgia
  • abdominal pain
  • fatigue
  • dizziness
  • headache
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • loss of appetite
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  • itching
  • rash
  • hair loss
  • hives
  • chronic alcoholic liver disease
  • palpitations
  • thrombocytopenia
  • anemia
  • pharyngitis
  • sinusitis
  • upper respiratory tract infection
  • increased serum creatinine
  • elevated blood pressure
  • increased blood urea
  • elevated CPK
  • abnormal liver function tests
  • nosebleeds
  • bronchitis
  • cough
  • phlegm
  • runny nose
  • arthralgia
  • low back pain
  • erectile dysfunction
  • urinary problems.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain room temperature between 1 to 30 degrees Celsius to well-preserve the efficacy of the drug and prevent degradation.

Appearance and packaging

Appearance

White or milky white oblong film-coated tablet

Package unit

30 tablets/box [10 tablets /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.