Medication info

Torzetto Tablets 10/40 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White or whitish oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Approval withdrawn

MFDS item code 202101526 · 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This product's status changed to Approval withdrawn on 2024.09.26.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 due to increased HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage ranges from 10/10 mg to 10/80 mg per day, with an initial recommended dose of 10/10 mg or 10/20 mg once daily. For patients who require more significant reduction in LDL cholesterol (55% or more), an initial dose of 10/40 mg once daily is recommended. After starting treatment or adjusting the dose, lipid levels should be checked with an interval of more than 2 weeks.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and suppression of cardiovascular disease risk due to increased HDL.

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease caused by hypercholesterolemia
  • dyslipidemia.
View approved original text

This medication is used to improve the imbalanced blood lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It reduces total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels, while increasing good HDL cholesterol levels. It is also used as an adjunct with other treatment methods for patients with homozygous familial hypercholesterolemia, and can be administered when other lipid-lowering treatments are ineffective. This medication should be used in conjunction with an appropriate diet, and it is important to identify and treat other causes of dyslipidemia. Monitoring blood lipid levels regularly helps reduce the risk of cardiovascular diseases. Therefore, this medication is effectively used for the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage ranges from 10/10 mg to 10/80 mg per day, with an initial recommended dose of 10/10 mg or 10/20 mg once daily. For patients who require more significant reduction in LDL cholesterol (55% or more), an initial dose of 10/40 mg once daily is recommended. After starting treatment or adjusting the dose, lipid levels should be checked with an interval of more than 2 weeks.

Precautions

This medication can rarely cause damage to muscle tissue, leading to muscle breakdown and renal impairment; if severe muscle pain or weakness occurs, you must inform your doctor immediately. Patients who are hypersensitive to this medication, those with active liver disease, muscle disease patients, women who are pregnant or breastfeeding, and those taking certain antiviral medications should not take this medication. Caution is advised for alcoholics, patients with poor liver function, patients with renal impairment, those with hypothyroidism, or those at risk of muscle disease. Regular liver function tests and muscle-related tests should be done while on this medication, and you should consult your doctor immediately if any abnormal symptoms arise. This medication may interact with several other drugs; if you are taking any other medications, it is essential to inform your healthcare provider, especially when taken with specific antibiotics, antiviral drugs, immunosuppressants, or fibrate medications. Women of childbearing age should use appropriate contraceptive methods while taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. Caution is required when driving or operating machinery, as dizziness and other symptoms may occur. Safety and efficacy in children and adolescents have not been established and are not recommended. During the use of this medication, it is important to check for adverse reactions with regular blood tests and liver function tests.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, and other severe allergic reactions.
  • Severe skin reactions such as high fever with severe rashes, blisters, skin peeling, and pain in the oral/ocular mucosa.
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory deterioration accompanied by cough and fever.
  • Yellowing of the skin or eyes (jaundice), extreme lethargy, and other liver dysfunction symptoms.
  • Sudden and severe headaches.

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • headache
  • dizziness
  • fatigue
Show 28 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • pharyngitis
  • upper respiratory infection
  • constipation
  • indigestion
  • belching
  • pancreatitis
  • tinnitus
  • dry eyes
  • itching
  • rash
  • hair loss
  • angioedema
  • skin rash
  • hives
  • skin ulcer
  • sweating
  • acne
  • eczema
  • seborrhea
  • thrombocytopenia
  • anemia
  • depression
  • insomnia
  • nightmares

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. This helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White or whitish oval film-coated tablet

Package unit

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.