Medication info
Atostajet Tablet 10/40 mg

Atostajet Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/box (10 tablets/Alu-Alu x 3), 30 tablets/bottle
Approval status
Active

MFDS item code 202101535 · Approved 2021.02.18 · Insurance code 642707050

Summary

Main use
Improvement of 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, the recommended dosage range is 10/10 mg to 10/80 mg daily. The initial dose recommended is 10/10 mg or 10/20 mg once daily. For patients requiring a larger reduction in LDL cholesterol, it is recommended to start at a dose of 10/40 mg once daily. After administration, lipid levels should be checked after an interval of more than 2 weeks.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of 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
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to diet to lower high total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing good HDL cholesterol. It is also administered as an adjunct in patients with homozygous familial hypercholesterolemia when other lipid-lowering treatments are ineffective. Although there is no evidence that this drug alone is superior to atorvastatin in reducing morbidity and mortality from cardiovascular disease, it is selected for use with an appropriate diet when treatment response is inadequate. Before treatment, it is necessary to identify other causes of dyslipidemia, such as diabetes and hypothyroidism, and treat them if necessary. Additionally, lipid tests should include total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels, and measuring lipid levels upon hospitalization in patients with acute cardiovascular events is important. This medication helps reduce the risk of atherosclerotic vascular disease due to dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the recommended dosage range is 10/10 mg to 10/80 mg daily. The initial dose recommended is 10/10 mg or 10/20 mg once daily. For patients requiring a larger reduction in LDL cholesterol, it is recommended to start at a dose of 10/40 mg once daily. After administration, lipid levels should be checked after an interval of more than 2 weeks.

Precautions

This medication may cause serious muscle problems; therefore, if sudden muscle pain or weakness occurs, consult a doctor immediately. If there is a risk of impaired kidney function due to severe infections, surgery, trauma, or electrolyte imbalances, this medication should be temporarily discontinued or stopped. Patients with allergies to any of the ingredients in this medication, hepatic impairment, muscular diseases, pregnant or nursing women should not take this medication. Moreover, patients with certain liver diseases or those taking specific other medications should also avoid using this medication, so be sure to consult a doctor. Caution should be exercised by individuals with alcohol dependence, reduced liver function, impaired kidney function, hypothyroidism, and elderly patients, and regular check-ups are necessary. This medication contains certain dyes that may cause allergic reactions, so patients with a history of dye allergies should be careful. During treatment, side effects such as muscle pain, abdominal pain, and abnormal liver function may occur, so if symptoms arise, promptly notify healthcare professionals. Liver function tests should be conducted before starting and regularly during treatment, and if liver damage symptoms appear, the medication should be discontinued. This drug has many drug interactions, so if other medications are being taken, it is essential to inform a doctor or pharmacist, especially if combined with certain antibiotics, antiviral agents, antifungals, immunosuppressants, etc. Pregnant women or those planning to become pregnant should not take this medication, and fertile women should use appropriate contraceptive methods during treatment. Nursing mothers are also recommended not to take this medication. It is not recommended for children as safety and efficacy have not been established, and caution is needed for the elderly due to the risk of muscle abnormalities. In case of overdose, there is no specific antidote, and treatment should be symptom-based with liver function and muscle enzyme assessments. This medication should be kept out of reach of children and should not be transferred to other containers. Dizziness may occur during treatment, so caution is required when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in the oral/eye mucosa, difficulty or shortness of breath, asthmatic attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • joint pain
  • musculoskeletal pain
  • muscle cramps
  • muscle fatigue
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • dyspepsia
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  • headache
  • dizziness
  • fatigue
  • malaise
  • chest pain
  • discomfort in the chest
  • swelling
  • pharyngitis
  • sinusitis
  • cough
  • hyperkalemia
  • flushing
  • blurred vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • skin nodules
  • anemia
  • thrombocytopenia
  • depression
  • insomnia
  • nightmares
  • vomiting
  • gallstones
  • cholecystitis
  • increased blood pressure
  • serum creatinine

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture and kept at room temperature, between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be safely maintained.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/box (10 tablets/Alu-Alu x 3), 30 tablets/bottle

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.