Medication info
Atostazet Tablets 10/10 mg

Atostazet Tablets 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/box (10 tablets/PTP packaging (Alu-Alu)x3), 30 tablets/bottle
Approval status
Active

MFDS item code 202101533 · Approved 2021.02.18 · Insurance code 642707030

Summary

Main use
Lipid improvement through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of mealtime. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily, with an initial dose of 10/10mg or 10/20mg recommended. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40mg daily is recommended. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than two weeks to determine appropriate dosage adjustments.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Lipid improvement through cholesterol reduction and HDL increase 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 levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia, including familial or non-familial hypercholesterolemia and mixed dyslipidemia, and to raise HDL cholesterol levels. It is also administered as an adjunctive treatment for patients with homozygous familial hypercholesterolemia when other lipid-lowering treatments are ineffective or used in combination. This medication helps to reduce the risk of cardiovascular disease, but it must be taken alongside an appropriate diet, and the causes of dyslipidemia must be accurately diagnosed; other treatments should be combined when necessary. During testing, it is important to closely monitor lipid levels to establish an appropriate treatment strategy. This medication is used to manage the risk of atherosclerotic vascular disease associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of mealtime. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily, with an initial dose of 10/10mg or 10/20mg recommended. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40mg daily is recommended. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than two weeks to determine appropriate dosage adjustments.

Precautions

This medication can cause a rare side effect called rhabdomyolysis, which can lead to acute renal failure. Therefore, patients showing symptoms of severe myopathy or those at high risk of renal failure, such as post major surgery, during severe infection, or with hypotension, should temporarily stop or discontinue this medication. Patients with allergies to the components of this drug, severely impaired liver function or persistent unexplained elevated liver enzymes, those with muscle diseases, pregnant or potentially pregnant women, lactating women, patients on certain antiviral medications, and those with genetic issues such as lactose intolerance should not take this medication. Alcoholics, patients with a history of liver disease or severe liver dysfunction, those with poor kidney function or hypothyroidism, patients with a family history of muscle disease, and elderly patients over 70 years old, who are at higher risk of myopathy, should use this medication cautiously. This medication may cause side effects such as myalgia, abdominal pain, and elevation of liver enzymes; severe liver injury, serious skin reactions, and allergic reactions can sometimes occur. If symptoms such as myalgia, muscle weakness, fatigue, or fever occur while taking this medication, the doctor should be informed immediately, and blood tests may be needed to check for muscle damage. If any symptoms of liver dysfunction appear, treatment should be discontinued and follow the doctor's instructions. This medication can interact with other drugs, so if there are currently any medications being taken, the doctor or pharmacist must be informed, especially when co-administering drugs that affect liver metabolism or those that increase the risk of muscle damage. Women of childbearing potential should use adequate contraception to avoid pregnancy while taking this medication, and if pregnancy is confirmed, the medication should be stopped immediately. Lactating women are advised not to take this medication, and safety in pediatric patients has not been established; thus, it is not recommended. Older adults should use this medication with caution due to a higher risk of myopathy, although dosage adjustment is generally not required. In case of overdose, as there is no specific antidote, appropriate treatment and supportive therapy should be provided based on symptoms. Finally, keep this medication out of the reach of children and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), liver abnormalities (jaundice), skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, severe allergic reactions, severe skin adverse reactions, difficulty in breathing, asthma attacks, rhabdomyolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), myopathy, acute renal failure, severe muscle weakness, ocular myasthenia gravis, thrombocytopenia, anaphylaxis, liver failure,

Mild side effects

  • Myalgia
  • abdominal pain
  • elevation of liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • arthralgia
  • muscle weakness
  • musculoskeletal pain
Show 27 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • headache
  • constipation
  • pharyngitis
  • sinusitis
  • upper respiratory infection
  • low back pain
  • muscle cramps
  • neck pain
  • muscle fatigue
  • itching
  • rash
  • hair loss
  • urticaria
  • skin rash
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • dry skin
  • sweating
  • acne
  • forgetfulness

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

30 tablets/box (10 tablets/PTP packaging (Alu-Alu)x3), 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.