Medication info
Atovanjett Tablet 10/10 mg

Atovanjett Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White, biconvex, oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 202101674 · Approved 2021.02.19 · Insurance code 654005660

Summary

Main use
Lipid improvement through reduction of cholesterol and LDL and increase of HDL in hypercholesterolemia (primary, familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day. Initial doses of 10/10 mg or 10/20 mg per day are recommended. For patients requiring greater reductions in LDL cholesterol (more than 55%), an initial dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Lipid improvement through reduction of cholesterol and LDL and increase of HDL in hypercholesterolemia (primary, familial) 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 dietary modifications to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, and to raise HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used in conjunction with or as an alternative therapy for patients with homozygous familial hypercholesterolemia. In particular, it is applied alongside diet in patients with hypercholesterolemia at high risk for cardiovascular disease, where secondary causes need to be identified and treated. The dosage should be administered appropriately based on lipid test results, resulting in an improvement in blood lipid levels through treatment efficacy.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day. Initial doses of 10/10 mg or 10/20 mg per day are recommended. For patients requiring greater reductions in LDL cholesterol (more than 55%), an initial dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication has been associated with a rare side effect known as rhabdomyolysis, which can cause severe muscle damage. This side effect may lead to acute renal failure, so it is important to immediately inform a physician if severe muscle pain or weakness occurs. Patients with severe infections, hypotension, major surgery or trauma, severe metabolic disorders, or uncontrolled seizures may need to temporarily discontinue this medication. Patients with allergies to any ingredients in this medication, as well as those with liver disease, muscle disease, and women who are pregnant or breastfeeding should not use this medication. Additionally, patients with certain antiviral therapy or lactose intolerance should also avoid administration. Careful use of this medication is necessary for patients with alcohol addiction, poor liver function, kidney issues, thyroid dysfunction, and elderly patients. Patients at risk for myopathy should have muscle enzyme levels checked before administration and monitored regularly during treatment. Since there are several medications that may interact with this drug, it is essential to inform healthcare providers of any medications being taken. Liver function tests should also be conducted regularly during treatment, and administration should be discontinued immediately if symptoms of liver damage appear. Women who are pregnant or may become pregnant must use adequate contraception while taking this medication and discontinue it immediately if pregnancy is confirmed. Caution is required during driving or operating machinery as dizziness may occur. The safety and effectiveness of this medication in children have not been established and it is not recommended.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attack, respiratory difficulties accompanied by cough and fever, skin or eye yellowing (jaundice), notable lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, fainting

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • nausea
  • constipation
  • diarrhea
  • joint pain
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
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  • sinusitis
  • flushing
  • increased AST
  • increased ALT
  • fatigue
  • chest pain
  • weakness
  • lethargy
  • vasogenic edema
  • facial swelling
  • rash
  • itching
  • hair loss
  • skin lump
  • headache
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • urticaria
  • angioedema
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • cholestatic syndrome

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

Storage

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

Appearance and packaging

Appearance

White, biconvex, oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*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.