Medication info
Atovaef Tablet 10/10 mg

Atovaef Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/box[(10 tablets/PTP x3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202101518 · Approved 2021.02.18 · Insurance code 645605510

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and improvement of lipids by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is taken once daily without regard to meals. For primary hypercholesterolemia, the dosing range is from 10/10 mg to 10/80 mg once a day. An initial dose of 10/10 mg or 10/20 mg once a day is recommended. For patients requiring more significant reductions in LDL cholesterol, an initial dose of 10/40 mg once a day is recommended. Dosage adjustments should be made at intervals of more than 2 weeks after checking blood lipid levels.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and improvement of lipids by increasing HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used in conjunction with diet to lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, especially those with heterozygous familial and non-familial types, and to increase HDL cholesterol levels. It can also be used as an adjunct therapy to reduce total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia and can be administered when other treatments are not feasible. This medication is used along with appropriate dietary guidelines in patients at high risk for cardiovascular diseases and assists in improving vascular health through lipid control. Before taking this medication, secondary causes such as diabetes and hypothyroidism should be checked and treated if necessary. This medication contributes to reducing the risk of atherosclerotic vascular diseases due to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is taken once daily without regard to meals. For primary hypercholesterolemia, the dosing range is from 10/10 mg to 10/80 mg once a day. An initial dose of 10/10 mg or 10/20 mg once a day is recommended. For patients requiring more significant reductions in LDL cholesterol, an initial dose of 10/40 mg once a day is recommended. Dosage adjustments should be made at intervals of more than 2 weeks after checking blood lipid levels.

Precautions

This medication can rarely cause muscle tissue damage, leading to muscle pain or weakness; in severe cases, it can result in a serious condition called rhabdomyolysis. Due to the risk of rapid deterioration of kidney function, treatment should be discontinued immediately, and a doctor should be consulted if severe myopathy symptoms occur. Additionally, it can affect liver function, so liver function tests should be performed regularly before and during treatment. This medication should not be administered to patients with certain liver diseases or those with abnormally high liver enzyme levels. Women who are pregnant, likely to become pregnant, or breastfeeding should not take this medication. There may be interactions when taken with other medications, so any medications currently being taken should be disclosed to healthcare providers. Special caution is needed when taken with medications that affect liver function or may increase muscle toxicity. Symptoms such as dizziness, muscle pain, or abdominal pain may occur, and if these symptoms persist or worsen, a doctor should be informed. Elderly patients or those with impaired kidney function should also exercise caution when taking this medication, and thorough consultation with a healthcare provider is recommended before taking it. It is advisable to avoid alcohol consumption during the treatment, and regular blood tests and clinical monitoring are recommended.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, difficulty in breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), generalized malaise, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • generalized edema
  • headache
  • constipation
  • dyspepsia
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • limb pain
  • thrombocytopenia
  • anaphylaxis
  • hepatitis
  • blurred vision
  • tinnitus
  • pruritus
  • rash
  • hair loss
  • vascular

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. 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 x3)], 30 tablets/bottle, 100 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.