Medication info
Atovaef 10/20 mg

Atovaef 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202101519 · Approved 2021.02.18 · Insurance code 645605520

Summary

Main use
Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg daily. The initial dose is recommended as 10/10 mg or 10/20 mg daily, and for patients requiring a greater reduction in LDL cholesterol, a dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dose, blood lipid levels should be checked after an interval of more than 2 weeks.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular diseases due to hypercholesterolemia.
View approved original text

This medication helps lower elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels, while increasing HDL cholesterol levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial dyslipidemia. It can also be used alone or in combination with other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This medication is typically used alongside dietary adjustments and non-pharmacologic treatments as an adjunctive therapy when other treatments are ineffective. It is important to assess and treat causes of dyslipidemia, such as diabetes and hypothyroidism, before initiation of therapy. Additionally, accurate lipid testing is needed when triglyceride levels are very high, and rapid lipid testing is recommended in the case of acute coronary events. Thus, this medication is effectively used in the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg daily. The initial dose is recommended as 10/10 mg or 10/20 mg daily, and for patients requiring a greater reduction in LDL cholesterol, a dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dose, blood lipid levels should be checked after an interval of more than 2 weeks.

Precautions

This medication may rarely cause side effects that affect the muscles; therefore, if symptoms like muscle pain or weakness occur, inform a doctor immediately. Because muscle damage may adversely affect kidney function, this medication should be temporarily or permanently stopped in the presence of serious myopathy symptoms or if kidney issues are present. Do not take this medication if you are allergic to any of its ingredients or have liver disease or muscle disorders. Women who are pregnant, possibly pregnant, or nursing should not take this medication, and women of childbearing potential should use appropriate contraceptive methods while on this medication. Patients with alcohol dependence or liver dysfunction should take this medication with caution and undergo regular liver function tests. Elderly patients or those with kidney impairment are at higher risk for myopathy, so caution is necessary. This medication may interact with other drugs, so if you are currently taking any other medications, consult your doctor or pharmacist. Side effects such as liver dysfunction, digestive issues, headaches, dizziness, muscle pain, etc., may occur, so if symptoms are severe, inform healthcare professionals. Regular monitoring for liver and muscle conditions should occur before and during treatment, and should any abnormal signs be found, the medication should be discontinued immediately, and a doctor should be consulted. It is recommended not to use this medication in children, as safety and effectiveness have not been established. In cases of overdose, there is no specific antidote, so symptomatic treatment and supportive care should be provided, while monitoring liver function and muscle enzyme levels is necessary. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or breathlessness, asthma attacks, respiratory distress accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision disturbances, paralysis, urination changes

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
  • malaise
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • generalized edema
  • headache
  • diarrhea
  • upper respiratory tract infection
  • urticaria
  • rash
  • itching
  • hair loss
  • angioedema
  • skin rash
  • dry cough
  • facial flushing
  • non-protein nitrogen increase
  • hyperuricemia
  • hypothermia

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular 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.