Medication info

Atorvaef Tablet 10/40 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 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
Approval withdrawn

MFDS item code 202101520 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2024.11.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipid levels through cholesterol reduction and HDL increase 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, it is administered in a dose range of 10/10mg to 10/80mg daily, with an initial recommended dose of 10/10mg or 10/20mg daily. For patients requiring a more significant reduction in LDL cholesterol (greater than 55%), an initial dose of 10/40mg daily is recommended. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of at least 2 weeks.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

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

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

This medication is used as an adjunct to dietary therapy to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia while increasing the level of good cholesterol, HDL cholesterol. It is also used either in conjunction with or as an alternative to other therapies in patients with rare homozygous familial hypercholesterolemia. This drug should be administered alongside an appropriate dietary regimen and is applied when dietary or non-drug treatments alone are inadequate. In patients at risk of atherosclerotic vascular disease with dyslipidemia, multiple risk factors should be considered, and other secondary causes should be evaluated and managed appropriately before treatment. It is important to consult with a physician to devise an accurate treatment plan based on the patient's health status, and this drug is used to effectively improve cholesterol control.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, it is administered in a dose range of 10/10mg to 10/80mg daily, with an initial recommended dose of 10/10mg or 10/20mg daily. For patients requiring a more significant reduction in LDL cholesterol (greater than 55%), an initial dose of 10/40mg daily is recommended. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of at least 2 weeks.

Precautions

This medication may pose a risk of serious muscle problems, so consult a physician immediately if severe muscle pain or weakness appears. Muscle damage may lead to impaired kidney function; therefore, in cases of severe infection, major surgery, trauma, or other risk factors, it may be necessary to temporarily discontinue this medication. This medication should not be taken by individuals who are allergic to its active ingredient or excipients, have significantly impaired liver function, have muscle disorders, are pregnant or breastfeeding, or are taking certain other medications. Caution should be exercised in individuals with a history of alcohol abuse or liver disease, renal impairment, hypothyroidism, elderly patients, etc., as the risk of myopathy may be higher, and regular check-ups are necessary. If symptoms such as muscle pain, fatigue, or fever occur during treatment with this medication, inform your doctor immediately, and liver function tests are required if liver dysfunction is suspected. This medication can elevate liver enzyme levels, so it is crucial to conduct liver function tests before and during treatment. This drug may interact with some other medications; particularly, when taken with drugs that interfere with hepatic metabolism, the risk of side effects may increase, so it is essential to inform your physician or pharmacist of all medications being taken. Women who are pregnant or may become pregnant should not take this medication, and women of childbearing age should use effective contraception while taking it. Breastfeeding women should also avoid this medication for the safety of the infant. The safety and efficacy of this drug have not been established in children, so its use is not recommended. Elderly patients are at higher risk of myopathy; caution is needed during use, but dosage adjustment is generally not necessary. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and monitoring of liver function and muscle-related tests should be performed regularly. This medication should be kept out of reach of children, and it is advisable to avoid transferring it to other containers, as this may adversely affect its quality. Caution is required when driving or operating machinery, as dizziness may occur.

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 fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress associated with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, 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
  • malaise
  • lethargy
  • chest discomfort
  • swelling
  • generalized edema
  • headache
  • intracranial aneurysm
  • restless legs syndrome
  • depression
  • bronchial inflammation
  • dental abscess
  • vestibular neuritis
  • bradycardia
  • hypotension
  • anemia
  • hernia
  • vitamin D deficiency
  • gastric polyp

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, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Avoid storing in excessively hot or cold places, as it is important to maintain an appropriate temperature to preserve the drug's effectiveness.

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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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.