Medication info
Aezetimibe/Atorvastatin Calcium 10/10 mg

Aezetimibe/Atorvastatin Calcium 10/10 mg

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

MFDS item code 202101549 · Approved 2021.02.18 · Insurance code 694003390

Summary

Main use
Reduction of cholesterol and increase of HDL in primary hypercholesterolemia (homozygous familial) and dyslipidemia to mitigate the risk of cardiovascular disease.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, it is given in the dosage range of 10/10mg to 10/80mg daily, with the recommended initial dose being 10/10mg or 10/20mg daily. For patients requiring significant reduction in LDL cholesterol, an initial dose of 10/40mg daily is suggested. After initiation of treatment or dosage adjustment, blood lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Reduction of cholesterol and increase of HDL in primary hypercholesterolemia (homozygous familial) and dyslipidemia to mitigate the risk of cardiovascular disease.

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

This medication helps lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly in heterozygous familial and non-familial cases. It also increases HDL cholesterol levels to help maintain a balanced lipid profile. It can be used in combination with other treatments or as an alternative for patients with homozygous familial hypercholesterolemia. This drug has been studied for specific types of dyslipidemia, and it is important to use it alongside a proper diet. It safely and effectively contributes to cholesterol level management in patients at high risk of hyperlipidemia and atherosclerotic vascular disease.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, it is given in the dosage range of 10/10mg to 10/80mg daily, with the recommended initial dose being 10/10mg or 10/20mg daily. For patients requiring significant reduction in LDL cholesterol, an initial dose of 10/40mg daily is suggested. After initiation of treatment or dosage adjustment, blood lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication may rarely cause rhabdomyolysis, which can result in severe muscle damage. Therefore, if symptoms of severe muscle pain or weakness occur, notify a doctor immediately. Special care should be taken by patients with impaired renal function, hypothyroidism, the elderly, and those taking certain medications when using this drug. Patients with poor liver function or a history of liver disease should not take this medication and must undergo regular liver function tests. Women who are pregnant or could become pregnant, and nursing mothers should not take this drug, and women of childbearing age should use appropriate contraception. The safety and efficacy in children have not been established, so it is not recommended for them. This drug may interact with other medications, so inform your doctor or pharmacist of any other medications being taken. In case of overdose, there is no specific antidote, so immediate hospital treatment is necessary. Caution is needed 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, paleness, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, breathing difficulty accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine difficulties.

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
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • constipation
  • abdominal bloating
  • dyspepsia
  • pharyngolaryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • paresthesia
  • sensory loss
  • dysgeusia
  • amnesia
  • peripheral nerve disorder.

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture intrusion and kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

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