Medication info
Atorvastatin/Ezetimibe Tablet 10/10 mg

Atorvastatin/Ezetimibe Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
White, biconvex, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202101381 · Approved 2021.02.18 · Insurance code 642105690

Summary

Main use
Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dose range is 10/10 mg to 10/80 mg per day, with a recommended starting dose of 10/10 mg or 10/20 mg per day. For patients requiring an LDL-cholesterol reduction of more than 55%, a starting dose of 10/40 mg per day is recommended. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of at least 2 weeks.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL-cholesterol
View approved original text

This medication helps lower elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL-cholesterol, the good cholesterol. It is also used, either in conjunction with or as an alternative to other therapies, to control cholesterol levels in patients with homozygous familial hypercholesterolemia (HoFH). It is important to continue treatment consistently along with an appropriate diet, and the underlying causes of dyslipidemia should be assessed as well. It can be safely administered to patients at high risk of atherosclerotic vascular diseases related to hypercholesterolemia, taking multiple risk factors into account. Overall, this medication is used to effectively improve cholesterol levels for the prevention of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dose range is 10/10 mg to 10/80 mg per day, with a recommended starting dose of 10/10 mg or 10/20 mg per day. For patients requiring an LDL-cholesterol reduction of more than 55%, a starting dose of 10/40 mg per day is recommended. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of at least 2 weeks.

Precautions

This medication may cause rare side effects affecting muscle tissue, which can result in severe muscle damage and kidney function issues; therefore, if severe muscle pain or weakness symptoms occur, consult a doctor immediately. This medication should not be used by those who are allergic to the active ingredients or components, individuals with severely impaired liver function, those with muscle disorders, pregnant or potentially pregnant women, nursing mothers, persons taking certain antiviral medications, and those with lactose intolerance. Patients who have a history of alcoholism or liver disease, those with severe liver function impairment, diminished kidney function, hypothyroid patients, those with a personal or family history of muscle disorders, elderly patients over 70, and individuals taking certain other medications should exercise caution while using this drug and seek medical attention if any abnormal symptoms occur. While taking this medication, symptoms like muscle pain, muscle weakness, abdominal pain, liver function abnormalities, etc., may appear; if these symptoms persist or worsen, inform your doctor. Regular tests for liver function and muscle-related tests are necessary, and if symptoms of liver function impairment or muscle issues arise, testing should be done immediately. This medication should not be given to women who are pregnant or nursing, and fertile women should use appropriate contraception while taking this drug. Not recommended in children as safety and efficacy have not been established, and caution is advised in the elderly due to the risk of myopathy. This drug can interact with several others, so if other medications are being taken, it is essential to inform a doctor or pharmacist, especially in combination with drugs that affect liver metabolism, as dose adjustment or monitoring may be necessary. Dizziness may occur while driving or operating machinery; thus, caution is needed. In case of overdose, there is no specific antidote, so treatment should focus on symptomatic management and supportive care, monitoring liver function and muscle condition. This medication should be stored out of reach of children and kept in its original packaging.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary incontinence

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • bronchitis
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  • sinusitis
  • cough
  • flushing
  • hyperkalemia
  • fatigue
  • fever
  • malaise
  • chest pain
  • asthenia
  • constipation
  • abdominal bloating
  • indigestion
  • oropharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • paresthesia
  • sensory impairment
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • visual disturbances

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. The ideal temperature is between 1°C and 30°C at room temperature. Storing it this way will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

White, biconvex, rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 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.