Medication info
Atorvastatin/Ezetimibe Tablet 10/40 mg

Atorvastatin/Ezetimibe Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
White or off-white oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu*3]
Approval status
Active

MFDS item code 202101492 · Approved 2021.02.18 · Insurance code 621804230

Summary

Main use
Improvement of lipid profile through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This drug is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage ranges from 10/10 mg to 10/80 mg per day, with an initial dose recommended at 10/10 mg or 10/20 mg daily. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg daily is recommended. After administration, serum lipid levels should be checked at intervals of more than two weeks.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement of lipid profile through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This drug is used as an adjunct to diet to lower total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia, particularly in familial and non-familial hypercholesterolemia, while simultaneously increasing HDL cholesterol levels. It can also be used alone or in conjunction with other therapies to help reduce LDL cholesterol in patients with homozygous familial hypercholesterolemia. This drug is used alongside a diet that restricts fats and cholesterol, which helps to lower the risk of atherosclerotic vascular disease due to hypercholesterolemia. It is important to identify and treat other causes of dyslipidemia, such as diabetes and hypothyroidism, before treatment if necessary. Additionally, lipid levels should be checked regularly to monitor treatment progress. This drug is effective in improving hypercholesterolemia.

Dosage and Administration

Adult dosage

This drug is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage ranges from 10/10 mg to 10/80 mg per day, with an initial dose recommended at 10/10 mg or 10/20 mg daily. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg daily is recommended. After administration, serum lipid levels should be checked at intervals of more than two weeks.

Precautions

This drug can cause serious muscle problems, so caution is required, especially in patients at risk of renal function impairment, such as after severe infections or major surgeries. This drug should not be used in patients with allergies to its components or severely impaired liver function, those with muscle disorders, pregnant or breastfeeding women, patients taking certain antiviral medications, and those with lactose intolerance. Patients at high risk for muscle problems, such as alcoholics or those with a history of liver disease, and those with compromised kidney function or hypothyroidism should use this drug cautiously. If symptoms like muscle pain, muscle weakness, fatigue, or fever appear while taking this drug, notify a doctor immediately, and muscle enzyme levels should be checked if necessary. Since there may be liver function abnormalities, liver function tests should be conducted before and during treatment, and if symptoms of liver damage (nausea, vomiting, fatigue, etc.) occur, the drug should be stopped immediately. Women who are pregnant or may become pregnant should not take this drug, and appropriate contraception should be used while taking it. Dizziness or cough may occur, so care is needed when driving or operating machinery. This drug may interact with other medications, so if you are currently taking any other drugs, you must inform your doctor or pharmacist. In the case of overdose, there is no specific antidote, so treatment and supportive care should be provided according to symptoms, and liver and muscle enzyme levels should be checked periodically. It is not recommended for children as safety and effectiveness have not been established. Elderly patients are at higher risk for muscle problems, so it should be used cautiously, and attention is also needed in patients with decreased liver or kidney function.

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, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, 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
  • ALT increase
  • AST increase
  • fatigue
  • chest pain
  • weakness
  • lethargy
  • fever
  • nausea
  • vomiting
  • dyspepsia
  • constipation
  • abdominal bloating
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy

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

Storage

This drug should be stored in a tightly closed container as it may be sensitive to air or moisture. It is recommended to maintain a storage temperature between 1°C and 30°C. Proper storage can help maintain the drug's effectiveness and safety over time.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu*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.