Medication info
Ezetimibe/Atorvastatin Calcium Tablet 10/40 mg

Ezetimibe/Atorvastatin Calcium Tablet 10/40 mg

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

MFDS item code 202101428 · Approved 2021.02.18 · Insurance code 628801810

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk through increase in HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily irrespective of meals. For primary hypercholesterolemia, dosages ranging from 10/10 mg to 10/80 mg are used, with an initial dose of 10/10 mg or 10/20 mg recommended. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg is recommended. After initiation or dosage adjustment, blood lipid levels should be checked after more than 2 weeks.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk through increase in HDL.

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

This medication assists in lowering total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It helps to increase HDL cholesterol levels for maintaining a healthy lipid balance. Additionally, it is used alone or in conjunction with other lipid-lowering therapies to control cholesterol levels in patients with homozygous familial hypercholesterolemia. This medication is more effective when used alongside dietary measures and plays an important role in reducing cardiovascular disease risk due to dyslipidemia. It is important to verify secondary causes such as diabetes and hypothyroidism before administration and to take necessary precautions. This treatment is used to control blood lipid levels and improve cardiovascular health.

Dosage and Administration

Adult dosage

This medication is administered once daily irrespective of meals. For primary hypercholesterolemia, dosages ranging from 10/10 mg to 10/80 mg are used, with an initial dose of 10/10 mg or 10/20 mg recommended. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg is recommended. After initiation or dosage adjustment, blood lipid levels should be checked after more than 2 weeks.

Precautions

This medication can cause serious muscle problems, so if sudden severe muscle pain or weakness occurs, consult a physician immediately. In particular, consider temporarily stopping or discontinuing this medication in cases of severe infections, hypotension, major surgery or trauma, severe metabolic abnormalities, or uncontrolled seizures. This medication should not be used in patients with allergies to its components, liver function issues, muscle diseases, pregnant or possibly pregnant women, nursing mothers, or patients taking certain hepatitis treatments. Additionally, patients with genetic conditions such as lactose intolerance should not take this medication. Patients with a history of alcohol addiction or liver disease, those with severe liver dysfunction, poor kidney function, hypothyroidism, a family history of muscle diseases, or previous muscle toxicity from similar medications, as well as elderly patients over 70 years of age, should use this medication with caution. Patients taking fibrate medications or those with severe muscle weakness also require careful monitoring. During the course of this medication, side effects such as muscle pain, abdominal pain, liver function abnormalities may occur, and it is important to regularly check liver function tests and muscle enzyme levels. If severe muscle pain or significant increases in muscle enzyme levels occur, the medication should be discontinued. Pregnant or nursing women should not use this medication, and women of childbearing age should use appropriate contraception while taking this medication. This medication is not recommended for children as safety and efficacy have not been established. When administered to the elderly, caution is required due to the risk of myopathy, although specific dose adjustments are not necessary. Patients with severe liver or kidney dysfunction should avoid using this medication, and those with liver function abnormalities should undergo regular testing. There is no specific antidote for overdose of this medication, so treatment and supportive care must be provided based on symptoms, and liver function and muscle enzyme levels should be monitored. This medication can interact with other drugs, so if you are taking other medications, it is essential to inform your doctor or pharmacist, especially when used with medications that affect liver metabolism or have effects on muscles. Caution should be exercised as dizziness may occur while driving or operating machinery. This medication should be kept out of the reach of children, and it is safer not to transfer it to another container.

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 fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination difficulty

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • musculoskeletal pain
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • weakness
  • lethargy
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • loss of appetite
  • indigestion
  • vomiting
  • belching
  • pharyngeal/laryngeal pain
  • nosebleed
  • muscle weakness
  • muscle cramps
  • thrombocytopenia
  • allergic reactions
  • hepatitis
  • blurred vision
  • tinnitus

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

Storage

This medication must be kept in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablets

Package unit

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