Medication info
Atorvastatin/Ezetimibe Tablets 10/20 mg

Atorvastatin/Ezetimibe Tablets 10/20 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
White oblong film-coated tablets
Packaging
30 tablets/Alu-Alu [(10 tablets/Alu-Alu x 3)]
Approval status
Active

MFDS item code 202101649 · Approved 2021.02.18 · Insurance code 622804520

Summary

Main use
Lipid improvement through cholesterol reduction and HDL increase in patients with hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
Administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. For patients requiring a greater reduction in LDL cholesterol (above 55%), the initial dose of 10/40 mg is recommended. Serum lipid levels should be checked at intervals of more than 2 weeks after starting therapy or after dose adjustment to adjust the dosage.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Lipid improvement through cholesterol reduction and HDL increase in patients with hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

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

This medication helps reduce serum levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial, as well as mixed dyslipidemia. It also increases HDL cholesterol levels, helping to maintain a healthy lipid profile. In patients with homozygous familial hypercholesterolemia (HoFH), this medication is used in combination with other lipid-lowering treatments or when alternative therapies are not available. It is administered alongside diet, serving as an adjunct when dietary control and other non-drug therapies are insufficient. In patients with increased risk of atherosclerotic vascular disease due to dyslipidemia, appropriate treatment should be undertaken considering multiple risk factors. In summary, this medication is effectively used for the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

Administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. For patients requiring a greater reduction in LDL cholesterol (above 55%), the initial dose of 10/40 mg is recommended. Serum lipid levels should be checked at intervals of more than 2 weeks after starting therapy or after dose adjustment to adjust the dosage.

Precautions

This medication may cause severe muscle problems, so if symptoms such as muscle pain, muscle weakness, or muscle cramps occur, contact your doctor immediately. Especially after severe infections, hypotension, major surgeries, trauma, severe metabolic and electrolyte issues, or uncontrolled seizures, this medication should be temporarily suspended or discontinued. Individuals allergic to any of the components in this medication, those with active liver disease or consistently elevated liver enzyme levels, should not take this medication. Individuals with muscle disorders, pregnant women or women who may become pregnant, and nursing mothers should also avoid using this medication. Additionally, certain antiviral agents or those with lactose intolerance should not take this medication. Caution is required for individuals with a history of alcohol use disorder, liver disease, poor kidney function, thyroid disorders, and elderly patients. The risk of muscle damage may increase when used with other medications, so consultation with a doctor is essential. Liver function abnormalities may occur during treatment, so regular liver function tests are necessary, and any abnormal liver symptoms should be reported to a doctor immediately. Pregnant or nursing women should not take this medication as it could harm the fetus or infant. Dizziness or drowsiness may occur, so caution is advised when driving or operating machinery. In cases of overdose, there is no specific antidote, and treatment should be based on symptoms with monitoring of liver function and muscle condition. This medication is not recommended for children as its safety and efficacy have not been established. Prior to and during treatment, consult with a doctor to inform them of your health condition and any other medications you are taking.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe general malaise, sudden and very severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • headache
  • diarrhea
  • insomnia
  • nightmares
  • vomiting
  • dry mouth
  • gallstones
  • cholecystitis
  • thrombocytopenia
  • itching
  • rash
  • hair loss
  • increased creatine kinase in blood
  • increased urea in blood
  • chest pain
  • malaise
  • palpitations
  • agitation

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius. Proper storage will ensure the medication's effectiveness is preserved safely.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

30 tablets/Alu-Alu [(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.