Medication info
Azetamiong 10/20 mg

Azetamiong 10/20 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
White oval film-coated tablets
Packaging
30 tablets/Alu-Alu[(10 tablets/Alu-Alu x3)]
Approval status
Active

MFDS item code 202101391 · Approved 2021.02.18 · Insurance code 645210480

Summary

Main use
Reduction of cholesterol levels in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, a dose of 10/10 mg to 10/80 mg per day is given, with an initial recommended dose of 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction of LDL cholesterol, an initial dose of 10/40 mg per day is recommended. Dose adjustments should be made based on blood lipid levels checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Reduction of cholesterol levels in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk by increasing HDL.

  • 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 medication helps lower high cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases good cholesterol (HDL). It can also be used as an adjunct treatment when homozygous familial hypercholesterolemia patients do not achieve sufficient effects with other treatments. This medication should be taken together with an appropriate diet, and it is important to treat any underlying conditions such as diabetes or hypothyroidism first. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be regularly monitored to evaluate treatment efficacy. This is used to lower the risk of atherosclerotic vascular disease and improve blood lipid status.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, a dose of 10/10 mg to 10/80 mg per day is given, with an initial recommended dose of 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction of LDL cholesterol, an initial dose of 10/40 mg per day is recommended. Dose adjustments should be made based on blood lipid levels checked at intervals of more than 2 weeks.

Precautions

This medication carries a risk of rhabdomyolysis, which can rarely cause damage to muscle tissue and may be accompanied by acute renal failure. Therefore, if severe muscle pain or weakness occurs, notify a physician immediately, and treatment should be discontinued if necessary. Patients at high risk for muscle damage, such as those with severe infections, hypotension, major surgeries, trauma, metabolic and electrolyte disorders, or uncontrolled seizures, should be monitored carefully. This medication should not be administered to patients with allergies to the main or component ingredients, active liver diseases, unexplained elevated liver enzyme levels, or muscle diseases. Women who are pregnant or may become pregnant and nursing mothers should not use this medication. This medication should also not be given to patients on certain antiviral drugs or patients with genetic lactose intolerance. Caution should be exercised in patients with histories of alcohol abuse, liver disease, moderate to severe liver impairment, kidney dysfunction, hypothyroidism, elderly individuals, and other patients at high risk for muscle damage. During treatment with this medication, adverse reactions such as myalgia, arthralgia, abdominal pain, elevated liver enzymes, dizziness, cough, nausea, diarrhea, weakness of muscles, musculoskeletal pain, hyperkalemia, bronchitis, sinusitis, flushing, increased AST, increased ALT, fatigue, lethargy, chest pain, chest discomfort, swelling, asthenia, headache, constipation, vomiting, dyspepsia, pharyngeal and laryngeal pain, epistaxis, insomnia, nightmares, paresthesia, sensory impairment, dysgeusia, amnesia, peripheral neuropathy, and blood abnormalities may occur. Regular liver function and muscle-related tests should be conducted, and if any unusual symptoms arise during medication, report it to healthcare providers promptly. As there are several medications that may interact with this medication, inform your physician of any other medications you are taking, especially if they are CYP3A4 inhibitors, cyclosporine, or fibrate medications, as caution is warranted.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination abnormalities.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • arthralgia
  • muscle weakness
  • musculoskeletal pain
Show 26 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • increased AST
  • increased ALT
  • fatigue
  • lethargy
  • chest pain
  • chest discomfort
  • swelling
  • asthenia
  • headache
  • constipation
  • vomiting
  • dyspepsia
  • pharyngeal and laryngeal pain
  • epistaxis
  • insomnia
  • nightmares
  • paresthesia
  • sensory impairment
  • dysgeusia
  • amnesia
  • peripheral neuropathy
  • blood

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 exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/Alu-Alu[(10 tablets/Alu-Alu x3)]

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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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.