Medication info
Azetib Tablet 10/20 Milligrams

Azetib Tablet 10/20 Milligrams

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP*3)], 30 tablets/bottle
Approval status
Active

MFDS item code 202100202 · Approved 2021.01.08 · Insurance code 652606970

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary and mixed) and suppression of the risk of atherosclerotic vascular diseases
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. Dosage should be adjusted according to the patient's baseline LDL cholesterol and target treatment goals, as well as the patient's response. For primary hypercholesterolemia, the dosage range is from 10/10mg to 10/40mg per day, with an initial dose of 10/10mg or 10/20mg per day. For patients needing further reduction in LDL cholesterol, the dosage can be adjusted.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary and mixed) and suppression of the risk of atherosclerotic vascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular diseases
View approved original text

This medication helps lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, and increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is primarily used as an adjunct to dietary therapy that restricts saturated fat and cholesterol intake, and is administered when there is insufficient response to such non-drug treatment. Additionally, it plays an important role in preventing the progression of vascular diseases in patients at high risk for cardiovascular diseases. Prior to using this medication, it is necessary to identify and treat secondary causes such as diabetes, hypothyroidism, liver disease, and renal failure. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be monitored regularly to ensure safe and effective therapy. Therefore, this medication is effectively used in the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. Dosage should be adjusted according to the patient's baseline LDL cholesterol and target treatment goals, as well as the patient's response. For primary hypercholesterolemia, the dosage range is from 10/10mg to 10/40mg per day, with an initial dose of 10/10mg or 10/20mg per day. For patients needing further reduction in LDL cholesterol, the dosage can be adjusted.

Precautions

This medication has been reported to cause rare side effects that can lead to serious muscle problems. Caution is needed for patients with risk factors such as acute infections, hypotension, major surgery, trauma, severe metabolic disturbances, and uncontrolled seizures; in such cases, medication may need to be temporarily stopped or discontinued. This medication should not be used by individuals with allergies to the active ingredient or components, those with severe liver issues or persistent unexplained elevation in liver enzymes, those with muscle diseases, pregnant women or women who may become pregnant, nursing mothers, or those taking certain other medications. Alcoholics, individuals with a history of liver disease, those with impaired kidney function, hypothyroidism patients, those with a family history of muscle diseases or past muscle problems with similar medications, and elderly patients over 70 years should use this medication cautiously. Side effects may include liver function abnormalities, muscle pain, fatigue, headaches, digestive disturbances, skin rashes, elevated blood pressure, etc. If symptoms like muscle pain or weakness, fatigue, or fever occur, inform a doctor immediately, and blood tests may be needed to check for muscle damage. Since liver function abnormalities may occur, it is essential to conduct regular liver function tests before starting and during treatment with this medication. If liver enzyme levels become significantly elevated, medication discontinuation may be necessary. This medication can interact with other drugs; particularly when taken with drugs affecting liver metabolism or those that may impact muscle function, consult a healthcare professional. Pregnant or nursing women should not take this medication, and women of childbearing age should use appropriate contraceptive methods while taking this medication. It is not recommended for children as safety and efficacy have not been established, and caution is advised for the elderly due to the risk of muscle problems. In the event of overdose, there is no specific antidote, so treatment will depend on symptoms and monitoring liver function and muscle damage may be necessary. Finally, this medication should be stored out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes (severe skin adverse reaction), shortness of breath or difficulty breathing, asthma attack, respiratory symptoms with cough and fever (respiratory distress), jaundice (yellowing of skin or eyes), systemic lethargy (liver dysfunction), sudden...

Mild side effects

  • Dizziness
  • hypertension
  • nasopharyngitis
  • cough
  • itching
  • fatigue
  • headache
  • abdominal pain
  • diarrhea
  • hypoglycemia
Show 21 more
  • nausea
  • myalgia
  • arthralgia
  • chest pain
  • malaise
  • thrombocytopenia
  • liver function abnormalities
  • blurred vision
  • tinnitus
  • alopecia
  • skin rash
  • sweating
  • hives
  • hyperhidrosis
  • gastritis
  • dry mouth
  • upper respiratory tract infection
  • anemia
  • thrombocytopenia
  • increased serum creatine kinase
  • etc.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This ensures that the efficacy and safety of the medication are well preserved.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*3)], 30 tablets/bottle

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.