Medication info
Azet Duo Tablets 10/40 Milligrams

Azet Duo Tablets 10/40 Milligrams

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
White, biconvex, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x3]
Approval status
Active

MFDS item code 202101425 · Approved 2021.02.18 · Insurance code 643606090

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, familial) and improvement of lipids through cholesterol reduction and HDL increase
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. 1. Primary hypercholesterolemia The recommended initial dose is 10/10mg or 10/20mg once daily. For patients requiring a more significant reduction in LDL-cholesterol (greater than 55%), an initial dose of 10/40mg once daily is recommended. 2. Homozygous familial hypercholesterolemia The recommended dose for patients with homozygous familial hypercholesterolemia is 10.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, familial) and improvement of lipids through cholesterol reduction and HDL increase

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

This medication is used to lower elevated total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol, and to raise HDL-cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. It may also be administered as an adjunct to other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia or when other treatments are ineffective. This drug is used in conjunction with an appropriate dietary regimen and is particularly beneficial for patients at high risk of cardiovascular disease. It is important to identify the secondary causes of dyslipidemia before administration, and to treat them if necessary. Regular blood lipid tests should be performed to monitor treatment effectiveness. This medication is used to improve hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. 1. Primary hypercholesterolemia The recommended initial dose is 10/10mg or 10/20mg once daily. For patients requiring a more significant reduction in LDL-cholesterol (greater than 55%), an initial dose of 10/40mg once daily is recommended. 2. Homozygous familial hypercholesterolemia The recommended dose for patients with homozygous familial hypercholesterolemia is 10.

Precautions

This medication has been reported to cause a rare side effect called rhabdomyolysis, which can result in serious muscle abnormalities. Patients with acute infections, hypotension, major surgeries or trauma, or metabolic disorders should temporarily discontinue or stop taking this medication. Patients who have allergies to this drug, have severe liver impairment, have muscular diseases, are pregnant or may become pregnant, are breastfeeding, or are taking certain other medications should not take this drug. Patients with a history of alcohol abuse, liver disease, poor kidney function, hypothyroidism, elderly individuals at high risk of muscle abnormalities should use this medication with caution. If muscle pain, muscle weakness, fatigue, or muscle pain accompanied by fever occurs during treatment, notify a doctor immediately, and check for muscle damage through blood tests. There may be liver function abnormalities, so liver function tests should be performed before and during treatment, and the drug should be discontinued if symptoms of liver damage occur. This medication should not be administered to pregnant or breastfeeding women, and fertile women should use appropriate contraception while taking it. Symptoms like dizziness may occur, so caution is advised when driving or operating machinery. This drug may interact with various other medications, so be sure to inform your doctor or pharmacist of any other medications you are taking. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle condition should be monitored. Safety in children has not been established, so it is not recommended; special caution is needed in elderly patients due to high risk of muscle abnormalities. This drug should be kept out of 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 (edema), chest tightness, shortness of breath, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues along with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues.

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
  • increased AST
  • increased ALT
  • fatigue
  • malaise
  • chest pain
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares.

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

Storage

This medication is susceptible to air and moisture, so it must be stored in a closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White, biconvex, rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP 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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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.