Medication info
Azet Duo Tablet 10/10mg

Azet Duo Tablet 10/10mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
White, bi-convex, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202101423 · Approved 2021.02.18 · Insurance code 643606070

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, familial) and dyslipidemia, and inhibition of cardiovascular disease risk through increases in HDL.
Who uses it
Adults
Adult dosage
This medication is taken once daily regardless of meals. The dosage range is from 10/10mg to 10/80mg per day, with the recommended initial doses being 10/10mg or 10/20mg per day. For patients requiring a significant reduction in LDL cholesterol, an initial dose of 10/40mg per day is recommended. After starting treatment or adjusting the dose, lipid levels in the blood should be checked after an interval of at least 2 weeks to adjust the dosage accordingly.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, familial) and dyslipidemia, and inhibition of cardiovascular disease risk through increases in HDL.

  • Primary hypercholesterolemia
  • dyslipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication is used as an adjunct to dietary measures to lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol. It is also used as an adjunct in patients with homozygous familial hypercholesterolemia along with other lipid-lowering treatments, or when other therapies are not effective. This medication is recommended only when there is insufficient response to appropriate dietary and non-pharmacological treatments, and a review and treatment of secondary causes are necessary. Before administration, total cholesterol, LDL, HDL cholesterol, and triglyceride levels should be measured to establish a treatment plan. This helps reduce cardiovascular risks associated with hypercholesterolemia and aids in effectively controlling blood lipid levels. Therefore, this medication is used for the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is taken once daily regardless of meals. The dosage range is from 10/10mg to 10/80mg per day, with the recommended initial doses being 10/10mg or 10/20mg per day. For patients requiring a significant reduction in LDL cholesterol, an initial dose of 10/40mg per day is recommended. After starting treatment or adjusting the dose, lipid levels in the blood should be checked after an interval of at least 2 weeks to adjust the dosage accordingly.

Precautions

This medication is used to lower blood cholesterol levels. However, it can rarely cause serious muscle damage leading to kidney dysfunction, so symptoms such as muscle pain or weakness should be reported to a physician immediately. Patients at higher risk for myopathy or rhabdomyolysis may require temporary or permanent discontinuation of treatment. Patients with allergies to this medication or severely impaired liver function, women who are pregnant or breastfeeding should not use this medication. Additionally, patients with muscle diseases or those taking specific antiviral medications should also avoid using this medication. Alcoholics, those with a history of liver disease, the elderly, and patients with reduced kidney function should take special care when using this medication. This medication can affect liver function, so regular liver function tests should be conducted before and during treatment. Side effects such as muscle pain, abdominal pain, increased liver enzyme levels may occur, and if such symptoms persist or worsen, medical consultation is advised. Drug interactions may occur when used in combination with other medications, so be sure to inform healthcare providers of any other medications currently being taken. Women of childbearing potential should use appropriate contraception during the use of this medication, and should discontinue use immediately if pregnancy is confirmed. Safety and efficacy have not been established in children, so it is not recommended for pediatric use. There is no specific antidote in case of overdose, so appropriate treatment and supportive care are needed depending on the symptoms. This medication should be kept out of reach of children and should not be transferred to another container.

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 fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma exacerbation, respiratory difficulties with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary problems.

Mild side effects

  • Muscle pain
  • abdominal pain
  • hyperkalemia
  • dizziness
  • cough
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • nausea
  • diarrhea
Show 26 more
  • fatigue
  • malaise
  • headache
  • sweating
  • itching
  • rash
  • hair loss
  • back pain
  • bronchitis
  • sinusitis
  • thrombocytopenia
  • blurred vision
  • tinnitus
  • insomnia
  • nightmares
  • sensory abnormalities
  • amnesia
  • muscle cramps
  • muscle fatigue
  • hives
  • increased creatine kinase in the blood
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • forgetfulness.

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

Storage

This medication should be stored in a tightly closed container as it may be sensitive to air or moisture. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Proper storage can help maintain the drug’s effectiveness and safety.

Appearance and packaging

Appearance

White, bi-convex, rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP 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.