Medication info
Azetam 10/40 mg

Azetam 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
White oval film-coated tablet
Packaging
30 tablets/Alu-Alu[(10 tablets/Alu-Alu x 3)]
Approval status
Active

MFDS item code 202101390 · Approved 2021.02.18 · Insurance code 645210470

Summary

Main use
Reduction of cholesterol and LDL-C, Increase of HDL-C for the improvement of dyslipidemia in primary hypercholesterolemia (homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the usual dose ranges from 10/10 mg to 10/80 mg, with an initial recommended dose of 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg per day is recommended. Dose adjustments should occur after checking blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Reduction of cholesterol and LDL-C, Increase of HDL-C for the improvement of dyslipidemia in primary hypercholesterolemia (homozygous familial) and dyslipidemia.

  • 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 blood cholesterol levels, bad LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol while increasing good HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, it is used as an adjunct to other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia, maximizing the effects alongside dietary therapy. This medication is suitable for individuals at high risk for cardiovascular disease and should be used after confirming the absence of other secondary causes. It is essential to monitor treatment effectiveness through regular blood tests, including total cholesterol and LDL cholesterol measurements. This way, this medication is used to improve hypercholesterolemia and dyslipidemia with proper management.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the usual dose ranges from 10/10 mg to 10/80 mg, with an initial recommended dose of 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg per day is recommended. Dose adjustments should occur after checking blood lipid levels at intervals of more than 2 weeks.

Precautions

This medication can rarely cause muscle tissue damage, resulting in symptoms like muscle pain or weakness. If these symptoms are severe or muscle enzyme levels rise significantly, treatment should be discontinued. This medication may affect liver function, so liver function tests should be performed before initiation, and liver condition should be regularly monitored during treatment. If symptoms of liver function abnormalities appear, consult a doctor immediately. When used in conjunction with certain medications, the blood concentration of this medication may increase, leading to an increased risk of side effects; therefore, inform the healthcare provider if you are taking other medications. Women who are pregnant or may become pregnant, and those who are breastfeeding, should not take this medication, and women of childbearing age should employ appropriate contraceptive methods while on it. Patients with kidney issues, elderly individuals, alcoholics, or those with a history of liver disease should use this medication cautiously, as muscle disease risk is heightened, requiring regular monitoring. Be cautious as dizziness may occur while driving or operating machinery. The safety and efficacy of this medication in children have not been established, hence it is not recommended. In cases of overdose, there is no specific antidote, and symptomatic treatment and supportive care should be administered, with periodic checks of liver function and muscle enzyme levels. During the use of this medication, side effects such as muscle pain, fatigue, abdominal pain, headaches, and dizziness may occur; if abnormal symptoms persist, consult with a healthcare provider.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blistering, skin peeling, pain in mouth/eye mucosa, shortness of breath or breathing difficulties, asthma attacks, cough with fever and respiratory impairment, yellowing of skin or eyes (jaundice), extreme general fatigue, sudden and severe headache, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • constipation
  • pharyngitis
  • sinusitis
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  • bronchitis
  • hair loss
  • itching
  • hives
  • rash
  • allergic reactions
  • headaches
  • fatigue
  • malaise
  • chest pain
  • elevated blood pressure
  • vomiting
  • dry mouth
  • loss of appetite
  • weight gain
  • sensory disturbances
  • memory loss
  • drowsiness
  • insomnia
  • nightmares
  • joint pain
  • muscle weakness
  • muscle cramps
  • muscle fatigue
  • thrombocytopenia
  • hepatitis
  • cholestasis.

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 recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White oval film-coated tablet

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.