Medication info
Azetam10/10mg

Azetam10/10mg

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

MFDS item code 202101392 · Approved 2021.02.18 · Insurance code 645210490

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. The dosing range for primary hypercholesterolemia is 10/10mg to 10/80mg per day, with a recommended initial dose of 10/10mg or 10/20mg per day. For patients requiring greater reductions in LDL cholesterol (more than 55%), an initial dose of 10/40mg per day is recommended. After starting the medication or adjusting the dose, lipid levels should be monitored at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication lowers elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing the good cholesterol HDL-cholesterol levels. It aids in cholesterol level control in homozygous familial hypercholesterolemia patients, either in conjunction with other treatments or used alone. This medication is used with an appropriate diet and serves as an adjunctive treatment when dietary measures alone are insufficient. It is essential to confirm other causes of dyslipidemia before treatment and to treat them first if necessary. Continuously monitoring lipid levels and adjusting treatment according to the patient's condition is critical. This medication contributes to reducing the risk of vascular diseases associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. The dosing range for primary hypercholesterolemia is 10/10mg to 10/80mg per day, with a recommended initial dose of 10/10mg or 10/20mg per day. For patients requiring greater reductions in LDL cholesterol (more than 55%), an initial dose of 10/40mg per day is recommended. After starting the medication or adjusting the dose, lipid levels should be monitored at intervals of more than 2 weeks.

Precautions

This medication has a rare risk of causing rhabdomyolysis, which can severely damage muscles and affect kidney function. Therefore, if severe muscle pain or weakness occurs, immediate consultation with a physician is necessary. Patients with severe infections, hypotension, major surgery, trauma, metabolic disorders, etc., may need to temporarily suspend or discontinue this medication. This medication should not be taken if there is an allergy to its active ingredients or components, liver disease, or muscle disease. Women who are pregnant or may become pregnant, as well as nursing mothers, should avoid this medication. Additionally, patients with certain antiviral medications or lactose intolerance should also avoid this medication. Caution is advised for alcoholics, patients with impaired liver function, patients with weak kidney function, patients with thyroid dysfunction, and the elderly regarding the use of this medication. This medication may cause side effects such as muscle pain, abdominal pain, and liver function abnormalities; if such symptoms occur, notify the healthcare provider. Liver function tests should be performed regularly before and during treatment, and if liver enzyme levels rise significantly, the medication should be discontinued. This medication may interact with other drugs, so inform the healthcare provider of any other medications being taken. Women of childbearing age should use appropriate contraceptive methods while taking this medication, and caution should be taken during driving or operating machinery as dizziness may occur. The safety of this medication has not been established in pediatric populations; therefore, it is not recommended for children. In case of overdose, as there is no specific antidote, immediate medical attention is required. 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

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, 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 attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning bolt headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

Muscle pain, abdominal pain, dizziness, nausea, diarrhea, fatigue, malaise, chest pain, chest discomfort, edema, weakness, headache, constipation, pharyngitis, sinusitis, bronchitis, rhinitis, cough, sputum, nosebleed, urticaria, rash, itching, hair loss, thrombocytopenia, hepatitis, cholestasis, blurred vision, tinnitus, hearing loss, skin lumps, hematological and lymphatic abnormalities, anemia, allergic reactions, sweating, acne, eczema, seborrhea, amblyopia

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

Storage

This medication may be sensitive to air and moisture; thus, it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This helps in preserving the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

White, oblong 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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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.