Medication info
Atovamib Tablets 10/5 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Atovamib Tablets 10/5 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›5.425mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Pink oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202301683 · Approved 2023.05.26 · Insurance code 642106070

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia
Who uses it
Adults
Adult dosage
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/80 mg once daily. Initial dosage of 10/5 mg, 10/10 mg, or 10/20 mg is recommended. In patients requiring greater reduction of LDL-cholesterol (more than 55%), an initial dose of 10/40 mg is recommended. After administration or dosage adjustment, check blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL-cholesterol
View approved original text

This drug is used to assist dietary measures in patients with primary hypercholesterolemia and mixed dyslipidemia to lower total cholesterol, LDL-cholesterol, Apo B protein, triglyceride, and non-HDL-cholesterol levels, and to increase HDL-cholesterol levels. This effectively improves blood lipid levels, helping to prevent cardiovascular diseases.

Dosage and Administration

Adult dosage

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/80 mg once daily. Initial dosage of 10/5 mg, 10/10 mg, or 10/20 mg is recommended. In patients requiring greater reduction of LDL-cholesterol (more than 55%), an initial dose of 10/40 mg is recommended. After administration or dosage adjustment, check blood lipid levels at intervals of more than 2 weeks.

Precautions

This drug may cause serious muscle problems, so if symptoms such as muscle pain or weakness occur, inform a doctor immediately. In particular, if there are risk factors such as severe infection, trauma, or post-surgery, the use of this drug should be paused temporarily. It should not be taken by those with allergies to the ingredients, liver disease, muscle disorders, or women who are pregnant or breastfeeding. Those with alcoholism, poor liver function, kidney problems, and hypothyroidism should use this drug with caution. This drug may affect liver function, so liver function tests should be conducted before and during treatment. Additionally, during use of this drug, one should closely monitor for symptoms of muscle pain or weakness, fatigue, and fever. This drug can interact with other medications, so inform a doctor or pharmacist of any current medications. Women of childbearing age should use appropriate contraception to avoid pregnancy while taking this drug, and if pregnancy is confirmed, use should be stopped immediately. The safety and efficacy of this drug have not been established in children and is therefore not recommended. Elderly patients are at higher risk of myopathy and should use caution during treatment. In cases of overdose, there are no specific antidotes, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • skin rash
  • angioedema
  • anaphylaxis
  • severe rash with fever
  • blisters
  • skin peeling
  • mucosal pain in the mouth/eyes
  • shortness of breath
  • asthma attack
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  • jaundice
  • abnormal liver function
  • hepatitis
  • fulminant hepatitis
  • severe liver damage
  • severe edema
  • edema accompanying high blood pressure
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusion
  • vision abnormalities
  • paralysis
  • severe neurological symptoms
  • rhabdomyolysis

Mild side effects

  • Abdominal pain
  • dizziness
  • headache
  • osteochondritis
  • cough
  • pruritus
  • gastritis
  • colon polyps
  • sensory loss
  • back pain
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  • renal cysts
  • dysuria
  • iridocyclitis
  • fibroma
  • myalgia
  • elevated liver enzymes
  • fatigue
  • malaise
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • generalized edema
  • sensory abnormalities
  • depression
  • diabetic neuropathy
  • tremors
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • dyspepsia
  • loss of appetite
  • hypertension
  • anemia
  • urticaria
  • rash

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, maintaining storage temperature between 1 and 30 degrees Celsius at room temperature. It is important to avoid direct sunlight and not to store it in excessively hot or cold places.

Appearance and packaging

Appearance

Pink oblong 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.