Medication info
Atovanduo Tablet 10/5 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Atovanduo Tablet 10/5 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

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

MFDS item code 202400543 · Approved 2024.03.15 · Insurance code 653405600

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed type) and treatment of dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. The dosage should be adjusted according to the patient's baseline LDL cholesterol, treatment target, and response. The dose range for primary hypercholesterolemia is from 10/5 mg to 10/80 mg daily. The recommended initial dose is 10/5 mg, 10/10 mg, or 10/20 mg once daily. In cases where significant reduction in LDL cholesterol is required, an initial dose of 10/40 mg can be recommended.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed type) 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 medication helps reduce total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol, and increase HDL cholesterol in patients with primary hypercholesterolemia and heterozygous familial and non-familial mixed dyslipidemia. It is used to improve blood lipid levels as an adjunct to dietary therapy, thus reducing the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. The dosage should be adjusted according to the patient's baseline LDL cholesterol, treatment target, and response. The dose range for primary hypercholesterolemia is from 10/5 mg to 10/80 mg daily. The recommended initial dose is 10/5 mg, 10/10 mg, or 10/20 mg once daily. In cases where significant reduction in LDL cholesterol is required, an initial dose of 10/40 mg can be recommended.

Precautions

This medication carries a risk of serious side effects, including rhabdomyolysis, which is a rare but severe muscle-related issue. Patients with acute infections, hypotension, major surgery, trauma, metabolic disorders, seizures, etc., should temporarily discontinue or withhold treatment with this medication. This medication should not be administered to individuals with allergies to the active ingredients or excipients, those with active liver disease, patients with unexplained persistent elevation of liver enzymes, those with muscle diseases, pregnant or breastfeeding women, patients taking specific antiviral medications, and patients with lactose intolerance. Patients with a history of alcohol abuse or liver disease, those with impaired kidney function, patients with hypothyroidism, individuals with risks for myopathy or rhabdomyolysis, elderly patients over 70 years old, and patients taking fibrate-class drugs should use this medication cautiously. Regular liver function tests and muscle-related tests are required during treatment, and any symptoms such as muscle pain, weakness, fatigue, or fever should be reported to a physician immediately. As this medication may raise liver enzyme levels, treatment should be stopped and medical advice sought if symptoms of liver damage such as nausea, vomiting, fatigue, or jaundice occur. Women who are pregnant or capable of becoming pregnant should not take this medication, and those who are taking it must use appropriate contraception. Breastfeeding women are also advised to avoid this medication. Elderly individuals are at a higher risk of myopathy, so they need to take precautions when using this medication, but dosage adjustment is generally not necessary. This medication can interact with various drugs, so patients taking other medications must inform their healthcare provider, especially when taking medications that affect liver metabolism, as dosage adjustments or monitoring may be necessary. Caution is advised while driving or operating machinery as dizziness or other symptoms may occur.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, peeling skin, pain in oral or ocular mucosa, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden severe headache, thunderclap headache, seizures, consciousness confusion, vision disturbances, paralysis, urinary issues

Mild side effects

  • Abdominal pain
  • elevated liver enzymes
  • dizziness
  • headache
  • osteochondrosis
  • pruritus
  • COVID-19
  • vaginal infection
  • gastritis
  • colon polyps
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  • sensory loss
  • back pain
  • renal cyst
  • difficulty urinating
  • iridocyclitis
  • soft fibroma
  • cough
  • photosensitivity reaction
  • thyroid nodule
  • joint pain
  • lower back pain
  • muscle pain
  • muscle weakness
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • diarrhea
  • nausea
  • vomiting
  • constipation
  • dyspepsia
  • pharyngitis/laryngitis
  • nosebleed
  • insomnia

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture, at a temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the effectiveness of the drug and ensures safe use.

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.