Medication info
Atoez 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Atoez 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
White to pale white, bilaterally convex oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202101588 · Approved 2021.02.18 · Insurance code 646005220

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and suppression of cardiovascular disease risk through HDL increase
Who uses it
Adults
Adult dosage
This medication is to be taken once daily regardless of meals. For treatment of primary hypercholesterolemia, the dosage is between 10/10 mg and 10/80 mg daily. The initial dose is recommended to be 10/10 mg or 10/20 mg once daily. If a greater reduction in LDL cholesterol (more than 55%) is required, the initial dose of 10/40 mg daily is recommended. Dose adjustments should be made based on blood lipid levels after an interval of more than 2 weeks.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and suppression of cardiovascular disease risk through HDL increase

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medicine helps lower high total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases good cholesterol (HDL cholesterol) levels. It can also be used as an alternative therapy in patients with homozygous familial hypercholesterolemia who are unable to use other therapies alone or as an adjunct. This medication is used in conjunction with a diet and lifestyle modifications such as limiting saturated fat and cholesterol intake should precede it. Before administering, other causes of dyslipidemia, such as diabetes or hypothyroidism, must be identified and treated if necessary. During treatment, cholesterol and triglyceride levels should be regularly monitored to ensure appropriate management. This medication is used to reduce the risk of hypercholesterolemia and its related atherosclerotic vascular diseases.

Dosage and Administration

Adult dosage

This medication is to be taken once daily regardless of meals. For treatment of primary hypercholesterolemia, the dosage is between 10/10 mg and 10/80 mg daily. The initial dose is recommended to be 10/10 mg or 10/20 mg once daily. If a greater reduction in LDL cholesterol (more than 55%) is required, the initial dose of 10/40 mg daily is recommended. Dose adjustments should be made based on blood lipid levels after an interval of more than 2 weeks.

Precautions

This medication helps lower blood cholesterol levels and reduce cardiovascular disease risk. Muscle issues may arise during administration, so if symptoms such as muscle pain or weakness occur, you should inform your doctor immediately. Caution should be taken in patients with a history of muscle-related diseases, poor kidney function, the elderly, or those with hypothyroidism. Liver function may be affected, so liver function tests should be conducted before starting the drug, and if any symptoms of liver dysfunction occur during treatment, tests should be repeated. This medication should not be used in patients with certain liver diseases, pregnant or potentially pregnant women, nursing mothers, and patients with lactose intolerance. There may be drug interactions, especially when taking medications that affect hepatic metabolism or those that can affect muscles, so it's important to discuss with a doctor. There may be dizziness when driving or operating machinery, so caution is advised. It is recommended to avoid or limit alcohol consumption during this medication treatment, and regular check-ups to monitor for side effects are important. In the event of overdose, there is no specific antidote; treatment and supportive care should be according to symptoms, and liver function and muscle enzyme levels should be checked. The safety and efficacy in children have not been established, and therefore it is not recommended.

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 high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

Muscle pain, abdominal pain, nausea, diarrhea, dizziness, fatigue, headache, joint pain, muscle weakness, musculoskeletal pain, bronchitis, sinusitis, cough, flushing, hyperkalemia, anemia, hernia, depression, bronchiolitis, tooth abscess, vestibular neuritis, bradycardia, hypotension, skin nodules, ingrown toenails, skin rash, itching, hair loss, angioedema, erythema multiforme, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, the drug should be kept at room temperature between 1 to 30 degrees Celsius, rather than in very hot or very cold places to maintain effectiveness.

Appearance and packaging

Appearance

White to pale white, bilaterally convex oval 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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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.