Medication info
Atoket Tablets 10/10 mg

Atoket Tablets 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
케이엠에스제약(주)
Appearance
White or off-white oblong film-coated tablet
Packaging
30 tablets/box (10 tablets/Alu-Alu x 3)
Approval status
Active

MFDS item code 202101556 · Approved 2021.02.18 · Insurance code 654702180

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and suppression of cardiovascular disease risk through increased HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10mg to 10/80mg daily. For initial dosing, 10/10mg or 10/20mg once daily is recommended. For patients requiring greater LDL cholesterol reduction (more than 55%), an initial dose of 10/40mg once daily is recommended. After starting administration or adjusting the dose, lipid levels should be checked at intervals of more than two weeks.

Ingredients

Manufacturer
케이엠에스제약(주)

Efficacy & effects

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

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

This medication helps lower total cholesterol and LDL cholesterol (bad cholesterol) levels, while increasing HDL cholesterol (good cholesterol) levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly used as an adjunct to other therapies in patients with homozygous familial hypercholesterolemia or when other treatments are ineffective. Additionally, this medication is important as a lipid regulator in patients at high risk for cardiovascular disease and should be used in conjunction with dietary modifications. Monitoring various blood lipid levels is necessary to check for other causes of dyslipidemia and address them accordingly. Patients should strictly adhere to dietary modifications, including limiting saturated fats and cholesterol intake, to effectively improve blood cholesterol levels alongside medication. This medication is used to treat hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10mg to 10/80mg daily. For initial dosing, 10/10mg or 10/20mg once daily is recommended. For patients requiring greater LDL cholesterol reduction (more than 55%), an initial dose of 10/40mg once daily is recommended. After starting administration or adjusting the dose, lipid levels should be checked at intervals of more than two weeks.

Precautions

This medication may cause serious muscle issues, so if you experience sudden muscle pain or weakness accompanied by fever, you must notify your doctor immediately. Patients with severe infections, hypotension, major surgeries or trauma, severe metabolic disorders or seizures should temporarily suspend or discontinue the use of this medication. This medication is not administered to patients with liver dysfunction or muscle diseases, pregnant or breastfeeding women, or those on specific other medications. Caution is advised for individuals with a history of alcohol addiction or liver disease, those with reduced kidney function, or hypothyroidism. Regular liver function tests and muscle-related tests must be conducted; if there are symptoms related to liver function abnormalities or muscles, consult healthcare professionals immediately. Furthermore, it may interact with several medications, so inform your doctor or pharmacist if you are taking other drugs. Women of childbearing age should employ appropriate contraception methods to avoid pregnancy while on this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. Be cautious when driving or operating machinery, as dizziness may occur. Safety and efficacy have not been established in children, so it is not recommended. In case of overdose, there is no specific antidote, so it is essential to visit a medical institution immediately for appropriate care. Keep this medication out of the reach of children and avoid transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination difficulties.

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • cough
  • nausea
  • joint pain
  • musculoskeletal pain
  • muscle weakness
  • hyperkalemia
  • sinusitis
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  • diarrhea
  • headache
  • fatigue
  • malaise
  • fever
  • chest pain
  • chest discomfort
  • weakness
  • nausea
  • vomiting
  • dyspepsia
  • belching
  • abdominal bloating
  • constipation
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • skin nodules
  • thrombocytopenia
  • anemia
  • urticaria
  • upper respiratory tract symptoms.

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. Additionally, it is advisable to store it at room temperature, between 1 degree and 30 degrees Celsius, and not in excessively hot or cold conditions.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablet

Package unit

30 tablets/box (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.