Medication info
Atorvaem Tablet 10/20 mg

Atorvaem Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
White or off-white rectangular film-coated tablets
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101522 · Approved 2021.02.18 · Insurance code 647304000

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day, and an initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol (>55%), an initial dose of 10/40 mg per day is recommended. Dosage adjustments should be made with intervals of at least two weeks based on the blood lipid levels.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia and dyslipidemia

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

This medicine helps to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol levels. It can also be used as adjunct therapy in patients with homozygous familial hypercholesterolemia when other treatments are insufficient. This medication is used in conjunction with appropriate dietary therapy, and other causes of dyslipidemia should be identified and treated. It is important to measure blood lipid levels accurately to assess the effectiveness of treatment, and lipid testing should be performed upon admission or within 24 hours after admission in patients with acute coronary events. Overall, this drug is effectively used for the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day, and an initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol (>55%), an initial dose of 10/40 mg per day is recommended. Dosage adjustments should be made with intervals of at least two weeks based on the blood lipid levels.

Precautions

This drug can cause a rare side effect known as rhabdomyolysis, which may lead to problems with kidney function, so if severe muscle pain or weakness occurs, contact your doctor immediately. This drug should not be administered to patients who are allergic to the active ingredient or any component of the formulation, those with severe liver problems, people with muscle disorders, women who are pregnant or breastfeeding, and those on certain antiviral medications. Patients with a history of liver disease or alcohol dependence, elderly patients at risk for myopathy, or those with risk factors such as hypothyroidism or decreased kidney function should use this drug cautiously and undergo regular testing as directed by a physician if necessary. If symptoms like muscle pain, muscle weakness, fatigue, fever, etc., occur while taking this medication, inform healthcare professionals immediately, and regular testing is needed as abnormalities in liver function or blood tests may be found. Additionally, this medication can affect liver function, so liver function tests should be conducted before and during treatment, and if liver function markers significantly increase, the medication should be discontinued. This drug may interact with other medications, so especially when taken in conjunction with certain antibiotics, antivirals, antifungals, immunosuppressants, blood pressure medications, and diabetes medications, consultation with a doctor or pharmacist is necessary. Women of childbearing age should use appropriate contraception while taking this medication and must inform healthcare professionals if they are planning to become pregnant or are pregnant. The safety and efficacy of this medication in children have not been established, and it is not recommended. Elderly patients are at a higher risk for myopathy and should use it with caution. In case of an overdose, as there is no specific antidote, treatment and supportive care according to symptoms are required, and liver function tests and blood tests should monitor the condition. Finally, this drug should be stored out of reach of children, and transferring it to another container should be avoided.

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 fever, blistering, skin peeling, 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), generalized severe malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination changes

Mild side effects

  • Muscle pain
  • abdominal pain
  • hyperkalemia
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • muscle cramps
  • muscle fatigue
  • headache
  • dizziness
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  • nausea
  • diarrhea
  • fatigue
  • malaise
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • fever
  • upper respiratory infection
  • pharyngitis
  • sinusitis
  • cough
  • nosebleed
  • flushing
  • anemia
  • hives
  • itching
  • rash
  • hair loss
  • skin lesions
  • ingrown toenails
  • allergic reactions
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • vomiting

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius. Proper storage ensures the safety of the drug's effectiveness.

Appearance and packaging

Appearance

White or off-white rectangular film-coated tablets

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.