Medication info
New Atorjet Tablet 10/10 mg

New Atorjet Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3]
Approval status
Active

MFDS item code 202101555 · Approved 2021.02.18 · Insurance code 053601630

Summary

Main use
Lipid improvement by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medicine should be taken once daily without regard to meals. For primary hypercholesterolemia, it should be administered within a dosage range of 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg once daily is recommended, while those requiring greater reduction in LDL-cholesterol should be given 10/40 mg once daily. Blood lipid levels should be checked after an interval of more than 2 weeks to adjust the dose.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Lipid improvement by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia

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

This medicine is used as an adjunct to dietary therapy to lower elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels and to increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, it can be administered as an adjunctive treatment in patients with homozygous familial hypercholesterolemia when other lipid-lowering therapies are ineffective. Lipid control therapy should be initiated when there is insufficient response to dietary therapy and non-pharmacological measures, and it is important to identify and treat secondary causes of dyslipidemia such as diabetes and hypothyroidism. This medicine can be safely used in patients at high risk for cardiovascular disease, helping to improve blood lipid levels and reduce the risk of atherosclerotic vascular disease. Therefore, it is used in the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medicine should be taken once daily without regard to meals. For primary hypercholesterolemia, it should be administered within a dosage range of 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg once daily is recommended, while those requiring greater reduction in LDL-cholesterol should be given 10/40 mg once daily. Blood lipid levels should be checked after an interval of more than 2 weeks to adjust the dose.

Precautions

This medication has a rare side effect that can cause muscle damage, so if symptoms such as muscle pain or weakness occur, you must inform your doctor immediately. Patients at high risk for serious myopathy or rhabdomyolysis (e.g., severe infections, hypotension, post major surgery, etc.) should temporarily stop or discontinue this medication. Patients allergic to any components of this drug, those with active liver disease, patients with muscle disorders, and pregnant or breastfeeding women should not take this drug. Additionally, patients with certain antivirals or lactose intolerance should not use this medication. Patients at risk for myopathy, such as those with liver dysfunction, alcoholism, hypothyroidism, or the elderly, should use this medication cautiously with regular monitoring of liver function and muscle status. While taking this medication, side effects such as elevated liver enzymes, muscle pain, abdominal pain, dizziness, etc., may occur, and if these symptoms arise, consultation with medical personnel is required. This medication may interact with other drugs, so caution is needed, especially when taken together with CYP3A4 inhibitors or certain antibiotics and antivirals. Women of childbearing potential should avoid pregnancy while taking this medicine, and should stop taking it immediately if pregnancy is confirmed. The safety of this drug in children has not been established and is therefore not recommended. In cases of overdose, there is no specific antidote, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels. Keep this medicine out of reach of children and do not transfer 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 accompanied by high fever, blisters, skin shedding, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, vision changes, paralysis, urine

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • bronchitis
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  • sinusitis
  • flushing
  • fatigue
  • chest pain
  • malaise
  • lethargy
  • breast discomfort
  • swelling
  • vascular neurogenic edema
  • facial swelling
  • fever
  • neck stiffness
  • constipation
  • hyperkalemia
  • fatigue
  • urticaria
  • rash
  • itching
  • hair loss
  • angioedema
  • sweating
  • eczema
  • seborrhea
  • skin ulcers
  • sensory abnormalities
  • insomnia
  • nightmares
  • tinnitus

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3]

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.