Medication info
New Atorjet Tablets 10/20 mg

New Atorjet Tablets 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White, rectangular film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3]
Approval status
Active

MFDS item code 202101554 · Approved 2021.02.18 · Insurance code 053601610

Summary

Main use
Improvement of lipids through cholesterol reduction and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily, with an initial dose of 10/10 mg or 10/20 mg recommended. For patients requiring a more significant (over 55%) reduction in LDL-cholesterol, an initial dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels should be monitored at intervals of at least two weeks.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Improvement of lipids through cholesterol reduction and increase of HDL in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to diet to lower total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while simultaneously increasing HDL-cholesterol. For patients with homozygous familial hypercholesterolemia, this medication may be administered alongside other lipid-lowering treatments or as an alternative therapy. This medication has not been studied in some types of dyslipidemia and should be used when there is insufficient response to appropriate dietary and non-pharmacological measures. Additionally, it is important to identify and treat secondary causes of dyslipidemia before starting therapy, and to monitor lipid levels regularly. This medication helps reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia, contributing to the improvement of patient health.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily, with an initial dose of 10/10 mg or 10/20 mg recommended. For patients requiring a more significant (over 55%) reduction in LDL-cholesterol, an initial dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels should be monitored at intervals of at least two weeks.

Precautions

This medication carries a risk of muscle problems, so if severe muscle pain or weakness occurs, inform a doctor immediately. Particularly, in cases of severe acute infections, hypotension, following major surgery, trauma, or severe metabolic disorders, the use of this medication should be temporarily discontinued or stopped. Patients allergic to ingredients in this medication, those with severely impaired liver function, individuals with muscle disorders, and pregnant or breastfeeding women should not take this medication. Additionally, certain antiviral agents or patients with genetic lactose intolerance should also avoid this medication. Caution is required for patients with a history of alcohol addiction, liver disease, impaired kidney function, hypothyroidism, or susceptibility to myopathy. This medication may cause side effects such as liver dysfunction and abdominal pain, so regular liver function tests and muscle-related tests should be performed. Especially, if liver enzyme levels become significantly elevated or musculoskeletal enzyme (CPK) levels greatly increase, medication use should be discontinued. This medication may interact with other drugs, so it is essential to inform a doctor or pharmacist about any other medications being taken. Women of childbearing age should use appropriate contraception while taking this medication and immediately discontinue use if pregnant. This medication is not recommended for children, and caution is needed for the elderly due to the risk of myopathy. In case of overdose, specific antidotes are not available, and symptomatic treatment and supportive care should be received, along with liver function and muscle enzyme tests. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, oral/ocular mucosa pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, urinary changes

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • lethargy
  • chest pain
  • discomfort in the chest
  • edema
  • weakness
  • headache
  • constipation
  • dyspepsia
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • muscle cramps
  • muscle fatigue
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • cholestasis

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. It is also advisable to avoid extremely hot or cold environments and to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, rectangular film-coated tablets

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.