Medication info
New Atorjet Tablets 10/40 Milligrams

New Atorjet Tablets 10/40 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP packaging (Alu-Alu)x3]
Approval status
Active

MFDS item code 202101553 · Approved 2021.02.18

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, suppression of cardiovascular disease risk by increasing HDL.
Who uses it
Adults
Adult dosage
This medication should be taken once daily regardless of meals. For primary hypercholesterolemia, the dose range is 10/10 mg to 10/80 mg daily, with a recommended starting dose of 10/10 mg or 10/20 mg daily. For patients who require a greater than 55% reduction in LDL-cholesterol, a starting dose of 10/40 mg daily is recommended. After initiating therapy or adjusting the dosage, lipid levels should be checked with intervals of at least 2 weeks.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

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

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

This medication is used as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL-cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, and for increasing HDL-cholesterol. It may also be administered as an adjunct in homozygous familial hypercholesterolemia patients when other lipid-lowering therapies are not effective. This drug is not used for certain types of dyslipidemia, and appropriate dietary therapy and lifestyle changes are essential prior to treatment. Other causes of dyslipidemia should be identified and treated concurrently if necessary before initiation of therapy. Treatment effects should be monitored through blood lipid tests, which play an important role in managing cardiovascular risk. This drug is effectively used in the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication should be taken once daily regardless of meals. For primary hypercholesterolemia, the dose range is 10/10 mg to 10/80 mg daily, with a recommended starting dose of 10/10 mg or 10/20 mg daily. For patients who require a greater than 55% reduction in LDL-cholesterol, a starting dose of 10/40 mg daily is recommended. After initiating therapy or adjusting the dosage, lipid levels should be checked with intervals of at least 2 weeks.

Precautions

This medication has a rare risk of causing serious muscle issues; therefore, if severe muscle pain or weakness occurs, it should be reported to a physician immediately. It may be necessary to temporarily discontinue the drug in conditions such as severe infections, hypotension, or after major surgery. This medication should not be administered to individuals with certain medical conditions, pregnant women, nursing women, or those with known allergic reactions. Additionally, individuals with liver dysfunction or muscle disorders may be at risk when using this drug. Individuals who consume a lot of alcohol or have a history of liver disease, as well as the elderly or those with decreased kidney function, should be especially cautious when using this medication and may need to consult with a physician if taken with other medications due to an increased risk of muscle problems. While taking this medication, regular checks of liver function and muscle status should be conducted, and if liver function tests are elevated or muscle-related symptoms occur, healthcare professionals should be notified immediately. Pregnant women or those who may become pregnant should not take this medication, and effective contraceptive methods should be used if taking the drug. Nursing women should also refrain from taking this medication for safety. This medication is not recommended for children as its safety and efficacy in this population have not been established. In case of overdose, there is no specific antidote, and management should be based on symptoms along with liver function and muscle enzyme tests. Keep this medication out of the reach of children and do not transfer it to other containers. Additionally, dizziness may occur during driving or operating machinery while taking this drug, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, 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 coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual abnormalities, paralysis, and urination issues.

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
  • fatigue
  • malaise
  • chest pain
  • headache
  • constipation
  • vomiting
  • belching
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • altered perception
  • sensory loss
  • altered taste
  • memory loss
  • peripheral neuropathy
  • itching
  • rash
  • hair loss
  • angioedema
  • urticaria
  • eczema
  • and others.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, rectangular 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.