Medication info

Newstajet A Tablets 10/20 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Approval withdrawn

MFDS item code 202100218 · Approved 2021.01.08

This product's status changed to Approval withdrawn on 2025.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. The dosage should be adjusted according to the patient’s baseline LDL-cholesterol, treatment target levels, and the patient’s response. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with a recommended starting dose of 10/10 mg or 10/20 mg. If greater reductions in LDL-cholesterol are required, the dosage can be adjusted.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

  • Primary hypercholesterolemia
  • heterozygous familial dyslipidemia
  • non-familial dyslipidemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • LDL-cholesterol
  • apo B protein
  • triglycerides
  • non-HDL-cholesterol
View approved original text

This medication helps to reduce elevated total cholesterol, LDL-cholesterol, apo B protein, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL-cholesterol levels. It is used as an adjunct to dietary therapy and should be administered alongside an appropriate diet. Notably, this medication has established efficacy for certain types of dyslipidemia, but caution is warranted for others due to limited research. Before taking this medicine, it is essential to identify any secondary causes of dyslipidemia and treat them as necessary. Moreover, accurately measuring lipid levels is crucial to determining the treatment direction. This medication improves blood lipid levels in patients with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. The dosage should be adjusted according to the patient’s baseline LDL-cholesterol, treatment target levels, and the patient’s response. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with a recommended starting dose of 10/10 mg or 10/20 mg. If greater reductions in LDL-cholesterol are required, the dosage can be adjusted.

Precautions

This medication may rarely cause serious side effects related to muscles, such as rhabdomyolysis. This condition can cause muscle damage and may lead to kidney problems, so if severe muscle pain or weakness occurs, you should consult a doctor immediately. Additionally, this medication can affect liver function, so liver function tests should be performed before treatment, and liver condition should be monitored regularly during treatment. It is safe to avoid this medication if there are liver problems or abnormally elevated liver enzyme levels. This drug may be contraindicated or require cautious use for patients with certain diseases or those taking specific medications. For example, patients with liver disease, muscle disorders, pregnant or potentially pregnant women, lactating women, and those taking certain antiviral agents or fibrate medications should not use this drug. This medication can interact with various drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist, particularly when combining with CYP3A4 inhibitors or certain antibiotics and antiviral agents. During treatment, if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, inform medical personnel immediately, and blood tests may be required to check for muscle damage. Moreover, this drug should not be administered to pregnant or lactating women, and women of childbearing age should employ adequate contraceptive methods while taking this drug. Dizziness or fatigue may occur, so caution is needed while driving or operating machinery. The safety and efficacy of this medication for children have not been established, thus it is not recommended for pediatric use. When storing the medication, keep it 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 with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough+fever, yellowing of the skin or eyes (jaundice), profound malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes.

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • itching
  • chest pain
  • fatigue
  • fever
  • nasopharyngitis
  • cough
  • constipation
Show 28 more
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • oropharyngeal/laryngeal pain
  • epistaxis
  • insomnia
  • nightmares
  • sensory impairment
  • taste disorder
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • visual disturbances.

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. Furthermore, it should be kept at a normal room temperature between 1°C to 30°C, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP*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.