Medication info
Newtojet Tablet 10/20 mg

Newtojet Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Active

MFDS item code 202101608 · Approved 2021.02.18 · Insurance code 669908070

Summary

Main use
Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) 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 recommended dose of 10/10 mg or 10/20 mg once daily. For patients requiring a greater reduction of LDL-cholesterol (more than 55%), an initial dose of 10/40 mg once daily is recommended. After initiation of therapy or dose adjustment, blood lipid levels should be checked with intervals of at least 2 weeks.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL-cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL-cholesterol
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used to improve blood lipid levels by controlling high cholesterol and fat components in patients with primary hypercholesterolemia. It particularly helps lower total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol in patients with heterozygous familial and non-familial hypercholesterolemia and mixed dyslipidemia, while simultaneously increasing HDL-cholesterol. In patients with homozygous familial hypercholesterolemia, it is used as an adjunct when other treatments are ineffective and contributes to lipid control to reduce the risk of cardiovascular disease. It is used in conjunction with dietary management, and it is essential to manage secondary causes such as diabetes and hypothyroidism. Prior to starting treatment for dyslipidemia, accurate measurement of blood lipid levels is important for establishing a safe and effective treatment plan. This medication is used to improve hypercholesterolemia and dyslipidemia.

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 recommended dose of 10/10 mg or 10/20 mg once daily. For patients requiring a greater reduction of LDL-cholesterol (more than 55%), an initial dose of 10/40 mg once daily is recommended. After initiation of therapy or dose adjustment, blood lipid levels should be checked with intervals of at least 2 weeks.

Precautions

This medication may rarely cause muscle cell damage, leading to muscle pain or weakness, and in severe cases, it can affect kidney function. Patients should inform their physician immediately if they notice unusual muscle symptoms. This medication should not be administered to patients with allergies to its components, active liver disease, muscle disease, pregnant women or women who may become pregnant, breastfeeding women, or patients taking certain antiviral medications. Caution should be taken when administering to patients with a history of alcohol dependence, liver function issues, decreased kidney function, hypothyroidism, elderly patients, or those at higher risk of myopathy. These patients require regular monitoring. During the use of this medication, liver function abnormalities, gastrointestinal symptoms (abdominal pain, nausea, etc.), muscle pain, headaches, dizziness, and other side effects may occur. If symptoms persist or worsen, it is advisable to consult a doctor. This medication may elevate liver enzyme levels, so liver function tests should be performed before and during treatment, and if liver function worsens, treatment should be discontinued. This medication may interact with other drugs, especially those metabolized in the liver or that may impact muscle function, so it is essential to consult with a physician or pharmacist when taking these medications together. Women of childbearing age should use appropriate contraceptive methods to prevent pregnancy while taking this medication, and if pregnancy is confirmed, use should be discontinued immediately, and a doctor should be consulted. The safety and effectiveness of this medication in children have not been established, so it is not recommended for them, and caution is needed for elderly patients due to the risk of myopathy. In cases of overdose, there is no specific antidote, so appropriate treatment and supportive therapy should be administered based on symptoms, while closely monitoring liver function and muscle condition. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, sores on the lips/eyes, difficulty breathing or respiratory distress, asthma attack, respiratory problems with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • headache
  • fatigue
  • malaise
  • chest pain
  • discomfort in the chest
  • swelling
  • weakness
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  • muscle cramps
  • joint pain
  • limb pain
  • muscle fatigue
  • muscle weakness
  • nausea
  • diarrhea
  • indigestion
  • constipation
  • vomiting
  • belching
  • pancreatitis
  • pharyngitis
  • sinusitis
  • bronchitis
  • nasopharyngitis
  • cough
  • nosebleed
  • flushing
  • sweating
  • itching
  • rash
  • hair loss
  • urticaria
  • skin nodules
  • contact dermatitis
  • dry skin
  • angioedema
  • eczema

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

Storage

This medication must be stored in a tightly sealed container to prevent air or moisture ingress. Additionally, the medicine should be kept away from excessively hot or cold places, ideally stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White oblong film-coated tablet

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.