Medication info

Newstazet A Tablets 10/10 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium›10.85mg / 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Approval withdrawn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 202100220 · 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This product's status changed to Approval withdrawn on 2025.09.04.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 cholesterol and triglycerides in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication should be taken once daily, regardless of meals. The dosage range is 10/10 mg to 10/40 mg per day. For the initial dose, 10/10 mg or 10/20 mg is recommended. For patients requiring a greater reduction in LDL cholesterol, dosage adjustments may be made. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of cholesterol and triglycerides in hypercholesterolemia and dyslipidemia

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

This medication helps lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing the levels of HDL cholesterol, commonly referred to as 'good cholesterol.' It is used as an adjunct to dietary therapy to reduce the risk of atherosclerotic vascular disease. It is important to ascertain the existence of dyslipidemia due to other diseases or medications before prescribing this medication and to administer it alongside an appropriate diet. Additionally, for patients with acute coronary events, lipid tests should be conducted as soon as possible after hospitalization to determine the treatment plan. This medication contributes to safe and effective lipid management and is used to improve cardiovascular health in patients.

Dosage and Administration

Adult dosage

This medication should be taken once daily, regardless of meals. The dosage range is 10/10 mg to 10/40 mg per day. For the initial dose, 10/10 mg or 10/20 mg is recommended. For patients requiring a greater reduction in LDL cholesterol, dosage adjustments may be made. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication is a lipid-lowering agent containing atorvastatin and ezetimibe, used to lower blood cholesterol levels. Before taking this medication, be cautious as symptoms such as muscle pain or weakness may occur, especially in patients at risk for severe myopathy or rhabdomyolysis. Immediate consultation with a physician is necessary if symptoms like muscle pain, muscle cramps, muscle weakness, fever, or fatigue appear, and it may be necessary to check muscle enzyme levels via blood tests. Furthermore, this medication can affect liver function, so liver tests are essential before starting and during treatment. If liver enzyme levels significantly exceed the normal range, the use of the medication should be stopped or the dosage adjusted. This medication may be contraindicated or used with caution in patients with specific diseases or those taking other medications. For instance, patients with active liver disease, unexplained elevated liver enzymes, muscle disorders, pregnant or breastfeeding women, and those taking certain antiviral or fibrate medications should not take this drug. Elderly patients or those with reduced kidney function may have an increased risk of myopathy, so caution is needed, and dosage adjustments or regular monitoring is recommended. Additionally, this medication can interact with various drugs, so it is essential to inform the physician or pharmacist if other medications are being taken. Particularly, caution and dosage adjustments are needed when co-administering with CYP3A4 inhibitors, cyclosporine, certain antibiotics, antiviral drugs, and fibrate medications. Women who are pregnant or may become pregnant should not take this medication, and women of childbearing age should use appropriate contraceptive methods while on this drug. Nursing mothers should also avoid using this medication. This medication is not recommended for children, as its safety and efficacy have not been established. In case of overdose, specific antidotes are not available, so appropriate treatment and supportive therapy according to symptoms should be provided, monitoring liver function and muscle enzyme levels. Finally, this medication should be stored out of the reach of children, and it is advisable not to 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, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Diminished sensation
  • abnormal sensation
  • hypertension
  • increased ALT
  • increased GGT
  • nasopharyngitis
  • cough
  • itching
  • dizziness
  • diabetes
Show 27 more
  • headache
  • fatigue
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • abnormal sensation
  • sensory reduction
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • visual impairment
  • tinnitus

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius. This helps to ensure the medication's efficacy and safety.

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.