Medication info
Newstazet Al Tablet 10/5 mg

Newstazet Al Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink, oblong, film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004607 · Approved 2020.06.23 · Insurance code 647805040

Summary

Main use
Treatment for improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed type) and dyslipidemia
Who takes it
Adults
Adult dose
The medication is administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dose can be adjusted. After initiation of therapy or dosage adjustment, blood lipid levels should be checked at intervals of at least 4 weeks before making further adjustments.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Treatment for improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed type) and dyslipidemia

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

This medication is used for primary hypercholesterolemia, particularly including both familial and non-familial cases, and is used as an adjunct to dietary therapy to lower total cholesterol, LDL-cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels, and to increase HDL-cholesterol. It is also administered as a lipid-lowering agent to patients with an increased risk of atherosclerotic vascular disease due to hypercholesterolemia, and is used together with dietary therapy to effectively control blood lipid levels. Before treatment, secondary causes such as diabetes and hypothyroidism should be identified and treated if necessary, and treatment efficacy should be monitored through regular lipid testing. This medication is used in cases where dietary therapy has proven insufficient, and may also be used in cases of acute coronary events, referencing lipid levels for treatment. Therefore, this medication is safely and effectively used for the treatment of dyslipidemia.

How to take

Adult dose

The medication is administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dose can be adjusted. After initiation of therapy or dosage adjustment, blood lipid levels should be checked at intervals of at least 4 weeks before making further adjustments.

Precautions

This medication may pose a risk of muscle side effects, so if symptoms such as muscle pain or weakness occur, the prescribing physician should be notified immediately. In particular, severe myopathy or rhabdomyolysis may occur, and if such symptoms are suspected, treatment should be discontinued. Patients with poor liver function or a history of liver disease should avoid using this medication. Patients with severely impaired kidney function should also avoid this medication, and careful monitoring is needed for patients with mildly impaired kidney function. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. This medication may interact with other drugs, so anyone currently taking other medications should inform their physician or pharmacist. Individuals who consume alcohol excessively or have liver issues should use this medication cautiously, and regular liver function testing may be required. Liver enzyme levels may increase during treatment with this medication, so liver function tests should be conducted regularly. Use in children and the elderly is not recommended or requires caution. There is no specific antidote for overdose, so immediate medical attention is necessary. When storing this 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, edema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin adverse reaction, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough and fever, jaundice (yellowing of skin or eyes), generalized malaise, liver issues (jaundice), sudden and severe

Mild side effects

  • Nasopharyngitis
  • dyspepsia
  • headache
  • dizziness
  • abdominal pain
  • diarrhea
  • fatigue
  • itching
  • rash
  • weakness
Show 20 more
  • myalgia
  • arthralgia
  • constipation
  • nausea
  • pruritus
  • cough
  • chest discomfort
  • dry mouth
  • elevated blood sugar
  • elevated blood pressure
  • increased blood alkaline phosphatase
  • increased blood cholesterol
  • elevated blood lactate dehydrogenase
  • increased creatinine
  • thrombocytopenia
  • tremor
  • depression
  • sleep disturbances
  • urticaria
  • hair loss

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It should be kept at room temperature, ideally between 1 degree and 30 degrees Celsius, avoiding extreme temperatures.

Appearance and packaging

Appearance

Pink, oblong, film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle, 100 tablets/bottle

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.