Medication info
NewStatJet R Tablet 10/20 mg

NewStatJet R Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004606 · Approved 2020.06.23 · Insurance code 647805020

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily regardless of meals. For primary hypercholesterolemia, treatment starts at 10/5 mg daily, and may be increased to a maximum of 10/20 mg daily if necessary. Dose adjustments are made based on LDL cholesterol levels, with blood lipid levels checked at intervals of more than 4 weeks after any dose adjustments.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and suppression of the risk of atherosclerotic vascular disease

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

This medication serves to supplement diet in lowering high total cholesterol, LDL-cholesterol, Apo B protein, triglyceride, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, as well as to raise HDL cholesterol levels. Particularly in patients at increased risk of atherosclerotic vascular disease, multiple risk factors should be taken into account when using lipid-lowering medication. Furthermore, this medication should be used alongside appropriate dietary restrictions such as limiting saturated fats and cholesterol, and is administered when dietary treatment alone is insufficient. Before treatment, it is vital to identify and treat other causes of dyslipidemia, such as diabetes and hypothyroidism. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be regularly monitored and managed appropriately. This medication helps improve patients' blood lipid levels and reduce the risk of cardiovascular disease.

How to take

Adult dose

This medication is taken once daily regardless of meals. For primary hypercholesterolemia, treatment starts at 10/5 mg daily, and may be increased to a maximum of 10/20 mg daily if necessary. Dose adjustments are made based on LDL cholesterol levels, with blood lipid levels checked at intervals of more than 4 weeks after any dose adjustments.

Precautions

This medication can rarely cause a serious muscle disorder called rhabdomyolysis, which may lead to acute renal failure. Patients with conditions that can exacerbate muscle damage, such as severe infection, hypotension, major surgery, trauma, or severe metabolic disorders, should temporarily discontinue or stop this medication. This medication should not be administered to patients allergic to the active ingredient or any components, patients with active liver disease, patients with muscle disorders, patients with severe renal failure, or women who are pregnant or breastfeeding. Patients at high risk of myopathy, such as those with impaired kidney function, hypothyroidism, a history of muscle disorders, elderly individuals, and alcoholics, should use this medication with caution. If symptoms of muscle pain, cramps, or weakness occur during treatment, patients should promptly inform their physician and undergo examination; in severe cases, the medication should be discontinued. Abnormal liver function may occur, so liver function tests should be performed before treatment, and if signs of liver damage appear during treatment, tests should be repeated. If liver enzyme levels remain elevated, dose adjustment or discontinuation may be necessary. This medication may raise blood sugar levels, so patients at risk of diabetes should regularly monitor their blood sugar. Caution is advised when co-administering with other medications, especially anticoagulants, fibrates, some antibiotics, antifungal agents, and immunosuppressants. Women who are pregnant or may become pregnant must use effective contraception while taking this medication and should discontinue it immediately if pregnancy is confirmed. Safety in children and adolescents has not been adequately established, so it is not recommended for pediatric use. Elderly patients are at higher risk of myopathy, requiring careful observation during use. This medication should be stored out of reach of children, and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • dyspepsia
  • headache
  • dizziness
  • thrombocytopenia
  • itching
  • rash
  • asthenia
  • fatigue
  • nausea
Show 21 more
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • chest discomfort
  • high blood sugar
  • increased blood lactate dehydrogenase
  • increased serum creatinine
  • elevated blood pressure
  • increased serum urea
  • increased serum CPK
  • abnormal liver function test results
  • chest pain
  • myalgia
  • dizziness

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 exposure to air or moisture, and it is important to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help to maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Pink oval 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.