Medication info
EzeSant 10/10 mg Tablet (Ezetimibe, Rosuvastatin)

EzeSant 10/10 mg Tablet (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
Light pink, rectangular film-coated tablet
Packaging
30 tablets / box (10 tablets / PTP X 3)
Approval status
Active

MFDS item code 201601211 · Approved 2016.02.29 · Insurance code 641906350

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and reduction of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dosage may be adjusted. Following initiation of treatment or adjustment of dosage, lipid levels should be checked at least 4 weeks later before making any further dosage adjustments, with a maximum of 10/20 mg once daily.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and reduction of the risk of atherosclerotic vascular diseases

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • increased apo B protein
  • increased triglyceride
  • increased non-HDL-cholesterol
  • increased risk of atherosclerotic vascular diseases due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to diet for reducing elevated total cholesterol, LDL-cholesterol, apo B protein, triglyceride, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia, while increasing HDL-cholesterol levels. It is particularly indicated for patients at high risk of atherosclerotic vascular diseases due to hypercholesterolemia and must be used alongside dietary measures. Before administering this medication, it is important to identify and treat secondary causes of dyslipidemia, such as diabetes and hypothyroidism, if present. Additionally, treatment should only begin after lipid tests are performed to ascertain the exact condition, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride levels. In cases of acute coronary events, lipid levels should also be checked early in the hospitalization period to inform appropriate treatment. Thus, this medication is effectively used for improving dyslipidemia and reducing cardiovascular disease risk.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dosage may be adjusted. Following initiation of treatment or adjustment of dosage, lipid levels should be checked at least 4 weeks later before making any further dosage adjustments, with a maximum of 10/20 mg once daily.

Precautions

This medication may cause severe muscle issues; therefore, if severe muscle pain or weakness occurs, consult a physician immediately. Patients with renal conditions or other risk factors should consult a physician before taking this medication as muscle damage can rapidly impair renal function. Patients allergic to any ingredients in this medication, those with liver disease, or those with severe renal impairment should not take this medication. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication and should use appropriate contraception during treatment. If there are abnormalities in liver function or significantly elevated liver enzyme levels, regular liver function tests should be performed before and during the use of this medication. This medication may interact with other drugs; patients taking other medications must inform their physician, particularly if anticoagulants, fibrates, certain antibiotics, or antifungals are being used concomitantly. Elderly patients or those at risk for myopathy should be monitored more carefully while on this medication, and if muscle pain or weakness occurs, inform medical staff immediately. Neurological symptoms such as dizziness or headaches may occur, so caution is advised when driving or operating machinery. The safety and efficacy of this medication have not been sufficiently proven in children, so it is not recommended for pediatric use. Store out of reach of children, and do not transfer to a different container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, cold sweat, severe skin adverse reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms), difficulty breathing, respiratory distress, chest tightness, severe swelling (edema, generalized edema), elevated blood pressure, renal dysfunction, renal failure, jaundice, hepatic toxicity, acute hepatitis, toxic hepatitis, severe allergic reactions, liver abnormalities (jaundice), severe neurological symptoms (headaches, dizziness, somnolence,

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headaches
  • dizziness
  • upper respiratory infections
  • myalgia
  • constipation
  • nausea
  • abdominal pain
  • acneiform dermatitis
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  • pruritus
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • itching
  • rash
  • urticaria
  • hyperhidrosis
  • alopecia
  • vomiting
  • gastritis
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • cough

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C. This will safely preserve the efficacy of the medication.

Appearance and packaging

Appearance

Light pink, rectangular film-coated tablet

Package unit

30 tablets / box (10 tablets / PTP 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.