Medication info
Ezerosuzon 10/2.5 mg (Ezetimibe, Rosuvastatin)

Ezerosuzon 10/2.5 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›2.6mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202300829 · Approved 2023.03.10 · Insurance code 648508220

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage ranges from 10/2.5 mg to 10/20 mg per day, with a recommended starting dose of 10/2.5 mg or 10/5 mg per day. Dosage can be adjusted for patients who require more significant reductions in LDL cholesterol. After initiation of treatment or adjustment of dosage, lipid levels should be checked at intervals of more than 4 weeks.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and treatment of 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
View approved original text

This medication helps control cholesterol and related lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Specifically, it lowers total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, while increasing HDL cholesterol, which is known as good cholesterol. This medication is used in conjunction with dietary measures and helps improve blood lipid levels to reduce the risk of cardiovascular disease. Thus, it is suitable for those needing cholesterol management and is used to maintain healthy lipid levels.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage ranges from 10/2.5 mg to 10/20 mg per day, with a recommended starting dose of 10/2.5 mg or 10/5 mg per day. Dosage can be adjusted for patients who require more significant reductions in LDL cholesterol. After initiation of treatment or adjustment of dosage, lipid levels should be checked at intervals of more than 4 weeks.

Precautions

This medication has been reported to potentially cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle damage, and thus, caution is required. Patients with severe infections, hypotension, recent major surgery, trauma, metabolic or endocrine disorders, or uncontrolled seizures should temporarily suspend or discontinue this medication. It should not be used in patients with a known allergy to this medication, active liver disease or persistent unexplained liver enzyme elevations, muscle disease, certain renal impairment, women who are pregnant or breastfeeding. Special caution is advised when administering to patients at high risk for myopathy, such as those with renal impairment, hypothyroidism, family history of muscle diseases, alcoholism, or those taking certain medications concurrently. This medication contains lactose, therefore it should not be administered to patients with lactose intolerance or related genetic disorders. During treatment, if symptoms such as muscle pain, fatigue, or fever occur, immediate consultation with a physician is necessary, and tests for potential muscle damage should be carried out. Since liver function abnormalities may occur, liver function tests should be conducted before and during administration, and if liver enzyme levels rise significantly, the medication should be discontinued. This medication can raise blood sugar levels, so patients with diabetes should periodically check their blood sugar levels. As this medication may interact with other drugs, it is especially important to consult a physician or pharmacist if taking anticoagulants, fibrates, certain antibiotics, or antifungal medications. Women who are pregnant or may become pregnant must use appropriate contraception while taking this medication and should stop immediately if pregnancy is confirmed. Breastfeeding while on this medication is not recommended. The safety and efficacy of this medication in children have not been sufficiently established, thus use in children is not recommended. Caution is needed when administering to the elderly due to the risk of myopathy, and it should be administered cautiously in patients with impaired kidney or liver function. In cases of overdose, as there is no specific antidote, treatment should be symptomatic, and monitoring should be conducted through liver function and muscle enzyme tests. This medication should be kept out of reach of children, and it is safe not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain of mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities associated with cough and fever, jaundice (yellowing of the skin or eyes), extreme overall tiredness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary abnormalities.

Mild side effects

  • Headache
  • dizziness
  • dental discomfort
  • chest pain
  • joint pain
  • microvascular coronary artery disease
  • lower limb fractures
  • orthostatic dizziness
  • diabetes
  • hypoglycemia
Show 18 more
  • chronic cholecystitis
  • cholelithiasis
  • nasopharyngitis
  • dyspepsia
  • elevated ALT
  • edema
  • myalgia
  • elevated AST
  • acute pyelonephritis
  • dry mouth
  • elevated liver enzymes
  • abnormal liver function tests
  • elevated blood lactate dehydrogenase
  • pruritus
  • nasopharyngitis
  • dyspepsia
  • upper respiratory infection
  • elevated blood sugar.

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

Storage

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

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.