Medication info
Ezetimibe 5 mg (Rosuvastatin Calcium)

Ezetimibe 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
에스케이케미칼(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 201400383 · Approved 2014.01.28 · Insurance code 644704200

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, it may be adjusted to the maintenance dose. The maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient responses, with a maximum daily dose of 20 mg.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The dosing should be adjusted according to the recommended treatment goals for individual patients. The dosage may be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
에스케이케미칼(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • high-sensitivity C-reactive protein increase
  • hypertension
  • low HDL cholesterol level
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is primarily used as an adjunct to diet and exercise when primary hypercholesterolemia, mixed dyslipidemia, or familial hypercholesterolemia cannot be controlled. It particularly lowers LDL cholesterol levels, delaying the progression of atherosclerosis, and is also used in certain pediatric patients aged 10 years and older. Furthermore, it helps reduce the risk of cardiovascular complications such as stroke, myocardial infarction, and arterial revascularization in patients at high risk for cardiovascular disease. Thus, this drug is used for cholesterol control and cardiovascular disease prevention.

How to take

Adult dose

The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, it may be adjusted to the maintenance dose. The maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient responses, with a maximum daily dose of 20 mg.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosing should be adjusted according to the recommended treatment goals for individual patients. The dosage may be adjusted at intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to this drug, have severely impaired liver function, muscle disorders, severe kidney disorders, or are pregnant or nursing should not take it. Additionally, since this drug may affect liver function, patients with a history of liver disease or those who consume alcohol heavily should use it cautiously. It is advisable to have regular liver function tests before and during the use of this medication. Symptoms such as muscle pain or weakness may occur, and in rare cases, serious muscle damage known as rhabdomyolysis may develop. If these symptoms occur, notify a doctor immediately, and the medication may need to be stopped if necessary. This drug may interact with other medications, so caution should be exercised, especially when taken with certain antiviral agents, immunosuppressants, antibiotics, and fibrate drugs. Increased risk of muscle damage may occur with combinations, so consult a doctor. Women of childbearing potential should use appropriate contraceptive methods to avoid pregnancy, and it is safest not to take this medication during pregnancy. Nursing mothers are also advised to avoid this medication. In the event of an overdose, there is no specific antidote, and treatment should be symptomatic, while checking liver function and muscle-related tests to monitor the condition. This drug has rarely been reported to cause interstitial lung disease, liver damage, increased blood glucose levels, and memory loss, so if any abnormal symptoms occur, the healthcare provider should be notified immediately. Caution is needed as dizziness may occur when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, severe muscle weakness, respiratory distress, ocular muscle weakness, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, increased serum creatinine, liver failure, severe headache, chest tightness, difficulty breathing

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • transaminase increase
  • muscle rupture
  • lupus-like syndrome
  • hematuria
  • edema
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a well-sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets per 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.