Medication info
Ezrosu 10/5 mg

Ezrosu 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201601194 · Approved 2016.02.29 · Insurance code 648507540

Summary

Main use
Improvement of hypercholesterolemia (lipid abnormalities) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This drug is administered once daily, irrespective of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. The dosage range is from 10/5 mg to 10/20 mg daily, and if patients require more reduction in LDL cholesterol, the dose may be adjusted accordingly. Blood lipid levels should be checked at intervals of more than four weeks after starting administration or adjusting the dose.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (lipid abnormalities) 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 is used to lower total cholesterol, LDL cholesterol, Apo B protein, triglyceride, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly familial and non-familial and mixed dyslipidemia, while increasing good cholesterol, HDL cholesterol levels. It is primarily used as an adjunct to diet, in conjunction with dietary management that limits saturated fat and cholesterol intake. It also helps in the treatment to reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia. Before using this medication, secondary causes of dyslipidemia such as diabetes and hypothyroidism should be identified and treated if necessary. It is important to regularly check blood lipid levels when administering the drug, especially if triglyceride levels are very high, accurate measurement is required. Thus, this medication is effective for complex lipid management and is used to improve vascular health in patients.

How to take

Adult dose

This drug is administered once daily, irrespective of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. The dosage range is from 10/5 mg to 10/20 mg daily, and if patients require more reduction in LDL cholesterol, the dose may be adjusted accordingly. Blood lipid levels should be checked at intervals of more than four weeks after starting administration or adjusting the dose.

Precautions

This drug poses a risk of serious problems in muscles, so if symptoms such as muscle pain or weakness occur, notify a physician immediately. In particular, if there are severe infections, low blood pressure, major surgery, trauma, or metabolic disorders, this drug may need to be temporarily discontinued or stopped. Patients with allergies to this drug, severely impaired liver function, muscle diseases, certain kidney function impairments, pregnant or nursing women should not be administered this drug. In addition, patients at high risk of myopathy should use this drug with caution and require regular monitoring of muscle enzyme levels. Liver function tests should be conducted before starting this drug and should be repeated if abnormalities occur during treatment. This drug should be administered with caution in patients with a history of alcoholism or liver disease, and the risk of side effects may increase due to drug interactions, so any other medications being taken must be reported. Women who are pregnant or may become pregnant should use appropriate contraception while taking this drug and must stop taking it immediately upon confirming pregnancy. This medication has not been established for safety and effectiveness in children and is not recommended. Elderly patients may be at risk for myopathy, so caution is needed, but dose adjustment is generally not required. In the case of overdose, there is no specific antidote; appropriate treatment and liver function and muscle enzyme tests are required based on symptoms. Store this medication out of reach of children, and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rashes with high fever, blisters, pain in mucous membranes of mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe symptoms

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • ALT elevation
  • AST elevation
  • ALP elevation
  • abnormal liver function tests
  • dizziness
  • chest pain
  • fatigue
Show 26 more
  • muscle pain
  • rash
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • itching
  • fatigue
  • chest pain
  • discomfort in the chest
  • weakness
  • generalized edema
  • tremors
  • cough
  • epigastric pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue-related disorders
  • hives
  • sweating
  • hair loss

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

Storage

This drug is sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature is best maintained at room temperature between 1 degree and 30 degrees. Storing it this way can help maintain the drug’s effectiveness for a long time.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle, 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.