Medication info
Ezrovastatin Tablet 10/5 mg

Ezrovastatin Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets (15 tablets/PTP × 2)
Approval status
Active

MFDS item code 201606045 · Approved 2016.10.12 · Insurance code 643704390

Summary

Main use
Effect of lowering LDL-cholesterol and total cholesterol through treatment of hypercholesterolemia (primary and mixed type)
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring greater reduction of LDL-cholesterol, the dose can be adjusted to range between 10/5 mg and 10/20 mg per day. After starting treatment or adjusting the dose, check serum lipid levels at intervals of at least 4 weeks; the maximum dose is 10.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Effect of lowering LDL-cholesterol and total cholesterol through treatment of hypercholesterolemia (primary and mixed type)

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B proteins
  • elevated triglycerides
  • elevated non-HDL-cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to diet to lower total cholesterol and LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Especially in cases with a high risk of atherosclerotic vascular disease due to hypercholesterolemia, it is crucial to take this medication alongside an appropriate diet. Before administration of this medication, other causes of dyslipidemia, such as diabetes and hypothyroidism, should be ruled out and treated if necessary. Regular lipid testing should be conducted to manage total cholesterol and LDL, HDL, and triglyceride levels during treatment. In this manner, this medication helps improve vascular health through safe and effective lipid regulation.

How to take

Adult dose

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring greater reduction of LDL-cholesterol, the dose can be adjusted to range between 10/5 mg and 10/20 mg per day. After starting treatment or adjusting the dose, check serum lipid levels at intervals of at least 4 weeks; the maximum dose is 10.

Precautions

This medication may cause rare side effects that can affect the muscles, so if severe muscle pain or weakness occurs, notify a doctor immediately. This medication may affect liver function; therefore, patients with liver issues or abnormally high liver enzyme levels should not use it and should have regular liver function tests during treatment. Do not use this medication in patients with severe kidney impairment, and those with kidney problems should use it cautiously under medical supervision. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication, and women of childbearing age should use appropriate contraception. This medication should not be administered to patients with certain genetic lactose intolerance and should also not be used in patients with allergic reactions or muscle disease. Special caution is required for elderly patients or those with liver disease or alcohol addiction when administering this medication; interactions with other drugs may increase the risk of side effects, so consult a doctor. While taking this medication, if symptoms such as muscle pain, fatigue, or fever occur, consult a doctor immediately. Serious skin reactions or muscle weakness may occur, so careful monitoring is necessary. Dizziness may occur when driving or operating machinery, so caution is required. This medication may interact with other drugs, so inform healthcare providers about all medications being taken, especially anticoagulants, fibrates, and certain antibiotics, due to precautions needed during combination therapy. In case of overdose, there is no specific antidote; therefore, seek hospital treatment immediately for symptomatic management along with liver function and blood tests. Keep out of the reach of children and do not transfer to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities associated with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning-type headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Nasopharyngitis
  • joint pain
  • headache
  • increased ALT
  • increased AST
  • muscle pain
  • edema
  • elevated blood bilirubin
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infection
  • fatigue
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • chest pain
  • discomfort in the chest
  • weakness
  • generalized edema
  • diabetes
  • tremors
  • vomiting
  • dry mouth
  • discomfort in the epigastrium
  • burping
  • gastrointestinal disturbances

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to keep the medication effective longer.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets (15 tablets/PTP × 2)

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.