Medication info
Ezrovab Tablet 10/20 mg

Ezrovab Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Round film-coated tablet, white to nearly white
Packaging
30 tablets (15 tablets/PTP X 2)
Approval status
Active

MFDS item code 201606043 · Approved 2016.10.12 · Insurance code 643704400

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, mixed) and dyslipidemia, and suppression of the risk of atherosclerotic vascular disease through increasing HDL.
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily, with an initial dose of 10/5 mg recommended. In cases where greater reduction of LDL-cholesterol is required, the dosage can be adjusted. After initiating treatment or adjusting the dosage, blood lipid levels should be checked after at least 4 weeks.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, mixed) and dyslipidemia, and suppression of the risk of atherosclerotic vascular disease through increasing HDL.

  • 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
  • decreased HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication is used for patients with primary hypercholesterolemia, including familial and non-familial hypercholesterolemia, and mixed dyslipidemia. It helps to lower total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, while increasing HDL cholesterol levels. It is especially effective in patients with an increased risk of atherosclerotic vascular disease due to hypercholesterolemia when combined with lipid-modifying drugs and appropriate dietary therapy. Dietary therapy should include restrictions on saturated fats and cholesterol, and this medication is administered when improvement with non-pharmacological measures is insufficient. Before taking this medication, the causes of other dyslipidemias should be identified and treated if necessary, and regular blood lipid tests should be conducted for management. This medication is used to improve these dyslipidemic conditions.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily, with an initial dose of 10/5 mg recommended. In cases where greater reduction of LDL-cholesterol is required, the dosage can be adjusted. After initiating treatment or adjusting the dosage, blood lipid levels should be checked after at least 4 weeks.

Precautions

This medication has a risk of severe muscle problems, so if symptoms of muscle pain or weakness occur, you must notify your doctor immediately. In particular, significant muscle damage can worsen kidney function, so it may be necessary to temporarily suspend this medication in cases of acute infections, hypotension, major surgery, or trauma. Patients with allergies to this medication, liver or muscle diseases, severe kidney impairment, pregnant or breastfeeding women should not take this medication. Additionally, the risk of muscle damage may increase when taken with certain drugs, so it is essential to inform your healthcare provider if you are taking other medications. Patients with poor liver function, those who consume alcohol heavily, elderly individuals, and those with hypothyroidism should use this medication cautiously and should have regular liver and muscle-related tests. During use, liver enzyme levels and muscle enzyme levels should be regularly checked for abnormalities, and if there is significant liver damage or worsening muscle pain, usage should be stopped immediately, and a doctor's care should be sought. Women who are pregnant or may become pregnant should use contraception while taking this medication, as it could be harmful to the fetus, and use should be stopped immediately if pregnancy is confirmed. This medication is not recommended for children and adolescents as safety and efficacy have not been sufficiently established. Elderly individuals are at an increased risk of myopathy, so caution is necessary during use. In case of overdose, there is no specific antidote, so treatment should be provided according to symptoms, and liver and muscle function tests should be performed. This medication should be stored out of the reach of children and should not be transferred to other containers. Caution should be taken while driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin desquamation, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities associated with cough + fever, yellowing of skin or eyes (jaundice), severe general malaise, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Headache
  • arthralgia
  • rhinitis
  • pruritus
  • myalgia
  • itching
  • edema
  • elevated bilirubin levels
  • acneiform dermatitis
  • dizziness
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  • upper respiratory infection
  • abdominal pain
  • diarrhea
  • constipation
  • cough
  • fatigue
  • asthenia
  • chest discomfort
  • nausea
  • loss of appetite
  • abdominal bloating
  • dermatitis
  • alopecia
  • vomiting
  • epigastric discomfort
  • belching
  • gastrointestinal disturbances
  • urticaria
  • hyperhidrosis
  • rash
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain.

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. The optimal storage temperature is between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Round film-coated tablet, white to nearly white

Package unit

30 tablets (15 tablets/PTP X 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.