Medication info
Ezrovah Tablets 10/10 mg

Ezrovah Tablets 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets (15 tablets/PTP × 2)
Approval status
Active

MFDS item code 201606044 · Approved 2016.10.12 · Insurance code 643704380

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily. For the initial dose, 10/5 mg once daily is recommended. In patients who require more significant reductions in LDL cholesterol, dosages may be adjusted accordingly. After starting treatment or adjusting the dosage, lipid levels in the blood should be checked at intervals of at least 4 weeks and dosage adjusted accordingly.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) 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
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication is used as an adjunct to diet in patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia to reduce total cholesterol, LDL cholesterol, Apo B protein, triglycerides, non-HDL cholesterol levels and to increase HDL cholesterol levels. Care should be taken to consider risk factors particularly when administering to patients at increased risk of atherosclerotic vascular disease due to hypercholesterolemia. This medication must be used together with an appropriate diet that restricts saturated fat and cholesterol intake, and is used when diet and non-drug measures are insufficient. Before treatment, other causes of dyslipidemia such as diabetes and hypothyroidism should be identified and treated if necessary, and treatment efficacy should be evaluated through lipid testing. Additionally, following an acute coronary event, lipid levels should be measured promptly to inform treatment planning. This medication is used to improve dyslipidemia and reduce the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily. For the initial dose, 10/5 mg once daily is recommended. In patients who require more significant reductions in LDL cholesterol, dosages may be adjusted accordingly. After starting treatment or adjusting the dosage, lipid levels in the blood should be checked at intervals of at least 4 weeks and dosage adjusted accordingly.

Precautions

This medication is a combination product containing both Rosuvastatin and Ezetimibe, primarily used for the treatment of hypercholesterolemia. Patients with muscle-related diseases or at risk of acute renal failure should use caution before taking this drug. If there are acute infections, hypotension, major surgery, trauma, or severe metabolic disorders, the use of this drug may need to be temporarily or completely halted. The following patients should not take this drug: those with allergies to its ingredients, those with active liver disease, those with unexplained persistent elevations in liver enzymes, those with muscle diseases, those currently taking cyclosporine, those with severe renal failure, pregnant women or women of childbearing potential, nursing mothers, and patients at high risk of myopathy or rhabdomyolysis. Patients particularly at risk for myopathy should have their serum creatine kinase (CPK) levels checked before administration, and if symptoms such as muscle pain, muscle cramps, or muscle weakness occur, they should consult a doctor immediately. If CPK levels exceed five times the upper limit of normal, this medication should be discontinued. Patients with liver function issues should also exercise caution. Those with elevated liver enzyme levels or signs of liver damage should undergo regular liver function tests, and if serious liver damage is suspected, this medication should be discontinued. This medication may interact with other drugs, so any currently taken medications should be reported to a physician. This is particularly important when used in conjunction with cyclosporine, fibrate-class medications, and anticoagulants such as warfarin. Pregnant or nursing women should not take this medication, and women of childbearing age should ensure appropriate contraception while taking it. Elderly patients or those with impaired renal function are also at high risk for myopathy and should exercise caution, while safety in pediatric patients has not been established and is therefore not recommended. In case of overdose, treatment and supportive care should be based on symptoms, and monitoring of liver function tests and blood CPK levels is crucial. This medication should be kept out of reach of children, and care should be taken not to change the container as it may negatively affect the quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, edema, chest tightness, difficulty breathing, cold sweat, pallor, high fever, severe rash, blistering, peeling of the skin, pain in the mucous membranes of the mouth and eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), severe fatigue, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output

Mild side effects

  • Nasal pharyngitis
  • arthralgia
  • headache
  • ALT elevation
  • AST elevation
  • myalgia
  • edema
  • elevated serum bilirubin
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory tract infections
  • cough
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • urticaria
  • rash
  • dermatitis
  • skin burning sensation
  • alopecia
  • itching

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a sealed container. The storage temperature should be kept between 1 to 30 degrees Celsius at room temperature to maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

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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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.