Medication info

Ezervib Tablet 10 mg (Ezetimibe)

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
white to almost white oblong tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Expired

MFDS item code 201903416 · Approved 2019.05.27

This product's status changed to Expired on 2024.05.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and sitosterolemia
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, taken without regard to meals. If used in combination with HMG-CoA reductase inhibitors, initiate treatment at the recommended starting dose of the HMG-CoA reductase inhibitor in conjunction with this medication, and if already taking a high dose of HMG-CoA reductase inhibitors, continue that dosage while using this medication. If used with fenofibrate,

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Treatment for improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and sitosterolemia

  • primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • homozygous sitosterolemia
View approved original text

This medication is used for the treatment of several types of hyperlipidemia, including primary hypercholesterolemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It particularly helps to lower levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B. It can be used in combination with dietary therapy or other medications such as HMG-CoA reductase inhibitors and fenofibrate. This medication plays an important role in reducing the risk of atherosclerotic vascular disease caused by hypercholesterolemia. Additionally, a precise diagnosis of the cause of dyslipidemia should be made prior to treatment initiation, and secondary causes should also be treated if necessary. Regular lipid testing is essential for safe and effective treatment, and this medication significantly contributes to the management of hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, taken without regard to meals. If used in combination with HMG-CoA reductase inhibitors, initiate treatment at the recommended starting dose of the HMG-CoA reductase inhibitor in conjunction with this medication, and if already taking a high dose of HMG-CoA reductase inhibitors, continue that dosage while using this medication. If used with fenofibrate,

Precautions

This medication should not be used in patients with allergies to certain components. Patients with active liver disease or persistent liver dysfunction should avoid combining this medication with specific lipid-lowering agents. Pregnant or nursing women should exercise caution as the combination of this medication with specific lipid-lowering agents is prohibited. Patients with severe liver function impairment, gallbladder disease, or severe renal impairment are not recommended to use this medication in combination with specific lipid-lowering agents. Patients with lactose intolerance or genetic digestive disorders should not take this medication. Patients with moderate to severe liver dysfunction should be cautious as exposure to this medication may increase in these cases. This medication is generally well tolerated, but side effects such as headache, abdominal pain, diarrhea, fatigue, and myalgia may occur, so patients should consult a doctor if symptoms persist. When this medication is used with statins, there may be a slightly increased risk of elevation in liver enzyme levels and muscle-related side effects, hence regular monitoring is necessary. If symptoms of muscle pain or weakness occur, healthcare professionals should be notified immediately, and discontinuation of the medication may be required in some cases. Patients with renal function impairment also need to proceed with caution, particularly when combining with statins, requiring dose adjustment and monitoring. This medication may interact with other drugs, so patients must inform their healthcare provider of any other medications they are taking. Pregnant or nursing women should consult a doctor before taking this medication and consider its effects on the fetus or infant. In children, it is not recommended for those under 6 years old, while from 6 years old and older, they exhibit similar responses as adults. Elderly patients can generally use it safely, although they may have sensitive reactions depending on the individual. When storing the medication, keep it out of reach of children and do not transfer it to a different container.

Side effects and when to seek care immediately

Serious side effects

hives, severe swelling (edema), anaphylaxis, angioedema, severe allergic reactions, hepatitis, pancreatitis, thrombocytopenia, hives, erythema multiforme, cholelithiasis, cholecystitis, renal failure, liver dysfunction (jaundice), liver dysfunction, increased levels of liver aminotransferase, persistent elevation of aminotransferase levels (over thrice the normal upper limit), myopathy, rhabdomyolysis, severe swelling, abnormal urination

Mild side effects

  • fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • dizziness
Show 29 more
  • constipation
  • bloating
  • nausea
  • myalgia
  • headache
  • queasiness
  • vomiting
  • gastritis
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • chest pain
  • chest discomfort
  • weakness
  • generalized edema
  • trembling
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • and more

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 sealed container. It is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

white to almost white oblong tablet

Package unit

30 tablets (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.