Medication info

Vascepa Soft Capsules 998 mg (Eicosapentaenoic Acid Ethyl Ester)

Prescription medicationSoft capsuleOral
Ingredient · strength
Ethyl Icosapentate›1000mg / 1 capsule
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
Bright yellow to yellow oblong soft capsules containing a colorless to pale yellow liquid
Packaging
120 capsules/bottle
Approval status
Active

MFDS item code 202501261 · Approved 2025.05.22

Summary

Main use
Prevention of cardiovascular events (including myocardial infarction and stroke) in high-risk adults
Who takes it
Adults
Adult dose
The recommended adult dose is 2 capsules (998mg per capsule) twice daily (4 capsules total per day), taken orally with or after meals. If you miss a dose, take it as soon as you remember. However, do not take a double dose at one time to make up for the missed dose. Do not chew, dissolve, or crush this medicine.

Ingredients

Importer
Alvogen Korea Co., Ltd.

Efficacy & effects

Prevention of cardiovascular events (including myocardial infarction and stroke) in high-risk adults

View approved original text

This medication is used in adult patients who fall into the high-risk category for cardiovascular disease, with triglyceride levels above 150 mg/dL, and who are already receiving statin therapy. It particularly helps reduce the risk of cardiovascular events such as death from cardiovascular disease, myocardial infarction, stroke, revascularization procedures, or hospitalization for unstable angina in patients with a history of cardiovascular disease or with diabetes plus one or more cardiovascular risk factors. Therefore, it is effective in improving the cardiovascular health of these patients.

How to take

Adult dose

The recommended adult dose is 2 capsules (998mg per capsule) twice daily (4 capsules total per day), taken orally with or after meals. If you miss a dose, take it as soon as you remember. However, do not take a double dose at one time to make up for the missed dose. Do not chew, dissolve, or crush this medicine.

Precautions

This medication should not be used by individuals who are allergic to peanuts or legumes or who have a hypersensitivity to any of the components of this medication. Additionally, patients with hereditary fructose intolerance should avoid this medication due to the sorbitol and maltitol it contains. Individuals with fish allergies should use this medication with caution. Patients with impaired liver function should have regular liver function tests before and during treatment. Patients with a history of atrial fibrillation or flutter should carefully monitor their heart condition while taking this medication. Patients taking anticoagulants or antiplatelet drugs may have an increased risk of bleeding, thus regular blood tests are necessary. Taking this medication may cause side effects such as bleeding, peripheral edema, atrial fibrillation, constipation, muscle pain, gout, and skin rashes. In particular, caution is needed as bleeding can manifest as gastrointestinal bleeding, bruising, or hematuria. Symptoms of atrial fibrillation or flutter may worsen, and if related symptoms appear, one should immediately consult a healthcare professional. During pregnancy, the use of this medication should be carefully considered, weighing the potential risks to the fetus, and in cases of breastfeeding, consultation with a doctor is necessary since the components may be transmitted through breast milk. Use is not recommended for children under 18 years old as the safety and efficacy of this medication have not been established. For elderly patients, no special dosage adjustments are necessary. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms. This medication should be kept out of reach of children, and expired medications should never be used.

Side effects

  • Hemorrhage
  • peripheral edema
  • atrial fibrillation
  • constipation
  • musculoskeletal pain
  • gout
  • rash
  • pharyngitis
  • taste disorder
  • belching
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  • increased triglycerides in the blood
  • arthralgia
  • diarrhea
  • abdominal discomfort
  • limb pain
  • gastrointestinal hemorrhage
  • contusion
  • hematuria
  • epistaxis

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 sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Storing in this manner will help ensure the medication's effectiveness.

Appearance and packaging

Appearance

Bright yellow to yellow oblong soft capsules containing a colorless to pale yellow liquid

Package unit

120 capsules/bottle

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.

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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.