Medication info
Oter Soft Capsule (Omega-3 Fatty Acid Ethyl Ester 90)

Oter Soft Capsule (Omega-3 Fatty Acid Ethyl Ester 90)

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
(주)이든파마
Appearance
Transparent rectangular soft capsule filled with a pale yellow oily substance
Packaging
60 capsules/box[[(10 capsules/PTP*3)/pack]*2/box], 30 capsules/bottle, 60 capsules/bottle
Approval status
Active

MFDS item code 202004113 · Approved 2020.05.29 · Insurance code 628901830

Summary

Main use
Improvement of hypertriglyceridemia and hypercholesterolemia (mixed type)
Who takes it
Adults
Adult dose
This medication should only be taken after appropriate lipid-lowering dietary therapy has been implemented, and it should continue during the treatment period. The medication should be taken with food to avoid gastrointestinal discomfort. The usual initial dose is 2g (2 capsules) per day, and the dose may be increased to 4g per day if needed. It can be taken once or twice a day.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Improvement of hypertriglyceridemia and hypercholesterolemia (mixed type)

  • Hypertriglyceridemia
  • hypercholesterolemia
  • elevated triglyceride levels
View approved original text

This medication is used for endogenous hypertriglyceridemia, particularly as monotherapy for type IV. Additionally, it can be used in conjunction with statin drugs for type IIb patients who have combined hypercholesterolemia and hypertriglyceridemia. It is also helpful as combination therapy for patients with the mixed type whose triglyceride levels are not adequately controlled. Thus, this drug effectively acts in various cases associated with hypertriglyceridemia to reduce triglyceride levels in the blood.

How to take

Adult dose

This medication should only be taken after appropriate lipid-lowering dietary therapy has been implemented, and it should continue during the treatment period. The medication should be taken with food to avoid gastrointestinal discomfort. The usual initial dose is 2g (2 capsules) per day, and the dose may be increased to 4g per day if needed. It can be taken once or twice a day.

Precautions

This medication should not be used by individuals with an allergy to its components or children under 18 years of age. Patients at high risk for bleeding due to severe trauma or surgery, those with poor liver function, and individuals allergic to fish should use this medication cautiously. Various side effects may occur during use, with common symptoms including back pain, cold symptoms, dyspepsia, rash, and altered taste sensation. Rarely, various symptoms such as heart-related issues, gastrointestinal problems, neurological symptoms, and skin diseases have been reported, so if any abnormal symptoms appear, immediate consultation with a healthcare professional is necessary. Before taking this medication, it is important to check triglyceride levels through a blood test and to follow a diet and exercise regimen. Blood tests should be periodically conducted during treatment to monitor the drug's effects and side effects; if there is no effect, discontinuation may be considered. This medication is not indicated for certain types of dyslipidemia, and caution is required due to the lack of experience in combination with other lipid-regulating agents. Regular monitoring of liver function tests such as ALT and LDL cholesterol levels is necessary, and caution must be taken for patients at risk of bleeding, as their bleeding time may be prolonged. In patients with cardiovascular diseases or risk factors, a high dosage may increase the risk of atrial fibrillation, so if symptoms appear, immediate discontinuation is advised. Taking this medication with blood thinners or aspirin may increase the risk of bleeding, so if taken together, the coagulation status must be carefully monitored. During pregnancy, safety for the fetus has not been established, so it should only be used when the benefits outweigh the risks, and breastfeeding women should also use it with caution. Safety for children and the elderly has not been sufficiently confirmed, so caution should be exercised in these populations. In case of overdose, appropriate treatment should be administered according to the symptoms, and supportive therapy may be needed. Finally, this medication should be stored out of reach of children, and transferring it to another container is not advisable for safety and quality maintenance.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis,

Mild side effects

  • Back pain
  • cold symptoms
  • infections
  • pain
  • angina
  • dyspepsia
  • belching
  • rash
  • altered taste sensation
  • abdominal bloating
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  • asthenia
  • body odor
  • chest pain
  • chills
  • suicidal tendencies
  • fever
  • fungal infections
  • fatigue
  • sore throat
  • tumors
  • rheumatoid arthritis
  • sudden death
  • viral infections
  • arrhythmias
  • bypass surgery
  • cardiac arrest
  • hyperlipidemia
  • hypertension
  • migraines
  • myocardial infarction
  • myocardial ischemia
  • obstruction
  • peripheral vascular disorders
  • syncope
  • tachycardia
  • loss of appetite
  • constipation

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained at or below 25 degrees Celsius, and care should be taken to avoid freezing.

Appearance and packaging

Appearance

Transparent rectangular soft capsule filled with a pale yellow oily substance

Package unit

60 capsules/box[[(10 capsules/PTP*3)/pack]*2/box], 30 capsules/bottle, 60 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.

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.