
OMG-31000 mg
Drug International Ltd.
Indications Omega-3 Acid Ethyl Esters is FDA-approved as an adjunct to diet for the reduction of very high triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (fasting TG ≥…
Omega-3 Acid Ethyl Esters is FDA-approved as an adjunct to diet for the reduction of very high triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (fasting TG ≥ 500 mg/dL).
Before starting Omega-3 Acid Ethyl Esters, secondary causes of hypertriglyceridemia (poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, alcohol use, or certain medications) should be ruled out or treated.
| Indication | Population | Recommended Dose |
|---|---|---|
| Severe hypertriglyceridemia (adjunct to diet) | Adults | 4 grams per day, taken as a single 4-capsule dose once daily, or as 2 capsules twice daily |
| Severe hypertriglyceridemia | Pediatric patients | Safety and efficacy not established; not routinely recommended |
Patients should remain on an appropriate lipid-lowering diet throughout treatment with Omega-3 Acid Ethyl Esters. A lipid panel (including LDL-C) should be obtained before starting therapy and periodically thereafter to assess response and monitor for LDL-C elevation (see Precautions and Warnings).
No dedicated dose adjustment guidance exists for renal or hepatic impairment, but liver enzymes should be monitored periodically in patients with hepatic impairment (see Use in Special Populations).
The most commonly reported adverse effects with Omega-3 Acid Ethyl Esters include:
Less common but clinically important effects include elevated liver enzymes (ALT), increased LDL cholesterol, and an increased risk of atrial fibrillation or atrial flutter, particularly in patients with pre-existing cardiovascular disease (see Precautions and Warnings). Patients should seek prompt medical attention for palpitations, irregular heartbeat, unusual bleeding or bruising, or signs of an allergic reaction (rash, swelling, difficulty breathing).
Omega-3 Acid Ethyl Esters is contraindicated in patients with known hypersensitivity to Omega-3 Acid Ethyl Esters, fish-derived products, or any component of the formulation.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.