Omesoft

• Severe Hypertriglyceridemia: Adjunct to diet for reducing triglyceride levels ≥500 mg/dL in adults.
• Cardiovascular Risk Reduction: In adults with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease or diabetes with additional risk factors (specific to icosapent ethyl).
• Prevention of Pancreatitis: Secondary prevention in patients with severe hypertriglyceridemia.
• Off-label Uses: Adjunctive treatment for mixed dyslipidemia and certain inflammatory conditions.

• Route: Oral capsules.
• Adults:
• Severe hypertriglyceridemia: 4 grams daily (2 grams twice daily with meals or 4 grams once daily).
• Cardiovascular risk reduction (icosapent ethyl): 2 grams twice daily with meals.
• Pediatrics: Safety and efficacy not established.
• Elderly: No dosage adjustment needed.
• Renal Impairment: No dosage adjustment needed.
• Hepatic Impairment: Use cautiously; no specific dose recommendations.

Omega-3 acid ethyl esters contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). They reduce hepatic triglyceride synthesis by inhibiting diacylglycerol acyltransferase and increasing β-oxidation, which lowers very-low-density lipoprotein (VLDL) production and plasma triglyceride levels. EPA also exerts anti-inflammatory and antithrombotic effects, contributing to cardiovascular benefits.

• Absorption: Well absorbed orally; enhanced with food.
• Distribution: Incorporated into plasma phospholipids and lipoproteins; crosses blood-brain barrier and placenta.
• Metabolism: Metabolized primarily by β-oxidation; converted into bioactive eicosanoids.
• Half-life: Approximately 20–24 hours.
• Excretion: Mainly renal and fecal routes.

• Pregnancy: FDA Category C; limited human data but considered low risk. Essential fatty acids important for fetal development. Use only if clearly indicated.
• Lactation: Excreted into breast milk; generally considered safe and beneficial.

• Lipid-regulating agent; omega-3 fatty acid derivative.

• Known hypersensitivity to fish, shellfish, or product components.
• Caution in patients with bleeding disorders or on anticoagulants.
• Severe hepatic impairment (use cautiously).

• Increased bleeding risk; monitor if used with anticoagulants or antiplatelets.
• Possible LDL cholesterol increase with DHA-containing products.
• Monitor liver function in hepatic impairment.
• Use caution in fish allergy.
• Rare hypersensitivity reactions reported.

• Common: Burping, dyspepsia, nausea, diarrhea, fishy aftertaste.
• Less Common: Arthralgia, taste changes, rash.
• Serious (rare): Hypersensitivity, bleeding complications.

• May potentiate anticoagulants and antiplatelet agents, increasing bleeding risk.
• No significant CYP450 interactions.
• Best taken with meals for optimal absorption.

• Cardiovascular outcome trials (e.g., REDUCE-IT) support use of icosapent ethyl in high-risk patients with elevated triglycerides.
• Guidelines recommend omega-3 fatty acid ethyl esters as adjunct therapy in select patients for cardiovascular risk reduction.
• Safety alerts emphasize bleeding risk, particularly with anticoagulants.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from heat, moisture, and light.
• Keep capsules tightly sealed in original container.
• Do not freeze.