OMEGA-3-ACID ETHYL ESTERS 1 g Capsule, Liquid Filled
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Omega-3 fatty acids are used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood in people with very high triglycerides. Omega-3 fatty acids are in a class of medications called antilipemic or lipid-regulating agents. Omega-3 fatty acids may work by decreasing the amount of triglycerides and other fats made in the liver.
Read the full MedlinePlus article ↗- Great question. Omega-3-acid ethyl esters capsules — including the brand Lovaza — are a prescription-strength, highly concentrated form of omega-3 fatty acids. They're specifically...
- What exactly is this medication for — isn't fish oil something you can just buy at the store?
- Yes, absolutely. This medication is meant to work alongside a triglyceride-lowering diet — not replace it. You should start the diet before beginning treatment and continue it the...
- Do I still need to follow a diet even though I'm taking this medication?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.173 | $8.63 / 50 capsule |
| Medicaid paysCMS SDUD · 12 mo | $0.2432 | $12.16 / 50 capsule |
| Medicare drug plans payPart D · Q2 2026 | $0.2792 | $13.96 / 50 capsule |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Omega-3-Acid Ethyl Esters 1 gthis 00904-7495-06 | Major | 1 capsule | $0.173 | AB | Availability likely | — |
| Omega-3-Acid Ethyl Esters 1 g 24658-0350-12 | PURACAP | 120 capsules | $0.173 | AB | Availability likely | — |
| Omega-3-Acid Ethyl Esters 1 g 42806-0552-12 | EPIC | 120 capsules | $0.173 | AB | Availability likely | — |
| omega-3-acid ethyl esters 900 mg 60687-0846-65 | American | 50 capsules | $0.173 | AB | Availability likely | — |
| omega-3-acid ethyl esters 900 mg 62135-0780-12 | Chartwell | 120 capsules | $0.173 | AB | Availability likely | — |
| Omega-3-Acid Ethyl Esters 1 g 70756-0423-22 | Lifestar | 120 capsules | $0.173 | AB | Availability likely | — |
| Omega-3-acid ethyl esters 900 mg 00254-3010-08 | Par | 120 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 00615-8550-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 31722-0936-05 | Camber | 500 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 50090-5799-00 | A-S | 120 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 50090-5800-02 | A-S | 1440 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 50090-6691-00 | A-S | 120 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 50090-6692-00 | A-S | 120 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 50090-6822-00 | A-S | 120 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 51407-0763-12 | Golden | 120 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 63629-1918-01 | Bryant | 120 capsules | — | AB | FDA listed | — |
| omega-3-acid ethyl esters 900 mg 64380-0761-02 | Strides | 50 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 65162-0034-06 | Amneal | 60 capsules | — | — | Discontinued | — |
| Omega-3-Acid Ethyl Ester 900 mg 69452-0175-17 | Bionpharma | 60 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 70518-3040-00 | REMEDYREPACK | 180 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 71335-2024-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 72162-1310-02 | Bryant | 120 capsules | — | AB | FDA listed | — |
| Omega-3-acid ethyl esters 1 g 72865-0139-05 | XLCare | 500 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 72998-0850-12 | KD | 120 capsules | — | AB | FDA listed | — |
| Omega-3-Acid Ethyl Esters 1 g 72998-0851-12 | KD | 120 capsules | — | AB | FDA listed | — |
| Lovaza 1 g 80725-0420-12 | Waylis | 120 capsules | — | AB | Discontinued | — |
| Omega-3-acid ethyl esters 1 g 70518-4744-00 | REMEDYREPACK | 180 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00904-7495-06 You're viewing this | 50 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2024-12-13 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules.
Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of TG-lowering drug therapy. Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. Omega-3-acid ethyl esters capsules are combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: • The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.
( 1 ) • The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Assess TG levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high TG levels and manage as appropriate [see Indications and Usage (1) ] . • Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. In clinical studies, omega-3-acid ethyl esters capsules were administered with meals.
The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). Patients should be advised to swallow omega-3-acid ethyl esters capsules whole.
Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules. . • The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). ( 2 ) • Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, soft-gelatin capsules filled with light to pale yellow oil and bearing the designation "LS 423" on one side of the capsules. Capsules: 1 gram ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components. Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1 ) • Omega-3-acid ethyl esters capsules may increase levels of low-density lipoprotein (LDL). Monitor LDL levels periodically during therapy.
( 5.1 ) • Use with caution in patients with known hypersensitivity to fish and/or shellfish. ( 5.2 ) • There is a possible association between omega-3-acid ethyl esters capsules and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first months of initiating therapy. ( 5.3 )
5.1Monitoring: Laboratory Tests In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with omega-3-acid ethyl esters capsules. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed. In some patients, omega-3-acid ethyl esters capsules increases low-density lipoprotein cholesterol (LDL-C) levels.
LDL-C levels should be monitored periodically during therapy with omega-3-acid ethyl esters capsules. Laboratory studies should be performed periodically to measure the patient's TG levels during therapy with omega-3-acid ethyl esters capsules.
5.2Fish Allergy Omega-3-acid ethyl esters capsules contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to omega-3-acid ethyl esters capsules. Omega-3-acid ethyl esters capsules should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
5.3Recurrent Atrial Fibrillation (AF) or Flutter In a double-blind, placebo-controlled trial of 663 subjects with symptomatic paroxysmal AF (n = 542) or persistent AF (n = 121), recurrent AF or flutter was observed in subjects randomized to omega-3-acid ethyl esters capsules who received 8 grams/day for 7 days and 4 grams/day thereafter for 23 weeks at a higher rate relative to placebo. Subjects in this trial had median baseline TG levels of 127 mg/dL, had no substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control permitted), and were in normal sinus rhythm at baseline.
At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or flutter events on placebo and 141 (53%) on omega-3-acid ethyl esters capsules (primary endpoint, HR: 1.19; 95% CI: 0.93, 1.35). In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events on omega-3-acid ethyl esters capsules (HR: 1.63; 95% CI: 0.91, 2.18). For both strata combined, the HR was 1.25; 95% CI: 1.00, 1.40.
Although the clinical significance of these results is uncertain, there is a possible association between omega-3-acid ethyl esters capsules and more frequent recurrences of symptomatic AF or flutter in patients with paroxysmal or persistent AF, particularly within the first 2 to 3 months of initiating therapy. Omega-3-acid ethyl esters capsules are not indicated for the treatment of AF or flutter.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995- 4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported in at least 3% of subjects treated with omega-3-acid ethyl esters capsules and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1. Table 1.
Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of Omega-3-acid ethyl esters capsules a Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. Adverse Reaction a Omega-3-acid ethyl esters capsules (n = 655) Placebo (n = 370) n % n % Eructation 29 4 5 1 Dyspepsia 22 27 3 4 6 1 2 <1 Taste perversion Additional adverse reactions from clinical trials are listed below: Digestive System Constipation, gastrointestinal disorder, and vomiting. Metabolic and Nutritional Disorders Increased ALT and increased AST.
Skin Pruritus and rash.
6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of omega-3-acid ethyl esters capsules. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure. The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters capsules and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ( 7.1 )
7.1Anticoagulants or Other Drugs Affecting Coagulation Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of omega-3-acid ethyl esters capsules and concomitant anticoagulants.
Patients receiving treatment with omega-3-acid ethyl esters capsules and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters capsules in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (MRHD) of 4 grams/day, based on a body surface area comparison.
Omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data: In female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]). In a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through Postpartum Day 7 had decreased live births (20% reduction) and pup survival to Postnatal Day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the MRHD based on body surface area [mg/m 2 ]).
In pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/day (14 times the MRHD based on body surface area [mg/m 2 ]). In pregnant rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) from Gestation Day 14 through Lactation Day 21, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]).
In pregnant rabbits given oral doses of omega-3-acid ethyl esters (375, 750, or 1,500 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses given 375 mg/kg/day (2 times the MRHD based on body surface area [mg/m 2 ]). However, at higher doses, increases in fetal skeletal variations and reduced fetal growth were evident at maternally toxic doses (reduced food consumption and body weight gain) greater than or equal to 750 mg/kg/day (4 times the MRHD), and embryolethality was evident at 1,500 mg/kg/day (7 times the MRHD).
8.2Lactation Risk Summary Published studies have detected omega-3 fatty acids, including EPA and DHA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data available on the effects of omega3 fatty acid ethyl esters on the breastfed infant or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omega-3-acid ethyl esters capsules and any potential adverse effects on the breastfed child from omega-3-acid ethyl esters capsules or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters capsules. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters capsules in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (MRHD) of 4 grams/day, based on a body surface area comparison.
Omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data: In female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]). In a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through Postpartum Day 7 had decreased live births (20% reduction) and pup survival to Postnatal Day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the MRHD based on body surface area [mg/m 2 ]).
In pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/day (14 times the MRHD based on body surface area [mg/m 2 ]). In pregnant rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) from Gestation Day 14 through Lactation Day 21, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]).
In pregnant rabbits given oral doses of omega-3-acid ethyl esters (375, 750, or 1,500 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses given 375 mg/kg/day (2 times the MRHD based on body surface area [mg/m 2 ]). However, at higher doses, increases in fetal skeletal variations and reduced fetal growth were evident at maternally toxic doses (reduced food consumption and body weight gain) greater than or equal to 750 mg/kg/day (4 times the MRHD), and embryolethality was evident at 1,500 mg/kg/day (7 times the MRHD).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters capsules. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of omega-3-acid ethyl esters capsules are not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β -oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Omega-3-acid ethyl esters capsules may reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.
12.3Pharmacokinetics Absorption In healthy volunteers and in subjects with hypertriglyceridemia, EPA and DHA were absorbed when administered as ethyl esters orally. Omega-3-acids administered as ethyl esters (Omega-3-acid ethyl esters capsules) induced significant dose-dependent increases in serum phospholipid EPA content, though increases in DHA content were less marked and not dose-dependent when administered as ethyl esters. Specific Populations Age: Uptake of EPA and DHA into serum phospholipids in subjects treated with omega-3-acid ethyl esters capsules was independent of age (younger than 49 years versus 49 years and older).
Male and Female Patients: Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown. Pediatric Patients: Pharmacokinetics of omega-3-acid ethyl esters capsules have not been studied.
Patients with Renal or Hepatic Impairment: Omega-3-acid ethyl esters capsules have not been studied in patients with renal or hepatic impairment. Drug Interaction Studies Simvastatin: In a 14-day trial of 24 healthy adult subjects, daily coadministration of simvastatin 80 mg with omega-3-acid ethyl esters capsules 4 grams did not affect the extent (AUC) or rate (C max ) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin, at steady state. Atorvastatin: In a 14-day trial of 50 healthy adult subjects, daily coadministration of atorvastatin 80 mg with omega-3-acid ethyl esters capsules 4 grams did not affect AUC or C max of exposure to atorvastatin, 2- hydroxyatorvastatin, or 4- hydroxyatorvastatin at steady state.
Rosuvastatin: In a 14-day trial of 48 healthy adult subjects, daily coadministration of rosuvastatin 40 mg with omega-3-acid ethyl esters capsules 4 grams did not affect AUC or C max of exposure to rosuvastatin at steady state. In vitro studies using human liver microsomes indicated that clinically significant cytochrome P450-mediated inhibition by EPA/DHA combinations are not expected in humans.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of omega-3-acid ethyl esters capsules are not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β -oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Omega-3-acid ethyl esters capsules may reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram, transparent, soft-gelatin capsules filled with light to pale yellow oil and bearing the designation "LS 423" on one side of the capsules. Cartons of 50 liquid-filled capsules (10 liquid-filled capsules each blister pack x 5), NDC 0904-7495-06 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and do not freeze. Keep out of reach of children.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure
📋 Description ▾
11 DESCRIPTION Omega-3-acid ethyl esters, USP a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA — approximately 465 mg) and docosahexaenoic acid (DHA — approximately 375 mg).
The empirical formula of EPA ethyl ester is C 22 H 34 O 2 , and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is: The empirical formula of DHA ethyl ester is C 24 H 36 O 2 , and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is: Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg a-tocopherol, gelatin, glycerol, and purified water (components of the capsule shell).
EPA chemical structure DHA chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Information for Patients • Omega-3-acid ethyl esters capsules should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions (5.2) ] . • Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet [see Dosage and Administration (2) ] . • Advise patients not to alter omega-3-acid ethyl esters capsules in any way and to ingest intact capsules only [see Dosage and Administration (2) ] . • Instruct patients to take omega-3-acid ethyl esters capsules as prescribed.
If a dose is missed, advise patients to take it as soon as they remember. However, if they miss one day of omega-3-acid ethyl esters capsules, they should not double the dose when they take it. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd.
Mahwah, NJ 07430 USA Made in India Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Revised: January 2025, V-03