omega-3-acid ethyl esters
Omega-3-Acid Ethyl Esters is an omega-3 fatty acid.
Omega-3 Fatty Acid · by Puracap Pharm LLC
Key facts
- Active ingredient
- Omega-3-Acid Ethyl Esters
- Drug class
- Omega-3 Fatty Acid
- Form
- Capsule
- Strength
- OMEGA-3-ACID Ethyl Esters 1GM Contains AT Least 900MG OF THE Ethyl Esters OF OMEGA-3 Fatty Acids
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Puracap Pharm LLC
- What the pharmacy pays
- ~$5.16 for 30 — not your price
- FDA application
- ANDA210093
What is Omega-3-Acid Ethyl Esters?
From the FDA label:Omega-3-acid ethyl esters, USP, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters 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: gelatin, glycerin and purified water. The imprinting ink contains the following: propylene glycol, shellac glaze and titanium dioxide. EPA.jpg DHA.jpg
How to use
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 was 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 )
Side effects
The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [Epic Pharma LLC at 1-888-374-2791] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 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 Adverse Reaction * Omega-3-Acid Ethyl Esters (n = 655) Placebo (n = 370) n % n % Eructation 29 4 5 1 Dyspepsia 22 3 6 2 Taste perversion 27 4 1 <1 * Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. 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. 6.2 Postmarketing Experience In addition to…
Warnings
Important safety information
In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1 ) Omega-3-acid ethyl esters 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 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 ) 5.1 Monitoring: 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. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed. In some patients, omega-3-acid ethyl esters increases low-density lipoprotein cholesterol (LDL-C) levels. LDL-C levels should be monitored periodically during therapy with omega-3-acid ethyl esters. Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy with omega-3-acid ethyl esters. 5.2 Fish Allergy Omega-3-acid ethyl esters 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. Omega-3-acid ethyl esters should be used with caution in patients with known hypersensitivity to fish and/or shellfish. 5.3 Recurrent 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 who received 8 grams per 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 [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 [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 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 are not indicated for the treatment of AF or flutter.
Who should not take Omega-3-Acid Ethyl Esters
Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters 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 or any of its components. ( 4 )
Interactions
Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ( 7.1 ) 7.1 Anticoagulants 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 and concomitant anticoagulants. Patients receiving treatment with omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Drug class
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How much does Omega-3-Acid Ethyl Esters cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $5.16 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Omega-3-Acid Ethyl Esters?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Omega-3-Acid Ethyl Esters. To pay less, Omega-3-Acid Ethyl Esters is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Omega-3-Acid Ethyl Esters?
- Omega-3-Acid Ethyl Esters is marketed by Puracap Pharm LLC. You can see Puracap Pharm LLC's full profile, rating, and other products on pharmaranks.
- Is Omega-3-Acid Ethyl Esters a brand-name or generic drug?
- Omega-3-Acid Ethyl Esters is a generic medication; its active ingredient is Omega-3-Acid Ethyl Esters. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Omega-3-Acid Ethyl Esters available over the counter?
- No. Omega-3-Acid Ethyl Esters is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Omega-3-Acid Ethyl Esters come in?
- Omega-3-Acid Ethyl Esters is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Omega-3-Acid Ethyl Esters?
- Omega-3-Acid Ethyl Esters is classified as omega-3 fatty acid, per the FDA's Established Pharmacologic Class.
- Is Omega-3-Acid Ethyl Esters FDA-registered?
- Omega-3-Acid Ethyl Esters is on record with the U.S. FDA under application number ANDA210093. You can verify this on its official FDA label.
- Is Omega-3-Acid Ethyl Esters safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Omega-3-Acid Ethyl Esters. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Omega-3-Acid Ethyl Esters?
- Omega-3-Acid Ethyl Esters's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [Epic Pharma LLC at 1-888-374-2791] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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