Omega-3 Acid Ethyl Esters (omega-3 acid ethyl esters)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Omega-3-acid ethyl esters, a combination consisting predominantly of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is used as an antilipemic agent.
Omega-3-acid ethyl esters is a preparation consisting predominantly of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA, collectively known as marine-derived omega-3 fatty acids (n-3 fatty acids), are long-chain, polyunsaturated fatty acids (PUFAs) that are obtained mainly from marine sources such as fatty fish (e.g., herring, mackerel, salmon, sardines, tuna). Capsules of Lovaza(R) also contain alpha-tocopherol in a carrier of soybean oil or sunflower oil, respectively.
The mechanism of action of omega-3-acid ethyl esters is not completely understood; however, the drug may inhibit diacylglycerol O-acyltransferase, increase mitochondrial and peroxisomal beta-oxidation in the liver, decrease lipogenesis in the liver, and increase plasma lipoprotein lipase activity. Omega-3-acid ethyl esters may reduce the synthesis of triglycerides and very low-density lipoprotein (VLDL)-cholesterol in the liver because EPA and DHA are poor substrates for the enzymes responsible for triglyceride synthesis; EPA and DHA also inhibit esterification of other fatty acids.
EPA and DHA are absorbed systemically following oral administration as ethyl esters. Oral administration of omega-3-acid ethyl esters results in substantial, dose-dependent increases in EPA content in serum phospholipids and less substantial, non-dose-dependent increases in DHA content. Uptake of EPA and DHA into serum phospholipids in patients receiving omega-3-acid ethyl esters is independent of age.
EPA uptake, however, appears to be higher in women than in men. Pharmacokinetics of omega-3-acid ethyl esters have not been specifically studied in pediatric patients or patients with hepatic or renal impairment.
Omega-3-acid ethyl esters is commercially available in the US as a prescription drug. Each 1-g capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids (approximately 465 mg from ethyl esters of EPA and 375 mg from ethyl esters of DHA) from fish oil sources. Marine-derived omega-3 fatty acids also are commercially available in the US as nonprescription dietary supplements (fish-oil capsules) containing widely variable amounts and ratios of EPA and DHA; the most common fish-oil capsules in the US provide approximately 180 mg of EPA and 120 mg of DHA per capsule.
USES: Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by non-drug treatments (such as diet changes, exercise, decreasing alcohol intake, weight loss if overweight, controlling blood sugar if diabetic, and regulating your thyroid hormone levels).
Lowering triglycerides and increasing "good" cholesterol may help decrease the risk for strokes and heart attacks. Omega-3 acid ethyl esters are thought to work by decreasing the amount of triglyceride the body makes.
Generic name: omega-3 acid ethyl esters
Pronunciation: (oh-MAY-gah 3 AS-id ETH-il ES-ters)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Omega-3 Acid Ethyl Esters
Indications
The following indications are listed for Omega-3 Acid Ethyl Esters:
- Hypertriglyceridemia
Also known as: Abnormally Increased Triglycerides In The Blood, Elevated Triglyceride Level, Increased Triglyceride Levels.
Dosing
Each 1-g capsule contains at least 900 mg of the ethyl esters of omega-3 fatty acids (approximately 465 mg from ethyl esters of EPA and 375 mg from ethyl esters of DHA).
In clinical studies, omega-3-acid ethyl esters (Lovaza(R)) was administered with meals.
Omega-3-acid ethyl esters capsules should be swallowed whole and should not be broken, crushed, dissolved, or chewed.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in >=3% of patients receiving omega-3-acid ethyl esters and more frequently than with placebo include eructation, dyspepsia, and taste perversion.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of omega-3-acid ethyl esters have not been established in pediatric patients.
Available data are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes with the use of omega-3-acid ethyl esters in pregnant women.
No teratogenic or adverse developmental effects have been observed in animal reproduction studies.
Omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been detected in human milk. Higher levels of omega-3 fatty acids have been observed in the milk of lactating women receiving omega-3 fatty acid supplementation. There are no data on the effects of omega-3 fatty acid ethyl esters on the breast-fed infant or on milk production.
Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
Experience in patients >65 years of age is limited. No substantial differences in safety and efficacy were observed between patients >60 years of age and younger patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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