omega 3 carboxylic acids (Rx)

>10%

Diarrhea (7-15%)

1-10%

Nausea (4-6%)

Abdominal pain/discomfort (3-5%)

Eructation (3%)

Postmarketing Reports

Vomiting

Flatulence

Dysgeusia

Contraindications

Hypersensitivity (eg, anaphylaxis)

Cautions

May increase LDL-C levels, monitor periodically

Monitor ALT and AST levels periodically in patients with hepatic impairment

Contains polyunsaturated free fatty acids derived from fish oils; caution in patients with known allergies to fish and/or shellfish

Prolonged bleeding time reported with omega- 3 fatty acids; caution if coadministered with anticoagulants or antiplatelet agents

Pregnancy: There are no studies in pregnant women and the limited available data are not sufficient to inform a drug-associated risk for major birth defects or miscarriages

Lactation: Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from the underlying maternal condition

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Omega-3 fatty acids reduce hepatic production of triglyceride (TG)-rich very low density lipoproteins (VLDL) and may increase the removal rate of TG-rich lipoproteins by increasing lipoprotein lipase activity, in humans

Some potential cellular mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal beta-oxidation in the liver, and decreased lipogenesis in the liver

Absorption

Peak plasma time: 5-9 hr

Steady state (EPA, DHA) achieved: 2 weeks

Directly absorbed in small intestine, then enters systemic circulation mainly via the thoracic duct lymphatic system

Distribution

Majority of EPA and DHA in plasma incorporated in phospholipids, triglycerides, and cholesteryl esters

Metabolism

Mainly oxidized in liver to fatty acids derived from dietary sources

Elimination

Half-life: 37 hr (EPA); 46 hr (DHA)

Plasma clearance: 548 mL/hr (EPA); 518 mL/hr (DHA)

Does not undergo renal excretion

Oral Administration

May take with or without food

Swallow capsule whole; do not break open, crush, dissolve, or chew

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

Do not freeze