Dosing & Uses
Dosage Forms & Strengths
capsule
- 1g
- Each 1-gram capsule contains at least 96% eicosapentaenoic acid (EPA); does not contain any docosahexaenoic acid (DHA)
Severe Hypertriglyceridemia
Indicated as an adjunct to diet to reduce high triglyceride levels (ie, ≥500 mg/dL)
2g PO q12hr with food
Administration
Swallow capsule whole; do not break open, dissolve, crush, or chew
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
Arthralgia (2.3%)
Frequency Not Defined
Oropharyngeal pain
Warnings
Contraindications
Hypersensitivity to drug or any of its components
Cautions
Lipid levels should be assessed prior to initiating therapy
Identify other potential causes of hypertriglyceridemia (eg, hypothyroidism, diabetes mellitus, alcohol intake, medications) and provide appropriate treatment as necessary
Medications such as estrogens, beta blockers and thiazides have been shown to exacerbate hypertriglyceridemia; discontinue or change medications if possible, otherwise monitor carefully
Prior to therapy, patients must start on a healthy regimen that includes an appropriate lipid-lowering diet and exercise, and this must be continued during treatment
Effect on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined
Effect on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined
Monitor ALT and AST levels periodically in patients with hepatic impairment
Contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA) obtained from fish oil; caution in patients with known hypersensitivity to fish and/or shellfish
Omega-3 fatty acids may cause prolongation of bleeding time; monitor patients receiving concomitant anticoagulants/ anti-platelet therapy periodically
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Omega-3-acid ethyl esters excreted in human breast milk; effects unknown, exercise caution
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.
Pharmacology
Mechanism of Action
Ethyl ester of eicosapentaenoic acid (EPA); EPA has been shown to reduce hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion; enhances triglyceride clearance from circulating VLDL particle; may also increase beta-oxidation, inhibits acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT), decrease lipogenesis in liver, and increase plasma lipoprotein lipase activity
Absorption
De-esterified during absorption to active EPA that is absorbed in small intestine
Peak Plasma Time: 5 hr
Distribution
Protein Bound: >99% of unesterified EPA
Vd: 88 L
Metabolism
Mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids; minor CYP450 mediated metabolism
Elimination
Half-life: 89 hr
Does not undergo renal excretion
Total plasma clearance: 684 mL/hr
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Formulary
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