Classes
Omega 3 Fatty Acids
DEA Class; Rx
Common Brand Names; Lovaza, Vascazen, Omtryg, Omega-3-acid ethyl esters
- Lipid-Lowering Agents, Other;
- Nutritionals, Other
Description
Mixtures of ethyl esters or free fatty acids derived from fish oil primarily composed of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (500 mg/dL or greater) hypertriglyceridemia
Unknown effect on the risk for pancreatitis or cardiovascular morbidity and mortality
Indications
Indicated for the treatment of hypertriglyceridemia (i.e., triglyceride blood concentrations 500 mg/dL or more) as an adjunct to diet.
Contraindications
Hypersensitivity
Adverse Effects
- Eructation (4.9%)
- Infection (4.4%)
- Flu-like syndrome (3.5%)
- Dyspepsia (3.1%)
- Taste perversion (2.7%)
- Back pain (2.2%)
- Pain (1.8%)
- Rash (1.8%)
- Angina pectoris (1.3%)
- Anaphylactic reaction
- Hemorrhagic diathesis
- Urticaria
Warnings
Discontinue medications that exacerbate hypertriglyceridemia
Use caution in patients allergic to fish
May increase liver ALT without increasing AST (monitor)
May increase LDL levels (monitor)
May prolong bleeding time (use caution)
Recurrent AF or flutter observed when initial high dose of Lovaza administered (ie, 8 g/day x1 week, then 4 g/day thereafter)
Pregnancy and Lactation
Available data from published case reports and pharmacovigilance database on use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Published studies have detected omega-3 fatty acids, including EPA and DHA, in human milk
Maximum Dosage
4 capsules/day PO.
4 capsules/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Omega 3 fatty acids
Omega-3-acid ethyl esters
