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Adjunct to diet to reduce TG levels in adults with severe (≥500mg/dL) hypertriglyceridemia.
Adults: 4g/day (4 caps qd or 2 caps bid).
Increases in ALT levels without a concurrent increase in AST levels reported. Increased LDL-C levels reported; monitor LDL-C levels periodically during therapy. Contains ethyl esters of omega-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), obtained from oil of several fish sources; caution with known hypersensitivity to fish and/or shellfish. Recurrent atrial fibrillation/flutter (A-fib/flutter) reported in patients with paroxysmal or persistent A-fib, particularly within the first 2-3 months of initiating therapy; not indicated for the treatment of A-fib/flutter. Assess TG levels carefully before initiating therapy and monitor TG levels periodically during therapy.
Eructation, taste perversion, dyspepsia.
Periodically monitor patients receiving concomitant treatment with an anticoagulant or other drugs affecting coagulation (eg, antiplatelet agents). D/C or change medications known to exacerbate hypertriglyceridemia (eg, β-blockers, thiazides, estrogens), if possible, prior to consideration of therapy.
Category C, caution in nursing.
Lipid-regulating agent; not established. Potential mechanisms of action include inhibition of acyl CoA: 1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. May reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.
Distribution: Found in breast milk.
Assess for hypersensitivity to drug, fish and/or shellfish, hepatic impairment, A-fib/flutter, pregnancy/nursing status, and possible drug interactions. Attempt to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems that are contributing to lipid abnormalities (eg, diabetes mellitus, hypothyroidism). Assess LDL-C and TG levels.
Monitor for allergic reactions and other adverse reactions. Periodically monitor ALT and AST levels in patients with hepatic impairment. Monitor LDL-C and TG levels periodically during therapy.
Instruct to notify physician if allergic to fish and/or shellfish. Advise that the use of lipid-regulating agents does not reduce the importance of adhering to diet. Advise not to alter caps in any way and to ingest intact caps only. Instruct to take as prescribed.
Administration: Oral route. Swallow whole; do not break open, crush, dissolve, or chew. Storage: 25oC (77oF); excursions permitted to 15-30°C (59-86°F). Do not freeze.