Dosing & Uses
Dosage Forms & Strengths
capsule
- 1g
- Note: 1g capsule free fatty acids derived from fish oil contains at least 850mg of polyunsaturated fatty acids, including omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) being the most abundant
Hypertriglyceridemia
Indicated as an adjunct to diet in patients with severe hypertriglyceridemia (ie, TG ≥500 mg/dL)
2-4 g PO qDay
Individualize dose according to response and tolerability
Dosing Considerations
Effect on risk of pancreatitis has not been determined
Effect on cardiovascular mortality and morbidity has not been determined
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (25)
- alteplase
omega 3 carboxylic acids, alteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- anagrelide
omega 3 carboxylic acids, anagrelide. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- antithrombin alfa
omega 3 carboxylic acids, antithrombin alfa. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- antithrombin III
omega 3 carboxylic acids, antithrombin III. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- argatroban
omega 3 carboxylic acids, argatroban. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- aspirin
omega 3 carboxylic acids, aspirin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- aspirin/citric acid/sodium bicarbonate
omega 3 carboxylic acids, aspirin/citric acid/sodium bicarbonate. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- betrixaban
omega 3 carboxylic acids, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- bivalirudin
omega 3 carboxylic acids, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- cilostazol
omega 3 carboxylic acids, cilostazol. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- clopidogrel
omega 3 carboxylic acids, clopidogrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- dabigatran
omega 3 carboxylic acids, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- dalteparin
omega 3 carboxylic acids, dalteparin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- desirudin
omega 3 carboxylic acids, desirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- dipyridamole
omega 3 carboxylic acids, dipyridamole. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- enoxaparin
omega 3 carboxylic acids, enoxaparin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- fondaparinux
omega 3 carboxylic acids, fondaparinux. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- heparin
omega 3 carboxylic acids, heparin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- prasugrel
omega 3 carboxylic acids, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- reteplase
omega 3 carboxylic acids, reteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- tenecteplase
omega 3 carboxylic acids, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- ticlopidine
omega 3 carboxylic acids, ticlopidine. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- vorapaxar
omega 3 carboxylic acids, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- vortioxetine
omega 3 carboxylic acids, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- zanubrutinib
omega 3 carboxylic acids, zanubrutinib. Either increases effects of the other by anticoagulation. Modify Therapy/Monitor Closely. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.
Minor (0)
Adverse Effects
>10%
Diarrhea (7-15%)
1-10%
Nausea (4-6%)
Abdominal pain/discomfort (3-5%)
Eructation (3%)
Postmarketing Reports
Vomiting
Flatulence
Dysgeusia
Warnings
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 & Lactation
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.Pharmacology
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
Administration
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
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Formulary
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