Epanova (omega 3 carboxylic acids) dosing, indications, interactions, adverse effects, and more

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Sections omega 3 carboxylic acids
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Dosing & Uses

AdultPediatric

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

Interaction Checker

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Contraindicated

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Significant - Monitor Closely

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>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 & 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.

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

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections omega 3 carboxylic acids
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

omega 3 carboxylic acids (Rx)