Omega-3 Fatty Acid Formulations
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Omega-3 Fatty Acid Formulations

Disclaimer - Please see package insert if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer   |   <BACK
EPANOVA® (omega-3-carboxylic acids) OMTRYG™ (omega-3-acid ethyl esters A)

 EPANOVA® (omega-3-carboxylic acids): top of page

INDICATIONS AND USAGE:
EPANOVA, a fish oil-derived mixture of free fatty acids primarily composed of EPA
and DHA, is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult
patients with severe (geq500 mg/dL) hypertriglyceridemia.
Limitations of Use:
• The effect of EPANOVA on the risk for pancreatitis has not been determined.
• The effect of EPANOVA on cardiovascular mortality and morbidity has not been
determined.

DOSAGE AND ADMINISTRATION:
• The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules) once
daily. Individualize therapy according to patient response and tolerability. In
clinical trials, EPANOVA was administered without regard to meals.

• Patients should be advised to swallow EPANOVA capsules whole. Do not break
open, crush, dissolve or chew EPANOVA.

CONTRAINDICATIONS:
EPANOVA is contraindicated in patients with known hypersensitivity (e.g.,
anaphylactic reaction) to EPANOVA or any of its components.

WARNINGS AND PRECAUTIONS:
• In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be
monitored periodically during therapy with EPANOVA.
• In patients with hepatic impairment, monitor ALT and AST levels periodically
during therapy.
• EPANOVA should be used with caution in patients with known hypersensitivity
to fish and/or shellfish.

ADVERSE REACTIONS:
Most common adverse reactions (incidence geq3% and greater than placebo) are
diarrhea, nausea, abdominal pain or discomfort, and eructation.

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at
1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:
Omega-3 fatty acids may prolong bleeding time. Patients receiving treatment
with EPANOVA and other drugs affecting coagulation (e.g., anti-platelet agents)
should be monitored periodically.

USE IN SPECIFIC POPULATIONS:
Pregnancy: Use during pregnancy only if the potential benefit justifies the
potential risk to the fetus

See package insert for PATIENT COUNSELING INFORMATION [and FDA-approved patient
labeling].

DOSAGE FORMS AND STRENGTHS:
Soft gelatin capsules: 1 gram

SOURCE:
Package insert data: Accessed June 2014.
Manufactured by: Catalent Germany GmbH, Eberbach and Schorndorf, Germany
Manufactured for: AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
EPANOVA is a registered trademark licensed to the AstraZeneca group of companies.
©AstraZeneca 2014
Rev. 5/14 2985402 5/14

 OMTRYG™ (omega-3-acid ethyl esters A) : top of page

INDICATIONS AND USAGE:
OMTRYG is a combination of ethyl esters of omega-3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (geq500 mg/dL) hypertriglyceridemia.

Limitations of Use:
The effect of OMTRYG on the risk for pancreatitis has not been determined.

The effect of OMTRYG on cardiovascular mortality and morbidity has not been determined.

DOSAGE AND ADMINISTRATION:
The daily dose of OMTRYG is 4 capsules per day taken as a single dose or as 2 capsules given twice daily. OMTRYG should be taken with meals.

Patients should be advised to swallow OMTRYG capsules whole. Do not break open, crush, dissolve or chew OMTRYG.

CONTRAINDICATIONS:
Patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of OMTRYG.

WARNINGS AND PRECAUTIONS:
•In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
•OMTRYG may increase levels of LDL. Monitor LDL levels periodically during therapy.
•Use with caution in patients with known hypersensitivity to fish and/or shellfish.
•There is a possible association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first months of initiating therapy.

ADVERSE REACTIONS:
The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion.

To report SUSPECTED ADVERSE REACTIONS, contact Trygg Pharma at 1-855-3-OMTRYG (1-855-366-8794) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:
Omega-3-acids may prolong bleeding time. Patients taking OMTRYG and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

USE IN SPECIFIC POPULATIONS:
Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

DOSAGE FORMS AND STRENGTHS:
Capsules: 1.2 grams.

SOURCE:
Package insert data: accessed: June 2014
Trygg Pharma, Inc.
1001 North 19th St.
Suite 1200
Arlington, VA 22209
Approved: 04/2014

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

Listed dosages are for - Adult patients ONLY. if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer   |   <BACK
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