Omega-3 Well Pack Kit
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG)
levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG).
Usage Considerations : Patients should be placed on an appropriate lipid-lowering diet before
receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with
omega-3-acid ethyl esters capsules, USP.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before
instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids
with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such
as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications
known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be
discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
Sections or subsections omitted from the full prescribing information are not listed.
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been
determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has
not been determined.
History
There is currently no drug history available for this drug.
Other Information
Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel
capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP
contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are
predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and
docosahexaenoic acid (DHA - approximately 375 mg).
The molecular formula of EPA ethyl ester is C H O , and the molecular weight of EPA ethyl ester is
330.51.
The molecular formula of DHA ethyl ester is C H O , and the molecular weight of DHA ethyl ester
is 356.55.
Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-
tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components
of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol,
shellac glaze, simethicone and titanium dioxide.
Sources
Omega-3 Well Pack Kit Manufacturers
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Tmig, Inc.
![Omega-3 Well Pack Kit [Tmig, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Omega-3 Well Pack Kit | Tmig, Inc.
Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes
mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate [see
Indications and Usage (1)].
Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl
esters capsules, and should continue this diet during treatment with omega-3-acid ethyl esters
capsules. In clinical studies, omega-3-acid ethyl esters capsules were administered with meals.The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken
as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open,
crush, dissolve, or chew omega-3-acid ethyl esters capsules.
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