Omtryg

Omtryg

Omtryg Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

OMTRYG™ (omega-3-acid ethyl esters A) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting OMTRYG therapy. 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:

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.

History

There is currently no drug history available for this drug.

Other Information

OMTRYG, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1.2-gram capsule of OMTRYG 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 empirical formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:

EPA ethyl ester structural formula

The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:

DHA ethyl ester structural formula

OMTRYG capsules also contain the following inactive ingredients: 4.6 mg α-tocopherol (in a carrier of sunflower oil), gelatin, glycerol, and purified water (components of the capsule shell).

Omtryg Manufacturers


  • Trygg Pharma Inc
    Omtryg (Omega-3-acid Ethyl Esters A) Capsule [Trygg Pharma Inc]

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