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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.
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