icosapent ethyl capsule

1 INDICATIONS AND USAGE Icosapent ethyl is indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: • The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )

hikma pharmaceuticals usa inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] off label use` `[5] pain` `[6] diarrhoea` `[7] headache` `[8] dizziness` `[9] dyspnoea` `[10] fall`

3 years ago

CAPSULE YELLOW 54 648

16 HOW SUPPLIED/STORAGE AND HANDLING

ICOSAPENT ETHYL capsules 1 gram capsules are supplied as a clear, oblong capsule filled with colorless to pale yellow oily liquid and printed with “54 648” in black ink on one side. NDC 0054-0508-23: Bottle of 120 capsules 0.5 gram capsules are supplied as a clear, oval capsule filled with colorless to pale yellow oily liquid, and printed with ‘109” in black ink on one side. NDC 0054-0621-27: Bottle of 240 capsules Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature.] Keep out of reach of children.

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icosapent ethyl capsule

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] nausea [4] off label use [5] pain [6] diarrhoea [7] headache [8] dizziness [9] dyspnoea [10] fall

CAPSULE YELLOW 54 648

More pills like CAPSULE 54 648

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] off label use` `[5] pain` `[6] diarrhoea` `[7] headache` `[8] dizziness` `[9] dyspnoea` `[10] fall`