icosapent ethyl 1 g

1 INDICATIONS AND USAGE Icosapent ethyl capsules are 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 capsules 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 capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)

american health packaging

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

10 months ago

OVAL WHITE A1000

16 HOW SUPPLIED/STORAGE AND HANDLING

ICOSAPENT ETHYL capsules are supplied as 1 gram oblong, natural colored transparent soft gelatin capsules with the logo “A1000” printed in white ink. Supplied as follows: Unit dose packages of 30 (3 x 10) NDC 60687-764-21 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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icosapent ethyl 1 g

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

OVAL WHITE A1000

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