Edecrin

Pregnancy

There are no adequate and well-controlled studies of ethacrynate in pregnant women. Animal reproduction studies have not been conducted with ethacrynate. Patients are advised to inform their prescriber if they are pregnant or plan to become pregnant during treatment.

Lactation

It is not known whether ethacrynate is excreted in human milk. Patients are advised to consult their prescriber before breastfeeding while on ethacrynate, as the effects on a breastfed infant and milk production are not established.

Pediatric Use

The safety and effectiveness of ethacrynate in pediatric patients have not been established. Therefore, its use is not recommended in this population.

Geriatric Use

Clinical studies of ethacrynate did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. However, increased sensitivity in some older individuals cannot be ruled out, and dose adjustments may be necessary.

Renal Impairment

Patients with renal impairment may require dose adjustments based on their renal function. The prescribing information advises caution in patients with significant renal impairment.

Hepatic Impairment

No specific dosing recommendations for patients with hepatic impairment are provided in the labeling. Caution is advised when administering ethacrynate to patients with liver dysfunction.