Difluprednate

The Basics

What is Difluprednate?

Used to treat swelling and pain after eye surgery and to treat endogenous anterior uveitis.

Brand names for Difluprednate

Durezol

How Difluprednate is classified

Anti-Inflammatory Agents, Corticosteroids – Ophthalmic, Glucocorticoids

Difluprednate During Pregnancy

Difluprednate pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Difluprednate while pregnant

Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal) anomalies when administered subcutaneously to rabbits during organogenesis at a dose of 1–10 mcg/kg/day. The noobserved- effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of DUREZOL, since DUREZOL is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, DUREZOL should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

Taking Difluprednate While Breastfeeding

What are recommendations for lactation if you're taking Difluprednate?

No information is available on the ophthalmic use of difluprednate during breastfeeding. Because absorption from the eye is limited, ophthalmic difluprednate would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Maternal / infant drug levels

No information is available on the ophthalmic use of difluprednate during breastfeeding. Because absorption from the eye is limited, ophthalmic difluprednate would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Possible effects of Difluprednate on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Difluprednate

Prednisolone.