Loteprednol

The Basics

What is Loteprednol?

Ophthalmic loteprednol 0.38%, 0.5% and 1% (Lotemax SM, Lotemax, Inveltys) are used to treat eye swelling and pain after cataract surgery. Loteprednol 0.2% (Alrex) is used as a short term treatment to reduce eye redness, itching, and swelling caused by seasonal allergies.

Brand names for Loteprednol

Alrex, Lotemax Sm, Lotemax, Inveltys

How Loteprednol is classified

Anti-Inflammatory Agents, Corticosteroids – Ophthalmic, Glucocorticoids

Loteprednol During Pregnancy

Loteprednol 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 Loteprednol while pregnant

Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ‚â• 5 mg/kg/day doses, and cleft palate and umbilical hernia at ‚â• 50 mg/kg/day) and embryotoxicity (increased postimplantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ‚â• 50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (15 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ‚â• 5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. There are no adequate and well controlled studies in pregnant women. ALREX Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Loteprednol While Breastfeeding

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

No information is available on the ophthalmic use of loteprednol during breastfeeding. Because absorption from the eye is limited, ophthalmic loteprednol 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 loteprednol during breastfeeding. Because absorption from the eye is limited, ophthalmic loteprednol 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 Loteprednol on milk supply

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

Possible alternatives to Loteprednol

Prednisolone.