Pregnancy Warnings

Loteprednol/tobramycin ophthalmic Pregnancy and Breast Feeding Warnings

Loteprednol/tobramycin ophthalmic is also known as: Zylet

Overview

If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Loteprednol/Tobramycin Drops while you are pregnant. It is not known if Loteprednol/Tobramycin Drops is found in breast milk. If you are or will be breast-feeding while you use Loteprednol/Tobramycin Drops, check with your doctor. Discuss any possible risks to your baby.

Loteprednol/tobramycin ophthalmic Pregnancy Warnings

Loteprednol-tobramycin has been assigned to pregnancy category C by the FDA. Animal data have revealed evidence of teratogenicity and embryotoxicity following oral administration of loteprednol etabonate in doses up to 85 times the recommended human ophthalmic dose. Animal studies have failed to reveal evidence of fetal harm with tobramycin ophthalmic. There are no controlled data in human pregnancy. Loteprednol-tobramcyin ophthalmic should only be given during pregnancy when benefit outweighs risk.

Loteprednol/tobramycin ophthalmic Lactation Warnings

There are no data on the excretion of loteprednol-tobramycin ophthalmic into human milk. Topically applied steroids have been reported to be absorbed systemically and could suppress infant growth and endogenous corticosteroid production. Loteprednol undergoes limited systemic absorption after ocular administration (<1 ng/mL). The manufacturer recommends caution when administering loteprednol-tobramycin ophthalmic to nursing women.

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