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Loteprednol / tobramycin ophthalmic Pregnancy and Breastfeeding Warnings

Loteprednol / tobramycin ophthalmic is also known as: Zylet

Loteprednol / tobramycin ophthalmic Pregnancy Warnings

Animal studies have revealed evidence of teratogenicity and embryotoxicity (with no maternal toxicity) following oral administration of loteprednol etabonate to rabbits in doses 35 times the maximum daily clinical dose. The no observed effect level for such effects was a dose 6 times the maximum daily clinical dose. Animal studies have failed to reveal evidence of fetal harm with parenteral tobramycin. There are no controlled data in human pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

See references

Loteprednol / tobramycin ophthalmic Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

It is unknown if there is sufficient systemic absorption with ophthalmic administration of corticosteroids to have detectable quantities in 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 (less than 1 ng/mL).

See references

References for pregnancy information

  1. "Product Information. Zylet (loteprednol-tobramycin ophthalmic)." Bausch and Lomb, Rochester, NY.

References for breastfeeding information

  1. "Product Information. Zylet (loteprednol-tobramycin ophthalmic)." Bausch and Lomb, Rochester, NY.

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