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Loteprednol / tobramycin ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Zylet

Medically reviewed by Drugs.com. Last updated on Nov 18, 2024.

Loteprednol / tobramycin ophthalmic Pregnancy Warnings

Use only if the potential benefit justifies the potential risk to the fetus.

US FDA pregnancy category: C

Animal studies have revealed evidence of embryotoxicity (delayed ossification) and teratogenicity (increased incidence of meningocele, abnormal left common carotid artery, and limb fixtures) when loteprednol was administered orally at 35 times the maximum daily clinical dose. Reproductive studies in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally revealed no evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy.

US 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.

See references

Loteprednol / tobramycin ophthalmic Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Due to limited absorption from the eye, neither component is expected to cause any adverse effects in breastfed infants.
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.

It is unknown whether topically administered ophthalmic corticosteroids could result in sufficient systemic absorption to produce detectable levels in breast milk; however, systemically administered corticosteroids may appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects.

See references

See also

References for pregnancy information

  1. (2005) "Product Information. Zylet (loteprednol-tobramycin ophthalmic)." Bausch and Lomb Americas, Inc.

References for breastfeeding information

  1. (2005) "Product Information. Zylet (loteprednol-tobramycin ophthalmic)." Bausch and Lomb Americas, Inc.
  2. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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