Gentamicin / prednisolone ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Pred-G, Pred-G S.O.P.

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Gentamicin / prednisolone 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 that gentamicin has been shown to depress newborn body weights, kidney weights, and median glomerular counts following systemic administration to pregnant rats at daily doses about 500 times the maximum recommended ophthalmic dose. Prednisolone was teratogenic in animals when given in doses 1 to 10 times the human ocular dose. 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.

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Gentamicin / prednisolone ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The individual components of this combination product have each been detected in breast milk following systemic administration.
-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 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

Further information

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