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Prednisolone Pregnancy and Breastfeeding Warnings

Prednisolone is also known as: AsmalPred Plus, Bubbli-Pred, Cotolone, Delta-Cortef, Flo-Pred, Hydeltra-TBA, Hydeltrasol, Key-Pred, Key-Pred SP, Medicort, Millipred, Orapred, Orapred ODT, PediaPred, Pred-Ject-50, Predacort 50, Predaject-50, Predalone 50, Predate-50, Predcor, Predicort RP, Predicort-50, Prelone, Pri-Cortin 50, Veripred 20

Prednisolone Pregnancy Warnings

In the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there were 143 first trimester exposures to prednisolone (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). A statistically significant increase in the total number of birth defects was found, with eleven cases reported compared with only six cases expected. However, no association between prednisolone and the six categories of defects studied (cardiovascular, oral clefts, spina bifida, polydactylies, limb reduction defects/syndactylies, hypospadias) was found.

Prednisolone has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of fetal harm, although data are conflicting. There are no controlled data in human pregnancy. Prednisone is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Prednisolone Breastfeeding Warnings

Prednisolone is excreted into human milk in small amounts. Animal studies have revealed an increased incidence of cleft palate in offspring. In one study of six lactating women, prednisolone milk concentrations were 5% to 25% of corresponding serum concentrations. The authors estimated that a nursing infant would be exposed to negligible amounts of drug with maternal doses of 20 to 40 mg per day. The excretion of prednisolone into breast milk has been evaluated in six women on chronic prednisolone therapy. Milk prednisolone concentrations ranged from less than 10 to 106 ng/mL in patients receiving 10 mg to 45 mg per day (N=5). In a patient receiving 80 mg per day, milk prednisolone concentrations ranged from less than 10 ng/mL prior to the morning dose to 317 ng/mL at one hour post-dose. The peak milk to plasma concentration ratio ranged from 0.12 to 0.25. The authors recommend that nursing be withheld for four hours after administration of doses greater than 20 mg. In a recent study, prednisolone excretion into breast milk was evaluated in three women following administration of prednisolone phosphate 50 mg intravenously one time. During the six-hour study period, 0.010% to 0.049% of the administered dose of prednisolone was recovered in breast milk. Nursing infants would be expected to experience minimal exposure. Data from this study also suggest that exchange of unbound prednisolone between breast milk and serum is rapid and bi-directional. Prednisone is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that caution be used when administering prednisone to nursing women.

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