Prednisolone

Drug Levels and Effects:




Summary of Use during Lactation:


Limited information indicates that maternal doses of prednisolone up to 50 mg produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants. With high maternal doses, avoiding breastfeeding for 4 hours after a dose should markedly decrease the dose received by the infant. However, this maneuver is probably not necessary in most cases.


Drug Levels:


Maternal Levels.

Seven women were given 5 mg of radiolabeled prednisolone orally. A total of 0.14% of the total radioactivity was recovered from breastmilk over the next 48 to 61 hours.[1]

After oral prednisolone, levels of 23 to 40 mcg/L occurred with doses of 10 to 20 mg in 3 women, while peak levels of 106 and 137 mcg/L occurred after doses of 30 and 45 mg, respectively, and a peak prednisolone level of 317 mcg/L occurred after a dose of 80 mg. The ratio of the peak milk to peak plasma prednisolone levels were about 0.1 with doses of 20 mg or less, while it was 0.2 with doses of 30 mg or more. The ratios of the areas under the curve reached 0.2 only with an 80 mg dose. The higher ratios with higher doses are thought to be due to saturation of serum protein binding sites. Peak milk prednisolone levels occur about 1 hour after an oral dose of prednisolone and dropped with a half-life similar to the serum half-life. The authors estimated that a breastfed infant would receive less than 0.1% of the mother's total dosage of prednisolone; however, using the higher accepted milk intake value (150 mL/kg daily), this value would be less than 0.015% of the mother's dose.[2]

Three women were given 50 mg of prednisolonesodiumphosphateintravenously. Thirty minutes after injection, milk prednisolone concentrations varied from about 200 to 400 mcg/L and dropped with a half-life slightly faster than the 2.5 hour half-life in serum. The authors estimated that a nursing infant would receive an average 0.074% of the total dose administered to the mother.[3]

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


None reported with prednisone or any other corticosteroid. In a prospective follow-up study, 6 nursing mothers reported taking prednisone (dosage unspecified) with no adverse infant effects.[4] There are several reports of mothers breastfeeding during long-term use of corticosteroids with no adverse infant effects: prednisone 10 mg daily (2 infants)[5][6] and prednisolone 5 to 7.5 mg daily (14 infants).[7]

A woman who was nursing (extent not stated) her newborn infant was treated for pemphigus with oral prednisolone 25 mg daily, with the dosage increased over 2 weeks to 60 mg daily. She was also taking cetirizine 10 mg daily and topical betamethasone 0.1% twice daily to the lesions. Because of a poor response, the betamethasone was changed to clobetasol propionate ointment 0.05%. She continued breastfeeding throughout treatment and her infant was developing normally at 8 weeks of age and beyond.[8]

A woman with pemphigoid gestationis was treated with prednisolone in a dosage tapering from 0.7 mg/kg daily to 1 mg daily during breastfeeding. She also received courses of intravenous immune globulin 2 grams/kg over 3 days at 4, 9 and 13 weeks postpartum. She breastfed her infant (extent not stated) for 3 months with no problems noted.[9]


Possible Effects on Lactation:


Published information on the effects of prednisolone on serum prolactin or on lactation in nursing mothers was not found as of the revision date.

A study of 46 women who delivered an infant before 34 weeks of gestation found that a course of another corticosteroid (betamethasone, 2 intramuscular injections of 11.4 mg of betamethasone 24 hours apart) given between 3 and 9 days before delivery resulted in delayed lactogenesis II and lower average milk volumes during the 10 days after delivery. Milk volume was not affected if the infant was delivered less than 3 days or more than 10 days after the mother received the corticosteroid.[10] An equivalent dosage regimen of prednisolone might have the same effect.

A study of 87 pregnant women found that betamethasone given as above during pregnancy caused a premature stimulation of lactose secretion during pregnancy. Although the increase was statistically significant, the clinical importance appears to be minimal.[11] An equivalent dosage regimen of prednisolone might have the same effect.


Alternate Drugs to Consider:


Methylprednisolone,Prednisone


References:


1. McKenzie SA, Selley JA, Agnew JE. Secretion of prednisolone into breast milk. Arch Dis Child. 1975;50:894-6. PMID:1211963
2. Ost L, Wettrell G, Bjorkhem I, Rane A. Prednisolone excretion in human milk. J Pediatr. 1985;106:1008-11. PMID:3998938
3. Greenberger PA, Odeh YK, Frederiksen MC et al. Pharmacokinetics of prednisolone transfer to breast milk. Clin Pharmacol Ther. 1993;53:324-8. PMID:8453851
4. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID:8498418
5. Moretti ME, Sgro M Johnson DW et al. Cyclosporine excretion into breast milk. Transplantation. 2003;75:2144-6. PMID:12829927
6. Munoz-Flores-Thiagarajan KD, Easterling T, Davis C et al. Breast-feeding by a cyclosporine-treated mother. Obstet Gynecol. 2001;97(5 pt 2):816-8. PMID:11336764
7. Nyberg G, Haljamae U, Frisenette-Fich C et al. Breast-feeding during treatment with cyclosporine. Transplantation. 1998;65:253-5. PMID:9458024
8. Westermann L, Hugel R, Meier M et al. Glucocorticosteroid-resistant pemphigoid gestationis: successful treatment with adjuvant immunoadsorption. J Dermatol. 2012;39:168-71. PMID:22379622
9. Gan DC, Welsh B, Webster M. Successful treatment of a severe persistent case of pemphigoid gestationis with antepartum and postpartum intravenous immunoglobulin followed by azathioprine. Australas J Dermatol. 2012;53:66-9. PMID:22309336
10. Henderson JJ, Hartmann PE, Newnham JP, Simmer K. Effect of preterm birth and antenatal corticosteroid treatment on lactogenesis ii in women. Pediatrics. 2008;121:e92-100. PMID:18166549
11. Henderson JJ, Newnham JP, Simmer K, Hartmann PE. Effects of antenatal corticosteroids on urinary markers of the initiation of lactation in pregnant women. Breastfeed Med. 2009;4:201-6. PMID:19772378



Substance Identification:




Substance Name:

Prednisolone

CAS Registry Number:

50-24-8

Drug Class:


  • Corticosteroids, Systemic


  • Administrative Information:




    LactMed Record Number:


    223


    Last Revision Date:


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