Bicillin l-a Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned.
Risk summary: Malformative risk with use of this drug in pregnant women is unlikely.
Animal studies have failed to reveal evidence of fetal harm. No positive evidence of adverse effects on the fetus observed during human use of penicillins; however, there are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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Bicillin l-a Breastfeeding Warnings
Soluble penicillin is excreted in breast milk.
A 2.4 million unit IM dose was administered to 2 women 20 hours after delivery. Milk levels were 30 units/L on the 3rd day, 10 units/L on the 5th day, and undetectable thereafter. According to authors, a maximum of 6 to 7 units estimated to be ingested per day by an exclusively breastfed infant.
A Herxheimer's reaction occurred in a 1-month-old breastfed infant with congenital syphilis 6 hours after a 2.4 million unit IM dose was administered to the mother; the infant had also received 10 units of penicillin G at about the time of the maternal dose. The reaction was possibly due to penicillin in breast milk.
Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with penicillins; such effects have not been adequately evaluated.
Use is considered acceptable; caution is recommended.
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Limited data indicate that low levels in milk from single maternal doses are not expected to cause harmful effects in nursing infants.
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