Clindamycin Pregnancy and Breastfeeding Warnings
Clindamycin Pregnancy Warnings
Animal studies have failed to reveal evidence of teratogenicity. In clinical trials with pregnant women, systemic administration of clindamycin during the second and third trimesters was not associated with an increased frequency of congenital abnormalities. There are no controlled data in pregnant women during the first trimester of pregnancy. The results of a study have suggested that early second trimester treatment of bacterial vaginosis and abnormal vaginal flora with oral clindamycin may reduce the incidence of preterm delivery and late miscarriage (n=485). 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Use during the first trimester is not recommended unless clearly needed. AU TGA pregnancy category: A US FDA pregnancy category: B Comments: Clindamycin solution for injection contains benzyl alcohol as a preservative, which can cross the placenta and is associated with the potentially fatal "gasping syndrome" in pediatric patients.
Clindamycin Breastfeeding Warnings
Use is not recommended; an alternate drug may be preferred Excreted into human milk: Yes Comments: Infants should be monitored for side effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash), or rarely, blood in the stool.
A report of bloody stools in a 5-day-old breastfed infant may have been caused by the concurrent maternal administration of IV clindamycin and gentamicin. Symptoms resolved 24 hours after breastfeeding was stopped and no further difficulties reported when breastfeeding was resumed on day 6 of age, after the maternal antibiotics were stopped. Concentrations in breast milk after oral administration of clindamycin 150 mg orally three times a day after at least 1 week of therapy have been reported at 1.2 mg/L (average, 6 hours after dosing) and at 0.3 to 1.2 mg/L between one and 6 hours after a single 150 mg dose. Peak concentrations in breast milk after oral dosing of 300 mg every six hours have been reported at 1.3 mg/L after 3.5 hours and 1.8 mg/L after 2 hours. Peak concentrations in breast milk after IV administration of clindamycin 600 mg IV every six hours have been reported at 2.65 mg/L after 3.5 hours and 3.1 mg/L after 30 minutes.
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