Cleocin t 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: There are no available data to inform a drug-associated risk for adverse developmental outcomes. In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. Reproductive studies in rats and mice during organogenesis using subcutaneous or oral doses up to the equivalent of 432 mg/kg/day produced no evidence of fetal harm or malformations.
Animal studies have failed to reveal evidence of fetal harm when given oral or parenteral doses up to 58 (rats) and 29 (mice) times, the recommended human dose. In an unspecified number of pregnant women given a 2% vaginal cream formulation for 7 days during their second trimester, 1.1% experienced abnormal labor compared with 0.5% of patients given placebo. There are no adequate and well 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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Cleocin t Breastfeeding Warnings
This drug is excreted into breastmilk when given orally or intravenously.
Use is not recommended and 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: Unknown
Comment: The effects in the nursing infant are unknown.
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