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Use During Pregnancy/Fertility: Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to sultamicillin. Sulbactam and ampicillin cross the placental barrier. However, safety for use in human pregnancy has not been established. Therefore, sultamicillin should be used during pregnancy only if the potential benefits outweigh the potential risk.
Use During Lactation: Film-coated tablet: The use of sultamicillin during lactation is not recommended. Low concentrations of ampicillin and sulbactam are excreted in the milk. This should be considered as the neonate may be exposed, particularly since renal function is not fully developed in neonates.
Powder for injection: Low concentrations of sulbactam (~0.13 up to 2.8 mg/L) and ampicillin (~0.11 up to 3 mg/L) are excreted in the milk. The use of sulbactam sodium/ampicillin sodium by a nursing mother may lead to adverse effects such as diarrhea in the child. Sulbactam sodium/ampicillin sodium can be used during lactation if the potential benefits outweigh the potential risks.
