Irsuc Use In Pregnancy & Lactation

Data on limited number of exposed pregnancies indicated no adverse effects of Iron Sucrose Injection USP on pregnancy or on the health of the foetus/newborn child. No well-controlled studies in pregnant women are available to date. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Nevertheless, risk/benefit evaluation is required.
Iron sucrose Injection USP should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put the mother or foetus at risk.
Non metabolised Iron sucrose Injection USP is unlikely to pass into the mother's milk. No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.
Use in Pregnancy: Pregnancy Category B. No adequate and well controlled studies in pregnant women have been reported. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in Lactation: It is not known whether this drug is excreted in human milk. Caution should be exercised when iron sucrose is administered to a nursing woman.