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Women of childbearing potential and contraception in males and females: Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Pregnancy: There are no data from the use of sildenafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, and embryonal/foetal development. Studies in animals have shown toxicity with respect to postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Breast Feeding: There are no adequate and well-controlled studies in lactating women. Limited data indicate that sildenafil and its active metabolite are excreted into breast milk at very low levels.
Amounts ingested by the breastfed infant would not be expected to cause any adverse effects. Prescribers should carefully assess the mother's clinical need for Revatio and any potential adverse effects on the breastfed child.
Fertility: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
