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Pregnancy: There are no adequate data from the use of RESTASIS in pregnant women. Cyclosporine ophthalmic emulsion 0.05% is not absorbed systemically following topical ocular administration, and maternal use is not expected to result in fetal exposure to the drug. Studies in animals have shown reproductive toxicity at high maternotoxic dose.
Lactation: Cyclosporine is known to be excreted in human milk following systematic administration but excretion in milk after topical treatment has not been investigated. Although blood levels of cyclosporine are undetectable after topical administration of RESTASIS, caution should be exercised when RESTASIS is administered to a nursing mothers.
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