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There are no adequate and well-controlled studies in pregnant women. Sun-Dianox should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.
Caution should be exercised when Sun-Dianox is administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be excreted in breast milk and since it is known that atropine is excreted in breast milk.
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