Use in pregnancy: Pregnancy Category B: Reproduction studies in the hamster, rat and mouse have shown no definite impairment of fertility or harm to the animal fetus. The safety of Diutropan administered to women who are or who may become pregnant has not been established, therefore, Diutropan should not be given to pregnant women unless, in the judgment of the physicians, the probable benefits outweigh the possible hazards.
Use in lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Diutropan is administered to a nursing woman.