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Cysteamine ophthalmic Pregnancy and Breastfeeding Warnings

Cysteamine ophthalmic is also known as: Cystaran

Cysteamine ophthalmic Pregnancy Warnings

Use during pregnancy is recommended only if the potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: C

Animal studies have revealed evidence of teratogenicity and fetotoxicity. Teratogenic findings included cleft palate, kyphosis, heart ventricular septal defects, microcephaly, and exencephaly; fetotoxicity resulted in intrauterine death and growth retardation. This drug reduced the fertility of adult animals and the survival of their offspring at an oral dose 1.7 times the recommended human dose (RHD), but had no effect on fertility and reproductive performance at an oral dose 0.4 times the RHD. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Cysteamine ophthalmic Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available. Comments: The effects in the nursing infant are unknown; however, animal studies have revealed this drug has the potential to cause developmental toxicity in nursing offspring.

See references

References for pregnancy information

  1. "Product Information. Cystaran (cysteamine ophthalmic)." Sigma-Tau Pharmaceuticals Inc, Gaithersburg, MD.

References for breastfeeding information

  1. "Product Information. Cystaran (cysteamine ophthalmic)." Sigma-Tau Pharmaceuticals Inc, Gaithersburg, MD.

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