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Cysteamine ophthalmic Pregnancy and Breastfeeding Warnings

Cysteamine ophthalmic is also known as: Cystaran

Cysteamine ophthalmic Pregnancy Warnings

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

Animal studies have shown cysteamine to be teratogenic and fetotoxic at oral doses of 0.2 to 0.7 times the recommended human maintenance dose on a body surface basis. Teratogenic findings included cleft palate, kyphosis, heart ventricular septal defects, microcephaly, and exencephaly. Fetotoxicity resulted in intrauterine death and growth retardation. In addition, reduced animal fertility and survival of offspring was observed at oral doses 1.7 times the recommended human dose based on body surface area. There are no controlled data in human pregnancy. 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.

See references

Cysteamine ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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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