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Cyclosporine ophthalmic Pregnancy and Breastfeeding Warnings

Cyclosporine ophthalmic is also known as: Cequa, Restasis

Medically reviewed on Jun 29, 2017

Cyclosporine ophthalmic Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug is not detected systemically following topical ocular administration and therefore use during pregnancy is not expected to result in fetal exposure to this drug.

Comments: This drug is not recommended in women of childbearing potential not using effective contraception.

Animal studies have revealed evidence of teratogenicity when maternally toxic oral doses were administered to rats and rabbits. Animal studies with the ophthalmic formulation have not been reported, however, this drug is not detected systemically following ocular administration. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Cyclosporine ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (oral administration); data not available (ophthalmic administration)
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. "Product Information. Restasis (cyclosporine ophthalmic)." Allergan Inc, Irvine, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Restasis (cyclosporine ophthalmic)." Allergan Inc, Irvine, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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