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Phenylephrine ophthalmic Pregnancy and Breastfeeding Warnings

Phenylephrine ophthalmic is also known as: AK-Dilate, AK-Nefrin, Altafrin, Isopto Frin, Mydfrin, Neo-Synephrine Ophthalmic, Neofrin, Ocu-Phrin, Phenoptic, Prefrin, Refresh Redness Relief, Relief

Medically reviewed on Mar 14, 2018

Phenylephrine ophthalmic Pregnancy Warnings

Animal reproduction studies have not been conducted with topical phenylephrine. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Use only if clearly needed

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments: Safety for use in pregnancy has not been established.

See references

Phenylephrine ophthalmic Breastfeeding Warnings

Use caution

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-To diminish systemic absorption, place pressure over the tear duct by the corner of the eye for 1 minute or more after using eye drops; remove excess solution with an absorbent tissue.

Oral bioavailability of this drug is about 40%; if it is excreted in human milk, it is unlikely to reach the infant in large amounts. Oral and IV administration may decrease milk production. If precautions are taken to limit systemic absorption, it is unlikely that ophthalmic use will affect milk production.

See references

References for pregnancy information

  1. "Product Information. Phenylephrine Ophthalmic (phenylephrine ophthalmic)." Akorn Inc, Buffalo Grove, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Phenylephrine Ophthalmic (phenylephrine ophthalmic)." Akorn Inc, Buffalo Grove, IL.

Further information

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

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