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Prednisolone ophthalmic Pregnancy and Breastfeeding Warnings

Prednisolone ophthalmic is also known as: AK-Pred, Econopred, Econopred Plus, Inflamase Forte, Inflamase Mild, Ocu-Pred, Ocu-Pred Forte, Ocu-Pred-A, Omnipred, Pred Forte, Pred Mild, Prednisol

Prednisolone ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some experts, use should be avoided. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have revealed evidence of teratogenicity at doses 1 to 10 times the human dose. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.

See references

Prednisolone ophthalmic Breastfeeding Warnings

It is unknown whether topically administered corticosteroids could result in sufficient systemic absorption to produce detectable levels in breast milk; however, systemically administered corticosteroids may appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects.

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Due to limited absorption from the eye, this drug is not expected to cause any adverse effects in breastfed infants; however, due to the possibility an adverse effect may occur, a decision should be made to discontinue nursing or discontinue the drug. -Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Pred Mild (prednisoLONE ophthalmic (prednisolone ophthalmic))." Allergan Inc, Irvine, CA.
  4. "Product Information. PrednisoLONE Sodium Phosphate Ophthalmic (prednisoLONE ophthalmic (prednisolone ophthalmic))." Bausch and Lomb, Rochester, NY.
  5. "Product Information. Omnipred (prednisoLONE ophthalmic (prednisolone ophthalmic))." Alcon Laboratories Inc, Fort Worth, TX.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Omnipred (prednisoLONE ophthalmic (prednisolone ophthalmic))." Alcon Laboratories Inc, Fort Worth, TX.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Pred Mild (prednisoLONE ophthalmic (prednisolone ophthalmic))." Allergan Inc, Irvine, CA.
  6. "Product Information. PrednisoLONE Sodium Phosphate Ophthalmic (prednisoLONE ophthalmic (prednisolone ophthalmic))." Bausch and Lomb, Rochester, NY.

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