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Atropine ophthalmic Pregnancy and Breastfeeding Warnings

Atropine ophthalmic is also known as: Atropine-Care, Atropisol, Atrosulf-1, Isopto Atropine, Ocu-Tropine

Atropine ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk AU TGA pregnancy category: A US FDA pregnancy category: C

Animal studies have not been conducted. There are no adequate controlled data in human pregnancy. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. 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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Atropine ophthalmic Breastfeeding Warnings

Following IV administration, trace amounts of this drug have been found in human breast milk. Because some systemic absorption can be expected from eye drop use, the breastfed infant may experience dry skin, fever, or rapid pulse. A single use of this drug is not likely to interfere with breastfeeding. Long-term use may inhibit lactation, producing signs in the nursing infant (e.g., slow weight gain, insatiety). The American Academy of Pediatrics considers atropine to be compatible with breast-feeding.

Benefit to mother should outweigh risk to the infant Excreted into human milk: Yes Comment: Placing pressure over the tear duct for at least 1 minute during and after instillation can minimize systemic absorption.

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References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Atropisol (atropine ophthalmic)." Ciba Vision Ophthalmics, Duluth, GA.

References for breastfeeding information

  1. "American Academy of Pediatrics. Committee on Drugs. The transfer of drugs and other chemicals into human milk." Pediatrics 108 (2001): 776-89
  2. "Product Information. Atropisol (atropine ophthalmic)." Ciba Vision Ophthalmics, Duluth, GA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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