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Acetylcholine ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Miochol, Miochol Plus, Miochol-E, Miochol-E System Pak, Miochol-E/Steri-Tags

Acetylcholine ophthalmic Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-It is unknown whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
-Briggs, et al., state that acetylcholine, as a quaternary ammonium compound, is ionized at physiologic pH, and transplacental passage in significant amounts would not be expected.

Animal reproduction studies have not been conducted. There are no adequate and well-controlled studies in pregnant women.

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 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

Acetylcholine ophthalmic Breastfeeding Warnings

Use is not recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Product Information. Miochol (acetylcholine ophthalmic). Ciba Vision Ophthalmics. PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Miochol (acetylcholine ophthalmic). Ciba Vision Ophthalmics. PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.

Further information

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

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