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Nonoxynol 9 topical Pregnancy and Breastfeeding Warnings

Brand names: Advantage 24 Contraceptive, Advantage-S, Conceptrol, Delfen Foam, Emko, Encare, Gynol II Jelly with Applicator, K-Y Plus Nonoxynol 9, Koromex, Koromex Contraceptive, Koromex Crystal Clear Gel, Ramses Crystal Clear, Ramses Personal, Semicid Contraceptive Suppositories, Shur-Seal Gel, VCF Vaginal Contraceptive

Nonoxynol 9 topical Pregnancy Warnings

Animal studies showed rapid crossing of this drug across the vaginal wall into the systemic circulation. Available human data does not indicate a risk of congenital malformations with vaginal spermicides There are no controlled data in human pregnancy.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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.

Do not use if pregnancy is suspected or confirmed.

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

Comments:
-Available human data has not shown fetal adverse effects, but there is some evidence of embryotoxicity in animal models.

See references

Nonoxynol 9 topical Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Use is considered acceptable.

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

Comments:
-Trivial amounts have been found in animal milk after vaginal administration.
-Limited information has not shown adverse effects in breastfed infants of parents using this drug.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
  3. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.

References for breastfeeding information

  1. National Library of Medicine (US). Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2019.
  2. Product Information. VCF Vaginal Contraceptive (nonoxynol 9 topical). Apothecus Inc. 2019.

Further information

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

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