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Penciclovir topical Pregnancy and Breastfeeding Warnings

Penciclovir topical is also known as: Denavir

Penciclovir topical Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments: Patients should consult healthcare provider prior to use (AU, UK).

Animal studies have failed to reveal evidence of fetotoxicity associated with IV penciclovir. There are no controlled data in human pregnancy.

There is unlikely to be any reason for concern about side effects when this drug is used during pregnancy; systemic absorption of the active component after topical administration of this drug shown to be minimal.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Penciclovir topical Breastfeeding Warnings

Safety has not been established.
-AU: Caution is recommended.
-UK: Benefit should outweigh risk.
-US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (after administration of oral prodrug of penciclovir [famciclovir])

Comments:
-The effects in the nursing infant are unknown; infant side effects unlikely with maternal use when applied topically to small areas away from the mother's breast.
-Patients should consult healthcare provider prior to use (AU, UK).

After oral administration of famciclovir to lactating rats, penciclovir was recovered from breast milk in levels exceeding those in plasma.

There is unlikely to be any reason for concern about side effects when this drug is used in lactating women; systemic absorption of the active component after topical administration of this drug shown to be minimal.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  2. "Product Information. Denavir (penciclovir topical)." SmithKline Beecham, Philadelphia, PA.
  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. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  3. 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 -]):
  4. "Product Information. Denavir (penciclovir topical)." SmithKline Beecham, Philadelphia, PA.
  5. "Product Information. Famvir (famciclovir)." SmithKline Beecham, Philadelphia, PA.

Further information

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

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