Biogel Pregnancy

• Pregnancy of Biogel in details
• Biogel breastfeeding
• Biogel reviews

Pregnancy of Biogel in details

Animal studies revealed evidence of embryotoxicity and teratogenicity. 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.

AU: Use of Biogel is contraindicated; it is not recommended unless clearly needed and the benefit outweighs the risk. UK: Use of Biogel is contraindicated. US: Biogel should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

See references

Biogel breastfeeding

A nursing woman was treated with Biogel 200 mg orally once a day. Based on samples measured after the tenth dose, it was estimated that the infant received a maximum daily dosage that was 1.4% of the mother's weight-adjusted dosage. The mother continued to breastfeed the infant during therapy. No adverse effects were reported in the infant.

Breastfeeding is not recommended during use of Biogel. Excreted into human milk: Yes The effects in the nursing infant are unknown.

See references

References for pregnancy information

1. "Product Information. Nizoral (Biogel)." Janssen Pharmaceutica, Titusville, NJ.
2. 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." ():

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. Nizoral (Biogel)." Janssen Pharmaceutica, Titusville, NJ.
3. Moretti ME, Ito S, Koren G "Disposition of maternal Biogel in breast milk." Am J Obstet Gynecol 173 (1995): 1625-6

References

1. DailyMed. "KETOCONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubMed Health. "Xolegel: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
3. Human Metabolome Database (HMDB). "Ketoconazole: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology