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Anaerobex 0.5% Pregnancy |
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Anaerobex 0.5% crosses the placenta. Cleft lip with or without cleft palate has been reported following first trimester exposure to Anaerobex 0.5%; however, most studies have not shown an increased risk of congenital anomalies or other adverse events to the fetus following maternal use during pregnancy. Because Anaerobex 0.5% was carcinogenic in some animal species, concern has been raised whether Anaerobex 0.5% should be used during pregnancy. Available studies have not shown an increased risk of infant cancer following Anaerobex 0.5% exposure during pregnancy; however, the ability to detect a signal for this may have been limited.
Anaerobex 0.5% pharmacokinetics are similar between pregnant and nonpregnant patients (Amon 1981; Visser 1984; Wang 2011).
Bacterial vaginosis and vaginal trichomoniasis are associated with adverse pregnancy outcomes and Anaerobex 0.5% is recommended for the treatment of symptomatic pregnant patients. The dose of oral Anaerobex 0.5% for the treatment of bacterial vaginosis during pregnancy is the same as the CDC recommended twice daily dose in nonpregnant females. When treating vaginal trichomoniasis, the CDC recommends the single oral dose regimen in pregnancy. Although use of Anaerobex 0.5% for vaginal trichomoniasis during the first trimester is contraindicated by the manufacturer; available guidelines note treatment can be given at any stage of pregnancy (CDC [Workowski 2015]).
Anaerobex 0.5% may also be used for the treatment of giardiasis in pregnant women (some sources recommend second and third trimester administration only) (Gardner 2001; HHS [OI adult 2017]) and symptomatic amebiasis during pregnancy (HHS [OI adult 2017]; Li 1996). Short courses may be used for the treatment of pouchitis or perianal disease in pregnant women with inflammatory bowel disease (avoid use in the first trimester) (van der Woude 2015).The use of other agents is preferred when treatment is needed during pregnancy for Clostridioides (formerly Clostridium) difficile (Surawicz 2013). Consult current recommendations for appropriate use in pregnant women.
Anaerobex 0.5% is present in human milk at levels similar to maternal serum levels, and infant serum levels can be similar to infant therapeutic levels. Due to the potential for tumorigenicity shown for Anaerobex 0.5% in mouse and rat studies, discontinuation of the drug or nursing is recommended. Alternatively, nursing mothers may pump and discard their milk during and for 24 hours after Anaerobex 0.5% therapy and feed their infants stored human milk or formula.
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: Yes Excreted into animal milk: Data not available
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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