Amebazole Pregnancy

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Pregnancy of Amebazole in details

Pregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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Amebazole crosses the placenta. Cleft lip with or without cleft palate has been reported following first trimester exposure to Amebazole; 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 Amebazole was carcinogenic in some animal species, concern has been raised whether Amebazole should be used during pregnancy. Available studies have not shown an increased risk of infant cancer following Amebazole exposure during pregnancy; however, the ability to detect a signal for this may have been limited.

Amebazole 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 Amebazole is recommended for the treatment of symptomatic pregnant patients. The dose of oral Amebazole 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 Amebazole 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]).

Amebazole 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.

Amebazole breastfeeding

When a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!
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Amebazole 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 Amebazole 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 Amebazole 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

See references

References for pregnancy information

  1. Morales WJ, Schorr S, Albritton J "Effect of Amebazole in patients with preterm birth in preceding pregnancy and bacterial vaginosis: a placebo-controlled, double-blind study." Am J Obstet Gynecol 171 (1994): 345-9
  2. Mcdonald HM, Oloughlin JA, Vigneswaran R, Jolley PT, Mcdonald PJ "Bacterial vaginosis in pregnancy and efficacy of short-course oral Amebazole treatment: a randomized controlled trial." Obstet Gynecol 84 (1994): 343-8
  3. Sorensen HT, Larsen H, Jensen ES, Thulstrup AM, Schonheyder HC, Nielsen GL, Czeizel A "Safety of Amebazole during pregnancy: a cohort study of risk of congenital abnormalities, preterm delivery and low birth weight in 124 women." J Antimicrob Chemother 44 (1999): 854-5
  4. Thapa PB, Whitlock JA, Worrell KGB, Gideon P, Mitchel EF, Roberson P, Pais R, Ray WA "Prenatal exposure to Amebazole and risk of childhood cancer: A retrospective cohort study of children younger than 5 years." Cancer 83 (1998): 1461-8
  5. "Product Information. Flagyl (Amebazole)." Searle, Skokie, IL.
  6. CDC. Centers for Disease Control and Prevention "Sexually transmitted diseases treatment guidelines, 2010. Available from: URL: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5912a1.htm?s_cid=rr5912a1_e." ([2010 Dec 17]):
  7. Donders GGG "Treatment of sexually transmitted bacterial diseases in pregnant women." Drugs 59 (2000): 477-85
  8. Carvajal A, Sanchez A, Hurtarte G "Amebazole during pregnancy." Int J Gynaecol Obstet 48 (1995): 323-4
  9. Burtin P, Taddio A, Ariburnu O, Einarson TR, Koren G "Safety of Amebazole in pregnancy: a meta-analysis." Am J Obstet Gynecol 172 (1995): 525-9

References for breastfeeding information

  1. "Product Information. Flagyl (Amebazole)." Searle, Skokie, IL.
  2. Moore B, Collier J "Drugs and breast feeding." Br Med J 2 (1979): 211
  3. Erickson SH, Oppenheim GL, Smith GH "Amebazole in breast milk." Obstet Gynecol 57 (1981): 48-50
  4. Passmore CM, McElnay JC, Rainey EA, D'Arcy PF "Amebazole excretion in human milk and its effect on the suckling infant." Br J Clin Pharmacol 26 (1988): 45-51
  5. Heisterberg L, Branebjerg PE "Blood and milk concentrations of Amebazole in mothers and infants." J Perinat Med 11 (1983): 114-20
  6. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  7. Gray MS, Kane PO, Squires S "Further observations on Amebazole (flagyl)." Br J Vener Dis 37 (1961): 278-9
  8. Clements CJ "Amebazole and breast feeding." N Z Med J 92 (1980): 329


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References

  1. DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: 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. "Vandazole: 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). "Metronidazole: 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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