Antiinfective of the family of imidazoles indicated in the treatment of giardiasis, amebiasis, trichomoniasis and anaerobic infections (bacteroides and clostridium).
Oral administration one to three times a day. Intravenous use in severe cases.
Authorized and widely used in Pediatrics. The dose in minors of two months is 15 mg / kg / day and in greater than two months of 30 mg / kg / day (AEMPS 2018).
There are ancient studies that proved carcinogenic effects in rats receiving high doses. This has not been demonstrated in humans (Falagas 1998, Fahrig 1997, Beard 1988, Roe 1985), there is still much controversy (Adil 2018, Friedman 2009) and metronidazole is one of the most used antibiotics in vaginal, intestinal and other infections and whose use in humans is spreading (Adil 2018, Sobel 2015).
It is excreted in breast milk in a moderate but clinically insignificant amount (Zhang 1997, Passmore 1988, Heisterberg 1983, Erickson 1981, Gray 1961).
No problems have been observed in infants whose mothers were taking it (Passmore 1988, Gray 1961), except for a possible case of diarrhea (Clements 1980).
Plasma levels of such infants are undetectable or very low (Passmore 1988, Gray 1961).
Metronidazole can redden body fluids and give a bitter or metallic taste to milk (Chin 2001, Andersson 1981), without this being harmful.
Although the opinions are divided (Huang 2016), being contraindicated for some (van der Woude 2015 and 2010, Nielsen 2014, m Yarur 2013), various medical societies, experts and consensus experts consider the use of this medication safe during breastfeeding ( Hale 2017 p 647, Schulze 2014, Kong 2013, Rowe 2013, Bar-Oz 2003, Einarson 2000, Rubin 1986), recommending some authors when the dose is large wait to breastfeed 12 to 24 hours after administration in order to minimize the exposure (Ladies 2015, Huang 2014, Rowe 2013, CDC 2010, WHO 2002).
In case of the mother of a premature or newborn, which metabolize worse metronidazole may be prudent, either use the minimum effective dose, or choose an alternative.
See below the information of this related product:
- Metronidazole (Dermal and Vaginal use) (Very Low Risk)
Very Low Risk
Compatible. Not risky for breastfeeding or infant.
Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.
Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.
Very High Risk
Not recommended. Cessation of breastfeeding or alternative.
- Metronidazole Benzoate
- Metronidazole Hydrochloride
- μετρονιδαζόλη (Greek)
- ميترونيدازول (Arabic)
- Метронидазол (Cyrillic)
- 甲硝唑 (Chinese)
- メトロニダゾール (Japanese)
- C6 H9 N3 O3 (Molecular formula)
- 2-(2-Methyl-5-nitroimidazol-1-yl)ethanol (Chemical name)
- A01AB17; D06BX01; G01AF01; J01XD01; P01AB01 (ATC Code/s)
Drug trade names
- Eskapar Compuesto™
- Metral™ (Argentina)
- Tolbin™ (Argentina)
- МЕТРОГІЛ® ВАГІНАЛЬНИЙ ГЕЛЬ
- МЕТРОНІДАЗОЛУ БЕНЗОАТ
- Adil M, Iqbal W, Adnan F, Wazir S, Khan I, Khayam MU, Kamal MA, Ahmad S, Ahmad J, Khan IN. Association of Metronidazole with Cancer: A Potential Risk Factor or Inconsistent Deductions? Curr Drug Metab. 2018Abstract
- AEMPS-Sanofi. Metronidazol. Ficha técnica. 2018 Full text (in our servers)
- Huang VW, Chang HJ, Kroeker KI, Goodman KJ, Hegadoren KM, Dieleman LA, Fedorak RN. Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding Varies Widely: A Need for Further Education. Can J Gastroenterol Hepatol. 2016Abstract Full text (link to original source) Full text (in our servers)
- van der Woude CJ, Ardizzone S, Bengtson MB, Fiorino G, Fraser G, Katsanos K, Kolacek S, Juillerat P, Mulders AG, Pedersen N, Selinger C, Sebastian S, Sturm A, Zelinkova Z, Magro F; European Crohn’s and Colitis Organization. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015Abstract Full text (link to original source) Full text (in our servers)
- Sobel R, Sobel JD. Metronidazole for the treatment of vaginal infections. Expert Opin Pharmacother. 2015Abstract
- FDA Hospira. Metronidazole.. Drug Summary. 2015 Full text (in our servers)
- Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015Abstract Full text (in our servers)
- Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014Abstract Full text (link to original source) Full text (in our servers)
- Huang VW, Habal FM. From conception to delivery: managing the pregnant inflammatory bowel disease patient. World J Gastroenterol. 2014Abstract Full text (link to original source) Full text (in our servers)
- Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014Abstract
- Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013Abstract Full text (link to original source) Full text (in our servers)
- Kong YL, Tey HL. Treatment of acne vulgaris during pregnancy and lactation. Drugs. 2013Abstract
- Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. 2013Abstract
- CDC - Workowski KA, Berman S; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010Abstract Full text (link to original source) Full text (in our servers)
- Friedman GD, Jiang SF, Udaltsova N, Quesenberry CP Jr, Chan J, Habel LA. Epidemiologic evaluation of pharmaceuticals with limited evidence of carcinogenicity. Int J Cancer. 2009Abstract
- Bar-Oz B, Bulkowstein M, Benyamini L, Greenberg R, Soriano I, Zimmerman D, Bortnik O, Berkovitch M. Use of antibiotic and analgesic drugs during lactation. Drug Saf. 2003Abstract
- WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
- Chin KG, McPherson CE 3rd, Hoffman M, Kuchta A, Mactal-Haaf C. Use of anti-infective agents during lactation: Part 2--Aminoglycosides, macrolides, quinolones, sulfonamides, trimethoprim, tetracyclines, chloramphenicol, clindamycin, and metronidazole. J Hum Lact. 2001Abstract
- Einarson A, Ho E, Koren G. Can we use metronidazole during pregnancy and breastfeeding? Putting an end to the controversy. Can Fam Physician. 2000Abstract Full text (link to original source) Full text (in our servers)
- Falagas ME, Walker AM, Jick H, Ruthazer R, Griffith J, Snydman DR. Late incidence of cancer after metronidazole use: a matched metronidazole user/nonuser study. Clin Infect Dis. 1998Abstract
- Zhang Y, Zhang Q, Xu Z. [Tissue and body fluid distribution of antibacterial agents in pregnant and lactating women]. Zhonghua Fu Chan Ke Za Zhi. 1997Abstract
- Fahrig R, Engelke M. Reinvestigation of in vivo genotoxicity studies in man. I. No induction of DNA strand breaks in peripheral lymphocytes after metronidazole therapy. Mutat Res. 1997Abstract
- Passmore CM, McElnay JC, Rainey EA, D'Arcy PF. Metronidazole excretion in human milk and its effect on the suckling neonate. Br J Clin Pharmacol. 1988Abstract Full text (link to original source) Full text (in our servers)
- Beard CM, Noller KL, O'Fallon WM, Kurland LT, Dahlin DC. Cancer after exposure to metronidazole. Mayo Clin Proc. 1988Abstract
- Rubin PC. Prescribing in pregnancy. General principles. Br Med J (Clin Res Ed). 1986Abstract
- Roe FJ. Safety of nitroimidazoles. Scand J Infect Dis Suppl. 1985Abstract
- Heisterberg L, Branebjerg PE. Blood and milk concentrations of metronidazole in mothers and infants. J Perinat Med. 1983Abstract
- Erickson SH, Oppenheim GL, Smith GH. Metronidazole in breast milk. Obstet Gynecol. 1981Abstract
- Andersson KE. Pharmacokinetics of nitroimidazoles. Spectrum of adverse reactions. Scand J Infect Dis Suppl. 1981Abstract
- Clements CJ. Metronidazole and breast feeding. N Z Med J. 1980Abstract
- Wood BA, Monro AM. Pharmacokinetics of tinidazole and metronidazole in women after single large oral doses. Br J Vener Dis. 1975Abstract Full text (link to original source) Full text (in our servers)
- GRAY MS, KANE PO, SQUIRES S. Further observations on metronidazole (Flagyl). Br J Vener Dis. 1961Abstract Full text (link to original source) Full text (in our servers)