No information provided.
General: Topical metronidazole has been reported to cause tearing of
the eyes. Therefore, contact with the eyes should be avoided. If a reaction
suggesting local irritation occurs, patients should be directed to use the medication
less frequently or discontinue use. Metronidazole is a nitroimidazole and should
be used with care in patients with evidence of, or history of blood dyscrasia.
Carcinogenesis, mutagenesis, impairment of fertility
Metronidazole has shown evidence of carcinogenic activity in a number of studies
involving chronic, oral administration in mice and rats but not in studies involving
Metronidazole has shown evidence of mutagenic activity in several in vitro
bacterial assay systems. In addition, a dose-response increase in the frequency
of micronuclei was observed in mice after intraperitoneal injections and an
increase in chromosome aberrations have been reported in patients with Crohn's
disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months.
However, no excess chromosomal aberrations in circulating human lymphocytes
have been observed in patients treated for 8 months.
Teratogenic effects: Pregnancy category B
There are no adequate and well-controlled studies with the use of METROCREAM®
(metronidazole topical cream) Topical Cream in pregnant women. Metron-idazole
crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity
was observed after oral metronidazole in rats or mice. However, because animal
reproduction studies are not always predictive of human response and since oral
metronidazole has been shown to be a carcinogen in some rodents, this drug should
be used during pregnancy only if clearly needed.
After oral administration, metronida-zole is secreted in breast milk in concentrations
similar to those found in the plasma. Even though blood levels are significantly
lower with topically applied metronida-zole than those achieved after oral administration
of metronidazole, a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the drug to the
Safety and effectiveness in pediatric patients have not been established.