Flagyl Forte Special Precautions

The use of Flagyl for prolonged treatment duration should be carefully weighed.
If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Flagyl should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine (due to metronidazole metabolite).
Safety in children has not been established, except in amoebiasis.
Used with caution in nursing mothers as metronidazole is excreted in breast milk, during first and second trimesters of pregnancy as metronidazole crosses the placental barrier.
Doses should be reduced and administered with caution to patients with hepatic diseases.
Safety and effectiveness in pediatric patients have not been established, except in the treatment of amoebiasis.
Effects on ability to drive and use machines: Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.
Carcinogenicity: Metronidazole has been shown to be carcinogenic in the mouse and in the rat. However similar studies in the hamster have given negative results and extensive human epidemiological studies in humans have provided no evidence of an increased carcinogenic risk in humans. Therefore, the use of Flagyl for longer treatment than usually required prolonged treatment duration should be carefully weighed.
Mutagenicity: Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative. Therefore, the use of Flagyl for longer treatment than usually required prolonged treatment duration should be carefully weighed.