Flagyl/Flagyl Forte Special Precautions

Flagyl Forte/Flagyl Suspension: 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).
Flagyl Suspension: There is no suspicion in carcinogenicity in human although the product has proved carcinogenic in a certain strain of mouse but not in rats and hamsters.
Flagyl Suppository: Care must be taken for: Lactating woman as metronidazole is secreted in breast milk.
Second and third trimesters of pregnancy as metronidazole can pass the placenta barrier.
FLAGYL should be administered with caution to patients with CNS diseases. The CNS interference has been reported in some cases, but will disappear on the withdrawn or on the reduced doses of metronidazole.
When taken together with alcohol, metronidazole can provoke a dilsufiram-like reaction.
Count the blood examination is recommended for a long term treatment.
For patients with hepatic insufficiency, doses below those usually recommended should be administered caustiously.
Safety in children has not been established, except in amoebiasis.
Flagyl Forte: 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.