Flagyl (metronidazole) 500 mg I.V. injection RTU (in plastic container)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug eva luation and Research (CDER) -- August 2009
WARNINGS
Encephalopathy and peripheral neuropathy: Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole.
Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.
Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.
Convulsive seizures have been reported in patients treated with metronidazole.
Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.
The appearance of abnormal neurologic signs and symptoms demands the prompt eva luation of the benefit/risk ratio of the continuation of therapy.
ADVERSE REACTIONS
most serious adverse reactions reported with injection...encephalopathy, aseptic meningitis, optic neuropathy
Central Nervous System: encephalopathy, aseptic meningitis, optic neuropathy...and dysarthria
Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, flushing, nasal congestion, dryness of the mouth (or vagina or vulva) and fever
With oral metronidazole
Central Nervous System:Encephalopathy, aseptic meningitis, optic neuropathy, dysarthria
Hypersensitivity:..Stevens-Johnson Syndrome
 

View the label approved on 08/16/2013 (PDF)¹¹ for FLAGYL I.V. RTU IN PLASTIC CONTAINER, NDA no. 018353