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warnings and cautions
5 WARNINGS AND PRECAUTIONS Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole gel therapy. ( 5.1 ) Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. ( 5.2 ) If dermatitis occurs, patients may need to discontinue use. ( 5.3 ) Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. ( 5.4 ) 5.1 Neurologic Disease Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole gel therapy. Metronidazole should be administered with caution to patients with central nervous system diseases. 5.2 Blood Dyscrasias Metronidazole is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia. 5.3 Contact Dermatitis Irritant and allergic contact dermatitis have been reported. If dermatitis occurs, patients may need to discontinue use. 5.4 Eye Irritation Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.
6 ADVERSE REACTIONS Most common adverse reactions (incidence >2%) are nasopharyngitis, upper respiratory tract infection, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals, U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a controlled clinical trial, 557 patients used metronidazole gel, 1% and 189 patients used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occured at rate of > 1%: The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea. table01 table02 6.2 Post Marketing Experience The following adverse reaction has been identified during post approval use of topical metronidazole: peripheral neuropathy. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.