Metronidazole - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Central and Peripheral Nervous System Effects: Encephalopathy, convulsive seizures, aseptic meningitis and peripheral neuropathy have been reported with metronidazole.

Promptly evaluate the benefit/risk of continuation of LIKMEZ if abnormal neurological signs develop.

Blood Dyscrasias : Use LIKMEZ with care in patients with a history of blood dyscrasias.

LIKMEZ may cause mild transient leukopenia.

5.1 Potential for Carcinogenicity Metronidazole has been shown to be carcinogenic in mice and rats.

Tumors affecting the liver, lungs, mammary, and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters [ see Nonclinical Toxicology ] .

Avoid unnecessary use of LIKMEZ.

Reserve LIKMEZ for use in the following indications: trichomoniasis [ see Indications and Usage ] , amebiasis [ see Indications and Usage ] and anaerobic bacterial infections [ see Indications and Usage ].

5.2 Central and Peripheral Nervous System Effects Encephalopathy, aseptic meningitis, peripheral neuropathy (including optic neuropathy) and convulsive seizures 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.

Cases of aseptic meningitis have been reported with metronidazole [ see Adverse Reactions ] .

Symptoms may occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.

The appearance of abnormal neurological signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy.

5.3 Fungal Superinfections Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with LIKMEZ and requires treatment with an antifungal agent.

5.4 Blood Dyscrasias LIKMEZ is a nitroimidazole and should be used with care in patients with evidence of or history of blood dyscrasia.

A mild leukopenia has been observed during metronidazole administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies.

Total and differential leukocyte counts are recommended before and after therapy [ see Adverse Reactions ] .

5.5 Drug-Resistant Bacteria Prescribing LIKMEZ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.