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Convulsive Seizures And Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole (metronidazole (metronidazole injection) injection) . The appearance of abnormal neurologic signs demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy.

General

Prescribing Metronidazole (metronidazole (metronidazole injection) injection) Injection USP 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.

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole (metronidazole (metronidazole injection) injection) and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously.

Administration of solutions containing sodium ions may result in sodium retention. Care should be taken when administering Metronidazole (metronidazole (metronidazole injection) injection) Injection USP to patients receiving corticosteroids or to patients predisposed to edema.

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Metronidazole (metronidazole (metronidazole injection) injection) Injection USP and requires treatment with a candicidal agent.

Information for Patients

Patients should be counseled that antibacterial drugs including Metronidazole (metronidazole (metronidazole injection) injection) Injection USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Metronidazole (metronidazole (metronidazole injection) injection) Injection USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Metronidazole (metronidazole (metronidazole injection) injection) Injection USP or other antibacterial drugs in the future.

Laboratory Tests

Metronidazole is a nitroimidazole, and Metronidazole (metronidazole (metronidazole injection) injection) Injection USP should be used with caution in patients with evidence of or history of blood dyscrasia. A mild leukopenia has been observed during metronidazole (metronidazole (metronidazole injection) injection) administration; however, no persistent hematologic abnormalities attributable to metronidazole (metronidazole (metronidazole injection) injection) have been observed in clinical studies. Total and differential leukocyte counts are recommended before and after therapy.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Tumorigenicity in Rodents

Metronidazole (metronidazole (metronidazole injection) injection) has shown evidence of carcinogenic activity in studies involving chronic, oral administration in mice and rats, but similar studies in the hamster gave negative results. Also, metronidazole (metronidazole (metronidazole injection) injection) has shown mutagenic activity in a number of in vitro assay systems, but studies in mammals (in vivo) failed to demonstrate a potential for genetic damage.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Metronidazole (metronidazole (metronidazole injection) injection) crosses the placental barrier and enters the fetal circulation rapidly. Reproduction studies have been performed in rats at doses up to five times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to metronidazole. Metronidazole (metronidazole (metronidazole injection) injection) administered intraperitoneally to pregnant mice at approximately the human dose caused fetotoxicity; administered orally to pregnant mice, no fetotoxicity was observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because metronidazole (metronidazole (metronidazole injection) injection) is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for tumorigenicity shown for metronidazole (metronidazole (metronidazole injection) injection) in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Metronidazole (metronidazole (metronidazole injection) injection) is secreted in human milk in concentrations similar to those found in plasma.

Pediatric Use

Safety and effectiveness in children have not been established.

Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.