Tinidazole - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Tinidazole. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology ]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use [see Warnings and Precautions ]. WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent . Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only ( 1.1 , 1.2 , 1.3 ). Avoid chronic use .
5 WARNINGS AND PRECAUTIONS Seizures and neuropathy have been reported.
Discontinue Tinidazole Tablets if abnormal neurologic signs develop Vaginal candidiasis may develop with Tinidazole Tablets and require treatment with an antifungal agent Use Tinidazole Tablets with caution in patients with blood dyscrasias.
Tinidazole Tablets may produce transient leukopenia and neutropenia ( 5.3, 7.3 ) 5.1 Potential for Genotoxicity and Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole [see Nonclinical Toxicology ] .
Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects.
However, it is unclear if the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of Tinidazole Tablet.
Use should be limited to approved indications only.
5.2 Neurological Adverse Reactions Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with tinidazole.
The appearance of abnormal neurologic signs demands the prompt discontinuation of tinidazole therapy.
5.3 Vaginal Candidiasis The use of tinidazole may result in Candida vaginitis.
In a clinical study of 235 women who received tinidazole for bacterial vaginosis, a vaginal fungal infection developed in 11 (4.7%) of all study subjects [see Clinical Studies ].
5.4 Blood Dyscrasia Tinidazole should be used with caution in patients with evidence of or history of blood dyscrasia [see Drug Interactions ].
5.5 Development of Drug-Resistant Bacteria Prescribing Tinidazole Tablets 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.
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