WARNINGS AND PRECAUTIONS
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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.
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 ].
Blood Dyscrasia
Tinidazole should be used with caution in patients with evidence of or history
of blood dyscrasia [see Drug Interactions].
Drug Resistance
Prescribing Tindamax 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.
USE IN SPECIFIC POPULATIONS
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Pregnancy
Teratogenic effects: Pregnancy Category C
The use of tinidazole in pregnant patients has not been studied. Since
tinidazole crosses the placental barrier and enters fetal circulation it should
not be administered to pregnant patients in the first trimester.
Embryo-fetal developmental toxicity studies in pregnant mice indicated no
embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg
(approximately 6.3-fold the highest human therapeutic dose based upon body
surface area conversions). In a study with pregnant rats a slightly higher
incidence of fetal mortality was observed at a maternal dose of 500 mg/kg
(2.5-fold the highest human therapeutic dose based upon body surface area
conversions). No biologically relevant neonatal developmental effects were
observed in rat neonates following maternal doses as high as 600 mg/kg (3-fold
the highest human therapeutic dose based upon body surface area conversions).
Although there is some evidence of mutagenic potential and animal reproduction
studies are not always predictive of human response, the use of tinidazole after
the first trimester of pregnancy requires that the potential benefits of the
drug be weighed against the possible risks to both the mother and the fetus.
Nursing Mothers
Tinidazole is excreted in breast milk in concentrations similar to those seen in
serum. Tinidazole can be detected in breast milk for up to 72 hours following
administration. Interruption of breast-feeding is recommended during tinidazole
therapy and for 3 days following the last dose.
Pediatric Use
Other than for use in the treatment of giardiasis and amebiasis
in pediatric patients older than three years of age, safety and effectiveness of
tinidazole in pediatric patients have not been established.
Pediatric Administration: For those unable to
swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup,
to be taken with food [see Dosage and Administration ].
Geriatric Use
Clinical studies of tinidazole did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger
subjects. In general, dose selection for an elderly patient should be cautious,
reflecting the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or other drug therapy.
Renal Impairment
Because the pharmacokinetics of tinidazole in patients with
severe renal impairment (CrCL less than 22 mL/min) are not significantly different
from those in healthy subjects, no dose adjustments are necessary in these
patients.
Patients undergoing hemodialysis: If tinidazole is
administered on the same day as and prior to hemodialysis, it is recommended
that an additional dose of tinidazole equivalent to one-half of the recommended
dose be administered after the end of the hemodialysis [see
Clinical Pharmacology].
Hepatic Impairment
There are no data on tinidazole pharmacokinetics in patients with impaired
hepatic function. Reduced elimination of metronidazole, a chemically-related
nitroimidazole, has been reported in this population. Usual recommended doses of
tinidazole should be administered cautiously in patients with hepatic
dysfunction [see Clinical Pharmacology].
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