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VAGISTAT-1 (tioconazole) is intended for intravaginal administration only. Applicators should be opened just prior to administration to prevent contamination. Administration of VAGISTAT-1 (tioconazole) just prior to bedtime may be preferred. The VAGISTAT-1 (tioconazole) ointment base may interact with rubber or latex products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment is not recommended.
No long-term studies in animals have been performed to evaluate the carcinogenic potential of tioconazole.
Tioconazole did not demonstrate mutagenic activity at the levels examined in tests at either the chromosomal or subchromosomal level.
Impairment of Fertility
No impairment of fertility was seen in male rats administered tioconazole hydrochloride in oral doses up to 150 mg/kg/day. However, there was evidence of preimplantation loss in female rats at oral dose levels above 35 mg/kg/day.
Pregnancy Category C: Tioconazole hydrochloride had no adverse effects on fetal viability or growth when administered orally to pregnant rats at doses of 55, 110, and 165 mg/kg/day during the period of organogenesis. A drug- related increase in the incidence of dilated ureters, hydroureters, and hydronephrosis observed in the fetuses of this study was transient and no longer evident in pigs raised to 21 days of age. These effects did not occur following intravaginal administration of approximately 10 mg/kg/day in a 2% cream. There was no evidence of major structural anomalies. No embryotoxic or teratogenic effects were observed in rabbits receiving oral dose levels as high as 165 mg/kg/day or daily intravaginal application of approximately 2-3 mg/kg in a 2% tioconazole cream during organogenesis. Tioconazole hydrochloride, like other azole antimycotic agents, causes dystocia in rats when treatment is extended through parturition. Associated effects in rats include prolongation of pregnancy, in utero deaths, and impaired pup survival. The ''no-effect'' level for this phenomenon is 20 mg/kg/day orally and approximately 9 mg/kg/day intravaginally. No effect on parturition occurred in rabbits at 50 mg/kg/day orally.
There are no adequate and well-controlled studies in pregnant women. VAGISTAT® -1 (tioconazole 6.5%) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while VAGISTAT-1 (tioconazole) is administered.
Safety and effectiveness in children have not been established.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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