Gynomax Use In Pregnancy & Lactation

The pregnancy category is C.
Women having childbearing potential/Birth Control (Contraception): Since the effects of active ingredients in Tioconazole + Tinidazole + Lidocaine (Gynomax) for fetus and newborn growth are not clearly known, women who must use this product should avoid pregnancy with a proper birth control method.
Pregnancy: Tinidazole crosses the placental barrier. Animal studies are insufficient with respect to effects on pregnancy and/or embryonal/fetal development and/or parturition and/or postnatal development. The potential risk for humans is unknown.
Tioconazole + Tinidazole + Lidocaine (Gynomax) should not be used in the first trimester due to insufficient data. Usage during the second and third trimesters must be evaluated by the physician according to the benefits/risks ratio, and it should not be used during pregnancy unless clearly necessary.
Lactation: Breastfeeding should be discontinued during the treatment, since tinidazole appears in milk. Breastfeeding can be started again 72 hours after the end of treatment. It is not known if tioconazole is excreted in milk.
It is not known whether lidocaine is excreted in milk. Caution should be exercised when lidocaine is administered to a breastfeeding woman.
Reproduction/Fertility: In a 60-day fertility study, tinidazole reduced fertility and produced testicular histopathology in male rats at a 600 mg/kg/day dose level. Spermatogenic effects resulted from 300 and 600 mg/kg/day dose levels. The no observed adverse reaction level for testicular and spermatogenic effects was 100 mg/kg/day. This effect is characteristic of agents in the 5-nitroimidazole class.
No impairment of fertility was seen in male rats when oral tioconazole doses up to 150 mg/kg/day is administered.
However, there was evidence of preimplantation loss in female rats at oral dose levels above 35 mg/kg/day.
There is no evidence that lidocaine has harmful effects on animal or human fertility.