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PregnancyIn animal studies tioconazole was not teratogenic. At high doses it increased the incidence of renal abnormalities in rat embryos, but this effect was minor and transient and was not evident in weaned animals. There is insufficient evidence as to the drug's safety in human pregnancy although absorption after topical administration is negligible. Because of the extensive duration of treatment required for nail infections, the use of Trosyl Nail Solution is contra-indicated throughout pregnancy.
Breast-feedingIt is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while Trosyl is administered.
|System Organ Class||Frequency||Undesirable effects|
|Immune system disorders||Unknown||Allergic reaction|
|Nervous system disorders||Unknown||Paraesthesia|
|Skin and subcutaneous tissue disorders||Unknown||Bullous eruption, dermatitis contact, dry skin, edema periorbital, nail disorder (including nail discoloration, periungual inflammation and nail pain), pruritis, skin irritation, skin exfoliation, urticaria|
|General disorders and administration site conditions||Common||Oedema peripheral|
|Unknown||Pain, burning sensation|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
AbsorptionAbsorption is rapid and extensive on oral administration to rats, monkeys and man, the major metabolite being a glucuronide conjugate of tioconazole. Tissue uptake in rat and monkey was highest in liver, kidney and intestinal tract with excretion in all species mainly in faeces. Rat studies using oral, dermal and vaginal administration of C14 labelled tioconazole confirm significantly lower absorption via the topical route. In man, oral formulations of tioconazole (500 mg) gave plasma concentrations of 1300 ng/ml. Topical administration of dermal cream 1% (20 mg/day) for 28 days, or vaginal cream 2% (100 mg/day) for 30 days gave negligible mean peak plasma levels, i.e. 10.1 and 11.5 ng/ml respectively.
DistributionAfter single dose administration of tioconazole vaginal ointment 6.5% w/w (tioconazole 300 mg) the mean peak plasma concentration was 18 ng/ml in humans, achieved approximately 8 hours post dose.