No information provided.
None.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Gynozalain® cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.
In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Gynozalain® cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.
Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of Gynozalain cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In post-marketing surveillance for Gynozalain cream, 2%, the following were reported:
Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
Gynozalain® (sertaconazole nitrate) cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
In a multiple dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42 -140 cm²; mean, 93 cm²), Gynozalain cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm²). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.
Included as part of the PRECAUTIONS section.
PRECAUTIONS Local Adverse ReactionsIf irritation develops, treatment should be discontinued and appropriate therapy instituted.
Physicians should exercise caution when prescribing Gynozalain cream, 2%, to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.
Patient Counseling InformationSee FDA-approved Patient Labeling (PATIENT INFORMATION)
The patient should be instructed to:
In a rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).
No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.
At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.
Use In Specific Populations Pregnancy Pregnancy Category CThere are no adequate and well-controlled studies conducted with Gynozalain cream in pregnant women. Gynozalain cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Reproduction studies have not been performed with Gynozalain cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day sertaconazole nitrate in an oral peri-and post-natal development study in rats.
Nursing MothersIt is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing Gynozalain cream, 2%, to a nursing woman.
Pediatric UseThe efficacy and safety of Gynozalain cream, 2%, have not been established in pediatric patients below the age of 12 years.
Geriatric UseClinical trials of Gynozalain cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
In the treatment of interdigital tinea pedis, Gynozalain cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Gynozalain cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis.
Not for ophthalmic, oral, or intravaginal use.
