General: ERTACZO® Cream, 2%, is for use on the skin only. If irritation
or sensitivity develops with the use of ERTACZO® Cream, 2%, treatment should
be discontinued and appropriate therapy instituted.
Diagnosis of the disease should be confirmed either by direct microscopic examination
of infected superficial epidermal tissue in a solution of potassium hydroxide
or by culture on an appropriate medium.
Physicians should exercise caution when prescribing ERTACZO® Cream, 2%,
to patients known to be sensitive to imidazole antifungals, since cross-reactivity
may occur.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the car-cinogenic potential of sertaconazole
nitrate have not been conducted. No clastogenic potential was observed in a
mouse micronucleus test. Sertaconazole nitrate was considered negative for sister
chromatid exchange (SCE) in the in vivo mouse bone marrow SCE assay.
There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis
in rat primary hepatocyte cultures. Sertaconazole nitrate exhibited no toxicity
or adverse effects on reproductive performance or fertility of male or female
rats given up to 60 mg/kg/day orally by gastric intubation (16 times the maximum
recommended human dose based on a body surface area comparison).
Pregnancy
Teratogenic Effects
Pregnancy Category C: Oral reproduction studies in rats and rabbits
did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity
of ser-taconazole nitrate at an oral dose of 160 mg/kg/day (40 times (rats)
and 80 times (rabbits) the maximum recommended human dose on a body surface
area comparison). In an oral peri-postnatal study in rats, a reduction in live
birth indices and an increase in the number of still-born pups was seen at 80
and 160 mg/kg/day.
There are no adequate and well-controlled studies that have been conducted
on topically applied ERTACZO® Cream, 2%, in pregnant women. Because animal
reproduction studies are not always predictive of human response, ERTACZO®
Cream, 2%, should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known if sertaconazole is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when prescribing ERTACZO®
Cream, 2%, to a nursing woman.
Pediatric Use
The efficacy and safety of ERTACZO® Cream, 2%, have not been established
in pediatric patients below the age of 12 years.
Geriatric Use
Clinical studies of ERTACZO® Cream, 2%, did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently from
younger subjects.
Last updated on RxList: 12/29/2008