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Local Adverse Reactions
If irritation develops, treatment should be discontinued and appropriate therapy instituted.
Physicians should exercise caution when prescribing ERTACZO cream, 2%, to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.
Patient Counseling Information
See FDA-approved Patient Labeling (PATIENT INFORMATION)
The patient should be instructed to:
- Use ERTACZO cream, 2%, as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, mouth, vagina and other mucous membranes. ERTACZO cream, 2%, is for external use only.
- Dry the affected area(s) thoroughly before application, if you wish to use ERTACZO cream, 2%, after bathing.
- Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved.
- Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling or oozing.
- Avoid the use of occlusive dressings unless otherwise directed by the physician.
- Do not use this medication for any disorder other than that for which it was prescribed.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
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 Category C
There are no adequate and well-controlled studies conducted with ERTACZO cream in pregnant women. ERTACZO 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 ERTACZO 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.
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.
The efficacy and safety of ERTACZO cream, 2%, have not been established in pediatric patients below the age of 12 years.
Clinical trials 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 reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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