1INDICATIONS AND USAGE ERTACZO® (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 [see Clinical Studies (14) ]. ERTACZO cream 2% is an azole antifungal 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. (1)
3DOSAGE FORMS AND STRENGTHS Cream, 2%. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base. Cream, 2%. (3)
4CONTRAINDICATIONS None. None. (4)
5WARNINGS AND PRECAUTIONS 5.1Local 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 imidazole antifungals, since cross-reactivity may occur.
6ADVERSE REACTIONS Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1Clinical Trials Experience 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 ERTACZO® 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 ERTACZO® 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. 6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO 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 ERTACZO cream, 2%, the following were reported: Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
8USE IN SPECIFIC POPULATIONS 8.1Pregnancy 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. 8.3Nursing 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. 8.4Pediatric Use The efficacy and safety of ERTACZO cream, 2%, have not been established in pediatric patients below the age of 12 years. 8.5Geriatric Use 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.