Data from FDA - Curated by EPG Health - Last updated 02 June 2018

Indication(s)

1 INDICATIONS 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)

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None. (4)
Adverse reactions
6 ADVERSE 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. 6.1 Clinical 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, and 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. 6.2 Postmarketing 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 postmarketing surveillance for ERTACZO cream, 2%, the following were reported: Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION In the treatment of interdigital tinea pedis, ERTACZO cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of ERTACZO 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. ERTACZO cream, 2% should be applied to the affected and immediate surrounding area(s) twice daily for 4 weeks. (2) Not for ophthalmic, oral, or intravaginal use. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies conducted with ERTACZO cream, 2% in pregnant women. ERTACZO cream 2%, 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, 2%. 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 postnatal development study in rats. 8.3 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. 8.4 Pediatric Use The efficacy and safety of ERTACZO cream, 2%, have not been established in pediatric patients below the age of 12 years. 8.5 Geriatric 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.
Pregnancy and lactation
8.3 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.

More information

Category Value
Authorisation number NDA021385
Agency product number 1DV05410M5
Orphan designation No
Product NDC 0187-5115
Date Last Revised 13-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 580294
Storage and handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Marketing authorisation holder Valeant Pharmaceuticals North America LLC