Ertaczo Information
Ertaczo (Sertaconazole)
Ertaczo (Sertaconazole) Description
Ertaczo (Sertaconazole) (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.
Sertaconazole nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is CHClNOS • HNO, and the structural formula is as follows:
Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, sparingly soluble in alcohol and in methylene chloride. Each gram of Ertaczo (Sertaconazole) Cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol and polyethylene glycol palmitostearate, glyceryl isostearate, light mineral oil, methylparaben, polyoxyethylened saturated glycerides and glycolized saturated glycerides, sorbic acid and purified water.
Ertaczo (Sertaconazole) Clinical Pharmacology
Pharmacokinetics:
2
2
®
2
Microbiology:
Trichophyton rubrum
Trichophyton mentagrophytes
Epidermophyton floccosum
Ertaczo (Sertaconazole) Clinical Studies
In two randomized, double-blind, clinical trials, patients 12 years and older with interdigital tinea pedis applied either Ertaczo (Sertaconazole) Cream, 2%, or vehicle, twice daily for four weeks. Patients with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the study. Two weeks after completion of therapy (six weeks after beginning therapy), patients were evaluated for signs and symptoms related to interdigital tinea pedis.
Treatment outcomes are summarized in the table below.
In clinical trials, complete cure in sertaconazole treated patients was achieved in 32 of 160 (20%) patients with , in 7 of 28 (25%) patients with and in 2 of 13 (15%) patients with .
Ertaczo (Sertaconazole) Indications And Usage
Ertaczo (Sertaconazole) (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: (see Section).
Ertaczo (Sertaconazole) Contraindications
Ertaczo (Sertaconazole) Cream, 2%, is contraindicated in patients who have a known or suspected sensitivity to sertaconazole nitrate or any of its components or to other imidazoles.
Ertaczo (Sertaconazole) Warnings
Ertaczo (Sertaconazole) Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.
Ertaczo (Sertaconazole) Precautions
General:
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 (Sertaconazole) Cream, 2%, to patients known to be sensitive to imidazole antifungals, since cross-reactivity may occur.
Information for Patients:
Drug/Laboratory Test Interactions:
®
Carcinogenesis, Mutagenesis, Impairment of Fertility:
in vivo
Pregnancy: Teratogenic Effects. Pregnancy Category C:
There are no adequate and well-controlled studies that have been conducted on topically applied Ertaczo (Sertaconazole) Cream, 2%, in pregnant women. Because animal reproduction studies are not always predictive of human response, Ertaczo (Sertaconazole) Cream, 2%, should be used during pregnancy only if clearly needed.
Nursing Mothers:
®
Pediatric Use:
®
Geriatric Use:
®
Ertaczo (Sertaconazole) Adverse Events
In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) patients (2 of them severe) receiving Ertaczo (Sertaconazole) Cream, 2%, and in 7 of 291 (2%) patients (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site reaction and skin tenderness.
In a dermal sensitization study, 8 of 202 evaluable patients tested with Ertaczo (Sertaconazole) Cream, 2%, and 4 of 202 evaluable patients 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. In non-US post-marketing surveillance for Ertaczo (Sertaconazole) Cream, 2%, the following cutaneous adverse events were reported: contact dermatitis, erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
Ertaczo (Sertaconazole) Overdosage
Overdosage with Ertaczo (Sertaconazole) Cream, 2%, has not been reported to date. Ertaczo (Sertaconazole) Cream, 2%, is intended for topical dermatologic use only. It is not for oral, ophthalmic, or intravaginal use.
Ertaczo (Sertaconazole) Dosage And Administration
In the treatment of interdigital tinea pedis, Ertaczo (Sertaconazole) Cream, 2%, should be applied twice daily for 4 weeks. Sufficient Ertaczo (Sertaconazole) 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. If a patient shows no clinical improvement 2 weeks after the treatment period, the diagnosis should be reviewed.
Ertaczo (Sertaconazole) How Supplied
Ertaczo (Sertaconazole) Cream, 2%, is supplied in tubes in the following size:
Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].
Patent No. 5,135,943
Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045
Repackaged By: Rebel DistributorsThousand Oaks, CA 91320
Rev November 2005 128354
Ertaczo (Sertaconazole)
