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ERTACZO®
(sertaconazole nitrate) Cream, 2%
For Topical Dermatologic Use Only - Not for Oral, Ophthalmic or Intravaginal Use
DESCRIPTION
ERTACZO® (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-[b]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is C20H15Cl3N2OS • HNO3, 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® 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.
CLINICAL PHARMACOLOGY
CLINICAL STUDIES
In two randomized, double-blind, clinical trials, patients 12 years and older with interdigital tinea pedis applied either ERTACZO® 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.
* Complete Cure - Patients who had complete clearing of signs and symptoms and Mycological Cure. | ||||
** Effective Treatment - Patients who had minimal residual signs and symptoms of interdigital tinea pedis and Mycological Cure. | ||||
*** Mycological Cure - Patients who had both negative microscopic KOH preparation and a negative fungal culture. | ||||
| Study 1 | Study 2 | |||
| Sertaconazole | Vehicle | Sertaconazole | Vehicle | |
| Complete Cure* (Primary Efficacy Variable) | 13/99 (13.1%) | 3/92 (3.3%) | 28/103 (27.2%) | 5/103 (4.9%) |
| Effective Treatment** | 32/99 (32.3%) | 11/92 (12.0%) | 52/103 (50.5%) | 16/103 (15.5%) |
| Mycological Cure*** | 49/99 (49.5%) | 18/92 (19.6%) | 71/103 (68.9%) | 20/103 (19.4%) |
In clinical trials, complete cure in sertaconazole treated patients was achieved in 32 of 160 (20%) patients with Trichophyton rubrum, in 7 of 28 (25%) patients with Trichophyton mentagrophytes and in 2 of 13 (15%) patients with Epidermophyton floccosum.
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 Section).
CONTRAINDICATIONS
ERTACZO® 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.
WARNINGS
ERTACZO® Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.
PRECAUTIONS
ADVERSE EVENTS
In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) patients (2 of them severe) receiving ERTACZO® 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® 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® Cream, 2%, the following cutaneous adverse events were reported: contact dermatitis, erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
OVERDOSAGE
Overdosage with ERTACZO® Cream, 2%, has not been reported to date. ERTACZO® Cream, 2%, is intended for topical dermatologic use only. It is not for oral, ophthalmic, or intravaginal use.
DOSAGE AND ADMINISTRATION
In the treatment of interdigital tinea pedis, ERTACZO® Cream, 2%, should be applied twice daily for 4 weeks. Sufficient 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. If a patient shows no clinical improvement 2 weeks after the treatment period, the diagnosis should be reviewed.
HOW SUPPLIED
ERTACZO® 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].
Rx only.
Patent No. 5,135,943
Distributed By: OrthoNeutrogena
DIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.
Los Angeles, CA 90045
Rev November 2005
128354