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sertaconazole nitrate cream
* 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|
(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.
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).
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.
General: ERTACZO® Cream, 2%, is for use on the skin only. If irritation or sensitivity develops with the use of ERTACZO® Cream, 2%, treatment should be discontinued and appropriate therapy instituted.
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® Cream, 2%, to patients known to be sensitive to imidazole antifungals, since cross-reactivity may occur.
Information for Patients: The patient should be instructed to:
Drug/Laboratory Test Interactions: Potential interactions between ERTACZO® Cream, 2%, and other drugs or laboratory tests have not been systematically evaluated.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies to evaluate the carcinogenic potential of sertaconazole nitrate have not been conducted. No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered negative for sister chromatid exchange (SCE) in the in vivo mouse bone marrow SCE assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in rat primary hepatocyte cultures. Sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility of male or female rats given up to 60 mg/kg/day orally by gastric intubation (16 times the maximum recommended human dose based on a body surface area comparison).
Pregnancy: Teratogenic Effects. Pregnancy Category C: Oral reproduction studies in rats and rabbits did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity of sertaconazole nitrate at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose on a body surface area comparison). In an oral peri-postnatal study in rats, a reduction in live birth indices and an increase in the number of still-born pups was seen at 80 and 160 mg/kg/day.
There are no adequate and well-controlled studies that have been conducted on topically applied ERTACZO® Cream, 2%, in pregnant women. Because animal reproduction studies are not always predictive of human response, ERTACZO® Cream, 2%, should be used during pregnancy only if clearly needed.
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.
Pediatric Use: The efficacy and safety of ERTACZO® Cream, 2%, have not been established in pediatric patients below the age of 12 years.
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 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.
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.
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].
Patent No. 5,135,943
Distributed By: OrthoNeutrogena
DIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.
Los Angeles, CA 90045
Rev November 2005
sertaconazole nitrate cream
Revised: 03/2007 OrthoNeutrogena
Reproduced with permission of U.S. National Library of Medicine
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