Brand Name
Ertaczo
Generic Name
Sertaconazole
View Brand Information FDA approval date: December 10, 2003
Classification: Azole Antifungal
Form: Cream
What is Ertaczo (Sertaconazole)?
ERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Approved To Treat
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Brand Information
Ertaczo (Sertaconazole Nitrate)
1INDICATIONS AND USAGE
ERTACZO
2DOSAGE AND ADMINISTRATION
- Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin.
- Use ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved.
- Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing.
- Wash hands after use.
- Avoid the use of occlusive dressings or wrappings.
- For topical use.
- Not for ophthalmic, oral, or intravaginal use.
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.
4CONTRAINDICATIONS
None.
5DESCRIPTION
ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole 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-[
Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, and 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, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, purified water, and sorbic acid.
6CLINICAL STUDIES
In two randomized, double-blind clinical trials, subjects 12 years and older with interdigital tinea pedis applied either ERTACZO cream, 2%, or vehicle, twice daily for 4 weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (6 weeks after beginning therapy), subjects 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 negative fungal culture.
** 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 negative fungal culture.
In clinical trials, complete cure in ERTACZO cream, 2%-treated subjects was achieved in 32 of 160 (20%) subjects with
7HOW SUPPLIED/STORAGE AND HANDLING
ERTACZO cream, 2%, is white in color and supplied in tubes in the following size:
60-gram tube NDC 73159-004-60
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].
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Instruct the patient of the following:
Administration Instructions
- ERTACZO cream, 2% is for topical use only.
- Avoid contact with the eyes, mouth, vagina, and other mucous membranes.
- Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing.
- Wash hands after use.
- Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved.
- Avoid the use of occlusive dressings unless otherwise directed by the physician
Local Adverse Reactions
- Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling, or oozing
Distributed by:
Lacer Pharma, LLC
Biloxi, MS 39532 USA
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215
ERTACZO is a trademark of Lacer Pharma, LLC
141329
Lacer Pharma, LLC
Biloxi, MS 39532 USA
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215
ERTACZO is a trademark of Lacer Pharma, LLC
141329
9Patient Package Insert
This Patient Information has been approved by the U.S. Food and Drug Administration.
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 g Carton
NDC0187-5115-60
ERTACZO
(sertaconazole nitrate) cream, 2%
(sertaconazole nitrate) cream, 2%
Rx only
For Topical Use Only - Not for Ophthalmic, Oral, or Intravaginal Use
Net Wt. 60 g
