Ertaczo
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Questions & Answers
Side Effects & Adverse Reactions
ERTACZO® Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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).
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Ertaczo Manufacturers
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Rebel Distributors Corp.
![Ertaczo Cream [Rebel Distributors Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ertaczo | Rebel Distributors Corp.
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.
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Valeant Pharmaceutials North America Llc
Ertaczo | Noven Therapeutics, Llc
2.1 Dosage InformationThe recommended dosage of BRISDELLE for the treatment of moderate to severe VMS is 7.5 mg once daily, at bedtime, with or without food.
2.2 Use of BRISDELLE Before or After a Monoamine Oxidase Inhibitor (MAOI)Wait at least 14 days after discontinuation of an MAOI before initiating therapy with BRISDELLE. Conversely, allow at least 14 days after stopping BRISDELLE before starting an MAOI [see Contraindications (4.1), Warnings and Precautions (5.2) and Drug Interactions (7.3)].
![Ertaczo (Sertaconazole Nitrate) Cream [Valeant Pharmaceutials North America Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bf208751-e6d8-11e1-aff1-0800200c9a66&name=brisdelle-figure-2.jpg)
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