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Undecylenic Acid, Compound (Topical)


VA CLASSIFICATION
Primary: DE102{03}

Commonly used brand name(s): Caldesene Medicated Powder; Cruex Aerosol Powder; Cruex Antifungal Cream; Cruex Antifungal Powder; Cruex Antifungal Spray Powder; Cruex Cream; Cruex Powder; Decylenes Powder; Desenex Aerosol Powder; Desenex Antifungal Cream; Desenex Antifungal Liquid; Desenex Antifungal Ointment; Desenex Antifungal Penetrating Foam; Desenex Antifungal Powder; Desenex Antifungal Spray Powder; Desenex Foam; Desenex Ointment; Desenex Powder; Desenex Solution; Gordochom Solution.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antifungal (topical)—

Indications

Unaccepted
Compound undecylenic acid has been used for the topical treatment of tinea cruris, tinea pedis, {21} and other tinea infections. However, in the opinion of USP medical experts, it has been superseded by newer and more effective topical antifungal agents. {01}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Undecylenic acid: 184.28 {09}
    Zinc undecylenate: 431.92 {09}

Mechanism of action/Effect:

Compound undecylenic acid has a fungistatic action. The zinc present in the zinc undecylenate component provides a beneficial astringent action, which aids in reducing rawness and irritation.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented.

Breast-feeding

It is not known whether topical compound undecylenic acid is distributed into breast milk. However, problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of topical compound undecylenic acid have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date. Use in children up to 2 years of age is not recommended except under the advice and supervision of a physician. {02}


Geriatrics


No information is available on the relationship of age to the effects of topical compound undecylenic acid in geriatric patients.


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
    
Hypersensitivity{21} (skin irritation not present before therapy)




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Undecylenic Acid, Compound (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to compound undecylenic acid





Use in children—Not using on children up to 2 years of age, unless otherwise directed by physician


Proper use of this medication
Before applying, washing affected and surrounding areas, and drying thoroughly; applying sufficient medication to cover these areas

» Avoiding contact with the eyes

Proper administration technique for cream, powder, and aerosol foam and powder

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible

» Proper storage

Precautions while using this medication
Checking with physician or pharmacist if no improvement within 4 weeks

Using the powder or topical aerosol powder daily after bathing and careful drying to help prevent reinfection


Side/adverse effects
Signs of potential side effects, especially hypersensitivity


General Dosing Information
Use of topical antifungals may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical use of the medication.

Before application of this medication, the affected and surrounding areas should be cleansed and thoroughly dried.

The medication should be continued for 2 weeks after symptoms have disappeared.

For persistent fungal infection, the ointment is used for nighttime application and the powder for daytime application to relieve burning and itching.

Following complete remission of the infection, the powder or aerosol powder may be continued as part of a daily personal hygiene program to prevent reinfection.


Topical Dosage Forms

COMPOUND UNDECYLENIC ACID TOPICAL AEROSOL FOAM

Usual adult and adolescent dose
Tinea infections
Topical, to the skin, two times a day. {02} {20}


Usual pediatric dose
Infants and children up to 2 years of age—Use is not recommended except under the advice and supervision of a physician. {02}

Children 2 years of age and over—See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


10% of undecylenic acid (OTC) [Desenex Antifungal Penetrating Foam{02}{05}]

Canada—


10% of undecylenic acid (OTC) [Desenex Foam{07}{20}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Shake well.
   • For external use only.
   • Continue medication for full time of treatment.
   • Store away from heat and direct sunlight.


COMPOUND UNDECYLENIC ACID TOPICAL AEROSOL POWDER

Usual adult and adolescent dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Usual pediatric dose
See Compound Undecylenic Acid Topical Aerosol Foam. {02}

Strength(s) usually available
U.S.—


19% total undecylenate as undecylenic acid and zinc undecylenate (OTC) [Cruex Antifungal Spray Powder{11}] [Desenex Antifungal Spray Powder{02}{04}{05}]

Canada—


19.5% total undecylenate as 2.5% undecylenic acid and 20% zinc undecylenate (OTC) [Cruex Aerosol Powder]{19} [Desenex Aerosol Powder{07}{20}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Shake well.
   • For external use only.
   • Continue medication for full time of treatment.
   • Store away from heat and direct sunlight.


COMPOUND UNDECYLENIC ACID CREAM

Usual adult and adolescent dose
Tinea infections
Topical, to the skin, as often as needed.


Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


20% total undecylenate as undecylenic acid and zinc undecylenate (OTC) [Cruex Antifungal Cream]{11} [Desenex Antifungal Cream{02}{04}{05}{11}]

Canada—


20% total undecylenate as 3% undecylenic acid and 20% zinc undecylenate (OTC) [Cruex Cream{07}{19}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.


COMPOUND UNDECYLENIC ACID OINTMENT USP

Usual adult and adolescent dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Usual pediatric dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Strength(s) usually available
U.S.—


22% total undecylenate as undecylenic acid and zinc undecylenate (OTC) [Desenex Antifungal Ointment]{02}{05}[Generic]

Canada—


22.3% total undecylenate as 5.4% undecylenic acid and 20% zinc undecylenate (OTC) [Desenex Ointment{07}{20}]

Packaging and storage:
Do not store for a prolonged time at temperatures above 30 °C (86 °F). Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.


COMPOUND UNDECYLENIC ACID TOPICAL POWDER

Usual adult and adolescent dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Usual pediatric dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Strength(s) usually available
U.S.—


10% calcium undecylenate (OTC) [Caldesene Medicated Powder{14}] [Cruex Antifungal Powder{11}] [Decylenes Powder{04}{06}]


19% total undecylenate as undecylenic acid and zinc undecylenate (OTC) [Desenex Antifungal Powder{02}{05}]

Canada—


10% calcium undecylenate (OTC) [Cruex Powder{19}]


19% total undecylenate as 2% undecylenic acid and 20% zinc undecylenate (OTC) [Desenex Powder{07}{20}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.


COMPOUND UNDECYLENIC ACID TOPICAL SOLUTION

Usual adult and adolescent dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Usual pediatric dose
See Compound Undecylenic Acid Topical Aerosol Foam.

Strength(s) usually available
U.S.—


10% undecylenic acid (OTC) [Desenex Antifungal Liquid{02}][Generic]{05}{12}{15}


25% undecylenic acid (OTC) [Gordochom Solution{17} (3% chloroxylenol)]{21}

Canada—


10% undecylenic acid (OTC) [Desenex Solution]{20}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.



Revised: 07/25/94



References
  1. Indications Index review, 1986.
  1. Desenex (Pharmacraft). In: PDR Physicians' desk reference for nonprescription drugs. 10th ed. 1989. Montvale, NJ: Medical Economics Company, 1989: 547.
  1. VA Medication Classification System, USP DI 1989, 2472.
  1. Cruex (Fisons). In: Red book 1989. Montvale, NJ: Medical Economics Company, 1989: 253.
  1. Desenex (Fisons). In: Red book 1989. Montvale, NJ: Medical Economics Company, 1989: 269.
  1. Decylenes (Rugby). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 264.
  1. Desenex (Pennwalt). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988: 247-8.
  1. Hold
  1. Heller WM, editor. USAN 1990. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1989: 591, 609.
  1. Hold
  1. Cruex (Fisons). In: PDR Physicians' desk reference for nonprescription drugs. 10th ed. 1989. Montvale, NJ: Medical Economics Company, 1989: 546.
  1. Undecylenic acid, compound (Generic). In: Red book 1992. Montvale, NJ: Medical Economics Data, 1992: 597.
  1. Hold
  1. Caldesene (Fisons). In: PDR Physicians' desk reference for nonprescription drugs. 10th ed. 1989. Montvale, NJ: Medical Economics Company, 1989: 546.
  1. Over-the-counter topical antifungals. Consumer Reports Health Letter 1990 July: 55.
  1. Hold
  1. Gordochom package insert (Gordon—US), Rev 9/89, Rec 11/89.
  1. Hold
  1. Cruex (Fisons). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 25th ed. Ottawa: Canadian Pharmaceutical Association, 1990: 268.
  1. Desenex (Fisons). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 25th ed. Ottawa: Canadian Pharmaceutical Association, 1990: 315.
  1. Gordochom (Gordon). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 1026.
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