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USP DI Vol. II - UNDECYLENICACID, COMPOUND (Topical)

UNDECYLENICACID, COMPOUND (Topical)


Some commonly used brand names are:

In the U.S.?

  • Caldesene Medicated Powder
  • Cruex Antifungal Cream
  • Cruex Antifungal Powder
  • Cruex Antifungal Spray Powder
  • Decylenes Powder
  • Desenex Antifungal Cream
  • Desenex Antifungal Liquid
  • Desenex Antifungal Ointment
  • Desenex Antifungal Penetrating Foam
  • Desenex Antifungal Powder
  • Desenex Antifungal Spray Powder
  • Gordochom Solution

In Canada?

  • Cruex Aerosol Powder
  • Cruex Cream
  • Cruex Powder
  • Desenex Aerosol Powder
  • Desenex Foam
  • Desenex Ointment
  • Desenex Powder
  • Desenex Solution

Category

  • Antifungal, topical

Description

Compound undecylenic acid (un-de-sill-ENN-ik AS-id)belongs to the group of medicines called antifungals. It is used to treatsome types of fungus infections. However, compound undecylenic acid generallyhas been replaced by newer and more effective medicines for the treatmentof fungus infections.

Compound undecylenic acid is available without a prescription; however,your doctor may have special instructions on the proper use of this medicinefor your medical condition.

Compound undecylenic acid is available in the following dosage forms:

    Topical
  • Aerosol foam (U.S. and Canada)
  • Aerosol powder (U.S. and Canada)
  • Cream (U.S. and Canada)
  • Ointment (U.S. and Canada)
  • Powder (U.S. and Canada)
  • Solution (U.S. and Canada)


Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For compound undecylenic acid, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to compound undecylenic acid. Also tell your health careprofessional if you are allergic to any other substances, such as preservativesor dyes.

Pregnancy?Compound undecylenic acid topical preparations havenot been shown to cause birth defects or other problems in humans.

Breast-feeding?Compound undecylenic acid topical preparationshave not been reported to cause problems in nursing babies.

Children?Compound undecylenic acid should not be used on childrenup to 2 years of age, unless otherwise directed by your doctor. Although thereis no specific information comparing use of compound undecylenic acid topicalpreparations in children 2 years of age and older with use in other age groups,this medicine is not expected to cause different side effects or problemsin children 2 years of age and older than it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof compound undecylenic acid in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other topical prescription or nonprescription(over-the-counter [OTC]) medicine that is to be applied to the same area ofthe skin.


Proper Use of This Medicine

Before applyingcompound undecylenic acid, wash the affected and surrounding areas, and drythoroughly. Then apply enough medicine to cover these areas.

Keep this medicine away from the eyes.

For patients using the cream form of this medicine:

  • Apply cream generously to affected and surrounding areas. Rub inwell.
  • Do not use on pus-containing sores or on badly broken skin.

For patients using the powder form of thismedicine:

  • If the powder is used on the feet, sprinkle it between toes, on feet,and in socks and shoes.

For patients using the aerosol powder or aerosol foamform of this medicine:

  • From a distance of 4 to 6 inches, spray the affected and surroundingareas. If the medicine is used on the feet, spray it between the toes also.The powder may also be sprayed in socks and shoes.
  • Do not use this medicine around the eyes, nose, or mouth.
  • Do not inhale the aerosol.
  • Do not use near heat, near open flame, or while smoking.

To help clear up your infection completely, keep usingthis medicine for 2 weeks after burning, itching, or other symptoms have disappeared, unless otherwise directed by your doctor. Donot miss any doses.

Dosing?The dose of topical compound undecylenic acidwill be different for different patients. Follow yourdoctor's orders or the directions on the label. The following informationincludes only the average doses of topical compound undecylenic acid. If your dose is different, do not change it unless your doctortells you to do so.

  • For fungus infections:
    • For aerosol foam, aerosol powder, ointment,powder, or solution dosage forms:
      • Adults and children 2 years of age and over?Apply to the affectedarea(s) of the skin two times a day.
      • Children up to 2 years of age?Use is not recommended.
    • For cream dosage form:
      • Adults and children?Apply to the affected area(s) of the skinas often as necessary.

Missed dose?If you miss a dose of this medicine, apply it assoon as possible. Then go back to your regular dosing schedule.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store the powder form of this medicine in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
  • Keep the aerosol foam, aerosol powder, cream, ointment, and solutionforms of this medicine from freezing.
  • Do not puncture, break, or burn the aerosol foam or powder container.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If yourskin problem does not improve within 4 weeks, or if it becomes worse, checkwith your health care professional.

To help prevent reinfection after the period of treatment with this medicine,the powder or spray powder form of this medicine may be used each day afterbathing and careful drying.


Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

Check with your health care professional as soon as possible if the followingside effect occurs:

Skin irritation not present before use of this medicine

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your health care professional.


Revised: 07/25/94