Tolnaftate (Topical)


VA CLASSIFICATION
Primary: DE102{03}

Commonly used brand name(s): Aftate for Athlete's Foot Aerosol Spray Liquid; Aftate for Athlete's Foot Aerosol Spray Powder; Aftate for Athlete's Foot Gel; Aftate for Athlete's Foot Sprinkle Powder; Aftate for Jock Itch Aerosol Spray Powder; Aftate for Jock Itch Gel; Aftate for Jock Itch Sprinkle Powder; Genaspore Cream; NP-27 Cream; NP-27 Powder; NP-27 Solution; NP-27 Spray Powder; Pitrex Cream; Tinactin Aerosol Liquid; Tinactin Aerosol Powder; Tinactin Antifungal Deodorant Powder Aerosol; Tinactin Cream; Tinactin Jock Itch Aerosol Powder; Tinactin Jock Itch Cream; Tinactin Jock Itch Spray Powder; Tinactin Plus Aerosol Powder; Tinactin Plus Powder; Tinactin Powder; Tinactin Solution; Ting Antifungal Cream; Ting Antifungal Powder; Ting Antifungal Spray Liquid; Ting Antifungal Spray Powder; Zeasorb-AF Powder.

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



Category:


Antifungal (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Tinea capitis (treatment)—Tolnaftate is indicated in the topical treatment of tinea capitis. {24}

Tinea corporis (treatment)
Tinea cruris (treatment)
Tinea manuum (treatment) or
Tinea pedis (treatment)—Tolnaftate is indicated in the topical treatment of tinea corporis (ringworm of the body), tinea cruris (ringworm of the groin; jock itch), tinea manuum, and tinea pedis (ringworm of the foot; athlete's foot) caused by Trichophyton rubrum , T. mentagrophytes , T. tonsurans , Microsporum canis , M. audouini , and Epidermophyton floccosum . {24}

Tinea versicolor (treatment)—Tolnaftate is indicated in the topical treatment of tinea versicolor (pityriasis versicolor; ``sun fungus'') caused by Pityrosporon orbiculare (Malassezia furfur) . {24}

[Tinea barbae (treatment)]—Tolnaftate is used in the topical treatment of tinea barbae. {01}

—Not all species or strains of a particular organism may be susceptible to tolnaftate.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    307.41 {14}

Mechanism of action/Effect:

Fungicidal; exact mechanism unknown; however, it has been reported to distort the hyphae and to stunt mycelial growth in susceptible organisms.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented.

Breast-feeding

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

Pediatrics

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 tolnaftate 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 (skin irritation not present before therapy)




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

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

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to tolnaftate





Use in children—Not recommended in children up to 2 years of age


Proper use of this medication
Before applying, washing affected area and drying thoroughly

» Not using on children up to 2 years of age

» Avoiding contact with the eyes

Proper administration technique

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» 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 carefully drying to help prevent reinfection


Side/adverse effects
Possible stinging when spray solution form of medication is applied

Signs of potential side effects, especially hypersensitivity


General Dosing Information
Therapy for a period of 2 to 3 weeks is usually sufficient; however, treatment for 4 to 6 weeks may be necessary, especially if thickening of the skin has occurred.

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

Tolnaftate may be used concurrently with an oral antifungal agent, such as griseofulvin, in the treatment of onychomycosis or chronic infections of the scalp, palms, or skin.

The powder and powder aerosol forms are recommended for adjunctive use in fungal infections of intertriginous or other naturally moist skin areas in which drying may enhance the therapeutic response. They may also be used alone in the treatment of mild infections that respond to antifungal powder in conjunction with measures that promote skin hygiene.

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


Topical Dosage Forms

TOLNAFTATE TOPICAL AEROSOL POWDER USP

Usual adult and adolescent dose
Topical, to the skin, two times a day.

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.—


1% (OTC) [Aftate for Athlete's Foot Aerosol Spray Powder{25}] [Aftate for Jock Itch Aerosol Spray Powder{25}] [NP-27 Spray Powder{26}] [Tinactin Aerosol Powder{02}{24}] [Tinactin Antifungal Deodorant Powder Aerosol{30}] [Tinactin Jock Itch Spray Powder{24}] [Ting Antifungal Spray Powder{23}][Generic]

Canada—


1% (OTC) [Tinactin Aerosol Powder{02}{24}] [Tinactin Jock Itch Aerosol Powder{24}] [Tinactin Plus Aerosol Powder{19}]

Packaging and storage:
Store below 40 °C (104 °F), unless otherwise specified by manufacturer.

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


TOLNAFTATE TOPICAL AEROSOL SOLUTION

Usual adult and adolescent dose
See Tolnaftate Topical Aerosol Powder USP.

Usual pediatric dose
See Tolnaftate Topical Aerosol Powder USP.

Strength(s) usually available
U.S.—


1% (OTC) [Aftate for Athlete's Foot Aerosol Spray Liquid{25}] [Tinactin Aerosol Liquid{02}{24}] [Ting Antifungal Spray Liquid]{20}[Generic]

Canada—


1% (OTC) [Tinactin Aerosol Liquid{02}{24}]

Packaging and storage:
Store below 49 °C (120 °F), unless otherwise specified by manufacturer.

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


TOLNAFTATE CREAM USP

Usual adult and adolescent dose
See Tolnaftate Topical Aerosol Powder USP.

Usual pediatric dose
See Tolnaftate Topical Aerosol Powder USP.

Strength(s) usually available
U.S.—


1% (OTC) [Genaspore Cream{05}] [NP-27 Cream{26}] [Tinactin Cream{02}{24}] [Tinactin Jock Itch Cream{02}{24}] [Ting Antifungal Cream{21}][Generic]

Canada—


1% (OTC) [Pitrex Cream{11}] [Tinactin Cream{02}{24}] [Tinactin Jock Itch Cream{02}{24}]

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

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


TOLNAFTATE GEL USP

Usual adult and adolescent dose
See Tolnaftate Topical Aerosol Powder USP.

Usual pediatric dose
See Tolnaftate Topical Aerosol Powder USP.

Strength(s) usually available
U.S.—


1% (OTC) [Aftate for Athlete's Foot Gel{25}] [Aftate for Jock Itch Gel{25}]

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

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


TOLNAFTATE POWDER (TOPICAL) USP

Usual adult and adolescent dose
See Tolnaftate Topical Aerosol Powder USP.

Usual pediatric dose
See Tolnaftate Topical Aerosol Powder USP.

Strength(s) usually available
U.S.—


1% (OTC) [Aftate for Athlete's Foot Sprinkle Powder{25}]{25} [Aftate for Jock Itch Sprinkle Powder{25}] [NP-27 Powder{26}] [Tinactin Powder{24}] [Ting Antifungal Powder{22}] [Zeasorb-AF Powder{10}][Generic]

Canada—


1% (OTC) [Tinactin Plus Powder{19}] [Tinactin Powder{24}]

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

Auxiliary labeling:
   • For external use only.
   • Continue medicine for full time of treatment.
   • Keep container tightly closed.
   • Keep in a dry place.


TOLNAFTATE TOPICAL SOLUTION USP

Usual adult and adolescent dose
See Tolnaftate Topical Aerosol Powder USP.

Usual pediatric dose
See Tolnaftate Topical Aerosol Powder USP.

Strength(s) usually available
U.S.—


1% (OTC) [NP-27 Solution{26}] [Tinactin Solution{02}][Generic]

Canada—


1% (OTC) [Tinactin Solution{02}]

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

Stability:
Tolnaftate solution solidifies at low temperature, but liquefies readily when warmed, retaining its potency.

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



Revised: 08/10/1994



References

Note: All references used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Indications Index review, 1986.
  1. PI (US) Tinactin, Schering, as: Tinactin Aerosol Liquid; Tinactin Aerosol Powder; Tinactin Cream; Tinactin Jock Itch Cream; Tinactin Jock Itch Spray Powder; Tinactin Powder; Tinactin Solution; PDR-OTC-88: 693–94; PDR-OTC-89: 691.
  1. USP DI 1989, VA Medication Classification System: 2472.
  1. Redbook 1989, Aftate (Plough): 125.
  1. Redbook 1989, Genaspore (Goldline): 349.
  1. Redbook 1989, NP 27, (Thompson Med): 493.
  1. Redbook 1989, Tinactin (Schering): 687.
  1. Redbook 1989, Ting (Fisons): 687.
  1. Redbook 1989, Tolnaftate (generic): 690.
  1. Redbook 1989, Zeasorb-AF (Stiefel): 747.
  1. CPS 1988, Pitrex Cream (Taro): 723.
  1. CPS 1988, Tinactin (Schering): 929.
  1. USP DI 1989, USP Requirements, IV/93.
  1. USAN 1990: 571.
  1. Writer's notes.
  1. F&C, 12/90: 828. Ting Cream, Powder, Spray Powder, and Spray Liquid.
  1. F&C, 12/90: 828; Dermasept Spray Solution (US) Pharmakon is a combination.
  1. PI (Canada) Tinactin Plus Powder, Schering.
  1. PI (Canada) Tinactin Plus Aerosol Powder, Schering.
  1. PI (US) Ting Antifungal (aerosol) Spray Liquid, Fisons: Received 6/89.
  1. PI (US) Ting Antifungal Cream, Fisons: Received 6/89.
  1. PI (US) Ting Antifungal Powder, Fisons: Received 6/89.
  1. PI (US) Ting Antifungal (aerosol) Spray Powder, Fisons:
  1. PI (Canada) Tinactin, Schering, as: Tinactin Aerosol Liquid; Tinactin Aerosol Powder; Tinactin Cream; Tinactin Jock Itch Aerosol Powder; Tinactin Jock Itch Cream; Tinactin Plus Powder; Tinactin Plus Aerosol Powder; Tinactin Powder; Tinactin Solution; CPS-90: 1099.
  1. PI (US) Aftate, Plough, as: Aftate for Athlete's Foot Aerosol Spray Powder; Aftate for Athlete's Foot Aerosol Spray Liquid; Aftate for Athlete's Foot Gel; Aftate for Athlete's Foot Sprinkle Powder; Aftate for Jock Itch Aerosol Spray Powder; Aftate for Jock Itch Gel; Aftate for Jock Itch Sprinkle Powder; PDR-OTC-89: 636.
  1. PI (US) NP-27, Thompson, as: NP–27 Cream; NP–27 Solution; NP–27 Spray Powder; NP–27 Powder; PDR-OTC-89: 715.
  1. US Generics: Cream; Solution.
  1. Over-the-counter topical antifungals. Consumer Reports Health Letter, July 1990: 55.
  1. Brand name search on 2/90.
  1. PI (US) Tinactin Antifungal Deodorant Powder Aerosol, Schering-Plough. Received 12/91.
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