Tolnaftate (Monograph)

Brand names: Tinactin, Ting
Drug class: Thiocarbamates
ATC class: D01AE18
VA class: DE102
CAS number: 2398-96-1

Introduction

Antifungal; thiocarbamate.

Uses for Tolnaftate

Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Microsporum canis, M. audouinii, Trichophyton mentagrophytes, T. rubrum, or T. tonsurans.

Treatment of tinea pedis (athlete’s foot) and tinea manuum^{† [off-label]} (hand ringworm) caused by E. floccosum, M. canis, M. audouinii, T. mentagrophytes, T. rubrum, or T. tonsurans.

Available for self-medication (OTC use) for treatment of tinea corporis, tinea cruris, or tinea pedis and for prevention of reinfection of tinea pedis.

Should not be used for treatment of dermatophyte infections that occur on scalp or nails.

Topical antifungals usually effective for treatment of uncomplicated tinea corporis and tinea cruris. An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.

Topical antifungals usually effective for treatment of uncomplicated tinea pedis. An oral antifungal may be necessary for treatment of hyperkeratotic areas on palms and soles, for chronic moccasin-type tinea pedis, and for treatment of tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor^{† [off-label]} caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).

Topical antifungals generally effective; an oral antifungal (with or without a topical antifungal) may be necessary in patients who have extensive or severe infections or have failed to respond to or have frequent relapses with topical therapy.

Tolnaftate Dosage and Administration

Administration

Topical Administration

Apply topically to the infected skin as a 1% cream, aerosol liquid spray, aerosol powder spray, powder, or solution.

Avoid contact with eyes, nose, mouth, and other mucous membranes. Do not apply to scalp or nail infections.

Clean affected areas with soap and water and dry thoroughly prior to applying preparation.

A small amount of the cream or powder or 2 or 3 drops of the solution should be rubbed gently into affected areas. Alternatively, a thin layer of aerosol liquid spray or aerosol spray powder should be applied.

Although pruritus, burning, and soreness may be relieved within 24–72 hours after initiation of therapy, complete the full course of treatment.

When treating tinea pedis, pay special attention to spaces between toes. Also, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

Dosage

Pediatric Patients

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Children ≥2 years of age: Apply to affected area twice daily (morning and night) for 4 weeks for tinea corporis or 2 weeks for tinea cruris.

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.

Tinea Pedis

Topical

Children ≥2 years of age: Apply to affected area twice daily (morning and night) for 4 weeks.

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.

Daily use after treatment may help prevent reinfection.

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Children ≥2 years of age: Apply to affected area twice daily (morning and night).

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Apply to affected area twice daily (morning and night) for 4 weeks for tinea corporis or 2 weeks for tinea cruris.

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.

Tinea Pedis

Topical

Apply to affected area twice daily (morning and night) for 4 weeks.

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.

Daily use after treatment may help prevent reinfection.

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Apply to affected area twice daily (morning and night).

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.

Cautions for Tolnaftate

Contraindications

• Known hypersensitivity to tolnaftate or any ingredient in the formulation.

Warnings/Precautions

Warnings

Administration Precautions

For external use only. Do not administer orally or intravaginally. Avoid contact with nose, mouth, and other mucous membranes.

Do not apply to eye. If contact with the eye(s) occurs, wash with large amounts of water; consult a clinician if ocular irritation persists.

Intentional misuse by deliberately concentrating and inhaling the contents of the aerosols can be harmful or fatal.

Sensitivity Reactions

If irritation or hypersensitivity occurs, discontinue drug and consult clinician.

Sensitization to butylated hydroxytoluene, which is present in some creams, solutions, and aerosol powder formulations, has been confirmed.

Specific Populations

Pregnancy

Category C.

Lactation

Safety not established.

Pediatric Use

Should not be used in children <2 years of age unless otherwise directed by a clinician.

Common Adverse Effects

Skin irritation.

Drug Interactions

No formal drug interaction studies to date.

Stability

Storage

Topical

Cream

20–25°C. Avoid freezing.

Powder and Solution

Store in tight containers at <40°C, preferably between 15–30°C. Avoid freezing.

Aerosol

2–30°C. Do not use near fire or flame; do not expose to temperatures >49°C.

Actions and Spectrum

• Thiocarbamate antifungal structurally and pharmacologically unrelated to other commercially available antifungals.

• May be fungistatic or fungicidal against susceptible organisms.

• Mechanism of antifungal activity unknown. Appears to distort the hyphae and stunt mycelial growth in susceptible fungi.

• Dermatophytes: Active in vitro against Epidermophyton floccosum, Microsporum audouinii, M. canis, M. gypseum, M. japonicum, Trichophyton mentagrophytes, T. rubrum, T. schoenleinii, and T. tonsurans.

• Inactive against Candida albicans, Cryptococcus neoformans, and Aspergillus fumigatus. Inactive against bacteria, protozoa, and viruses.

Advice to Patients

• Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.

• Importance of completing full course of treatment, even if symptoms improve.

• Importance of contacting clinician if improvement does not occur by end of prescribed treatment period.

• Importance of consulting clinician if treated area becomes irritated, blisters, swells, or oozes.

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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