Tolnaftate (Monograph)

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

Introduction

Antifungal; thiocarbamate.^a

Uses for Tolnaftate

Dermatophytoses

Treatment of tinea corporis (body ringworm)¹⁰⁹ and tinea cruris (jock itch)^{110 111} caused by Epidermophyton floccosum, Microsporum canis, M. audouinii, Trichophyton mentagrophytes, T. rubrum, or T. tonsurans.^{109 110 111 a}

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.^{109 110 111 a}

Available for self-medication (OTC use) for treatment of tinea corporis,¹⁰⁹ tinea cruris,^{110 111} or tinea pedis and for prevention of reinfection of tinea pedis.^{109 110 111}

Should not be used for treatment of dermatophyte infections that occur on scalp or nails.^{109 110 111}

Topical antifungals usually effective for treatment of uncomplicated tinea corporis and tinea cruris.^{100 101 104 105 106} 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.^{100 101 104 105 106}

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.^{100 101 104 105 106} An oral antifungal may be necessary for treatment of hyperkeratotic areas on palms and soles,^{101 106} for chronic moccasin-type tinea pedis,^{100 101 105} and for treatment of tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).^{100 101 104 105 106}

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor^{† [off-label]} caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).¹⁰⁰

Topical antifungals generally effective;^{100 102 103 105 107} 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.^{102 103 105}

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.^{109 110 111 a}

Avoid contact with eyes, nose, mouth, and other mucous membranes.^{109 110 111 a} Do not apply to scalp or nail infections.^{109 110 111}

Clean affected areas with soap and water and dry thoroughly prior to applying preparation.^{109 110 111 a}

A small amount of the cream or powder or 2 or 3 drops of the solution should be rubbed gently into affected areas.^{109 110 111 a} Alternatively, a thin layer of aerosol liquid spray or aerosol spray powder should be applied.^{111 a}

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

When treating tinea pedis, pay special attention to spaces between toes.^{109 111} Also, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.^{109 111}

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 corporis¹⁰⁹ or 2 weeks for tinea cruris.¹¹⁰

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.^{109 110 a}

Tinea Pedis

Topical

Children ≥2 years of age: Apply to affected area twice daily (morning and night) for 4 weeks.^{109 110 111}

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.^{109 110 111 a}

Daily use after treatment may help prevent reinfection.^{109 110 111}

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Children ≥2 years of age: Apply to affected area twice daily (morning and night).^{100 a}

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

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Apply to affected area twice daily (morning and night) for 4 weeks for tinea corporis¹⁰⁹ or 2 weeks for tinea cruris.¹¹⁰

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.^{109 110 a}

Tinea Pedis

Topical

Apply to affected area twice daily (morning and night) for 4 weeks.^{109 110 111}

If improvement does not occur after 4 weeks of treatment, diagnosis and therapy should be reevaluated.^{109 110 111 a}

Daily use after treatment may help prevent reinfection.^{109 110 111}

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Apply to affected area twice daily (morning and night).^{100 a}

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

Cautions for Tolnaftate

Contraindications

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

Warnings/Precautions

Warnings

Administration Precautions

For external use only.^{109 110 111} Do not administer orally or intravaginally.^a Avoid contact with nose, mouth, and other mucous membranes.^{109 110 111 a}

Do not apply to eye.^{109 110 111 a} If contact with the eye(s) occurs, wash with large amounts of water; consult a clinician if ocular irritation persists.^a

Intentional misuse by deliberately concentrating and inhaling the contents of the aerosols can be harmful or fatal.¹¹¹

Sensitivity Reactions

If irritation or hypersensitivity occurs, discontinue drug and consult clinician.^{109 110 111 a}

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

Specific Populations

Pregnancy

Category C.¹¹²

Lactation

Safety not established.¹¹²

Pediatric Use

Should not be used in children <2 years of age unless otherwise directed by a clinician.^{109 110 111}

Common Adverse Effects

Skin irritation.^a

Drug Interactions

No formal drug interaction studies to date.^a

Stability

Storage

Topical

Cream

20–25°C.¹⁰⁹ Avoid freezing.^a

Powder and Solution

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

Aerosol

2–30°C.^a Do not use near fire or flame; do not expose to temperatures >49°C.^{111 a}

Actions and Spectrum

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

• May be fungistatic or fungicidal against susceptible organisms.^a

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

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

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

Advice to Patients

• Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.^{109 110 111}

• Importance of completing full course of treatment, even if symptoms improve.^{109 110 111 a}

• Importance of contacting clinician if improvement does not occur by end of prescribed treatment period.^{109 110 111 a}

• Importance of consulting clinician if treated area becomes irritated, blisters, swells, or oozes.^{109 110 111 a}

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.^{109 110 111 a}

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{109 110 111 a}

• Importance of informing patients of other important precautionary information.^{109 110 111 a} (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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