Usual Adult Dose for Dermatophytosis

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Onychomycosis - Fingernail

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Onychomycosis - Toenail

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Tinea Barbae

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Tinea Capitis

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Tinea Corporis

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Tinea Cruris

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Adult Dose for Tinea Pedis

Microsize formulation: 500 mg/day orally in 1 to 4 divided doses

• For widespread lesions: 750 to 1000 mg/day orally in 2 to 4 divided doses

Ultramicrosize formulation: 375 mg/day orally in single or divided doses

• For fungal infections more difficult to eradicate: 750 mg/day orally in divided doses

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients. Patients with less severe/extensive infections may require less than 500 mg/day; those with widespread lesions may require a starting dose of 750 to 1000 mg/day, which may be reduced to 500 mg or less after a response is observed.
• Ultramicrosize formulation: A daily dose of 375 mg provides a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis; a daily dose of 750 mg is recommended for fungal infections more difficult to eradicate (e.g., tinea pedis, tinea unguium).
• The duration of therapy for tinea unguium depends on the rate of growth.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: Epidermophyton floccosum, Microsporum audouinii, M canis, M gypseum, Trichophyton crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

Usual Pediatric Dose for Dermatophytosis

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Onychomycosis - Fingernail

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Onychomycosis - Toenail

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tinea Barbae

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tinea Capitis

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tinea Corporis

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tinea Cruris

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tinea Pedis

Older than 2 years:
Microsize formulation: 10 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 13.6 to 22.7 kg: 125 to 250 mg/day orally
• Weight greater than 22.7 kg: 250 to 500 mg/day orally in divided doses

Ultramicrosize formulation: About 7.3 mg/kg/day orally

• Based on this dose, the following regimen has been suggested:
• Weight 16 to 27 kg: 125 to 187.5 mg/day orally
• Weight greater than 27 kg: 187.5 to 375 mg/day orally

Typical Duration of Therapy:

• Tinea capitis: 4 to 6 weeks
• Tinea corporis: 2 to 4 weeks
• Tinea pedis: 4 to 8 weeks
• Tinea unguium:
• Fingernails: At least 4 months
• Toenails: At least 6 months

Comments:

• Microsize formulation: Dosage should be individualized in all patients; 10 mg/kg/day is usually adequate; safety not established at higher than recommended doses.
• Ultramicrosize formulation: Clinical experience with this drug in children with tinea capitis indicates a single daily dose is effective.
• The duration of therapy for tinea unguium depends on the rate of growth.
• Clinical relapse will occur if therapy is not continued until the infecting organism is eradicated.

Uses:

• Microsize formulation: For the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair, and nails (i.e., tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium [when due to at least 1 of the following: E floccosum, M audouinii, M canis, M gypseum, T crateriform, T gallinae, T interdigitale, T megninii, T mentagrophytes, T rubrum, T schoenleinii, T sulphureum, T tonsurans, T verrucosum])
• Ultramicrosize formulation: For the treatment of the following ringworm infections: tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails) when due to at least 1 of the following: T rubrum, T tonsurans, T mentagrophytes, T interdigitale, T verrucosum, T megninii, T gallinae, T crateriform, T sulphureum, T schoenleinii, M audouinii, M canis, M gypseum, E floccosum

American Academy of Pediatrics Recommendations:
2 years or older:
Microsize formulation: 20 to 25 mg/kg/day orally divided in 2 doses
Maximum dose: 1 g/day

Ultramicrosize formulation: 10 to 15 mg/kg orally once a day
Maximum dose: 750 mg/day

Duration of Therapy:

• Tinea capitis: At least 6 weeks; should continue until clinically clear
• Tinea corporis, tinea cruris: 4 to 6 weeks

Comments:

• Recommended for tinea capitis, tinea corporis (if lesions are extensive or unresponsive to topical therapy), and tinea cruris (if lesions are unresponsive to topical therapy)
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Hepatocellular failure: Contraindicated

Precautions

CONTRAINDICATIONS:
History of hypersensitivity to the active component; pregnancy; hepatocellular failure; porphyria

Safety and efficacy have not been established in patients 2 years of age and younger.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Before therapy, identify the causative dermatophyte.
• Before starting therapy, obtain appropriate specimens for laboratory testing (potassium hydroxide [KOH] preparation, fungal culture, or nail biopsy) to confirm the diagnosis.
• Microsize formulation: Serum level may be increased by administering with a high-fat meal.
• Ultramicrosize formulation: May swallow whole or crush and sprinkle onto 1 tablespoonful of applesauce and swallow immediately without chewing
• Continue therapy until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination.

Storage requirements:

• Store at 20C to 25C (68F to 77F).
• Dispense in a tight, light-resistant container.

General:

• Accurate diagnosis of the infecting organism is essential; identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of KOH or by culture on an appropriate medium.
• General measures in regard to hygiene should be observed to control sources of infection or reinfection.
• Concurrent use of appropriate topical agents is usually necessary, especially when treating tinea pedis. Yeasts and bacteria may be involved in some forms of tinea pedis; this drug will not eradicate these associated yeast or bacterial infections.
• This drug should not be used in minor/trivial infections which will respond to topical agents alone.
• This drug is not effective for bacterial infections, candidiasis, histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis, tinea versicolor, or nocardiosis.

Monitoring:

• General: Organ system function, including renal, hepatic, and hematopoietic (periodically during prolonged therapy)
• Hematologic: Hematopoietic function (periodically during prolonged therapy)
• Hepatic: For hepatic side effects; hepatic function (periodically during prolonged therapy)
• Renal: Renal function (periodically during prolonged therapy)

Patient advice:

• Avoid exposure to intense/prolonged natural or artificial sunlight due to potential photosensitivity reactions.
• This drug may enhance the effects of alcohol; nausea, vomiting, flushing, tachycardia, and severe hypotension reported after ingesting alcohol during therapy.