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Antifungals (Topical)
butenafine (Mentax ® )
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Mentax® Cream, 1%, contains the synthetic antifungal agent, butenafine
hydrochloride. Butenafine is a member of the class of antifungal
compounds known as benzylamines which are structurally related to the
allylamines. INDICATIONS Mentax® (butenafine HCl cream) Cream, 1%, is indicated for the topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare), interdigital tinea pedis (athlete's foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans. Butenafine HCl cream was not studied in immunocompromised patients. DOSAGE AND ADMINISTRATION Patients with tinea (pityriasis) versicolor should apply Mentax® once daily for two weeks. In the treatment of interdigital tinea pedis , Mentax® should be applied twice daily for 7 days OR once daily for 4 weeks (NOTE: in separate clinical trials, the 7 day dosing regimen was less efficacious than the 4 week regimen. While the clinical significance of this difference is unknown, these data should be carefully considered before selecting the dosage regimen for patients at risk for the development of bacterial cellulitis of the lower extremity associated with interdigital cracking/fissuring). Patients with tinea corporis or tinea cruris should apply Mentax® once daily for two weeks. Sufficient Mentax® Cream should be applied to cover affected areas and immediately surrounding skin of patients with tinea versicolor, interdigital tinea pedis, tinea corporis, and tinea cruris. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed. HOW SUPPLIED Mentax® (butenafine HCl cream) Cream, 1%, is supplied in tubes in the following sizes: 15-gram tube (NDC 62794-151-02) 30-gram tube (NDC 62794-151-03) |
ciclopirox (Loprox ® )
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INDICATIONS: Cream/suspension: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), cutaneous candidiasis, and tinea versicolor (pityriasis) Gel: Treatment of tinea pedis (athlete's foot), tinea corporis (ringworm); seborrheic dermatitis of the scalp Lacquer (solution): Topical treatment of mild-to-moderate onychomycosis of the fingernails and toenails due to Trichophyton rubrum (not involving the lunula) and the immediately-adjacent skin Shampoo: Treatment of seborrheic dermatitis of the scalp DOSING AND ADMINISTRATION: Topical: Children >10 years and Adults: Tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis, and tinea versicolor: Cream/suspension: Apply twice daily, gently massage into affected areas; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis Children >16 years and Adults: Tinea pedis, tinea corporis, seborrheic dermatitis of the scalp: Gel: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate diagnosis Seborrheic dermatitis of the scalp: Shampoo: Apply to wet hair, lather, and leave in place ~3 minute; rinse. Repeat twice weekly for 4 weeks; allow a minimum of 3 days between applications. Onychomycosis of the fingernails and toenails: Children >/= 12 years and Adults: Lacquer (solution): Apply to adjacent skin and affected nails daily (as a part of a comprehensive management program for onychomycosis). Remove with alcohol every 7 days Administration Cream, suspension: Gently massage into affected areas. Gel: Gently massage into affected areas and adjacent skin. Lacquer (solution): Apply evenly over nail and surrounding skin at bedtime (or allow 8 hours before washing); apply daily over previous coat for 7 days; after 7 days, may remove with alcohol and continue cycle. Shampoo: Apply to wet hair; lather and leave in place for ~3 minutes; rinse. SUPPLIED: Cream, as olamine (Loprox®): 0.77% (15 g, 30 g, 90 g) Gel (Loprox®): 0.77% (30 g, 45 g, 100 g) Shampoo (Loprox®): 1% (120 mL) Solution, topical [nail lacquer] (Penlac®): 8% (6.6 mL) Suspension, topical, as olamine (Loprox®): 0.77% (30 mL, 60 mL) |
clotrimazole (Lotrimin ® )
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Treatment of susceptible fungal infections, including dermatophytoses,
superficial mycoses, and cutaneous candidiasis. DOSING: Apply twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis SUPPLIED: Cream, topical: 1% (15 g, 30 g, 45 g) |
econazole (Spectazole ® )
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INDICATIONS SPECTAZOLE Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor. DOSAGE AND ADMINISTRATION Sufficient SPECTAZOLE Cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment. HOW SUPPLIED SPECTAZOLE (econazole nitrate 1%) Cream is supplied in tubes of 15 grams (NDC 0062-5460-02), 30 grams (NDC 0062-5460-01), and 85 grams (NDC 0062-5460-03). |
ketoconazole (Nizoril ® )
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------------CREAM------------------- INDICATIONS Ketoconazole cream, 2% is indicated for the topical treatment of tinea cor-poris, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis. DOSAGE AND ADMINISTRATION Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. HOW SUPPLIED Ketoconazole cream, 2% is supplied in 15, 30, and 60 gram tubes. ------------FOAM------------------- INDICATIONS Extina Foam is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Extina Foam for treatment of fungal infections have not been established. DOSAGE AND ADMINISTRATION Extina Foam should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense Extina Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Extina Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Extina Foam may be applied directly to the skin (rather than on the hair). Avoid contact with the eyes and other mucous membranes. Extina foam is not for ophthalmic, oral or intravaginal use. HOW SUPPLIED Extina Foam contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers. ------------SHAMPOO------------------- INDICATIONS Ketoconazole 2% shampoo is indicated for the reduction of scaling due to dandruff. DOSAGE AND ADMINISTRATION Moisten hair and scalp thoroughly with water. Apply sufficient shampoo to produce enough lather to wash the scalp and hair gently massage it over the entire scalp area for approximately one minute. Rinse the hair thoroughly with warm water. Repeat, leaving the shampoo on the scalp for an additional 3 minutes. After the second thorough rinse, dry the hair with a towel or warm air flow. Shampoo twice a week for four weeks with at least three days between each shampooing and then intermittently as needed to maintain control. HOW SUPPLIED Nizoral 2% shampoo is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle. Storage: Store at a temperature not above 25°C (77°F). Protect from light. |
miconazole (Micatin ® )
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Mechanism of Action Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients DOSING: Topical: Children and Adults: Note: Not for OTC use in children <2 years: Tinea pedis and tinea corporis: Apply twice daily for 4 weeks. Tinea cruris: Apply twice daily for 2 weeks. HOW SUPPLIED Cream, topical, as nitrate: 2% (15 g, 30 g, 45 g) Powder, topical, as nitrate: Lotrimin® AF, Micatin®, Micro-Guard®: 2% (90 g) Ointment, topical, as nitrate: (Aloe Vesta® 2-n-1 Antifungal): 2% (60 g, 150 g) |
naftifine (Naftin ®)
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INDICATIONS Topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans* and Epidermophyton floccosum.* *Efficacy for this organism in this organ system was studied in fewer than 10 infections. DOSAGE AND ADMINISTRATION GEL: A sufficient quantity of Naftin® Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftin® Gel, 1%, the patient should be re-evaluated. CREAM: A sufficient quantity of Naftin® Cream, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftin® Cream, 1%, the patient should be re-evaluated . HOW SUPPLIED Naftin® (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes: 20g - NDC 0259-4770-20 40g - NDC 0259-4770-40 60g - NDC 0259-4770-60 Naftin® (naftifine hydrochloride) 1% Cream is supplied in collapsible tubes in the following sizes : 15g_ NDC 0259-4126-15 30g_ NDC 0259-4126-30 60g_ NDC 0259-4126-60 60g (4x15g) - NDC 0259-4126-04 |
nystatin (Mycostatin ®)
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INDICATIONS Nystatin topical preparations are indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species. DOSAGE AND ADMINISTRATION Nystatin preparations should be applied liberally to affected areas twice a day or as indicated until healing is complete, Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous area; very moist lesions, however, are best treated with nystatin topical powder. The preparations do not stain skin or mucous membranes and they provide simple, convenient means of treatment. HOW SUPPLIED As light yellow products Nystatin Cream USP, (100,000 USP Nystatin Units/gram), and Nystatin Ointment USP, (100,000 USP Nystatin Units/gram) are supplied in both 15 g and 30 g tubes. |
oxiconazole (Oxistat ® )
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INDICATIONS OXISTAT Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur. OXISTAT Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT Cream has been shown to be effective rarely occur in children below the age of 12. DOSAGE AND ADMINISTRATION OXISTAT Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. OXISTAT Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed. Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. HOW SUPPLIED OXISTAT Cream, 1% is supplied in 15-g tubes (NDC 0173-0423-00), 30-g tubes (NDC 0173-0423-01), and 60-g tubes (NDC 0173-0423-04). Store between 15° and 30°C (59° and 86°F). OXISTAT Lotion, 1% is supplied in a 30-mL bottle (NDC 0173-0448-01). Store between 15° and 30°C (59° and 86°F). Shake well before using. |
terbinafine (Lamisil ® )
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INDICATIONS: Antifungal for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) [OTC/prescription formulations]; tinea versicolor DOSAGE AND ADMINISTRATION: Children >/= 12 years and Adults: Topical cream, solution: Athlete's foot (tinea pedis): Apply to affected area twice daily for at least 1 week, not to exceed 4 weeks [OTC/prescription formulations] Ringworm (tinea corporis) and jock itch (tinea cruris): Apply cream to affected area once or twice daily for at least 1 week, not to exceed 4 weeks; apply solution once daily for 7 days. Topical solution: Tinea versicolor: Apply to affected area twice daily for 1 week SUPPLIED: Cream (Lamisil® AT™): 1% (15 g, 30 g) Solution [topical spray] (Lamisil®, Lamisil® AT™): 1% (30 mL) |
tolnaftate (Tinactin ® )
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INDICATIONS: Treatment of tinea pedis, tinea cruris, tinea corporis DOSING: Children 2 years and Adults: Topical: Wash and dry affected area; spray aerosol or apply 1-3 drops of solution or a small amount of cream, gel, or powder and rub into the affected areas 2 times/day Note: May use for up to 4 weeks for tinea pedis or tinea corporis, and up to 2 weeks for tinea cruris [Avoid contact with the eyes; apply to clean dry area; consult the physician if a skin irritation develops or if the skin infection worsens or does not improve after 10 days of therapy; does not stain skin or clothing] SUPPLIED: Aerosol, liquid, topical: Tinactin® Antifungal: 1% (120 mL) Aerosol, powder, topical: Tinactin® Antifungal: 1% (45 g, 90 g, 100 g, 150 g) Cream, topical: 1% (15 g, 30 g) Powder, topical: 1% (45 g) |
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