Lamisil (Terbinafine) Indications and Dosage
- aspergillosis †
- Aspergillus sp. †
- Candida albicans †
- Candida parapsilosis †
- Epidermophyton floccosum
- Epidermophyton sp. †
- Histoplasma sp. †
- Malassezia furfur
- Microsporum canis †
- Microsporum gypseum †
- Microsporum nanum †
- Microsporum sp. †
- onychomycosis
- tinea capitis †
- tinea corporis
- tinea cruris
- tinea manuum
- tinea pedis
- tinea versicolor
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Trichophyton sp.
- Trichophyton verrucosum
† non-FDA-approved indication
Lamisil (Terbinafine) Indications and Dosage
The following organisms are generally considered susceptible to terbinafine in vitro: Aspergillus sp. † ; Blastomyces sp. † ; Candida albicans † ; Epidermophyton floccosum; Epidermophyton sp. † ; Histoplasma sp. † ; Malassezia furfur; Microsporum canis † ; Microsporum gypseum † ; Microsporum nanum † ; Microsporum sp. † ; Trichophyton mentagrophytes; Trichophyton rubrum; Trichophyton sp.; Trichophyton violaceum † ; Trichophyton verrucosum † ; Scopulariopsis brevicaulis † .
For the treatment of tinea infections due to susceptible organisms; like tinea versicolor due to Malassezia furfur; or for the treatment of tinea pedis; tinea cruris; tinea manuum; and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, or Trichophyton rubrum:
Topical dosage (cream or topical solution):
Adults and adolescents: Apply 1% topical preparation to affected areas twice daily until clinical signs and symptoms are significantly improved. Therapy should last for a minimum of 1 week and no longer than 4 weeks. NOTE: Tinea corporis or tinea cruris may respond to once-daily treatment. For moccasin-type plantar tinea pedis, apply 1% cream topically to the affected area and the immediately surrounding areas twice daily for at least 2 weeks.
Topical Dosage (dermal gel):
Adults and adolescents: Apply 1% topical preparation to affected areas once daily until clinical signs and symptoms are significantly improved. Therapy should last for a minimum of 1 week and no longer than 4 weeks.
Oral dosage † :
Adults and adolescents: A dosage of 250 mg PO once daily for 7 days has been suggested. In a clinical trial for interdigital tinea pedis, patients receiving oral terbinafine administered for 1 week achieved the same cure rates as those who received 4 weeks of topical clotrimazole 1% cream application (71%). Signs and symptoms of infection responded more quickly to oral terbinafine. For moccasin-type plantar tinea pedis, a dose of terbinafine 250 mg PO once daily has been recommended. In a comparison with oral itraconazole, significantly higher mycological cure rates and clinical improvement were seen with oral terbinafine after 2 weeks of therapy for interdigital or extensive tinea pedis.
For the treatment of tinea capitis † :
Oral dosage:
Adults and adolescents: A dose of 250 mg PO once daily for 1-4 weeks has been suggested. Treatment duration is based on the severity of the condition and patient response, but should not exceed 4 weeks.
Children † >= 2 years: One review has suggested a dose of 62.5 mg/day PO for children under 20 kg, and 125 mg/day PO for children between 20 and 40 kg; a dosage of 250 mg/day PO is suggested for children > 40 kg for 1-4 weeks. An updated trial using similar regimens reported that weight-based dosages > 4.5 mg/kg/day PO for 2-4 weeks (not to exceed 250 mg/day PO) are associated with higher cure rates in children. In a meta-analysis (n=603), terbinafine given for 4 weeks performed as well as oral griseofulvin (given for 6-8 weeks) in curing tinea capitis.
For the treatment of onychomycosis:
- for the routine treatment of onychomycosis (tinea unguium):
Oral dosage:
Adults and adolescents: The recommended dosage is 250 mg PO once daily. Treatment should continue for 6 weeks for treatment of fingernails, and 12 weeks for treatment of toenails. Alternatively, an intermittent dosage † of 500 mg PO once daily for 7 days during the first week of each month for 3 months was found to be equivalent to the standard continuous dosage.
Children † >= 2 years: Although experience is limited, a published review suggested a dose of 62.5 mg/day PO for children under 20 kg, and 125 mg/day PO for children between 20 and 40 kg.
- for the treatment of onychomycosis due to Candida parapsilosis † :
Oral dosage:
Adults: In a study of 20 patients, terbinafine 250 mg PO once daily for 16 weeks was utilized. At the end of the trial, 60% of target nails were cured clinically and mycologically.
For the treatment of refractory bronchopulmonary aspergillosis † due to various Aspergillus sp. † , including Aspergillus fumigatus † , in non-immunocompromised patients:
Oral dosage:
Adults and adolescents: A dosage of 5-15 mg/kg PO once daily for 3-5 months has been utilized in compassionate use trials. Eradication of Aspergillus was obtained in 3 patients; clinical improvement was seen in all seven patients.
Patients with hepatic impairment:
The use of oral terbinafine in patients with hepatic disease is contraindicated. In patients with hepatic cirrhosis, oral terbinafine clearance is reduced by approximately 50% compared to normal volunteers.
Patients with renal impairment:
CrCl > 50 ml/min: no dosage adjustment needed.
CrCl <= 50 ml/min: Use of oral terbinafine is not recommended. Oral terbinafine clearance is reduced by approximately 50% compared to normal volunteers.
† non-FDA approved indication
[ Last revised: 1/7/2005 4:07:00 PM ]
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