Primary navigation

    Lamisil Granules

    Drug - Lamisil Granules (terbinafine) packets for oral administration

    August 2010

    FDA approved indication 

    Lamisil Granules formulation is indicated for the treatment of tinea capitis (ringworm of the scalp) in patients 4 years of age and older. It is available in 125 mg and 187.5 mg packets.

    Dosing

    Once a day for 6 weeks (dose based on body weight). The entire contents of each packet of granules should be sprinkled on a spoonful of non-acidic food (for example, pudding or mashed potatoes) and swallowed in its entirety. The combination of food and granules should be swallowed without chewing.

    Tinea Capitis: Lamisil Granules should be administered orally at a dose of 125 mg/day for patients less than 25 kg; a dose of 187.5 mg/day for patients 25 to 35 kg; and a dose of 250 mg/day for patients greater than 35 kg.

    Criteria

    Lamisil Granules formulation is covered for patients who meet the following criteria:

    • Treatment of tinea capitis AND
    • Patient is 4 years of age or older AND
    • Patient is unable to use generic terbinafine tablets (eg. Inability to swallow terbinafine tablets or requires a dose lower than 250 mg)

    Rationale

    The state mac (generic cost) of terbinfine 250 mg tablet is $0.36. Another treatment for tinea capitis is griseofulvin, which has about 123 claims per quarter, 80% of which are for the oral suspension. Terbinafine is not superior in efficacy to grisiofulvin. (see table 1) The impact of continuing the PA on Lamisil Granules for on-label use is expected to be minimal and will help to ensure appropriate use of this more expensive dosage form of terbinafine.

    Table 1. Primary Efficacy Results by Dermatophyte Species
    Study 1

    Species Terbinafine 
    N (%)    		 Griseofulvin 
    N (%)
    All Dermatophytes
    Complete Cure    		 (N=411)
    190 (46.2%)    		 (N=197)
    67 (34.0%) 
    T. tonsurans
    Complete Cure     		 (N=264)
    148 (56.1%)    		 (N=131)
    45 (34.4%)
    M. canis
    Complete Cure    		 (N=80)
    19 (23.8%)    		 (N=37)
    13 (35.1%)
    Other*
    Complete Cure    		 (N=67)
    23 (34.2%)    		 (N=29)
    9 (31.0%)

    * T. violaceum, M. audouinii, T. mentagrophytes, T. rubrum, M. gypseum, and M. vanbreuseghemii.

    Table 2. Primary Efficacy Results by Dermatophyte Species
    Study 2

    Species Terbinafine 
    N (%)    		 Griseofulvin 
    N (%)
    All Dermatophytes
    Complete Cure    		 (N=441)
    194 (44.0%)    		 (N=237)
    103 (43.5%)
    T. tonsurans
    Complete Cure    		 (N=243)
    116 (47.7%)    		 (N=126)
    46 (36.5%)
    M. canis
    Complete Cure    		 (N=72)
    22 (30.6%)    		 (N=45)
    23 (51.1%)
    Other*
    Complete Cure    		 (N=126)
    56 (44.4%)    		 (N=66 )
    34 (51.5%)

    * T. violaceum, M. audouinii, T. mentagrophytes, T. rubrum, M. gypseum, and M. vanbreuseghemii.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

    back to top