Terbinafine Hydrochloride

Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).

(1)

Terbinafine tablets are contraindicated in patients with: Chronic or active liver disease [see Warnings and Precautions (5.1)] History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2)] Chronic or active liver disease. (4) History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. (4)

Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases. Prior to initiating treatment and periodically during therapy, assess liver function tests. Discontinue terbinafine tablets if liver injury develops. ( 5.1 ) Taste disturbance, including taste loss, has been reported with the use of terbinafine tablets. Taste disturbance can be severe, may be prolonged, or may be permanent.

Discontinue terbinafine tablets if taste disturbance occurs. ( 5.2 ) Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. Smell disturbance may be prolonged, or may be permanent. Discontinue terbinafine tablets if smell disturbance occurs. ( 5.3 ) Depressive symptoms have been reported with terbinafine use. Prescribers should be alert to the development of depressive symptoms.

( 5.4 ) Severe neutropenia has been reported. If the neutrophil count is less than or equal to 1,000 cells/mm 3 , terbinafine tablets should be discontinued. ( 5.5 ) Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with oral terbinafine use. If signs or symptoms of drug reaction occur, treatment with terbinafine tablets should be discontinued.

( 5.6 )

5.1