Terbinafine - Warnings and Precautions

WARNINGS AND PRECAUTIONS 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.

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.

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.

Depressive symptoms have been reported with terbinafine use.

Prescribers should be alert to the development of depressive symptoms.

Severe neutropenia has been reported.

If the neutrophil count is less than or equal to 1000 cells/mm 3 , Terbinafine tablets should be discontinued.

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.

5.1 Hepatotoxicity Terbinafine tablets are contraindicated for patients with chronic or active liver disease.

Before prescribing Terbinafine tablets, perform liver function tests because hepatotoxicity may occur in patients with and without preexisting liver disease.

Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine tablets in individuals with and without preexisting liver disease.

In the majority of liver cases reported in association with use of Terbinafine tablets, the patients had serious underlying systemic conditions.

The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

Periodic monitoring of liver function tests is recommended.

Discontinue Terbinafine tablets if biochemical or clinical evidence of liver injury develops.

Warn patients prescribed Terbinafine tablets and/or their caregivers to report immediately to their healthcare providers any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools.

Advise patients with these symptoms to discontinue taking oral terbinafine, and immediately evaluate the patient's liver function.