|Drug Name:||Terbinafine Hydrochloride|
A wide range of in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and human hepatocytes suggest that peroxisome proliferation in the liver is a rat-specific finding.
However, other effects, including increased liver weights and APTT, occurred in dogs and monkeys at doses giving Css trough levels of the parent terbinafine 2 to 3x those seen in humans at the MRHD.Higher doses were not tested.10003513/02 Revised February 2008 © RLI, 2008
Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine for the treatment of onychomycosis in individuals with and without pre-existing liver disease.In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine.
The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease (see PRECAUTIONS).
Treatment with terbinafine should be discontinued if biochemical or clinical evidence of liver injury develops (see PRECAUTIONS below).There have been isolated reports of serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis).If progressive skin rash occurs, treatment with terbinafine should be discontinued.