Terbinafine

DEA Class; Rx

Common Brand Names; Lamisil

• Antifungals, Systemic

terbinafine topical (OTC)

• Classes: Antifungals, Topical

Oral and topical antifungal
Fungicidal activity against dermatophytes; less active against Candida sp.
Used topically and orally for tinea infections; oral form effective for onychomycosis or for refractory aspergillosis

Hypersensitivity

Chronic or active liver disease

Headache (13%)

Rash (6%)

Pruritus (3%)

Nausea (3%)

Diarrhea (6%)

Dyspepsia (4%)

Abdominal pain (2%)

Taste disturbance (3%)

Elevated liver function test results (3%)

Visual disturbance (1%)

Discontinue if the following develop: Liver disease, neutropenia (absolute neutrophil count <1000 mcL); skin rash; signs or symptoms of SLE

Changes in ocular lens and retina reported; may require discontinuation of therapy

Use caution in renal and liver impairment

Periodic monitoring of liver function tests is recommended

Ask patients and caregivers to report immediately to healthcare provider any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools; if these symptoms occur discontinue taking oral terbinafine, and immediately evaluate patient’s liver function

Serious skin/hypersensitivity reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome); manifestations of DRESS syndrome may include cutaneous reaction (eg, rash, exfoliative dermatitis), eosinophilia, and 1 or more organ complications (eg, hepatitis, pneumonitis, nephritis, myocarditis, pericarditis)

Due to potential toxicity, confirmation of onychomycosis or dermatomycosis recommended

Smell disturbance reported; discontinue therapy if symptoms occur

CYP2D6 inhibitor; may also convert CYP2D6 extensive metabolizers to poor metabolizer status

Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported with terbinafine; discontinue terbinafine if clinical symptoms and laboratory findings consistent with TMA occur; the findings of unexplained thrombocytopenia and anemia should prompt further evaluation and consideration of diagnosis of TMA

Available data from postmarketing cases in pregnant women are insufficient to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

After oral administration, terbinafine is present in human milk; however, there are no data on effects on breastfed child or on milk production

Terbinafine hydrochloride

tablet

• 250mg

packet, oral granules (discontinued)

• 125mg
• 187.5mg

cream/topical solution

• 1%