Terbinafine (Systemic)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Combination:

Terbinex: 250 mg & 1% [DSC]

Packet, Oral:

LamISIL: 125 mg (1 ea [DSC], 14 ea [DSC]); 187.5 mg (1 ea [DSC], 14 ea [DSC]) [contains polyethylene glycol]

Tablet, Oral:

LamISIL: 250 mg

Generic: 250 mg

• LamISIL
• Terbinex [DSC]

In hepatic cirrhosis, terbinafine clearance is decreased 50%.

Sporotrichosis (lymphocutaneous and cutaneous)

Based on the Infectious Diseases Society of American (IDSA) guidelines for the Management of Sporotrichosis, terbinafine (systemic) is an effective and recommended treatment option for patients with lymphocutaneous and cutaneous sporotrichosis who do not respond to first-line therapy with itraconazole.

Tinea corporis/tinea cruris

Data from a double-blind, randomized clinical study suggest that oral terbinafine may be effective in the treatment of widespread tinea corporis/tinea cruris [Del Palacio Hernanz 1990]. Additional data may be necessary to further define the role of oral terbinafine in this condition.

Tinea pedis/manuum

Data from a double-blind, randomized phase III study support the use of oral terbinafine in the treatment of tinea pedis [Tausch 1998].

Hypersensitivity to terbinafine or any component of the formulation; chronic or active hepatic disease

Tinea capitis: Oral: Granules: Children ≥4 years and Adolescents:

<25 kg: 125 mg once daily for 6 weeks

25 to 35 kg: 187.5 mg once daily for 6 weeks

>35 kg: 250 mg once daily for 6 weeks

Onychomycosis (off-label use) (Gupta 1997): Oral: Tablet: Children and Adolescents:

10 to 20 kg: 62.5 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails)

20 to 40 kg: 125 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails)

>40 kg: 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails)

Administer tablets without regard to meals. Administer granules with food; sprinkle granules on a spoonful of pudding or other soft, nonacidic food (eg, mashed potatoes); swallow entire spoonful without chewing; do not mix granules with applesauce or other fruit-based foods.

Concerns related to adverse effects:

• Allylamine antifungal hypersensitivity: Use caution in patients sensitive to allylamine antifungals (eg, naftifine, butenafine); cross-sensitivity to terbinafine may exist.

• Depression: Has been reported with use; instruct patients to report depressive symptoms/mood changes.

• Gastrointestinal effects: Taste disturbance (including loss of taste) may occur and severe cases resulting in decreased food intake, weight loss, anxiety or depression have been reported; resolution may be delayed (eg, several weeks to >1 year) following discontinuation of therapy or in some cases, disturbance may be permanent. Discontinue therapy in patients with symptoms of taste disturbance.

• Hematologic effects: Transient decreases in absolute lymphocyte counts were observed in clinical trials; severe neutropenia (reversible upon discontinuation) has also been reported. Monitor CBC in patients with preexisting immunosuppression if therapy is to continue >6 weeks. Discontinue therapy if ANC ≤1,000/mm3.

• Hepatic failure: Cases of hepatic failure, some leading to liver transplant or death, have been reported. May occur in patients with and without preexisting hepatic disease; severity of hepatic events and/or outcomes may be worse in patients with active or chronic hepatic disease. Perform baseline and periodic liver function tests; discontinue use if clinical evidence of liver injury develops (eg, nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, pale stools) or elevated liver function tests occur.

• Hypersensitivity: Serious skin and hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome) have occurred. If progressive skin rash or signs and symptoms of a hypersensitivity reaction occur, discontinue treatment.

• Ocular effects: Although rare, changes in the ocular lens and retina have been reported; discontinuation of therapy may be required.

• Respiratory effects: Smell disturbance (including loss of smell) has been reported; resolution may be delayed (eg, >1 year) following discontinuation of therapy or in some cases, disturbance may be permanent. Discontinue therapy in patients with symptoms of smell disturbance.

• Thrombotic microangiopathy: Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, have been reported (some fatal). Discontinue if TMA occurs; consider diagnosis of TMA with unexplained thrombocytopenia and anemia.

Disease-related concerns:

• Autoimmune disease (Lupus): Precipitation or exacerbation of cutaneous or systemic lupus erythematosus has been observed; discontinue if signs and/or symptoms develop.

• Hepatic impairment: Use is contraindicated in patients with active or chronic hepatic disease; clearance is reduced by ~50% in hepatic cirrhosis.

• Renal impairment: Use with caution in patients with renal dysfunction (CrCl ≤50 mL/minute); clearance is reduced by ~50%.

Other warnings/precautions:

• Appropriate use: Due to potential toxicity, confirmation of diagnostic testing of nail or skin specimens prior to treatment of onychomycosis or dermatomycosis is recommended.