Terbinafine Tablets Generic Name & Formulations
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; in a tight container. Protect from light.
Mechanism of Action
Terbinafine Tablets Indications
Terbinafine Tablets Dosage and Administration
Terbinafine Tablets Contraindications
Terbinafine Tablets Boxed Warnings
Terbinafine Tablets Warnings/Precautions
Cases of liver failure, some leading to liver transplant or death, have occurred.
The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Discontinue if biochemical or clinical evidence of liver injury develops.
Patients with chronic or active liver disease: not recommended. Assess whether or not the patient has pre-existing liver disease before prescribing terbinafine tablets.
Taste Disturbance Including Loss of Taste
Taste disturbance, including taste loss, has been reported. Taste disturbance may resolve within several weeks after stopping treatment, or it may last greater than 1 year, or may be permanent.
Discontinue if taste disturbance occurs.
Smell Disturbance Including Loss of Smell
Smell disturbance, including loss of smell, has been reported. Smell disturbance may resolve after stopping treatment, or it may last greater than 1 year, or may be permanent.
Discontinue if smell disturbance occurs.
Instruct patients to report depressive symptoms to their physician.
Transient decreases in absolute lymphocyte counts (ALC) have been observed. Consider monitoring CBCs in patients with known or suspected immunodeficiency if treatment continues for more than 6 weeks.
Cases of severe neutropenia have been reported. Obtain CBCs if signs/symptoms suggestive of secondary infection occur. Discontinue and initiate supportive management if neutrophil count is <1,000 cells/mm3.
Serious skin reactions have been reported (eg, Stevens-Johnson Syndrome and toxic epidermal necrolysis). Discontinue if progressive skin rash occurs.
Precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported. Discontinue if signs and symptoms suggestive of lupus erythematosus.
Measurement of serum transaminases (ALT and AST) is advised for all patients before taking terbinafine tablets.
Pregnancy Category B
No adequate and well-controlled studies in pregnant women.
It is not recommended to initiate terbinafine during pregnancy.
Nursing Mother Considerations
Terbinafine is present in breast milk of nursing mothers.
It is not recommended to initiate terbinafine in nursing mothers.
The safety and efficacy of terbinafine have not been established in pediatric patients with onychomycosis.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Terbinafine Tablets Pharmacokinetics
Terbinafine is well absorbed (>70%) and the bioavailability is ~40%. Peak plasma concentrations of 1 μg/mL appear within 2 hours after a single 250 mg dose.
>99% plasma prot
Extensively metabolized by at least 7 CYP isoenzymes, including CYP2C9, CYP1A2, CYP3A4, CYP2C8 and CYP2C19.
Renal (70%). Terminal half-life: 200–400 hours.
Terbinafine Tablets Interactions
Terbinafine Tablets Adverse Reactions
Terbinafine Tablets Clinical Trials
The efficacy of terbinafine tablets in the treatment of onychomycosis is evaluated in 3 US/Canadian placebo-controlled clinical trials which included patients with toenail and/or fingernail infections.
In the first toenail study, results showed that 70% of patients achieved demonstrated mycological cure at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), defined as simultaneous occurrence of negative KOH plus negative culture. Moreover, 59% of patients achieved effective treatment (mycological cure plus 0% nail involvement or >5mm of new unaffected nail growth); 38% of patients achieved mycological cure plus clinical cure (0% nail involvement).
In a second toenail study of dermatophytic onychomycosis, in which non-dermatophytes were also cultured, similar efficacy against the dermatophytes was demonstrated. The pathogenic role of the non-dermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. The clinical significance of this association is unknown. Results of the fingernail study showed that 79% of patients achieved mycological cure as assessed at week 24 (6 weeks of treatment with 18 weeks follow-up after completion of therapy), 75% of the patients achieved effective treatment, and 59% of the patients achieved mycological cure plus clinical cure.
The mean time to overall success was approximately 10 months for the first toenail study and 4 months for the fingernail study. In the first toenail study, for patients evaluated at least six months after achieving clinical cure and at least one year after completing terbinafine hydrochloride therapy, the clinical relapse rate was approximately 15%.
Terbinafine Tablets Note
Terbinafine Tablets Patient Counseling
Advise patients that the optimal clinical effect is seen some months after mycological cure and cessation of treatment due to the time period required for outgrowth of healthy nail.
Advise patients to report to their physician any signs of taste or smell disturbance, and/or depressive symptoms. Discontinue using terbinafine tablets if these reactions occur.
Advise patients to report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine or pale stools. Discontinue using terbinafine tablets if these reactions occur.
Advise patients to report to their physician if any of the following symptoms occur: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing. Discontinue using terbinafine tablets if these reactions occur.
Advise to report to their physician if any symptoms of new onset or worsening lupus erythematosus. Discontinue using terbinafine tablets if this occurs.
Advise patients to minimize exposure to natural and artificial sunlight during treatment.
Prior to initiating treatment, advise patients to obtain ALT/AST levels.