Terbinafine (oral)

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# Overview
Terbinafine (oral) is an antifungal that is FDA approved for the treatment of tinea capitis in patients 4 years of age and older.   Common adverse reactions include diarrhea, dyspepsia, rash, pruritis, and urticaria.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Terbinafine (terbinafine hydrochloride) Oral Granules are indicated for the treatment of tinea capitis in patients 4 years of age and older.

### Dosage
- Terbinafine (terbinafine hydrochloride) Oral Granules should be taken once a day for 6 weeks based upon body weight (See Table 1). Sprinkle the contents of each packet on a spoonful of pudding or other soft, nonacidic food such as mashed potatoes and swallow the entire spoonful (without chewing); do not use applesauce or fruit-based foods. Take with food. If 2 packets (250 mg) are required with each dose, either the content of both packets may be sprinkled on 1 spoonful, or the contents of both packets may be sprinkled on 2 spoonfuls of nonacidic food as directed above.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Terbinafine (oral) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Terbinafine (oral) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Terbinafine (oral) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Terbinafine (oral) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Terbinafine (oral) in pediatric patients.

# Contraindications
- Terbinafine (terbinafine hydrochloride) Oral Granules are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.

# Warnings
- Hepatotoxicity
- Cases of liver failure, some leading to liver transplant or death, have occurred with the use of oral terbinafine during postmarketing experience in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with oral terbinafine use, 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. Treatment with Terbinafine Oral Granules should be discontinued if biochemical or clinical evidence of liver injury develops.
- Terbinafine Oral Granules are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine Oral Granules, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Terbinafine Oral Granules should be immediately discontinued in case of elevation of liver function tests. Patients prescribed Terbinafine Oral Granules and/or their guardians should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools.
- Patients with these symptoms should discontinue taking Terbinafine Oral Granules, and the patients liver function should be immediately evaluated.
- Taste Disturbance Including Loss of Taste
- Taste disturbance, including taste loss, has been reported with the use of oral terbinafine. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a taste disturbance occur, Terbinafine Oral Granules should be discontinued.
- Smell Disturbance Including Loss of Smell
- Smell disturbance, including loss of smell, has been reported with the use of oral terbinafine. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than one year), or may be permanent. If symptoms of a smell disturbance occur, Terbinafine Oral Granules should be discontinued.
- Depressive Symptoms
- Depressive symptoms have occurred during postmarketing use of oral terbinafine. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.
- Hematologic Effects
- Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 subjects receiving Terbinafine Tablets (1.7%) and 3/137 subjects receiving placebo (2.2%) had decreases in ALC to below 1000/mm3 on 2 or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than 6 weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of oral terbinafine, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is 1000 cells/mm3, Terbinafine Oral Granules should be discontinued and supportive management started.
- Serious Skin/Hypersensitivity Reactions
- There have been postmarketing reports of serious skin/hypersensitivity reactions [e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) with oral terbinafine. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with Terbinafine Oral Granules should be discontinued.
- Lupus Erythematosus
- During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking oral terbinafine. Therapy should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

# Adverse Reactions

## Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Terbinafine (terbinafine hydrochloride) Oral Granules
- The data described below reflect exposure to terbinafine including 1042 subjects exposed for a median of 42 days. Terbinafine Oral Granules was studied in 2 active-controlled trials (n=1042). The population was children aged 4 to 12 years old, 64% male and 36% female, 21% Caucasian, 47% Black, 32% Other. Baseline disease (dermatophyte) characteristics of subjects included 49% having T.tonsurans, 15% T. violaceum, 15% M. canis, 2% M. audouinii, and 1% others. Subjects received once daily, for 6 weeks, oral doses of Terbinafine Oral Granules based on body weight: 35 kg 250 mg/day.
- Adverse events reported in the 2 trials are listed in the table below.
- In the pooled pivotal trials, 2% (17/1042) of subjects in the terbinafine group and 2% (6/507) in the griseofulvin group experienced discontinuation of study drug due to adverse events. The most common categories of adverse events causing discontinuation in those exposed to terbinafine included gastrointestinal disorders, skin and subcutaneous disorders, and infections and infestations.
- No ophthalmologic safety signal was identified in the pooled pivotal trials. Ophthalmologic assessments included dilated fundoscopy to assess for refractile bodies in the retina, visual acuity assessment, and color vision testing. Of the 940 subjects in the terbinafine group and 471 subjects in the griseofulvin group who completed dilated fundoscopy at posttreatment visits, none of the subjects were found to have refractile bodies of the retina at baseline or end of treatment. For visual acuity, 1% (11/837) of subjects treated with terbinafine and 2% (7/426) of subjects treated with griseofulvin showed a doubling of visual angle after 6 weeks of treatment, while 2% (15/837) treated with terbinafine and 3% (12/426) treated with griseofulvin showed a halving of the visual angle after 6 weeks of treatment. Of subjects who completed yellow-blue color vision assessment for acquired defects, 5% (13/262) of subjects treated with terbinafine and 6% (8/129) of subjects treated with griseofulvin had color confusion on more than 1 symbol at week 6 than at baseline, while 13% (33/262) of subjects treated with terbinafine and 13% (17/129) of subjects treated with griseofulvin identified more symbols correctly at week 6 than at baseline.
- Terbinafine (terbinafine hydrochloride) Tablets
- Adverse events reported in three US/Canadian placebo-controlled trials included diarrhea (6%), rashes (6%), dyspepsia (4%), nausea (3%), liver abnormalities (3%), pruritus (3%), taste disturbances (3%), abdominal pain (2%), and urticaria (1%).
- Changes in the ocular lens and retina have been reported following the use of Terbinafine Tablets in clinical trials in adult subjects with onychomycosis. The clinical significance of these changes is unknown.

## Postmarketing Experience
- The following adverse events have been identified during postapproval use of oral terbinafine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia
- Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus , serum sickness-like reaction
- Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with oral terbinafine use. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy].
- Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of oral terbinafine. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Cases of smell disturbance, including smell loss, have been reported with the use of oral terbinafine . Cases of paresthesia and hypoesthesia have been reported with the use of oral terbinafine.
- Eye disorders: Visual field defects, reduced visual acuity
- Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus
- Vascular disorders: Vasculitis
- Gastrointestinal disorders: Pancreatitis, vomiting
- Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death , idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes  have been seen with the use of oral terbinafine.
- Skin and subcutaneous tissue disorders: Serious skin reactions , acute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss
- Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia
- General disorders and administration site conditions: Malaise, fatigue, influenza-like illness, pyrexia
- Investigations: Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased blood creatine phosphokinase have been reported

# Drug Interactions
- In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Coadministration of Terbinafine (terbinafine hydrochloride) Oral Granules should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug. In a study to assess the effects of terbinafine on desipramine in healthy volunteers characterized as normal metabolizers, the administration of terbinafine resulted in a 2-fold increase in Cmax and a 5-fold increase in area under the curve (AUC). In this study, these effects were shown to persist at the last observation at 4 weeks after discontinuation of Terbinafine. In studies in healthy subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increases the dextromethorphan/dextrorphan metabolite ratio in urine by 16- to 97-fold, on average. Thus, terbinafine may convert extensive CYP2D6 metabolizers to poor metabolizer status.
- In vitro studies with human liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride and fluvastatin.
- In vivo drug-drug interaction studies conducted in healthy volunteer subjects showed that terbinafine does not affect the clearance of antipyrine or digoxin. Terbinafine decreases the clearance of caffeine by 19%. Terbinafine increases the clearance of cyclosporine by 15%.
- The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant.
- Coadministration of a single dose of fluconazole (100 mg) with a single dose of terbinafine resulted in a 52% and 69% increase in terbinafine Cmax and AUC, respectively. Fluconazole is an inhibitor of CYP2C9 and CYP3A enzymes. Based on this finding, it is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g., ketoconazole, amiodarone) may also lead to a substantial increase in the systemic exposure (Cmax and AUC) of terbinafine when concomitantly administered.
- There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral terbinafine and warfarin, however, a causal relationship between terbinafine and these changes has not been established.
- Terbinafine clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine clearance is unaffected by cyclosporine. There is no information available from adequate drug-drug interaction studies with the following classes of drugs: oral contraceptives, hormone replacement therapies, hypoglycemics, phenytoins, thiazide diuretics, and calcium channel blockers.
- An evaluation of the effect of food on Terbinafine (terbinafine hydrochloride) Oral Granules was not conducted. However, in the clinical trials, Terbinafine (terbinafine hydrochloride) Oral Granules was administered with food

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
- There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of tinea capitis can be postponed until after pregnancy is completed, it is recommended that Terbinafine (terbinafine hydrochloride) Oral Granules not be initiated during pregnancy.
- Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day  and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Terbinafine (oral) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Terbinafine (oral) during labor and delivery.

### Nursing Mothers
- After oral administration, terbinafine is present in breast milk of nursing mothers. The ratio of terbinafine in milk to plasma is 7:1. Treatment with Terbinafine Oral Granules is not recommended in women who are nursing.

### Pediatric Use
- Terbinafine Oral Granules was studied in 2 randomized, active-controlled trials in which 1021 subjects, 4 to 12 years old, having a clinical diagnosis of tinea capitis confirmed by potassium hydroxide (KOH) microscopy were treated with Terbinafine Oral Granules at the labeled dose for up to 6 weeks. The most common adverse events were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection

### Geriatic Use
- Terbinafine Oral Granules has not been studied in geriatric patients.

### Gender
There is no FDA guidance on the use of Terbinafine (oral) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Terbinafine (oral) with respect to specific racial populations.

### Renal Impairment
- In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) the use of Terbinafine Oral Granules has not been adequately studied.

### Hepatic Impairment
There is no FDA guidance on the use of Terbinafine (oral) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Terbinafine (oral) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Terbinafine (oral) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Terbinafine (oral) in the drug label.
- Measurement of serum transaminases (ALT and AST) is advised for all patients before taking Terbinafine Oral Granules.

# IV Compatibility
There is limited information regarding IV Compatibility of Terbinafine (oral) in the drug label.

# Overdosage
- Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams in adults (20 times the therapeutic daily adult dose) have been reported without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

# Pharmacology

## Mechanism of Action
- Terbinafine is an allylamine antifungal
- Microbiology
- Terbinafine, an allylamine antifungal, inhibits biosynthesis of ergosterol, an essential component of fungal cell membrane, via inhibition of squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of squalene but not due to ergosterol deficiency. Depending on the concentration of the drug and the fungal species tested in vitro, terbinafine may be fungicidal. However, the clinical significance of in vitro data is unknown.
- Terbinafine Oral Granules has been studied in tinea capitis

## Structure
- Terbinafine (terbinafine hydrochloride) Oral Granules 125 mg and 187.5 mg contain the synthetic allylamine antifungal compound, terbinafine hydrochloride.
- Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. It has the empirical formula C21H26ClN with a molecular weight of 327.90, and the following structural formula:
- Terbinafine hydrochloride is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.
- Each packet of Terbinafine Oral Granules contains:
- Active Ingredients: terbinafine hydrochloride (equivalent to 125 mg or 187.5 mg terbinafine base)
- Inactive Ingredients: basic butylated methacrylate copolymer, colloidal silicon dioxide NF, dibutyl sebacate NF, hypromellose USP, magnesium stearate NF, microcrystalline cellulose NF, nitrogen NF (filling gas), polyethylene glycol NF, sodium lauryl sulfate NF, and sodium starch glycolate NF.

## Pharmacodynamics
- The pharmacodynamics of Terbinafine (terbinafine hydrochloride) Oral Granules is unknown.

## Pharmacokinetics
- The pharmacokinetics in children 4 to 8 years of age with tinea capitis was investigated in a pharmacokinetic study after single and repeated (for 42 days) oral administration of Terbinafine Oral Granules (N=16), once daily, using the body weight groups and doses described in Section 2. The systemic exposure (Cmax and AUC0-24) of terbinafine in children had a relatively high interindividual variability (ranging from 36% to 64%). At steady state the AUC0-24 increased by a mean factor of 1.9 to 2.1 across doses. The mean (SD) effective half-life obtained from the observed accumulation was 26.7 (13.8) hours and 30.5 (9.3) hours for the 125 mg and 187.5 mg doses, respectively.
- Systemic exposure to terbinafine in the children did not exceed the highest values of the systemic exposure in adults receiving repeated once daily doses of 250 mg Terbinafine (terbinafine hydrochloride) Tablets. A population pharmacokinetic evaluation of oral terbinafine that included children 4-12 years of age and adults 18-45 years of age (N=113) found that clearance (CL/F) of terbinafine is dependent on body weight in a nonlinear manner. For a typical child of 25 kg CL/F was predicted to be 19 L/h and for a typical adult of 70 kg body weight it was predicted to be 27 L/h. Over the weight range for pediatric patients included in the analysis (14.1 kg-68 kg), the predicted CL/F ranged between 15.6-26.7 L/hr. In plasma, terbinafine is >99% bound to plasma proteins. Prior to excretion, terbinafine is rapidly and extensively metabolized by at least 7 CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites have been identified that have antifungal activity similar to terbinafine. Approximately 70% of the administered dose is eliminated in the urine. In adult patients with renal impairment (creatinine clearance 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers.

## Nonclinical Toxicology
- In a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2x the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested.
- The results of a variety of in vitro (mutations in E. coli and S. typhimurium, DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential.
- Oral reproduction studies in rats at doses up to 300 mg/kg/day (approximately 12x the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/day in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.
- 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 2-3x those seen in humans at the MRHD. Higher doses were not tested.
- In a 52-week oral toxicology study conducted in juvenile maturing dogs, increased heart and liver weights were noted in males and signs of CNS disturbance including 3 cases of single episodes of seizures were noted in females at the highest dose tested, 100 mg/kg/day . No treatment related findings were noted at 30 mg/kg/day  in this study.

# Clinical Studies
- Two randomized, multinational trials were conducted to investigate the safety and efficacy of Terbinafine (terbinafine hydrochloride) Oral Granules in the treatment of subjects 4 to 12 years old with tinea capitis. Terbinafine Oral Granules was dosed based on body weight. Griseofulvin dosed at 10-20 mg/kg was used as a comparator. Subjects were dosed for 6 weeks and followed for an additional 4 weeks.
- The 2 trials enrolled 50% of subjects from the U.S. Additionally, among those with positive cultures, 65% and 54% of infections were due to T. tonsurans, and 19% and 17% due to M. canis in Studies 1 and 2, respectively.
- The primary efficacy endpoint was the proportion of subjects with complete cure (negative KOH, negative culture, and absence of clinical signs of infection) at week 10. Table 3 below lists the efficacy results for Studies 1 and 2 overall and according to the dermatophyte species (T. tonsurans, M. canis, or Other).

# How Supplied
- Terbinafine (terbinafine hydrochloride) Oral Granules 125 mg and 187.5 mg
- Terbinafine Oral Granules is supplied in cartons containing 14 laminated aluminum packets. Each packet contains approximately either 30 or 45 off-white to yellowish, round, biconvex, film-coated granules, corresponding to a single total dose of 125 mg or 187.5 mg (terbinafine base equivalent) per packet.
- 125 mg per packet
- Carton of 14 packets.....................................................NDC 0078-0499-58
- Pack of 3 cartons each containing 14 packets (42 packets).........NDC 0078-0499-59
- 187.5 mg per packet
- Carton of 14 packets.....................................................NDC 0078-0500-58
- Pack of 3 cartons each containing 14 packets (42 packets)..........NDC 0078-0500-59
- Storage conditions of Terbinafine Oral Granules 125 mg and 187.5 mg: Store at 25C (77F); excursions permitted to 1530C (5986F) .

## Storage
There is limited information regarding Terbinafine (oral) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Patients taking Terbinafine (terbinafine hydrochloride) Oral Granules should receive the following information and instructions:
- Advise patients and/or their guardian to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing. Terbinafine Oral Granules treatment should be discontinued.
- Advise patients prescribed Terbinafine Oral Granules and/or their guardian to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. Terbinafine Oral Granules treatment should be discontinued.
- Advise patients and/or their guardian to report to their physician any signs of taste disturbance, smell disturbance, and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of pigment, and unusual photosensitivity that can result in a rash. Terbinafine Oral Granules treatment should be discontinued.
- Advise patients and/or their guardian to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Terbinafine Oral Granules.
- Advise patients and/or their guardian to call their physician if they take too many Terbinafine Oral Granules.

# Precautions with Alcohol
- Alcohol-Terbinafine (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- LAMISIL

# Look-Alike Drug Names
There is limited information regarding Terbinafine (oral) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price