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| Product NDC Code | 43353-893 | ||||
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| Drug Name | Terbinafine hydrochloride |
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| Type | Generic | ||||
| Pharm Class | Allylamine Antifungal [EPC], Allylamine [CS] |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 313222 | ||||
| Application Number | ANDA077714 | ||||
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC | ||||
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Terbinafine Hydrochloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10. OVERDOSAGE Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6. ADVERSE REACTIONS Common (greater than 2% of patients treated with Terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or go to www.bpirx.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Terbinafine tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation. Adverse Event Discontinuation terbinafine (%) n=465 Placebo (%) n=137 terbinafine (%) n=465 Placebo (%) n=137 Headache 12.9 9.5 0.2 0.0 Gastrointestinal Symptoms: Diarrhea 5.6 2.9 0.6 0.0 Dyspepsia 4.3 2.9 0.4 0.0 Abdominal Pain 2.4 1.5 0.4 0.0 Nausea 2.6 2.9 0.2 0.0 Flatulence 2.2 2.2 0.0 0.0 Dermatological Symptoms: Rash 5.6 2.2 0.9 0.7 Pruritus 2.8 1.5 0.2 0.0 Urticaria 1.1 0.0 0.0 0.0 Liver Enzyme Abnormalities Liver enzyme abnormalities greater than or equal to 2× the upper limit of normal range. 3.3 1.4 0.2 0.0 Taste Disturbance 2.8 0.7 0.2 0.0 Visual Disturbance 1.1 1.5 0.9 0.0 6.2 Postmarketing Experience The following adverse events have been identified during post-approval use of Terbinafine tablets. 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, thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome [see Warnings and Precautions (5.5 , 5.8) ] Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus [see Warnings and Precautions (5.7) ] , serum sickness-like reaction Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with use of Terbinafine tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see Warnings and Precautions (5.4) ] . Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of Terbinafine tablets. 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 Terbinafine tablets [see Warnings and Precautions (5.2 , 5.3) ] . Cases of paresthesia and hypoesthesia have been reported with the use of Terbinafine tablets. 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 [see Warnings and Precautions (5.1) ] , idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes [see Warnings and Precautions (5.1) ] have been seen with the use of Terbinafine tablets. Skin and subcutaneous tissue disorders: Serious skin 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] [see Warnings and Precautions (5.6) ] , 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
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Terbinafine Hydrochloride Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7. DRUG INTERACTIONS Terbinafine is an inhibitor of CYP450 2D6 isozyme and has an effect on metabolism of desipramine. Drug interactions have also been noted with cimetidine, fluconazole, cyclosporine, rifampin, and caffeine. ( 7.1 ) 7.1 Drug-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 tablets 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 C max 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 tablets. 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 C max 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 (C max 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 tablets 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. 7.2 Food Interactions An evaluation of the effect of food on Terbinafine tablets was conducted. An increase of less than 20% of the AUC of terbinafine was observed when Terbinafine tablets were administered with food. Terbinafine tablets can be taken with or without food.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ] . 12.2 Pharmacodynamics The pharmacodynamics of Terbinafine tablets is unknown. 12.3 Pharmacokinetics Following oral administration, terbinafine is well absorbed (greater than 70%) and the bioavailability of Terbinafine tablets as a result of first-pass metabolism is approximately 40%. Peak plasma concentrations of 1 mcg/mL appear within 2 hours after a single 250 mg dose; the AUC is approximately 4.56 mcg•h/mL. An increase in the AUC of terbinafine of less than 20% is observed when Terbinafine tablets are administered with food. In plasma, terbinafine is greater than 99% bound to plasma proteins and there are no specific binding sites. At steady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consistent with an effective half-life of ~36 hours. Terbinafine is distributed to the sebum and skin. A terminal half-life of 200-400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is 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 patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of terbinafine was detected in clinical trials. No clinically relevant age-dependent changes in steady-state plasma concentrations of terbinafine have been reported. 12.4 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 test in vitro , terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Trichophyton mentagrophytes Trichophyton rubrum The following in vitro data are available, but their clinical significance is unknown. In vitro , terbinafine exhibits satisfactory MIC's against most strains of the following microorganisms; however, the safety and efficacy of terbinafine in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials: Candida albicans Epidermophyton floccosum Scopulariopsis brevicaulis
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ] .
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics The pharmacodynamics of Terbinafine tablets is unknown.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Following oral administration, terbinafine is well absorbed (greater than 70%) and the bioavailability of Terbinafine tablets as a result of first-pass metabolism is approximately 40%. Peak plasma concentrations of 1 mcg/mL appear within 2 hours after a single 250 mg dose; the AUC is approximately 4.56 mcg•h/mL. An increase in the AUC of terbinafine of less than 20% is observed when Terbinafine tablets are administered with food. In plasma, terbinafine is greater than 99% bound to plasma proteins and there are no specific binding sites. At steady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consistent with an effective half-life of ~36 hours. Terbinafine is distributed to the sebum and skin. A terminal half-life of 200-400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is 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 patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of terbinafine was detected in clinical trials. No clinically relevant age-dependent changes in steady-state plasma concentrations of terbinafine have been reported.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4. CONTRAINDICATIONS Terbinafine tablets are contraindicated in patients with: • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2) ] • Chronic or active liver disease [see Warnings and Precautions (5.1) ] • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. ( 4 ) • Chronic or active liver disease. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11. DESCRIPTION Terbinafine Tablets, USP 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. The empirical formula C 21 H 26 ClN 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 tablet contains: Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base). Inactive Ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2. DOSAGE AND ADMINISTRATION • Prior to administering, evaluate patients for evidence of chronic or active liver disease. ( 2.1 ) • Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks. ( 2.2 ) • Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks. ( 2.2 ) 2.1 Assessment Prior to Initiation Before administering Terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ] . 2.2 Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks. Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3. DOSAGE FORMS AND STRENGTHS Tablet, 250 mg, white, oblong, unscored, debossed "B" and "526" on one side and plain on the other side • Tablet, 250 mg ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1. INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.Terbinafine Hydrochloride Terbinafine Hydrochloride Terbinafine Hydrochloride Terbinafine Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato oblong B;526
Animal pharmacology and or toxicology
Information from studies of the drug in animals, if the data were not relevant to nor included in other parts of the labeling. Most labels do not contain this field.13.2 Animal Toxicology and/or Pharmacology 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 C ss trough levels of the parent terbinafine 2-3× those seen in humans at the MRHD. Higher doses were not tested.
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 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 (2× 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 12× 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.
Nonclinical toxicology
Information about toxicology in non-human subjects.13. NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 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 (2× 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 12× 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. 13.2 Animal Toxicology and/or Pharmacology 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 C ss trough levels of the parent terbinafine 2-3× those seen in humans at the MRHD. Higher doses were not tested.
Microbiology
Microbiology12.4 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 test in vitro , terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Trichophyton mentagrophytes Trichophyton rubrum The following in vitro data are available, but their clinical significance is unknown. In vitro , terbinafine exhibits satisfactory MIC's against most strains of the following microorganisms; however, the safety and efficacy of terbinafine in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials: Candida albicans Epidermophyton floccosum Scopulariopsis brevicaulis
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 250 mg NDC 43353-893 - Terbinafine HCl 250 mg - Rx Only Bottle Label 250 mg
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration: Assessment Prior to Initiation ( 2.1 ) 8/2016 Contraindications ( 4 ) 8/2016 Warnings and Precautions: Hepatotoxicty ( 5.1 ) 8/2016 Warnings and Precautions: Thrombotic Microangiopathy ( 5.8 ) 1/2017
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Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured by: Liconsa Guadalajara, Spain Made in Spain Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA Rev 07/2017 544132-01
Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 250 mg 6000 43353-893-16 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20171215JH Aphena Pharma Solutions - TN
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Terbinafine Hydrochloride: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Medication Guide. Patients taking Terbinafine tablets should receive the following information and instructions: • Advise patients 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 tablets treatment should be discontinued. • Advise patients to immediately report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. Terbinafine tablets treatment should be discontinued. • Advise patients 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 tablets treatment should be discontinued. • Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Terbinafine tablets. • Advise patients that if they forget to take Terbinafine tablets, to take their tablets as soon as they remember, unless it is less than 4 hours before the next dose is due. • Advise patients to call their physician if they take too many Terbinafine tablets.
Spl medguide
Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.MEDICATION GUIDE TERBINAFINE (ter' bin a feen) hydrochloride Tablets What is the most important information I should know about Terbinafine tablets? Terbinafine tablets may cause serious side effects, including: • Liver problems that can lead to the need for a liver transplant or death . This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of liver problems: Your doctor should do a blood test to check you for liver problems before you start treatment with Terbinafine tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking Terbinafine tablets if you develop liver problems. • nausea • poor appetite • tiredness • vomiting • upper right stomach-area (abdomen) pain • yellowing of your skin or eyes (jaundice) • dark (tea-colored) urine • pale or light colored stools What are Terbinafine tablets? Terbinafine tablets are a prescription medicine used to treat fungal infections of the fingernails and toenails (onychomycosis). Your doctor should do tests to check you for fungal infection of your nails before you start Terbinafine tablets. It is not known if Terbinafine tablets are safe and effective in children for the treatment of onychomycosis. Who should not take Terbinafine tablets? Do not take Terbinafine tablets if you: • have had a severe allergic reaction to terbinafine hydrochloride when taken by mouth. • have had liver disease for a long time (chronic) or have active liver disease. What should I tell my doctor before taking Terbinafine tablets? Before taking Terbinafine tablets, tell your doctor about all of your medical conditions, including if you: • have or had liver problems • have a weakened immune system (immunocompromised) • have lupus (an autoimmune disease) • are pregnant or plan to become pregnant. It is not known if Terbinafine tablets will harm your unborn baby. You should not start taking Terbinafine tablets during pregnancy. • are breastfeeding or plan to breastfeed. Terbinafine passes into your breast milk and may harm your baby. You should not breastfeed while taking Terbinafine tablets. Talk to your doctor about the best way to feed your baby if you take Terbinafine tablets. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Terbinafine tablets may affect the way other medicines work and other medicines may affect how Terbinafine tablets work. How should I take Terbinafine tablets? • Take Terbinafine tablets exactly as your doctor tells you to take it. • Terbinafine tablets come as a tablet that you take by mouth. • Terbinafine tablets are usually taken: • 1 time each day for 6 weeks to treat fungal infections of your fingernail, or • 1 time each day for 12 weeks to treat fungal infections of your toenail • Terbinafine tablets can be taken with or without food. • If you miss a dose of Terbinafine tablets, take it as soon as you remember. If it is less than 4 hours before your next dose, skip the missed dose. Just take the next dose at your regular time. • If you take too many Terbinafine tablets, call your doctor. You may have the following symptoms: • nausea • stomach-area (abdomen) pain • frequent urination • rash • headache • vomiting • dizziness What should I avoid while taking Terbinafine tablets? Avoid sunlight. Terbinafine tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn. What are the possible side effects of Terbinafine tablets? Terbinafine tablets may cause serious side effects, including: • See " What is the most important information I should know about Terbinafine tablets? " • Change in your sense of taste or loss of taste is common with Terbinafine tablets, but can also be severe. This may improve within several weeks after you stop taking Terbinafine tablets, but may last for a long time or may become permanent. Tell your doctor if you develop any of the following: • change in your sense of taste or loss of taste • poor appetite • weight loss • anxiousness • change in your mood or depressive symptoms. See the list of depressive symptoms below. • Change in your sense of smell or loss of smell may happen with Terbinafine tablets. This may improve after you stop taking Terbinafine tablets, but may last for a long time or may become permanent. Tell your doctor if you have a change in your sense of smell or loss of smell. • Depressive symptoms. Tell your doctor right away if you develop any of these signs or symptoms: • feel sad or worthless • change in sleep pattern • mood changes • loss of energy or interest in daily activities • restlessness • Low white blood cell count. Terbinafine tablets may decrease your white blood cell count, especially neutrophils. You may have a higher risk of getting an infection when your white blood cell count is low. • Serious skin or allergic reactions, which may include problems with some of your body organs. Tell your doctor right away or get emergency medical help if you get any of these symptoms: • skin rash • hives • sores in your mouth, or your skin blisters and peels • swelling of your face, eyes, lips, tongue or throat • trouble swallowing or breathing • fever • swollen lymph glands • Also tell your doctor about any new symptoms, such as cough, chest pain, fast heartbeat, or blood in your urine. • New or worsening lupus. Stop taking Terbinafine tablets and tell your doctor if you get any of the following: • a skin rash that gets worse (progresses), is scaly, red, shows scarring, or loss of skin color • unusual sensitivity to the sun that can cause a rash • Blood clotting problems. When taking Terbinafine tablets, you may develop a blood clotting problem. Tell your doctor, if you get any unexplained bleeding or bruising. The most common side effects of Terbinafine tablets include: • headache • diarrhea • rash • upset stomach • abnormal liver function tests • itching • nausea • stomach-area (abdomen) pain • gas These are not all of the possible side effects of Terbinafine tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Terbinafine tablets? • Store Terbinafine Tablets at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. • Keep Terbinafine tablets in a tightly closed container and keep out of the light. Keep Terbinafine tablets and all medicines out of the reach of children. General information about the safe and effective use of Terbinafine tablets. Medicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use Terbinafine tablets for a condition for which it was not prescribed. Do not give Terbinafine tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Terbinafine tablets that is written for health professionals. For more information, call 1-800-367-3395 or go to www.bpirx.com. What are the ingredients in Terbinafine tablets? Active ingredient: terbinafine hydrochloride Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Manufactured by: Liconsa Guadalajara, Spain Made in Spain Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA Revised: May 2017 544133-01
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14. CLINICAL STUDIES The efficacy of Terbinafine tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 US/Canadian placebo-controlled clinical trials. Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects. Fifty-nine percent (59%) of subjects experienced effective treatment (mycological cure plus 0% nail involvement or greater than 5mm of new unaffected nail growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% nail involvement). In a second toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also cultured, similar efficacy against the dermatophytes was demonstrated. The pathogenic role of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. The clinical significance of this association is unknown. Results of the fingernail trial, as assessed at week 24 (6 weeks of treatment with 18 weeks follow-up after completion of therapy), demonstrated mycological cure in 79% of subjects, effective treatment in 75% of the subjects, and mycological cure plus clinical cure in 59% of the subjects. The mean time to overall success was approximately 10 months for the first toenail trial and 4 months for the fingernail trial. In the first toenail trial, for subjects evaluated at least 6 months after achieving clinical cure and at least 1 year after completing therapy with Terbinafine tablets, the clinical relapse rate was approximately 15%.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of Terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.8.3 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 tablets is not recommended in women who are nursing.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and efficacy of Terbinafine tablets have not been established in pediatric patients with onychomycosis.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Pregnancy Category 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 onychomycosis can be postponed until after pregnancy is completed, it is recommended that Terbinafine tablets not be initiated during pregnancy. Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Pregnancy Category 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 onychomycosis can be postponed until after pregnancy is completed, it is recommended that Terbinafine tablets not be initiated during pregnancy. Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category 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 onychomycosis can be postponed until after pregnancy is completed, it is recommended that Terbinafine tablets not be initiated during pregnancy. Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine. 8.3 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 tablets is not recommended in women who are nursing. 8.4 Pediatric Use The safety and efficacy of Terbinafine tablets have not been established in pediatric patients with onychomycosis. 8.5 Geriatric Use Clinical studies of Terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Renal Impairment In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min), the use of Terbinafine tablets has not been adequately studied. 8.7 Hepatic Impairment Terbinafine tablets are contraindicated for patients with chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ] . Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine tablets in individuals with and without preexisting liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16. HOW SUPPLIED/STORAGE AND HANDLING Terbinafine Tablets, USP are supplied as white, oblong, unscored tablets debossed "B" and "526" on one side and plain on the other side. Bottles of 30 tablets NDC 60429-222-30 Store Terbinafine Tablets, USP at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
Storage and handling
Information about safe storage and handling of the drug product.Store Terbinafine Tablets, USP at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
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