Terbinafine is used to treat infections caused by a fungus. It works by killing the fungus or preventing its growth.
Terbinafine is applied to the skin to treat:
ringworm of the body (tinea corporis);
ringworm of the foot (interdigital and plantar tinea pedis; athlete's foot);
ringworm of the groin (tinea cruris; jock itch);
tinea versicolor (sometimes called “sun fungus”); and
yeast infections of the skin (cutaneous candidiasis).
Terbinafine is available both over-the-counter (OTC) and with your doctor's prescription.
Terbinafine indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Terbinafine tablets, USP 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.
How should I use Terbinafine?
Use Terbinafine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
To use the tablets: Take by mouth with or without food.
The tablets are taken for different amounts of time depending on your condition. The full benefit may not be seen for several months after stopping treatment. This includes the time period necessary for healthy nails to grow.
To use the nail lacquer: Use at bedtime, unless your doctor tells you otherwise. Wash and dry the affected nails, then apply a thin coat of medicine.
Do not apply the nail lacquer to a wound, or to broken or damaged skin.
Use the nail lacquer until a new, healthy nail has grown, unless your doctor tells you otherwise. This usually takes 6 to 12 months, depending on your condition.
To clear up your infection completely, take Terbinafine for the full course of treatment. Keep taking it even if you begin to see improvement before the end of your therapy.
If you miss a dose of Terbinafine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Terbinafine.
Uses of Terbinafine in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Onychomycosis (tablets only): Treatment of onychomycosis of the toenail or fingernail caused by dermatophytes (tinea unguium).
Tinea capitis (granules only): Treatment of tinea capitis in patients 4 years and older.
Data from a limited number of patients studied suggest that Terbinafine may be beneficial for the treatment of dermatophyte folliculitis.
Terbinafine description
Terbinafine (Lamisil) is a synthetic allylamine antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues. Like other allylamines, Terbinafine inhibits ergosterol synthesis by inhibiting the fungal squalene monooxygenase (squalene 2,3-epoxidase), an enzyme that is part of the fungal cell wall synthesis pathway.
Terbinafine dosage
Terbinafine Dosage
Applies to the following strength(s): 250 mg; 125 mg; 187.5 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Onychomycosis - Fingernail
Onychomycosis - Toenail
Tinea Capitis
Cutaneous Candidiasis
Tinea Corporis
Tinea Cruris
Tinea Pedis
Usual Pediatric Dose for:
Tinea Capitis
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments
Usual Adult Dose for Onychomycosis - Fingernail
Tablets: 250 mg orally once a day for 6 weeks
Comments:
-Optimal clinical effect observed some months after mycological cure and end of therapy; related to time required for outgrowth of healthy nail.
Approved
Indication: Treatment of onychomycosis of the fingernail due to dermatophytes (tinea unguium)
Usual Adult Dose for Onychomycosis - Toenail
Tablets: 250 mg orally once a day for 12 weeks
Comments:
-Optimal clinical effect observed some months after mycological cure and end of therapy; related to time required for outgrowth of healthy nail.
Approved
Indication: Treatment of onychomycosis of the toenail due to dermatophytes (tinea unguium)
Usual Adult Dose for Tinea Capitis
Oral granules: 250 mg orally once a day for 6 weeks
Comments:
-Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.
Usual Adult Dose for Cutaneous Candidiasis
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 4 weeks
Usual Adult Dose for Tinea Corporis
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 4 weeks
Usual Adult Dose for Tinea Cruris
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 4 weeks
Usual Adult Dose for Tinea Pedis
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 6 weeks
Usual Pediatric Dose for Tinea Capitis
Oral granules
:
4 years or older:
Less than 25 kg: 125 mg orally once a day
25 to 35 kg: 187.5 mg orally once a day
Greater than 35 kg: 250 mg orally once a day
Duration of therapy: 6 weeks
Comments:
-Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.
Renal Dose Adjustments
CrCl 50 mL/min or less: Data not available
Liver Dose Adjustments
Chronic or active liver disease: Not recommended.
Precautions
Consult WARNINGS section for dosing related precautions.
Dialysis
Data not available
Other Comments
Administration advice:
-Oral granules: Take with food. Sprinkle the contents of each packet on a spoonful of pudding or other soft, nonacidic food (e.g., mashed potatoes) and swallow the entire spoonful without chewing; do not use applesauce or fruit-based foods.
General:
-Before starting therapy with Terbinafine tablets, appropriate nail specimens for laboratory testing (potassium hydroxide preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
-Clinical resolution may not be observed until several weeks after mycological cure.
Monitoring:
-Hematologic: Complete blood counts in patients with immunodeficiency (known or suspected) using Terbinafine for more than 6 weeks or if clinical signs/symptoms suggestive of secondary infection develop
-Hepatic: Serum transaminases (ALT and AST) in all patients before starting therapy
-Psychiatric: Depressive symptoms
Patient advice:
-Minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) during therapy.
Ajmaline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Ajmaline. Monitor therapy
Amitriptyline: Terbinafine (Systemic) may increase the serum concentration of Amitriptyline. Management: Monitor for increased effects/toxicity of amitriptyline during concomitant administration with Terbinafine. Reduced dosages of amitriptyline may be needed. Consider therapy modification
Amphetamines: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amphetamines. Monitor therapy
ARIPiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy
Brexpiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Brexpiprazole. Management: If brexpiprazole is to be used together with both a moderate CYP2D6 inhibitor and a strong or moderate CYP3A4 inhibitor, the brexpiprazole dose should be reduced to 25% of the usual dose when treating indications other than major depressive disorder. Monitor therapy
CloZAPine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of CloZAPine. Monitor therapy
Codeine: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of Codeine. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Monitor therapy
CYP2D6 Substrates (High risk with Inhibitors): CYP2D6 Inhibitors (Moderate) may decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Exceptions: Tamoxifen. Monitor therapy
Desipramine: Terbinafine (Systemic) may increase the serum concentration of Desipramine. Management: Monitor for increased effects/toxicity of desipramine during concomitant administration with Terbinafine. Reduced dosages of desipramine may be needed. Consider therapy modification
DOXOrubicin (Conventional): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of DOXOrubicin (Conventional). Management: Seek alternatives to moderate CYP2D6 inhibitors in patients treated with doxorubicin whenever possible. One U.S. manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Consider therapy modification
Eliglustat: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Eliglustat. Management: Eliglustat dose is 84 mg daily with CYP2D6 inhibitors. Use is contraindicated (COI) when also combined with strong CYP3A4 inhibitors. When also combined with a moderate CYP3A4 inhibitor, use is COI in CYP2D6 EMs or IMs and should be avoided in CYP2D6 PMs. Consider therapy modification
Fesoterodine: CYP2D6 Inhibitors may increase serum concentrations of the active metabolite(s) of Fesoterodine. Monitor therapy
Imipramine: Terbinafine (Systemic) may increase the serum concentration of Imipramine. Management: Monitor for increased effects/toxicity of imipramine during concomitant administration with Terbinafine. Reduced dosages of imipramine may be needed. Consider therapy modification
Indoramin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Indoramin. Monitor therapy
Metoprolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Metoprolol. Monitor therapy
Nebivolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nebivolol. Monitor therapy
Nortriptyline: Terbinafine (Systemic) may increase the serum concentration of Nortriptyline. Management: Monitor for increased effects/toxicity of nortriptyline during concomitant administration with Terbinafine. Reduced dosages of nortriptyline may be needed. Consider therapy modification
Perhexiline: CYP2D6 Inhibitors may increase the serum concentration of Perhexiline. Management: Consider alternatives to this combination if possible. If combined, monitor for increased perhexiline serum concentrations and toxicities (eg, hypoglycemia, neuropathy, liver dysfunction). Perhexiline dose reductions will likely be required. Consider therapy modification
Pitolisant: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Pitolisant. Monitor therapy
Propafenone: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Propafenone. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy
RifAMPin: May decrease the serum concentration of Terbinafine (Systemic). Monitor therapy
Oral) may diminish the therapeutic effect of Saccharomyces boulardii.
Avoid combination
Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. Specifically, CYP2D6 inhibitors may decrease the metabolic formation of highly potent active metabolites. Management: Consider alternatives with less of an inhibitory effect on CYP2D6 activity when possible. Consider therapy modification
Tamsulosin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Tamsulosin. Monitor therapy
Thioridazine: CYP2D6 Inhibitors may increase the serum concentration of Thioridazine. Avoid combination
TraMADol: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of TraMADol. These CYP2D6 inhibitors may prevent the metabolic conversion of tramadol to its active metabolite that accounts for much of its opioid-like effects. Monitor therapy
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 U.S./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
Tablets (%)
n=465
Placebo
(%)
n=137
Terbinafine
Tablets (%)
n=465
Placebo
(%)
n=137
* Liver enzyme abnormalities ≥2 times the upper limit of normal range.
Headache
12.9
9.5
0.2
0
Gastrointestinal Symptoms:
Diarrhea
Dyspepsia
Abdominal Pain
Nausea
Flatulence
5.6
4.3
2.4
2.6
2.2
2.9
2.9
1.5
2.9
2.2
0.6
0.4
0.4
0.2
0
0
0
0
0
0
Dermatological Symptoms:
Rash
Pruritus
Urticaria
5.6
2.8
1.1
2.2
1.5
0
0.9
0.2
0
0.7
0
0
Liver Enzyme Abnormalities*
3.3
1.4
0.2
0
Taste Disturbance
2.8
0.7
0.2
0
Visual Disturbance
1.1
1.5
0.9
0
Postmarketing Experience
The following adverse events have been identified during postapproval 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
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 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
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. 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
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 Terbinafine tablets.
Skin and subcutaneous tissue disorders: Serious skin reactions [e.g., Stevens - Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, and bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome], 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.
DailyMed. "TERBINAFINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Terbinafine are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Terbinafine. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
3 consumers reported age
Users
%
6-15
2
66.7%
30-45
1
33.3%
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