Lamisil

Dosage Forms & Strengths

tablet

• 250mg

packet, oral granules

• 125mg
• 187.5mg

Onychomycosis

250 mg (1 tablet) PO daily for 6 weeks (fingernail) or 12 weeks (toenail)

Tinea Pedis (Off-label)

250 mg/day PO in single dose or divided q12hr for 2-6 weeks

Tinea Corporis, Tinea Cruris

250 mg/day PO in single dose or divided q12hr for 2-4 weeks

Sporotrichosis, Lymphocutaneous and cutaneous (Off-label)

500 mg/day PO q12hr for 2-6 weeks; treat for additional 2-4 weeks after resolution of all lesions (resolution may take 3-6 months)

Dosing Modifications

Renal impairment: Use not recommended if CrCl <50 mL/min

Hepatic impairment: Use contraindicated in chronic or active liver disease

Dosage Forms & Strengths

tablet

• 250mg

packet, oral granules

• 125mg
• 187.5mg

Tinea Capitis

>4 years (<25 kg): 125 mg/day PO for 6 weeks

>4 years (25-35 kg): 187.5 mg/day PO for 6 weeks

>4 years (>35 kg): 250 mg/day PO for 6 weeks

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• stomach pain
• dizziness
• rash
• frequent urination
• headache

• Lamisil^®

Lamisilis a prescription antifungal medicine used to treat fungal infections of the fingernails and toenails. The oral granule form is approved to treat tinea capitis (a fungal infection of the scalp hair follicles) in patients 4 years of age and older.

Lamisil is also available as an over-the-counter medication and is used to treat fungal infections (athlete's foot, jock itch, and ringworm).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Terbinafine is an antifungal medication that fights infections caused by fungus.

Terbinafine tablets are used to treat infections caused by fungus that affect the fingernails or toenails.

Terbinafine oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

Terbinafine may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, vomiting, stomach pain, rash, and increased urination.

• May be fungicidal or fungistatic in action, depending on concentration of the drug and specific fungal species tested.1 2 3 25 60

• Appears to interfere with sterol biosynthesis in susceptible fungi by inhibiting the enzyme squalene monooxygenase (squalene 2,3-epoxidase).1 2 3 17 18 19 20 22 24 25 27 60 The resulting accumulation of squalene (the usual substrate of the enzyme) in the cells and decreased amounts of sterols, especially ergosterol,1 3 14 16 17 19 22 25 27 50 60 may contribute to the antifungal effects.2 3 10 25 27

• Active against many fungi, including dermatophytes (Trichophyton, Microsporum, Epidermophyton), filamentous (e.g. Aspergillus), dimorphic (e.g., Blastomyces), and dematiaceous fungi and yeasts.3 25 27 Antifungal spectrum of activity similar to that of naftifine.3 4 10 13

• Dermatophytes: Active against most Trichophyton, including T. mentagrophytes,1 27 28 29 30 31 32 33 34 35 T. rubrum,1 27 28 29 30 31 32 33 34 35 T. tonsurans,66 and T. violaceum.66 Also active in vitro against E. floccosum3 6 8 13 44 and Microsporum,3 6 8 13 44 including M. audouinii66 and M. canis.66 More active than azole antifungals (e.g., fluconazole, itraconazole, ketoconazole) against dermatophytes.3 6 8 13 44

• Other fungi: Active in vitro against Aspergillus, Blastomyces, Histoplasma, Scopulariopsis brevicaulis.1 and some Candida,3 4 5 10 13 including C. albicans and C. parapsilosis.3 10 18 22 23 25 Less active than azole antifungals against Candida.3 9 10 44

• Tell all of your health care providers that you take Lamisil. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• It may take several weeks to see the full effects.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine may cause nervousness, shakiness, and a fast heartbeat.
• Low white blood cell counts have rarely happened with Lamisil. This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Liver problems have happened with this medicine. Sometimes, this has been very bad and has led to the need for a liver transplant or death. Liver problems may happen in people with or without liver disease. Talk with the doctor.
• Very bad and sometimes deadly blood problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with Lamisil in some people. Call your doctor right away if you feel very tired or weak or have any bruising or bleeding; dark urine or yellow skin or eyes; pale skin; change in the amount of urine passed; change in eyesight; change in strength on 1 side is greater than the other, trouble speaking or thinking, or change in balance; or fever.
• A very bad and sometimes deadly reaction has happened with this medicine. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Lamisil while you are pregnant.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Lamisil or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lamisil. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

      Assessment Prior to Initiation

Before administering Lamisil Tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1)].

      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.

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.

Common side effects of Lamisil include: headache. Other side effects include: diarrhea, dyspepsia, and skin rash. See below for a comprehensive list of adverse effects.

Applies to terbinafine: oral granule, oral tablet

General

In general, side effects have been mild to moderate and transient; however, this drug has been associated with serious life-threatening events such as hepatic failure, anaphylaxis, and severe neutropenia. Unless otherwise specified, the listed side effects were reported with the tablets.[Ref]

Nervous system

Taste disturbances were typically noticed 5 to 8 weeks after starting therapy and returned to normal within several weeks after stopping the medication. The taste alteration has been rarely accompanied by a discoloration of the tongue and/or a disturbance in the sense of smell.

Hypogeusia (including ageusia) usually recovered within several weeks after this drug was stopped. Isolated cases of prolonged hypogeusia have been reported.

Taste disturbance (including taste loss), paresthesia, hypoesthesia, tinnitus, and vertigo have also been reported during postmarketing experience. Some cases of taste disturbance were severe enough to cause decreased food intake, weight loss, anxiety, and depressive symptoms.[Ref]

Very common (10% or more): Headache (12.9%)
Common (1% to 10%): Taste disturbance/dysgeusia (including taste loss/ageusia), dizziness
Uncommon (0.1% to 1%): Hypogeusia, ageusia, paresthesia, hypoesthesia, tinnitus
Very rare (less than 0.01%): Vertigo, sedation, lightheadedness
Frequency not reported: Taste alteration
Postmarketing reports: Smell disturbance (including loss of smell), paresthesia, hypoesthesia, hearing impairment, hypoacusis, anosmia (including permanent anosmia), hyposmia[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal symptoms, feeling of fullness, abdominal distension, diarrhea, dyspepsia/gastritis, nausea, abdominal pain, flatulence, vomiting, mild abdominal discomfort, abdominal cramps, belching
Common (1% to 10%): Upper abdominal pain
Uncommon (0.1% to 1%): Toothache
Very rare (less than 0.01%): Parotid swelling
Frequency not reported: Mild to moderate gastrointestinal discomfort, gastritis, gastric fullness, nausea and vomiting, discoloration of the tongue, hypogeusia, ageusia, metallic taste, severe sialadenitis
Postmarketing reports: Pancreatitis[Ref]

Vomiting, upper abdominal pain, and toothache have been reported with the oral granules. Vomiting has also been reported during postmarketing experience with the tablets.[Ref]

Dermatologic

An 81-year-old male who had been treated with topical antifungal agents for tinea pedis started this drug (125 mg orally daily) as the lesions did not respond to topical therapy. He was not taking any other medications and had no history of skin disease. No other skin lesions were observed at that time. Two weeks later, he developed erythematous and pustular lesions on his fingers and toes, and an erythematous macular eruption on the limbs. This drug was discontinued, but the eruptions continued to worsen. Histopathology of a punch biopsy from his toe showed intraepidermal sterile pustules containing neutrophils, so-called Kogoj's spongiform pustules. He was then diagnosed with having acrodermatitis continua of Hallopeau and was treated with corticosteroids therapy.

An 80-year-old female experienced DRESS secondary to severe sialadenitis coincident with this drug. The patient was admitted with a generalized pruriginous eruption. She presented with erythematous and edematous widespread confluent plaques, with a scaly annular border. She had initiated therapy 14 days before onset of the generalized rash, for a nonspecific squamous plaque of the trunk. DRESS induced by this drug was diagnosed and therapy was discontinued. Topical therapy was started with 0.5% clobetasol propionate cream applied to the whole body. The rash progressively improved and blood eosinophilia decreased.

A 68-year-old male experienced acute generalized exanthematous pustulosis coincident with this drug. He presented with a symmetrical maculopapular eruption on both lower anterior legs. Within 2 days, the rash generalized with facial involvement. He developed the rash 20 days after initiating oral therapy for onychomycosis. After withdrawal of this drug, the exanthema abated within 10 days under topical therapy with corticosteroids.

Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis), psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, hair loss, and photosensitivity reactions have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Nonserious forms of skin reactions, rash, urticaria
Common (1% to 10%): Pruritus, erythema
Uncommon (0.1% to 1%): Photosensitivity reactions
Very rare (less than 0.01%): Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis), photosensitivity (e.g., photodermatosis, photosensitivity allergic reaction, polymorphic light eruption), alopecia/hair loss, psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, toxic skin eruption
Frequency not reported: Reversible alopecia areata of the scalp, pustular psoriasis, acrodermatitis continua of Hallopeau
Postmarketing reports: Serious skin reactions (e.g., drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome)[Ref]

Metabolic

Very common (10% or more): Decreased appetite/anorexia
Frequency not reported: Hypoglycemia, decreased food intake (due to taste disturbance)[Ref]

Arthralgia and myalgia have also been reported during postmarketing experience.[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal reactions, arthralgia, myalgia
Very rare (less than 0.01%): Cutaneous and systemic lupus erythematosus
Postmarketing reports: Rhabdomyolysis, increased blood creatine phosphokinase, precipitation and exacerbation of cutaneous and systemic lupus erythematosus[Ref]

Hepatic

Liver enzyme abnormalities (at least 2 times the upper limit of normal) have been reported in 3.3% of patients.

In most liver failure cases, patients had serious underlying systemic conditions; causal association with this drug was unclear.

A 57-year-old male with chronic hepatitis B virus (HBV) infection developed drug-induced acute autoimmune hepatitis coincident with this drug. He was given 250 mg once daily over a 12-week period for dermatophyte toenail onychomycosis. He developed the side effect just prior to completing the course of therapy. He was not taking any other drugs or herbal supplements, did not drink alcohol, and did not appear to suffer a flare of HBV infection. Liver function studies began to normalize 6 weeks after this drug was discontinued.

Cases of liver failure (some leading to death or liver transplant), hepatitis, cholestasis, and increased hepatic enzymes have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Liver enzyme abnormalities
Rare (0.01% to 0.1%): Serious liver dysfunction (including hepatic failure, increased hepatic enzymes, jaundice, cholestasis, liver decompensation, hepatitis), transient increases in liver enzymes, hepatobiliary dysfunction, cholestatic jaundice, liver failure (some cases leading to death or liver transplant)
Frequency not reported: Development of idiosyncratic and symptomatic hepatobiliary dysfunction, drug-induced autoimmune hepatitis
Postmarketing reports: Idiosyncratic and symptomatic hepatic injury[Ref]

Psychiatric

Common (1% to 10%): Depression
Very rare (less than 0.01%): Anxiety
Frequency not reported: Insomnia
Postmarketing reports: Anxiety (independent of taste disturbance), depressive symptoms (independent of taste disturbance), anxiety (secondary to taste disturbances), depressive symptoms (secondary to taste disturbances)[Ref]

Other

Common (1% to 10%): Pyrexia, tiredness/fatigue
Uncommon (0.1% to 1%): Weight decreased
Rare (0.01% to 0.1%): Malaise (secondary to dysgeusia)
Very rare (less than 0.01%): Chest pain
Frequency not reported: Weight loss (due to taste disturbance), weight decreased (secondary to hypogeusia)
Postmarketing reports: Influenza-like illness

Pyrexia has been reported with the oral granules; it has also been reported during postmarketing experience with the tablets.

Malaise and fatigue have also been reported during postmarketing experience.

Respiratory

Common (1% to 10%): Nasopharyngitis, cough, upper respiratory tract infection, influenza, pharyngolaryngeal pain, rhinorrhea, nasal congestion

Nasopharyngitis, cough, upper respiratory tract infection, influenza, pharyngolaryngeal pain, rhinorrhea, and nasal congestion have been reported with the oral granules.

Ocular

Changes in the ocular lens and retina have been reported; however, the clinical significance is unknown.

Dyschromatopsia, whereby the patient reported a greenish hue in her vision, and photopsia have occurred in a patient after 3 weeks of therapy. This problem resolved within 1 week of discontinuing the drug.[Ref]

Common (1% to 10%): Visual disturbance
Frequency not reported: Changes in ocular lens and retina, dyschromatopsia, photopsia
Postmarketing reports: Reduced visual acuity, visual field defect, blurred vision[Ref]

Hematologic

Agranulocytosis, thrombocytopenia, anemia, and pancytopenia have also been reported during postmarketing experience.[Ref]

Uncommon (0.1% to 1%): Anemia
Very rare (less than 0.01%): Neutropenia, agranulocytosis, thrombocytopenia, pancytopenia
Frequency not reported: Leukopenia, lymphopenia, transient decreases in hematocrit, transient decreases in hemoglobin, transient decreases in leukocytes
Postmarketing reports: Severe neutropenia, altered prothrombin time (prolonged and reduced) with concomitant warfarin[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactoid reactions (including angioedema)
Frequency not reported: Anaphylaxis, hypersensitivity reactions
Postmarketing reports: Serious hypersensitivity reactions (e.g., angioedema, allergic reactions [including anaphylaxis]), anaphylactic reaction, serum sickness-like reaction[Ref]

Renal

Frequency not reported: Renal function test impairment, transient increases in serum urea, transient increases in serum creatinine[Ref]

Genitourinary

Frequency not reported: Hematuria, transient erectile dysfunction in male patients[Ref]

Cardiovascular

Postmarketing reports: Vasculitis

Some side effects of Lamisil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.