Terbinafine

Contraindications

Hypersensitivity

Chronic or active liver disease

Cautions

Discontinue if the following develop: Liver disease, neutropenia (absolute neutrophil count <1000 mcL); skin rash; signs or symptoms of SLE

Changes in ocular lens and retina reported; may require discontinuation of therapy

Use caution in renal and liver impairment

Periodic monitoring of liver function tests is recommended

Ask patients and caregivers to report immediately to healthcare provider any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools; if these symptoms occur discontinue taking oral terbinafine, and immediately evaluate patient’s liver function

Serious skin/hypersensitivity reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome); manifestations of DRESS syndrome may include cutaneous reaction (eg, rash, exfoliative dermatitis), eosinophilia, and 1 or more organ complications (eg, hepatitis, pneumonitis, nephritis, myocarditis, pericarditis)

Due to potential toxicity, confirmation of onychomycosis or dermatomycosis recommended

Smell disturbance reported; discontinue therapy if symptoms occur

CYP2D6 inhibitor; may also convert CYP2D6 extensive metabolizers to poor metabolizer status

Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported with terbinafine; discontinue terbinafine if clinical symptoms and laboratory findings consistent with TMA occur; the findings of unexplained thrombocytopenia and anemia should prompt further evaluation and consideration of diagnosis of TMA

Before taking terbinafine,

• tell your doctor and pharmacist if you are allergic to terbinafine, any other medications, or any of the ingredients in terbinafine granules or tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Hemangeol, Inderal LA, Innopran XL); caffeine (in Excedrin, Fioricet, Fiorinal, others); cimetidine (Tagamet); cyclosporine (Gengraf, Neoral, Sandimmune); dextromethorphan (Delsym, in Mucinex DM, Promethazine DM, others); flecainide; fluconazole (Diflucan); ketoconazole (Nizoral); monoamine oxidase type B (MAO-B) inhibitors such as rasagiline (Azilect), and selegiline (Eldepryl, Emsam, Zelapar); propafenone (Rythmol); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); tricyclic antidepressants (TCAs) such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take terbinafine.
• tell your doctor if you have or have ever had human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), a weakened immune system, lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys), or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking terbinafine, call your doctor. Do not breastfeed while taking terbinafine.
• plan to avoid unnecessary or prolonged exposure to sunlight and artificial sunlight (tanning beds or UVA/B treatment) and wear protective clothing, sunglasses, and sunscreen. Terbinafine may make your skin sensitive to sunlight.

Unless your doctor tells you otherwise, continue your normal diet.

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You should tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking while taking Lamisil, especially:

• Blood thinners such as warfarin (Coumadin)
• Antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• Beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• Cimetidine (Tagamet)
• Medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf)
• Rifampin (Rifadin, Rimactane)
• Selegiline (Eldepryl)

Lamisil and Alcohol

You should avoid consuming alcoholic beverages while taking Lamisil.

Daily alcohol use can increase your risk of serious side effects. Talk to your doctor about this potential interaction.

Lamisil and Other Interactions

Try to avoid consuming coffee, cola, tea, or other drinks that contain caffeine while taking Lamisil.

The drug can make your skin more sensitive to sunlight.

Avoid excessive sun exposure and tanning beds, and wear protective clothing and use sunscreen while outdoors.

Terbinafine is part of the drug class:

• ANTIFUNGALS FOR SYSTEMIC USE

Before you take terbinafine, tell your doctor if you:

• have or had liver problems
• have a weakened immune system (immunocompromised)
• have lupus (an autoimmune disease)
• have kidney problems
• have any other medical conditions
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Terbinafine falls into category B. There are no good studies that have been done in humans with this Terbinafine. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Take terbinafine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose of terbinafine your doctor prescribes will be determined based on the type of fungal infection you have and other medical conditions you have. The dose is also dependent upon weight (when choosing a dose for children) and other medications you are taking.

• Terbinafine Dosage - Fingernail Fungus Infection - 250 mg once daily for six weeks
• Terbinafine Dosage for Toenail Fungus Infection - 250 mg once daily for 12 weeks
• Terbinafine Dosage for Ringworm of the Scalp - Oral Granule dosage based on child's weight. Usually taken for 6 weeks.

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.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medicine.

Avoid exposure to sunlight or tanning beds. Terbinafine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, terbinafine may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of fever, facial swelling, swollen glands, mouth sores, trouble swallowing, cough, chest pain, trouble breathing, fast heartbeats, blood in your urine, peeling skin, or a blistering rash.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Also call your doctor if you have:

• changes in your sense of taste or smell;

• depressed mood, sleep problems, lack of interest in daily activity, feeling anxious or restless;

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• swelling, rapid weight gain, little or no urinating;

• blood in your urine or stools;

• skin sores, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight);

• weight loss due to taste changes or loss of appetite; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• diarrhea, nausea, gas, stomach pain or upset;

• rash;

• headache;

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Onychomycosis -- Fingernail:

Tablets: 250 mg orally once a day

Duration of therapy:
-Fingernail onychomycosis: 6 weeks
-Toenail onychomycosis: 12 weeks

Comments:
-Before using this drug, patients should be evaluated for evidence of chronic or active liver disease.
-Before starting therapy, appropriate nail specimens for laboratory testing (potassium hydroxide preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
-Optimal clinical effect observed some months after mycological cure and completion of therapy; related to time required for outgrowth of healthy nail.

Use: For the treatment of onychomycosis of the fingernail or toenail due to dermatophytes (tinea unguium)

Usual Adult Dose for Onychomycosis -- Toenail:

Tablets: 250 mg orally once a day

Duration of therapy:
-Fingernail onychomycosis: 6 weeks
-Toenail onychomycosis: 12 weeks

Comments:
-Before using this drug, patients should be evaluated for evidence of chronic or active liver disease.
-Before starting therapy, appropriate nail specimens for laboratory testing (potassium hydroxide preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
-Optimal clinical effect observed some months after mycological cure and completion of therapy; related to time required for outgrowth of healthy nail.

Use: For the treatment of onychomycosis of the fingernail or toenail due to dermatophytes (tinea unguium)

Usual Adult Dose for Tinea Capitis:

Oral granules: 250 mg orally once a day for 6 weeks

Comments:
-Before using this drug, patients should be evaluated for evidence of chronic or active liver disease.

Usual Adult Dose for Tinea Corporis:

Some experts recommend:
-Tablets: 250 mg orally once a day for 2 to 4 weeks

Usual Adult Dose for Tinea Cruris:

Some experts recommend:
-Tablets: 250 mg orally once a day for 2 to 4 weeks

Usual Adult Dose for Tinea Pedis:

Some experts recommend:
-Tablets: 250 mg orally once a day for 2 to 6 weeks

Usual Pediatric Dose for Tinea Capitis:

4 years or older:
Oral granules:
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:
-Before using this drug, patients should be evaluated for evidence of chronic or active liver disease.

For Children, Some Experts Recommend:
Tablets: 5 mg/kg/day orally

Based on weight:
10 to 20 kg: 62.5 mg orally once a day
21 to 40 kg: 125 mg orally once a day
41 kg or more: 250 mg orally once a day

Duration of therapy:
-Trichophyton tonsurans infection: 2 to 4 weeks
-Microsporum canis infection: Longer duration needed.

In the U.S.

• LamISIL
• Terbinex

Available Dosage Forms:

• Packet
• Tablet

Therapeutic Class: Antifungal

Chemical Class: Allylamine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For terbinafine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to terbinafine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of terbinafine oral granules in children younger than 4 years of age with fungal infections of the scalp. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of terbinafine tablets in children with fungal infections of the fingernails or toenails. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of terbinafine oral granules have not been performed in the geriatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of terbinafine tablets in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving terbinafine tablets.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking terbinafine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using terbinafine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amphetamine
• Benzphetamine
• Brexpiprazole
• Deutetrabenazine
• Dextroamphetamine
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Eliglustat
• Fluoxetine
• Lisdexamfetamine
• Methamphetamine
• Metoprolol
• Nebivolol
• Valbenazine

Using terbinafine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aripiprazole Lauroxil
• Cyclosporine
• Nortriptyline
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of terbinafine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (eg, neutropenia) or
• Systemic lupus erythematosus or SLE or
• Weakened immune system—Use with caution. May make these conditions worse.

• Liver disease, active or chronic—Should not be used in patients with this condition.

Take terbinafine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

terbinafine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Terbinafine tablets may be taken with food or on an empty stomach. However, it is best to take terbinafine oral granules with food.

To help clear up your infection completely, it is very important that you keep using terbinafine for the full time of treatment, even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungal infections may be very slow to clear up, you may need to take terbinafine for several weeks or months. If you stop taking terbinafine too soon, your symptoms may return.

terbinafine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same times every day. If you need help in planning the best time to take your medicine, check with your doctor.

If you are using the oral granules, you may sprinkle the contents on a spoonful of pudding or other soft, non-acidic food such as mashed potatoes. This mixture must be swallowed immediately without chewing. Do not use applesauce or fruit-based foods. If you will need two packets of oral granules with each dose, you may sprinkle the content of both packets on one spoonful or two spoonfuls of non-acidic food.

Avoid caffeine (coffee, soda, chocolate) while you are using terbinafine. Terbinafine may cause caffeine to stay in your body longer than usual.

Dosing

The dose of terbinafine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of terbinafine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (granules):
  • For tinea capitis (fungus infections of the scalp):
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 250 milligrams (mg) once a day for 6 weeks.
    • Children 4 years of age and older and weighing over 35 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 250 mg once a day for 6 weeks.
    • Children 4 years of age and older and weighing 25 kg to 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 187.5 mg once a day for 6 weeks.
    • Children 4 years of age and older and weighing less than 25 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 125 mg once a day for 6 weeks.
    • Children younger than 4 years of age—Use and dose must be determined by the doctor.
• For oral dosage form (tablets):
  • For onychomycosis (fungus infections of the fingernails):
    • Adults—250 milligrams (mg) once a day for 6 weeks.
    • Children—Use and dose must be determined by the doctor.
  • For onychomycosis (fungus infections of the toenails):
    • Adults—250 milligrams (mg) once a day for 12 weeks.
    • Children—Use and dose must be determined by the doctor.
  • For tinea corporis (ringworm of the body):
    • Adults and teenagers—250 milligrams (mg) once a day for 2 to 4 weeks.
    • Children—Use and dose must be determined by the doctor.
  • For tinea cruris (ringworm of the groin; jock itch):
    • Adults and teenagers—250 milligrams (mg) once a day for 2 to 4 weeks.
    • Children—Use and dose must be determined by the doctor.
  • For tinea pedis (ringworm of the foot; athlete's foot):
    • Adults and teenagers—250 milligrams (mg) once a day for 2 to 6 weeks.
    • Children—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of terbinafine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of terbinafine tablets, take it as soon as you can. If your next regular dose is less than 4 hours away, wait until then to use the medicine and skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Some experts recommend:
-Tablets: 250 mg orally once a day for 2 to 4 weeks

4 years or older:
Oral granules:
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:
-Before using this drug, patients should be evaluated for evidence of chronic or active liver disease.

For Children, Some Experts Recommend:
Tablets: 5 mg/kg/day orally

Based on weight:
10 to 20 kg: 62.5 mg orally once a day
21 to 40 kg: 125 mg orally once a day
41 kg or more: 250 mg orally once a day

Duration of therapy:
-Trichophyton tonsurans infection: 2 to 4 weeks
-Microsporum canis infection: Longer duration needed.