Terbinex

• Innocutis

• JSJ Pharmaceuticals

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. 

This section provides information on the proper use of a number of products that contain terbinafine. It may not be specific to Terbinex. Please read with care.

Take this medicine 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.

This medicine 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 this medicine 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 this medicine for several weeks or months. If you stop taking this medicine too soon, your symptoms may return.

This medicine 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 this medicine. Terbinafine may cause caffeine to stay in your body longer than usual.

Dosing

The dose of this medicine 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 this medicine. 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 this medicine, 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.

• If you have an allergy to terbinafine or any other part of Terbinex (terbinafine tablets and hydroxypropyl-chitosan nail lacquer).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Kidney disease or liver disease.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Terbinex.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Terbinex as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Tablets:

• Take with or without food.

Nail solution:

• Use on nails and nail beds every day.
• Put the nail solution on after you wash and dry your nails. It is best to put the nail solution on at bedtime.
• Do not put on open wounds.

All products:

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

Tablets:

• Take a missed dose as soon as you think about it.
• If the next dose is less than 4 hours away, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Nail solution:

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Low mood (depression).
• Trouble swallowing.
• Swollen gland.
• Cough.
• Chest pain or pressure or a fast heartbeat.
• Blood in the urine.
• Pain when passing urine.
• Pale skin.
• Lupus has happened with this medicine, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Changes in taste or smell like loss of taste or smell have happened with Terbinex (terbinafine tablets and hydroxypropyl-chitosan nail lacquer). This most often goes back to normal after this medicine is stopped but may last for a long time or may never go back to normal. Call your doctor right away if you have a change in taste or loss of taste, weight loss without trying, change in mood like low mood (depression), or are not hungry.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Terbinafine is used to treat certain types of fungal infections (e.g., fingernail or toenail). It works by stopping the growth of fungus. This medication belongs to a class of drugs known as antifungals.

How to use Terbinex Kit

Read the Medication Guide provided by your pharmacist before you start taking terbinafine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food, usually once a day or as directed by your doctor. Dosage and length of treatment is based on your medical condition and response to treatment.

It may take several months after you finish treatment to see the full benefit of this drug. It takes time for your new healthy nails to grow out and replace the infected nails.

Continue to take this medication until the full prescribed amount is finished. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Diarrhea or stomach upset may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Changes in your sense of taste/smell or loss of taste/smell may occur. These side effects may improve after stopping terbinafine, but can last for a long time or become permanent. Tell your doctor right away if you notice either of these side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes, mental/mood changes (such as depression), unexplained bleeding/bruising, unusual tiredness, signs of kidney problems (such as change in the amount of urine).

Terbinafine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Applies to terbinafine: oral packet, oral tablet

Along with its needed effects, terbinafine (the active ingredient contained in Terbinex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking terbinafine:

• Fever

• Body aches or pain
• chills
• cough
• diarrhea
• difficulty with breathing
• ear congestion
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• loss of voice
• nasal congestion
• nausea
• runny nose
• shivering
• skin rash or itching
• sneezing
• sore throat
• sweating
• trouble with sleeping
• unusual tiredness or weakness
• upper abdominal or stomach pain
• vomiting

• Dark urine
• difficulty with swallowing
• pale skin
• pale stools
• redness, blistering, peeling, or loosening of the skin
• stomach pain
• unusual bleeding or bruising
• yellow skin or eyes

• Black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• chest pain
• constipation
• cough or hoarseness
• dizziness
• fast heartbeat
• feeling of discomfort
• flu-like symptoms
• general feeling of tiredness or weakness
• hair loss
• high fever
• hives
• indigestion
• inflammation of the joints
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• lower back or side pain
• muscle aches
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• persistent loss of appetite
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• stomach pain, continuing
• swollen glands
• swollen lymph glands
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unexplained bleeding or bruising

Some side effects of terbinafine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Stomach pain (mild)

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• change of taste or loss of taste
• heartburn
• toothache

• Decreased vision
• difficulty with moving
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of sense of smell
• muscle cramps or spasms
• muscle stiffness
• tiredness
• trouble concentrating

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