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Terbinafine (Oral route)

Pronunciation:

TER-bin-a-feen

Brand Names:

  • Lamisil
  • Terbinex

Dosage Forms:

  • Packet
  • Tablet

Classifications:

Therapeutic—

Antifungal

Chemical—

Allylamine

Uses of This Medicine:

Terbinafine belongs to the group of medicines called antifungals. It is used to treat fungus infections of the scalp, body, groin (jock itch), feet (athlete's foot), fingernails, and toenails.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

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—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Other 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 this medicine, 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 this medicine 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.

  • Clozapine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Fluoxetine

Using this medicine 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.

  • Cyclosporine
  • Nortriptyline
  • Warfarin

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood problems (e.g., neutropenia) or
  • Systemic lupus erythematosus or SLE or
  • Weakened immune system—Use with caution. May make these conditions worse.
  • Liver disease, active or chronic—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

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 patient information leaflet. Read and follow the instructions in the leaflet 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 milligrams (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.

Precautions While Using This Medicine:

It is important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If your or your child's symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several weeks or months before your infection gets better.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash, itching, hives, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth while you or your child are using this medicine.

This medicine may cause serious liver problems, including liver failure. Stop taking this medicine and check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you or your child are using this medicine.

This medicine may cause problems with your sense of taste or smell. Stop taking this medicine and tell your doctor if you or your child have change or loss of sense of smell, change in taste or loss of taste, poor appetite, or weight loss.

You may become depressed when taking this medicine. Tell your doctor right away if you or your child thinks this medicine is causing changes in your mood or behavior. Other symptoms include feeling very sad or empty, irritable, lack of appetite, loss of interest or pleasure, restlessness, trouble concentrating, or trouble sleeping.

Liver problems may be more likely to occur if you drink alcoholic beverages while you are taking this medicine. You should not drink alcoholic beverages while you are taking this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you or your child get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Stop taking this medicine and tell your doctor right away if you or your child have a red, scaly, skin rash or unusual sensitivity of the skin to the sun that can lead to a rash.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common
Fever
Less common
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
Rare
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
Incidence not known
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
shortness of breath or troubled breathing
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
wheezing

Some side effects 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:

More common
Stomach pain (mild)
stuffy nose
Less common
Acid or sour stomach
bad, unusual, or unpleasant (after) taste
belching
change of taste or loss of taste
heartburn
toothache
Incidence not known
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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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