Pronunciation:

TER-bin-a-feen

Brand Names:

• Lamisil

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.

Terbinafine 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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of terbinafine in children with use in other age groups.

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

Older adults—

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

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.

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 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
• Metoprolol
• 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:

• Alcohol abuse (or history of)—Problems with alcohol may increase the chance of side effects caused by terbinafine.

• Blood problems (e.g., neutropenia) or
• Skin disorders (e.g., Stevens-Johnson Syndrome or lupus)—May make these conditions worse .

• Kidney disease or
• Liver disease, active or chronic—Terbinafine is not recommended for patients with liver or kidney problems .

Proper Use of This Medicine:

Terbinafine may be taken with food or on an empty stomach.

To help clear up your infection completely, it is very important that you keep taking 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 fungus 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, and then swallow. Do not chew. 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 .

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 and teenagers—250 mg once a day for six weeks.
    • Children 4 years of age and older—125 or 187.5 mg once a day for six weeks.
    • Children below 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 or toenails):
    • Adults and teenagers—250 milligrams (mg) once a day for six to twelve weeks.
    • Children—Use and dose must be determined by the doctor.
  • For tinea corporis (ringworm of the body):
    • Adults and teenagers—250 mg once a day for two to four weeks.
    • Children—Use and dose must be determined by the doctor.
  • For tinea cruris (ringworm of the groin; jock itch):
    • Adults and teenagers—250 mg once a day for two to four 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 mg once a day for two to six 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.

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 your progress at regular visits. This will allow your doctor to check for any unwanted effects.

If your symptoms do not improve within a few weeks (or months for onychomycosis), or if they become worse, check with your doctor.

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

It is important that you check with your doctor immediately if you persistently experience any discomforts of liver disease (e.g., nausea or vomiting, lack or loss of appetite, general feeling of tiredness or weakness, stomach pain, yellow eyes or skin, dark urine, or pale stools).

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 in 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 sleeping

unusual tiredness or weakness

vomiting

Rare

Dark urine

difficulty in swallowing

pale skin

pale stools

redness, blistering, peeling, or loosening of skin

stomach pain

unusual bleeding or bruising

yellow skin or eyes

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

Muscle aches

stomach pain (mild)

stuffy nose

Less common

Change of taste or loss of taste

toothache

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.