Terbinex (Oral)

Terbinafine is part of a group of medicines known as antifungals. It is used to treat fungal infections on the scalp, body, groin (jock itch), feet (athlete's foot), fingernails, and toenails.

You can only get this medicine with a prescription from your doctor.

It is important for your doctor to check how you or your child are doing at regular visits to ensure that this medicine is working correctly. Blood tests may be needed to look for any side effects.

If your or your child's symptoms do not get better, or if they get worse, talk to your doctor. You may need to take this medicine for several weeks or months before your infection improves.

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

This medicine may lead to serious liver problems, including liver failure. Contact your doctor right away if you start experiencing nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellowing of your eyes or skin while you or your child are using this medicine.

This medicine may affect your sense of taste or smell. Inform your doctor immediately if you or your child experience changes or loss of sense of smell, changes in taste or loss of taste, poor appetite, or weight loss.

You may feel depressed while taking this medicine. Notify your doctor right away if you or your child believe this medicine is causing changes in your mood or behavior. Other symptoms may include feeling very sad or empty, irritability, lack of appetite, loss of interest or pleasure, restlessness, trouble concentrating, or trouble sleeping.

Serious skin reactions can occur with this medicine. Contact your doctor immediately if you experience 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 reduce the number of white blood cells in your blood, which increases the risk of getting an infection. If possible, avoid close contact with people who have infections. Check with your doctor right away if you think you are getting an infection or if you or your child have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may make your skin more sensitive to sunlight. Inform your doctor immediately if you or your child develop a red, scaly skin rash or unusual sensitivity of the skin to the sun. Use sunscreen when outdoors and avoid sunlamps and tanning beds.

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

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine versus the benefits it may provide. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There haven't been appropriate studies on how age affects the use of terbinafine oral granules in children younger than 4 years with fungal infections of the scalp. Safety and effectiveness have not been established.

There haven't been appropriate studies on how age affects the use of terbinafine tablets in children with fungal infections of the fingernails or toenails. Safety and effectiveness have not been established.

Geriatric

Appropriate studies on how age affects the use of terbinafine oral granules have not been performed in older adults. Safety and effectiveness have not been established.

Current studies have not shown any problems specific to older adults that would limit the usefulness of terbinafine tablets in this age group. However, older patients are more likely to have liver, kidney, or heart issues related to aging, which may require caution when taking terbinafine tablets.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In these cases, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Eliglustat

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amphetamine
• Aripiprazole
• Benzphetamine
• Brexpiprazole
• Clozapine
• Codeine
• Deutetrabenazine
• Dextroamphetamine
• Dihydrocodeine
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Fenfluramine
• Fluoxetine
• Hydroxyamphetamine
• Levoketoconazole
• Lisdexamfetamine
• Methamphetamine
• Methotrexate
• Metoclopramide
• Metoprolol
• Nebivolol
• Oxycodone
• Pitolisant
• Risperidone
• Tramadol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both are prescribed together, your doctor may adjust the dose or frequency of one or both.

• Aripiprazole Lauroxil
• Cyclosporine
• Dextromethorphan
• Lofexidine
• Nortriptyline
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform 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 worsen these conditions.

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

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
• 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 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)

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.

In the U.S.

• LamISIL
• Terbinex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antifungal

Chemical Class: Allylamine

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.

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