LamISIL (Topical)

Terbinafine is used to treat infections caused by a fungus. It works by killing the fungus or stopping it from growing.

Terbinafine is applied to the skin to treat:

• ringworm of the body (tinea corporis);
• ringworm of the foot (interdigital and plantar tinea pedis; athlete's foot);
• ringworm of the groin (tinea cruris; jock itch);
• tinea versicolor (sometimes called “sun fungus”); and
• yeast infections of the skin (cutaneous candidiasis).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Discontinue using this medicine and check with your doctor if you experience increased irritation or possible sensitization (redness, itching, burning, blistering, swelling, or oozing) while using the medication.

If your skin issue does not improve within 4 to 7 weeks, or if it gets worse, consult your doctor.

To fully clear your infection and help prevent it from returning, good health habits are also necessary. The following steps will help reduce chafing and irritation and keep the area cool and dry.

• For patients using terbinafine for ringworm of the body: Carefully dry yourself after bathing. Avoid excessive heat and humidity if possible. Try to prevent moisture from building up on affected areas of the body. Wear well-ventilated, loose-fitting clothing. Use a bland, absorbent powder (for example, talcum powder) once or twice a day. Be sure to apply the powder after the terbinafine cream or solution has been applied and has absorbed into the skin.
• For patients using terbinafine for ringworm of the groin: Avoid wearing tight-fitting underwear or underwear made from synthetic (man-made) materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear. Use a bland, absorbent powder (for example, talcum powder) on the skin. It is best to use the powder between the times you apply terbinafine.
• For patients using terbinafine for ringworm of the foot: Carefully dry your feet, especially between the toes, after bathing. Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot. Wear sandals or well-ventilated shoes (for example, shoes with holes). Use a bland, absorbent powder (for example, talcum powder) between the toes, on the feet, and in socks and shoes once or twice a day. It is best to use the powder between the times you use terbinafine.

If you have any questions about these steps, consult your health care professional.

In deciding to use a medicine, you need to consider the risks and benefits together with your doctor. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or ingredients list.

Pediatric

Studies on this medicine have only been conducted with adult patients, and there is no specific information about using terbinafine in children under 12 compared to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be clear if they work the same way in older people as they do in younger adults. Although there is no specific information about using terbinafine in older people compared to other age groups, this medicine is not expected to cause different side effects or problems in older adults than it does in younger adults.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together, in other cases, two different medicines may be used together, even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and may not include all possibilities.

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

• 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 taking both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been chosen for their potential significance and may not include all possibilities.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Fungus infection of the nails—this condition may reduce the effectiveness of terbinafine when used to treat a type of ringworm of the foot (plantar tinea pedis).

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Dryness
• redness
• itching
• burning
• peeling
• rash
• stinging
• tingling
• or other signs of skin irritation not present before using this medicine

Other side effects not listed may also happen 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
• LamISIL AT

In Canada

• LamISIL Dermgel

Available Dosage Forms:

• Gel/Jelly
• Cream
• Spray

Therapeutic Class: Antifungal

Chemical Class: Allylamine

Apply enough terbinafine cream to cover the affected and surrounding skin areas and rub in gently.

Apply enough terbinafine solution to wet and cover the affected and surrounding skin areas. Allow it to dry.

Keep this medicine away from the eyes, nose, mouth, and other mucous membranes. The solution may be especially irritating to the eyes.

Terbinafine spray solution contains alcohol and should not be applied to the face.

Do not apply an occlusive dressing (airtight covering, such as a tight bandage or plastic kitchen wrap) over this medicine unless you have been directed to do so by your doctor.

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 topical dosage form (cream): For cutaneous candidiasis: Adults—Use one or two times a day for seven to fourteen days. Children—Use and dose must be determined by your doctor. For tinea corporis or tinea cruris: Adults and children 12 years of age and older—Use one or two times a day for seven to twenty-eight days. Infants and children younger than 12 years of age—Use and dose must be determined by your doctor. For tinea pedis (interdigital): Adults and children 12 years of age and older—Use two times a day for seven to twenty-eight days. Infants and children younger than 12 years of age—Use and dose must be determined by your doctor. For tinea pedis (plantar): Adults and children 12 years of age and older—Use two times a day for fourteen days. Infants and children younger than 12 years of age—Use and dose must be determined by your doctor. For tinea versicolor: Adults—Use one or two times a day for fourteen days. Children—Use and dose must be determined by your doctor.
• For topical dosage form (spray solution): For tinea corporis or tinea cruris: Adults—Use once a day for seven days. Children—Use and dose must be determined by your doctor. For tinea pedis or tinea versicolor: Adults—Use two times a day for seven days. Children—Use and dose must be determined by your doctor.

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 after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Missed Dose

If you miss a dose of this medicine, apply 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.

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.