Terbinafine (Lamisil)

Generic Name: Terbinafine

Lamisil Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1- naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.90, and the following structural formula:


LAMISIL® (terbinafine hydrochloride) Structural Formula Illustration

Terbinafine hydrochloride is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.

Each tablet contains:

Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base)

Inactive Ingredients: colloidal silicon dioxide NF, hydroxypropyl methylcellulose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.

No health feed found.

Terbinafine is hypothesized to act by inhibiting squalene monooxygenase, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes. This inhibition also results in an accumulation of squalene, which is a substrate catalyzed to 2,3-oxydo squalene by squalene monooxygenase. The resultant high concentration of squalene and decreased amount of ergosterol are both thought to contribute to terbinafine's antifungal activity.

Terbinafine is mainly effective on the dermatophyte group of fungi.

As a cream or powder, it is used topically for superficial skin infections such as jock itch (tinea cruris), athlete's foot (tinea pedis), and other types of ringworm (tinea corporis). Terbinafine cream works in about half the time required by other antifungals.

Tablets by mouth are often prescribed for the treatment of onychomycosis, a fungal nail infection, typically by a dermatophyte or Candida species. Fungal nail infections are located deep under the nail in the cuticle to which topically applied treatments are unable to penetrate in sufficient amounts. The tablets may, rarely, cause hepatotoxicity, so patients are warned of this and may be monitored with liver function tests. Alternatives to by mouth administration have been studied.

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.

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.

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.

  • Brexpiprazole
  • Clozapine
  • Donepezil
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Eliglustat
  • Fluoxetine
  • Metoprolol
  • Nebivolol

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.

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.

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.

Pediatric

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.

Geriatric

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

Animal 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.

Breastfeeding

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.

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