terbinafine hydrochloride

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terbinafine hydrochloride

Lamisil, Lamisil AT

Pharmacologic class: Synthetic allylamine derivative

Therapeutic class: Antifungal

Pregnancy risk category B


Unclear. Thought to interfere with sterol biosynthesis of fungal cell membrane permeability by inhibiting enzymes responsible for normal fungal growth and maturation, resulting in cell death.


Cream: 1%

Gel (topical): 1%

Oral granules: 125 mg, 187.5 mg

Solution (topical): 1%

Spray (topical): 1%

Tablets: 250 mg

Indications and dosages

Tinea cruris; tinea corporis; tinea pedis; tinea versicolor

Adults and children ages 12 and older: Massage cream into affected area and surrounding area once or twice daily for 7 to 14 days, not to exceed 4 weeks. Or, for tinea pedis, apply gel to affected area once daily at bedtime for 1 week. Or, for tinea cruris and tinea corporis, spray or apply gel to affected area once daily (morning or night) for 1 week. Or, for tinea pedis, spray between toes b.i.d. (morning and night) for 1 week.

Onychomycosis of fingernail or toenail

Adults: For fingernail infection, 250 mg P.O. daily for 6 weeks. For toenail infection, 250 mg P.O. daily for 12 weeks.

Tinea capitis

Children ages 4 and older weighing less than 25 kg (55 lb): 125 mg P.O. daily for 6 weeks

Children ages 4 and older weighing 25 to 35 kg (55 to 77 lb): 187.5 mg P.O. daily for 6 weeks

Children ages 4 and older weighing more than 35 kg (77 lb): 250 mg P.O. daily for 6 weeks


• Hypersensitivity to drug or its components

• Chronic active hepatic disease


Use cautiously in:

• renal impairment (use not recommended)

• pregnant or breastfeeding patients (use not recommended)

• children younger than age 12 (safety and efficacy not established with cream, spray, or tablet use).


• Give with or without food, but not with coffee, cola, or tea.

• Know that oral granules should be sprinkled on nonacidic food, such as pudding or mashed potatoes. Fruit-based food such as applesauce shouldn't be used.

• Know that oral granules should be swallowed without being chewed.

• Don't put occlusive dressing over affected area after cream application.

Adverse reactions

CNS: headache, depression

EENT: visual disturbances

GI: nausea, diarrhea, dyspepsia, abdominal pain, flatulence

Hematologic: neutropenia

Hepatic: hepatic failure

Skin: burning, stinging, dryness, itching, and local irritation (with topical form); rash; pruritus; urticaria; erythema multiforme; Stevens-Johnson syndrome

Other: taste and smell disturbances


Drug-drug. Cimetidine: decreased terbinafine clearance

Cyclosporine: increased cyclosporine clearance

Dextromethorphan: increased dextromethorphan blood level

Rifampin: increased terbinafine clearance

Warfarin: altered warfarin efficacy

Drug-diagnostic tests. Hepatic enzymes: increased levels

Neutrophils: decreased count

Drug-food. Caffeine-containing foods and beverages: decreased caffeine clearance

Drug-herbs. Chaparral, comfrey, germander, jin bu huan, kava, pennyroyal: increased risk of hepatotoxicity

Cola nut, guarana, yerba maté: decreased clearance of these herbs

Patient monitoring

• Monitor CBC and liver function tests.

Watch for signs and symptoms of erythema multiforme. Report early indications before they progress to Stevens-Johnson syndrome.

Patient teaching

• Tell patient he may take with or without food.

• Advise caregiver that oral granules should be sprinkled on nonacidic food, such as pudding or mashed potatoes and not to use fruit-based food such as applesauce.

• Advise caregiver that oral granules should be swallowed without being chewed.

• Instruct patient to avoid coffee, tea, and colas, which can worsen adverse drug reactions.

• Tell patient drug may take 4 weeks to be effective in fingernail infections and 10 weeks in toenail infections. Urge him to keep taking it even though symptoms don't improve right away.

Advise patient to immediately report rash, sore throat, cough, fever, or yellowing of skin or eyes.

• Instruct patient how to use topical drug, to wash affected area with soap and water and dry area completely before applying drug, and to wash hands after each use.

• Instruct patient not to place occlusive dressing over affected area after applying cream.

• Advise patient to wear well-fitting, ventilated shoes and to change shoes and socks at least once daily when receiving treatment for athlete's foot.

• Caution patient not to let topical drug contact eyes, nose, or mouth.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved
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References in periodicals archive ?
Terbinafine hydrochloride, a potent antifungal agent from allylamine antifungals, was selected as a model drug because it is very effective in treatment of dermatophyte infections and is a drug of choice for treatment of onychomycosis.
Terbinafine hydrochloride was received as a kind gift from M/s Elder Pharmaceuticals Ltd., Mumbai, India, and cellulose acetate was obtained as a free sample from M/s Torrent Pharmaceuticals Ltd., Ahmadabad, India.
To determine the effect of HP-[beta]-CD on solubility of terbinafine hydrochloride, an excess amount of the drug was added to 0, 2, 4, 6, 8, and 10% w/v aqueous solution of HP-[beta]-CD.
A nail lacquer drug delivery formulation of terbinafine hydrochloride (formulation code L0) was designed using cellulose acetate and ethyl cellulose as film forming polymers, triethyl citrate as plasticizer, and isopropyl alcohol and acetone as solvents (Table 1).
In order to determine the transungual permeation of terbinafine hydrochloride from nail lacquer formulation (formulation code L0), an in vitro drug permeation study was carried out for 48 hr using the Franz diffusion cell apparatus.
In addition to terbinafine tablets, FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride, 1 percent) to treat athlete's foot, a skin disease caused by a fungus that usually occurs between the toes.
Terbinafine hydrochloride is a relatively new allylamine with a broad range of in vitro antifungal activity.
The use of terbinafine hydrochloride in the treatment of avian fungal disease.
Terbinafine hydrochloride tablets, Watson Laboratories 3/28/2006
Terbinafine hydrochloride tablets, Invagen 7/28/2006
Terbinafine hydrochloride (Lamisil, Novartis, East Hanover, NJ, USA) was released in 1996 for treatment of human mycotic nail infections (onychomyscosis).
Pharmacokinetic parameters of orally administered terbinafine hydrochloride from compartmental and noncompartmental analyses (a) (mean [+ or -] SD) in red-tailed hawks (n = 10).