Dosing & Uses
Dosage Forms & Strengths
cream/topical solution
- 1%
Tinea Pedis
Apply to affected area BID until significant clinical improvement (no more than 4 weeks)
Tinea Corporis & Cruris
Apply qDay x1 week (no more than 4 weeks)
Not FDA approved for peds
Adverse Effects
1-10%
Burning
Contact dermatitis
Dryness
Exfoliation
Irritation
Pruritus
Rash
Irritation
Stinging
Warnings
Contraindications
Hypersensitivity
Cautions
For external use only
Not for use on scalp, near the mouth or eyes, or to treat vaginal yeast infections
If eye contact occurs, rinse thoroughly with water
Do not puncture or incinerate contents under pressure; do not expose to heat or store at temperature above 120 oF (49 oC)
Stop use and talk to a doctor if too much irritation occurs or gets worse
Keep out of reach of children; if swallowed, get medical help or contact poison control center right away
Pregnancy & Lactation
Pregnancy
Oral doses of terbinafine hydrochloride up to 300 mg/kg/day (in terms of mg/m2/day equivalent to 146 and 329 times the maximum potential exposure at the recommended topical human dose*) during organogenesis in rats and rabbits, respectively, were not teratogenic
Similarly, a subcutaneous study in rats at doses up to 100 mg/kg/day (in terms of mg/m2/day equivalent to 49 times the maximum potential exposure at the recommended topical human dose*) and a percutaneous study in rabbits, including doses up to 150 mg/kg/day (in terms of mg/m2/day equivalent to 329 times the maximum potential exposure at the recommended topical human dose*), did not reveal any teratogenic potential; there are, however, no adequate and well-controlled studies in pregnant women
Because animal reproduction studies are not always predictive of human response, drug should be used only if clearly indicated during pregnancy
Lactation
Absorption from topical application limited; because of the small amount of data on human neonatal exposure, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother; nursing mothers should avoid application of drug to the breast
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Metabolism: liver
Excretion: urine
Mechanism of Action
Inhibits squalene epoxidase, reducing cell membrane ergosterol synthesis
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| terbinafine HCl topical - | 1 % cream |  | |
| terbinafine HCl topical - | 1 % cream |  | |
| Lamisil (Aerosol) topical - | 1 % aerosol |  | |
| Lamisil AT topical - | 1 % cream |  | |
| Lamisil AT topical - | 1 % cream |  | |
| Jock Itch (terbinafine) topical - | 1 % cream |  | |
| Athlete's Foot (terbinafine) topical - | 1 % cream |  | |
| Athlete's Foot (terbinafine) topical - | 1 % cream |  | |
| terbinafine HCl oral - | 250 mg tablet |  | |
| terbinafine HCl oral - | 250 mg tablet |  | |
| terbinafine HCl oral - | 250 mg tablet |  | |
| terbinafine HCl oral - | 250 mg tablet |  | |
| terbinafine HCl oral - | 250 mg tablet |  | |
| terbinafine HCl oral - | 250 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
terbinafine HCl topical
TERBINAFINE CREAM - TOPICAL
(ter-BIN-uh-feen)
COMMON BRAND NAME(S): Lamisil
USES: This medication is used to treat a variety of fungal skin infections such as ringworm, athlete's foot, and jock itch. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Terbinafine is an antifungal that works by preventing the growth of fungus.
HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply a thin layer of the medication on and around the affected area, usually once or twice daily as directed on the product package. If you have any questions, ask your doctor or pharmacist. Wash your hands after using unless the area being treated includes the hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor.Do not apply the medication in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.Do not apply this medication on the scalp or nails unless otherwise directed by your doctor.The dosage and length of treatment depends on the type of infection being treated.Do not apply more often or use longer than directed. This may increase the risk of side effects.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.Continue to use this medication until the full treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Your condition may continue to improve after the full treatment is finished. It may take several weeks after treatment for the infection to completely heal. Inform your doctor if your condition worsens or does not improve within 2 weeks for jock itch and ringworm and within 4 weeks for athlete's foot.
SIDE EFFECTS: Burning, irritation, or itching at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: blistering/swelling/oozing at the application site.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using terbinafine, tell your doctor or pharmacist if you are allergic to it; or to other allylamine antifungals (such as naftifine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.If you have any health problems, consult your doctor or pharmacist before using this product.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk when applied to the skin. Other forms of this medication pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Keep all medical and lab appointments.If you are treating athlete's foot, make sure to wear well-fitting, ventilated shoes. Also, change shoes and socks at least once daily.When this medication is used to treat pityriasis, your normal skin color may not return right away. It may take several months after treatment is completed for your natural skin color to return.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Do not refrigerate. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
