terbinafine topical (OTC)

Brand and Other Names:Lamisil AT topical
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

1-10%

Burning

Contact dermatitis

Dryness

Exfoliation

Irritation

Pruritus

Rash

Irritation

Stinging

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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

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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.

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Pharmacology

Metabolism: liver

Excretion: urine

Mechanism of Action

Inhibits squalene epoxidase, reducing cell membrane ergosterol synthesis

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
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
terbinafine HCl topical
-
1 % cream
terbinafine HCl topical
-
1 % cream
Athlete's Foot (terbinafine) topical
-
1 % cream
Athlete's Foot (terbinafine) topical
-
1 % cream
Lamisil AT topical
-
1 % cream
Lamisil AT topical
-
1 % cream
Lamisil (Aerosol) topical
-
1 % aerosol
Jock Itch (terbinafine) topical
-
1 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
terbinafine HCl oral

TERBINAFINE - ORAL

(ter-BIN-uh-feen)

COMMON BRAND NAME(S): Lamisil

USES: Terbinafine is used to treat certain types of fungal infections (for example, of the fingernail or toenail). It works by stopping the growth of fungus. This medication belongs to a class of drugs known as antifungals.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking terbinafine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food, usually once a day or as directed by your doctor. Dosage and length of treatment is based on your medical condition and response to treatment.It may take several months after you finish treatment to see the full benefit of this drug. It takes time for your new healthy nails to grow out and replace the infected nails.Continue to take this medication until the full prescribed amount is finished. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Diarrhea or stomach upset may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because 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.Changes in your sense of taste/smell or loss of taste/smell may occur. These side effects may improve after stopping terbinafine, but can last for a long time or become permanent. Tell your doctor right away if you notice either of these side effects.Tell your doctor right away if you have any serious side effects, including: vision changes, mental/mood changes (such as depression), unexplained bleeding/bruising, unusual tiredness, signs of kidney problems (such as change in the amount of urine).Terbinafine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.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: fever, swollen lymph nodes, 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 taking terbinafine, tell your doctor or pharmacist if you are allergic to it; 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney disease, liver disease, lupus.Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.During pregnancy, this medication should be used only when clearly needed. Fungal nail infection treatment can usually wait until after you have had your baby. Discuss the risks and benefits with your doctor.This drug passes into breast milk. 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.Some products that may interact with this drug include: warfarin, drugs affecting liver enzymes that remove terbinafine from your body (such as amiodarone, cimetidine, rifampin, azole antifungals such as fluconazole/ketoconazole), drugs removed from your body by certain liver enzymes (such as tricyclic antidepressants, SSRI antidepressants, beta blockers, dextromethorphan, thioridazine, drugs to treat heart rhythm problems, monoamine oxidase inhibitors type B such as rasagiline).

OVERDOSE: 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: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as complete blood counts, liver function tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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 August 2021. Copyright(c) 2021 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.

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.