Terbinafine

Jump to: navigation, search
Terbinafine®
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

For patient information regarding Terbinafine, click here.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Ammu Susheela, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.


Overview

Terbinafine is a antifungal that is FDA approved for the treatment of itching, burning, cracking and scaling in athlete's foot and jock itch,. Common adverse reactions include diarrhea, dyspepsia, rash, pruritis, utricaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Cures most athlete's foot (tinea pedis)
  • Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • Relieves itching, burning, cracking and scaling which accompany these conditions

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Terbinafine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Terbinafine in adult patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Terbinafine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Terbinafine in pediatric patients.

Contraindications

Warnings

  • For external use only
  • Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections
  • When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
  • Stop use and ask a doctor if too much irritation occurs or gets worse.

side effects occur.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

There is no FDA guidance on usage of Terbinafine in women who are pregnant.

Pregnancy Category (AUS):

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Terbinafine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Terbinafine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Terbinafine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Terbinafine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Terbinafine in geriatric settings.

Gender

There is no FDA guidance on the use of Terbinafine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Terbinafine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Terbinafine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Terbinafine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Terbinafine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Terbinafine in patients who are immunocompromised.


Administration and Monitoring

Administration

Adults and Children 12 years and Older
  • Use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes.
  • Change shoes and socks at least once daily.
  • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
  • For jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
  • Wash hands after each use

Monitoring

IV Compatibility

There is limited information regarding the compatibility of Terbinafine and IV administrations.

Overdosage

There is limited information regarding Terbinafine overdose. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Terbinafine.png
Terbinafine
Systematic (IUPAC) name
[(2E)-6,6-dimethylhept-2-en-4-yn-1-yl](methyl)(naphthalen-1-ylmethyl)amine
Identifiers
CAS number 91161-71-6
78628-80-5
ATC code D01AE15 D01BA02
PubChem 1549008
DrugBank DB00857
Chemical data
Formula C21H25N 
Mol. mass 291.43 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability Readily absorbed: 70–90%
Protein binding >99%
Metabolism Hepatic
Half life Highly variable
Excretion  ?
Therapeutic considerations
Pregnancy cat.

B

Legal status

Low-strength preparations available without prescription

Routes Oral, topical

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

  • Store at controlled room temperature 20°-25°C (68°-77°F)

Images

Drug Images

Package and Label Display Panel

Terbinafine01.jpg
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

Precautions with Alcohol

Alcohol-Terbinafine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.



Terbinafine
LamISIL®,FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-In-Chief: Ahmed Zaghw, M.D. [4]

Overview

Category

Antifungal

US Brand Names

LamISIL®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Mechanism of Action

References


Linked-in.jpg