Terbinafine (topical)

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Terbinafine (topical) is an 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, and urticaria.

• 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

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

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

There is limited information regarding Terbinafine (topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

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

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

There is limited information regarding Terbinafine (topical) Contraindications in the drug label.

• 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.

There is limited information regarding Terbinafine (topical) Clinical Trials Experience in the drug label.

There is limited information regarding Terbinafine (topical) Postmarketing Experience in the drug label.

There is limited information regarding Terbinafine (topical) Drug Interactions in the drug label.

Pregnancy Category (FDA): There is no FDA guidance on usage of Terbinafine (topical) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Terbinafine (topical) in women who are pregnant.

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

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

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

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

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

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

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

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

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

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

• 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

There is limited information regarding Terbinafine (topical) Monitoring in the drug label.

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

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

There is limited information regarding Terbinafine (topical) Mechanism of Action in the drug label.

There is limited information regarding Terbinafine (topical) Structure in the drug label.

There is limited information regarding Terbinafine (topical) Pharmacodynamics in the drug label.

There is limited information regarding Terbinafine (topical) Pharmacokinetics in the drug label.

There is limited information regarding Terbinafine (topical) Nonclinical Toxicology in the drug label.

There is limited information regarding Terbinafine (topical) Clinical Studies in the drug label.

There is limited information regarding Terbinafine (topical) How Supplied in the drug label.

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

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There is limited information regarding Terbinafine (topical) Patient Counseling Information in the drug label.

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

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There is limited information regarding Terbinafine (topical) Look-Alike Drug Names in the drug label.

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