Onychomycosis: Topical: Apply to affected toenail(s) once daily for 48 weeks.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Tavaborole: Pediatric drug information")
Onychomycosis: Children ≥6 years and Adolescents: Topical: Apply to affected toenail(s) once daily for 48 weeks.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment may not be necessary as systemic absorption is low.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment may not be necessary as systemic absorption is low.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Kerydin: 5% (4 mL, 10 mL) [contains edetate (edta) calcium disodium, propylene glycol]
Generic: 5% (4 mL, 10 mL)
Yes
Topical: Affected toenails should be clean and dry. Apply to completely cover affected toenail surface using provided dropper; also apply under the tip of each affected toenail. Avoid contact with skin other than skin surrounding the treated toenails; wipe away excess solution from surrounding skin and allow solution to dry. Wash hands with soap and water after application.
Topical: For external use only; not for oral, ophthalmic, or intravaginal use. Avoid use near heat or open flame; product is flammable. Prior to application, affected toenails should be cleaned and dried. Apply solution using the provided dropper and completely cover affected toenail surface; more than 1 drop may be needed. Use the tip of the dropper to spread the solution to the edges of the toenail; also apply under the tip of each affected toenail. Avoid contact with skin other than skin surrounding the treated toenails; wipe away excess solution from surrounding skin and allow solution to dry. Wash hands with soap and water after application.
Onychomycosis: Topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Ingrown nail (3%)
Local: Local skin exfoliation (3%), application site erythema (2%), application-site dermatitis (1%)
<1%, postmarketing, and/or case reports: Allergic contact dermatitis
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse events:
• Local irritation: Persistent local irritation, erythema, exfoliation, or dermatitis may develop; instruct the patient to contact their health care provider if this occurs.
Dosage form specific issues:
• Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
Other warnings/precautions:
• Appropriate use: For topical use only; avoid contact with eyes or mucous membranes. Avoid contact with skin (other than skin immediately surrounding treated toenail).
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
None known.
There are no known significant interactions.
Adverse events were observed in some animal reproduction studies.
It is not known if tavaborole is present in breast milk following application. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Tavaborole is an oxaborole antifungal that inhibits fungal protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS).
Metabolism: Extensive
Excretion: Urine
Solution (Kerydin External)
5% (per mL): $181.30
Solution (Tavaborole External)
5% (per mL): $10.80 - $162.99
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