Filoma

Drug overview for FILOMA (ciclopirox olamine/fluconazole/terbinafine hcl):

Generic name: CICLOPIROX OLAMINE/FLUCONAZOLE/TERBINAFINE HCL
Drug class: Topical Antifungals
Therapeutic class: Dermatological

Ciclopirox and ciclopirox olamine are synthetic antifungal agents. Terbinafine hydrochloride is a synthetic allylamine antifungal agent.

Ciclopirox olamine cream or lotion is used topically for the treatment of certain dermatophytoses (i.e., tinea pedis, tinea cruris, tinea corporis) caused by Trichophyton mentagrophytes, T. rubrum, Epidermophyton floccosum, or Microsporum canis; for the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale); and for the treatment of cutaneous candidiasis (moniliasis) caused by Candida albicans. Ciclopirox gel is used topically for the treatment of tinea corporis and interdigital tinea pedis caused by T.

rubrum, T. mentagrophytes, or E. floccosum and for the treatment of seborrheic dermatitis of the scalp.

Ciclopirox shampoo is used topically for the treatment of seborrheic dermatitis of the scalp. Ciclopirox solution (nail lacquer) is used topically for the treatment of mild to moderate onychomycosis of fingernails and toenails, without lunula involvement, caused by T. rubrum in immunocompetent patients.

DRUG IMAGES

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The following indications for FILOMA (ciclopirox olamine/fluconazole/terbinafine hcl) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

Moderate List
No disease contraindications

The following adverse reaction information is available for FILOMA (ciclopirox olamine/fluconazole/terbinafine hcl):

Overview
Severe
Less Severe

Adverse reaction overview.

The most frequent adverse effects reported with topical terbinafine are irritation, burning/tingling, pruritus, dryness, skin exfoliation, and erythematous rash.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Blistering skin Erythema Paresthesia Pruritus of skin Skin inflammation Skin irritation

There are 3 less severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Erythema Hair discoloration Nail disorders

The following precautions are available for FILOMA (ciclopirox olamine/fluconazole/terbinafine hcl):

Pediatric
Pregnant
Lactation
Geriatric

Topical terbinafine should not be used for self-medication in children younger than 12 years of age unless directed by a clinician; safety and efficacy have not been established in children in this age group.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category B. Reproduction studies in mice, rats, rabbits, and monkeys using ciclopirox olamine dosages (via various routes of administration) 10 or more times the topical human dosage have not revealed evidence of harm to the fetus. Reproduction studies in rats and rabbits using topical dosages of ciclopirox up to 120 and 100 mg/kg of body weight, respectively, (approximately 121 and 147 times the maximum recommended topical human dosage based on surface area, respectively), also have not revealed evidence of fetotoxicity.

In addition, reproduction studies in mice, rats, rabbits, and monkeys using oral dosages of ciclopirox up to 100, 30, 30, and 50 mg/kg of body weight, respectively (approximately 37.5, 30, 44, and 77 times the maximum recommended topical human dosage based on surface area, respectively), have not revealed evidence of fetotoxicity. There are no adequate and controlled studies to date using topical ciclopirox or ciclopirox olamine in pregnant women; topical ciclopirox olamine cream and lotion and ciclopirox shampoo should be used during pregnancy only when clearly needed, while topical ciclopirox gel and solution (nail lacquer) should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Terbinafine is distributed into milk following oral administration. A decision should be made to discontinue nursing or the drug. It is not known whether ciclopirox or ciclopirox olamine is distributed in human milk. Because many drugs are distributed in human milk, ciclopirox or ciclopirox olamine preparations should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.