Dafilor

Drug overview for DAFILOR (ciclopirox olamine/salicylic acid):

Generic name: CICLOPIROX OLAMINE/SALICYLIC ACID
Drug class: Topical Antifungals
Therapeutic class: Dermatological

Ciclopirox and ciclopirox olamine are synthetic antifungal agents. Salicylic acid is a keratolytic agent.

Ciclopirox olamine cream or lotion is used topically for the treatment of Salicylic acid is used topically for its keratolytic effect in the certain dermatophytoses (i.e., tinea pedis, tinea cruris, tinea corporis) management of acne and other skin conditions such as seborrheic dermatitis, caused by Trichophyton mentagrophytes, T. rubrum, Epidermophyton floccosum, psoriasis, and dandruff; the drug also is used topically for the removal of or Microsporum canis; for the treatment of tinea (pityriasis) versicolor warts, corns, and calluses. caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale); and for Salicylic acid is not used systemically because of its severe irritating the treatment of cutaneous candidiasis (moniliasis) caused by Candida albicans.

Ciclopirox gel is used topically for the treatment of tinea effect on GI mucosa and other tissues. (See the Salicylates General corporis and interdigital tinea pedis caused by T. rubrum, T. Statement 28:08.04.24.) 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 DAFILOR (ciclopirox olamine/salicylic acid) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for DAFILOR (ciclopirox olamine/salicylic acid):

Dosing
Administration
Dosing Information
Generic

The labeled strengths of ciclopirox olamine creams and lotions are no longer expressed in terms of the olamine salt (i.e., 1% ciclopirox olamine), but instead are expressed in terms of the base, ciclopirox (i.e., 0.77% ciclopirox).

Salicylic acid is applied topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, solution, or suspension. Topical preparations of salicylic acid are for external use only. Contact with the eyes should be avoided; if contact occurs, the affected eye(s) should be washed thoroughly with water.

Prior to topical application, the affected area(s) to be treated should be cleansed and allowed to dry. Prior to removal of warts, corns, and calluses, the affected area may be soaked in warm water for 5 minutes. Salicylic acid is commercially available in various preparations, some of which are intended for self-medication; the manufacturer's product labeling should be consulted for complete directions regarding appropriate dosage and administration of specific products.

Ciclopirox olamine is applied topically to the skin as a cream or lotion while ciclopirox is applied topically to the skin as a gel or shampoo and to nails as a solution (nail lacquer). The ciclopirox olamine lotion, which should be shaken vigorously before each use, may be particularly useful for infections involving relatively large areas or areas where a less viscous formulation might be preferred. Occlusive dressings or wrappings should not be used.

Ciclopirox and ciclopirox olamine preparations should not be applied to the eye nor administered orally or intravaginally. Patients should remove any loose nail or nail material (using nail clippers or nail files) before initiating therapy with ciclopirox solution (nail lacquer). Removal of unattached, infected nail(s) as frequently as once monthly by a qualified clinician in nail disorders, weekly self-trimming of infected nail(s) by the patient, and daily application of the topical solution (nail lacquer) are all essential components of the topical management of onychomycosis.

No dosing information available.

No generic dosing information available.

Contraindication List
Aspirin exacerbated respiratory disease
Hemolytic anemia from pyruvate kinase and g6PD deficiencies

Moderate List
No disease contraindications
Peripheral vascular disease

The following adverse reaction information is available for DAFILOR (ciclopirox olamine/salicylic acid):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 15 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Burns Dyspnea Facial edema Hypersensitivity drug reaction Periorbital edema Pharyngeal edema Pruritus of skin Skin inflammation Skin irritation Skin ulcer Superficial skin ulcer Syncope Throat constriction Urticaria

There are 7 less severe adverse reactions.

More Frequent	Less Frequent
Stinging of skin	Dry skin Skin irritation

Rare/Very Rare
Erythema Hair discoloration Nail disorders Pruritus of skin

The following precautions are available for DAFILOR (ciclopirox olamine/salicylic acid):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There are no adequate and well-controlled studies of topical salicylic acid in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the possible risks to the fetus. 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.

Because of the potential for serious adverse reactions to salicylic acid in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. If used in nursing women, the drug should not be applied to the chest area to avoid accidental contamination of the infant. 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.