Fervina

Drug overview for FERVINA (ciclopirox olamine/itraconazole/urea):

Generic name: CICLOPIROX OLAMINE/ITRACONAZOLE/UREA
Drug class: Topical Antifungals
Therapeutic class: Dermatological

Ciclopirox and ciclopirox olamine are synthetic antifungal agents. Urea, at concentrations of 10-30%, promotes hydration of keratin and mild keratolysis in dry and hyperkeratotic skin.

Ciclopirox olamine cream or lotion is used topically for the treatment of Urea is used topically in the treatment of dry skin. At concentrations of 10-30%, urea promotes hydration of keratin and mild keratolysis in dry and certain dermatophytoses (i.e., tinea pedis, tinea cruris, tinea corporis) caused by Trichophyton mentagrophytes, T. rubrum, Epidermophyton floccosum, hyperkeratotic skin.

The drug increases the uptake of water by the stratum corneum, giving it a high water-binding capacity. Topically applied urea or Microsporum canis; for the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale); and for may also have an antipruritic effect. At high concentrations (e.g., 40%), the treatment of cutaneous candidiasis (moniliasis) caused by Candida urea is a protein denaturant.

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 FERVINA (ciclopirox olamine/itraconazole/urea) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for FERVINA (ciclopirox olamine/itraconazole/urea):

Dosing
Administration
Dosing Information
Generic

Urea is applied topically as a cream or lotion. The moisturizing effect of urea may be enhanced by applying the preparation to the skin while it is still moist after washing or bathing. Urea is applied topically to the affected area 1-3 times daily or as directed by a physician.

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).

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.

Moderate List
No disease contraindications

The following adverse reaction information is available for FERVINA (ciclopirox olamine/itraconazole/urea):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 3 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Pruritus of skin Skin inflammation Skin irritation

There are 6 less severe adverse reactions.

More Frequent	Less Frequent
Pruritus of skin Skin irritation Stinging of skin	None.

Rare/Very Rare
Erythema Hair discoloration Nail disorders

The following precautions are available for FERVINA (ciclopirox olamine/itraconazole/urea):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

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.