Hixdefrima (ciclopirox olamine/fluconazole/terbinafine HCl)
Topical Antifungals Topical Solution, Non-Oral
Last reviewed · Source: First Databank (FDB) drug data
Overview
Ciclopirox and ciclopirox olamine are synthetic antifungal agents.
Terbinafine hydrochloride is a synthetic allylamine antifungal agent.
Terbinafine hydrochloride is a synthetic allylamine antifungal agent. Terbinafine is derived from naphthalenemethanamine, and is structurally and pharmacologically related to naftifine.
Terbinafine is active in vitro against dermatophytes, including Epidermophyton floccosum, Trichophyton mentagrophytes, T. rubrum, T. verrucosum, Microsporum canis, and M. gypseum. The drug also is active in vitro against Malassezia furfur and some Candida, including C. albicans and C. parapsillosis. The antifungal spectrum of activity of terbinafine is similar to that of naftifine.
Terbinafine usually is fungicidal in action against susceptible dermatophytes, but may be fungicidal or fungistatic against Candida. Terbinafine is more active than azole antifungals (e.g., itraconazole, ketoconazole) against dermatophytes, but is less active than these drugs against Candida.
Following topical application of terbinafine hydrochloride 1% cream or 1% solution to healthy skin, percutaneous absorption occurs and terbinafine concentrations attained in the stratum corneum are similar with both preparations. Terbinafine is absorbed systemically following topical application to intact skin, and low concentrations of the drug are attained in plasma. Systemically absorbed terbinafine is extensively metabolized.
Approximately 75% of percutaneously absorbed terbinafine is eliminated in urine, principally as metabolites. Following topical application to skin, the half-life of systemically absorbed terbinafine is approximately 21 hours.
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.
Generic name: ciclopirox olamine/fluconazole/terbinafine HCl
Drug class: Topical Antifungals
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Hixdefrima
Indications
No indications are available for this drug.
Dosing
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 is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Topical preparations containing terbinafine are contraindicated in patients hypersensitive to the drug or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most frequent adverse effects reported with topical terbinafine are irritation, burning/tingling, pruritus, dryness, skin exfoliation, and erythematous rash.
Rare or Very Rare
- Blistering skin
- Erythema
- Paresthesia
- Pruritus of skin
- Pruritus of skin
- Skin inflammation
- Skin inflammation
- Skin irritation
- Skin irritation
Rare or Very Rare
- Erythema
- Hair discoloration
- Nail disorders
Precautions
No enhanced messaging available.
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.
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.
Category B.
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.
Terbinafine is distributed into milk following oral administration. A decision should be made to discontinue nursing or the drug.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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