Fenovia (fluconazole/ibuprofen/itraconazole/terbinafine HCl)
Topical Antifungals Topical Solution, Non-Oral
Last reviewed · Source: First Databank (FDB) drug data
Overview
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.
Generic name: fluconazole/ibuprofen/itraconazole/terbinafine HCl
Drug class: Topical Antifungals
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
No indications are available for this drug.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
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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.
- Aspirin exacerbated respiratory disease
- Cerebrovascular accident
- History of roux-en-Y gastric bypass
- Post-operative from CABG surgery
- Pregnancy
- Renal transplant
- Acute myocardial infarction
- Alcohol use disorder
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- CYp2c9 intermediate metabolizer (activity score 1)
- CYp2c9 poor metabolizer
- Gastrointestinal perforation
- Gastrointestinal ulcer
- Hemorrhage
- History of kidney donation
- Increased risk of bleeding
- Nephrectomy
- Systemic mastocytosis
- Thrombotic disorder
- Chronic heart failure
- Disease of liver
- Hypertension
- Kidney disease with likely reduction in glomerular filtration rate (GFr)
- No disease contraindications
- Tobacco smoker
Adverse reactions
The most frequent adverse effects reported with topical terbinafine are irritation, burning/tingling, pruritus, dryness, skin exfoliation, and erythematous rash.
More Frequent
- Skin rash
Less Frequent
- Pruritus of skin
Rare or Very Rare
- Anaphylaxis
- Angioedema
- Asthma exacerbation
- Blistering skin
- Bronchospastic pulmonary disease
- Bullous dermatitis
- Dyspnea
- Erythema
- Erythema multiforme
- Paresthesia
- Pruritus of skin
- Purpura
- Skin inflammation
- Skin irritation
- Toxic epidermal necrolysis
- Urticaria
More Frequent
- Abdominal pain with cramps
Less Frequent
- Dyspepsia
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.
Category B.
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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