Each gram of gel contains: Fluconazole USP 5 mg (0.5 % w/w).
Excipients/Inactive Ingredients: Carbomer-940, benzyl alcohol, propylene glycol, polysorbate 80, sodium hydroxide, fragrance delite, 2-octyldodecanol, purified water.
Pharmacotherapeutic group: Antifungal agent. ATC code: D01AC15.
Pharmacology: Pharmacodynamics: Flusum contains fluconazole which is antifungal belonging to a new class of triazole agents, which is a potent and specific inhibitor of fungal sterol synthesis. Administered orally or intravenously, proved active in several modes of fungal infections.
Its activity has been demonstrated to fungal infections, such as those of Candida spp., (including systemic candidiasis in animals and immunocompromised), of Cryptococcus neoformans (including intracranial infections), of Microsporum spp. and of Trichophyton spp.
Fluconazole has also been shown to be active in animal models of endemic mycoses, including of Blastomyces dermatitidis and of Coccidioides immitis (including intracranial infections) and of Histoplasma capsulatum in normal and immunocompromised animals. Fluconazole used topically is a broad-spectrum antifungal agent. It was effective against the microorganisms responsible for dermatomycoses, cutaneous candidiasis and versicolor pityriasis (i.e. Microsporum spp., Trichophyton spp., Epidermophyton spp., Candida spp. and Malassezia furfur or Pityrosporum orbiculata.)
Its activities are performed against dermatophytes, yeasts and molds. Fluconazole is highly specific for fungal enzymes dependent on cytochrome P-450. It inhibits lanosterol C-14 demethylase enzyme that converts lanosterol in to the sterol present in the membrane of fungi i.e. the ergosterol.
Pharmacokinetics: A pharmacokinetic study conducted with the fluconazole Gel, showed that plasma levels achieved by fluconazole are so low as to exclude a systemic effect of the drug.
Moreover, the characteristics of a gel combined with the type of emulsion O/W allows excellent tolerability. There have been no pharmacokinetic studies conducted with the fluconazole Gel in children, but studies in adults have shown that the drug has a very low absorption systemically. Fluconazole has also been widely studied systemically in pediatric patients and neonates and showed a good tolerability profile similar to that of the adult patient.
A study conducted to evaluate the dermal tolerance and phototoxicity of the drug showed that the fluconazole Gel is well tolerated by human skin and is not phototoxic, so it is suitable for use as a topical antifungal.
Flusum is indicated in the treatment of dermatomycoses caused by dermatophytes, yeasts and molds: in particularly Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and infections of Candida.
Flusum should be applied once in a day, using a gentle massage on the affected skin and the immediate surrounding area. In internal areas should be applied in small quantities and spread well to avoid phenomena of maceration.
The duration of treatment required for healing varies with etiological agent responsible for the infection. Treatment of 1 - 3 weeks is usually sufficient for healing in most patients.
Particularly with resistant forms, the treatment period may be extended up to 6 weeks depending on the decision of the doctor.
Mode of administration: Topical.
So far no cases of overdose have been reported.
Hypersensitivity to the components of the product or to other closely related substances from the chemical point of view. Generally contraindicated in pregnancy and lactating mothers.
Should not be used for ophthalmic use.
Effects on Ability to Drive and Use Machines: The drug does not adversely affect the ability to drive vehicle and other potentially dangerous machinery.
Pregnancy: Studies in animals have shown reproductive toxicity. There have been reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis) in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. So use of Flusum is not advised during pregnancy.
Breast-feeding: Fluconazole passes into breast milk to reach concentrations lower than those in plasma. Use of Flusum during lactation is not advised.
Fertility: Fluconazole did not affect the fertility of male or female rats.
In clinical trials conducted prior to marketing mild skin irritation were seen rarely. The use of topical products, especially if prolonged, may give rise to phenomena of sensitization and produce side effects. In this case the patient must stop treatment and establish an appropriate therapy.
Adverse Drug Reactions: Inform doctors about unexpected reactions after using drugs.
In clinical trials conducted so far there were no interactions or incompatibility reported with other drugs. There have been no specific studies of drug interactions conducted related to fluconazole gel.
Store below 30°C in cool place.
Protect from direct sunlight. Do not freeze.
Shelf-Life: 24 months.
D01AC15 - fluconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Topical gel 0.5% w/w (clear colourless to opaque smooth homogeneous, with characteristic odour) x 30 g x 1's.
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