Fungiderm

Fungiderm

clotrimazole

Manufacturer:

PT Konimex

Distributor:

Maxxcare
Full Prescribing Info
Contents
Clotrimazole.
Action
Clotrimazole is an imidazole derivative which has a broad-spectrum antifungal activity. It is active against certain gram-positive bacteria, especially staphylococci, and against Trichomonas.
Like other imidazoles, clotrimazole alters the permeability of fungal cell walls by interfering with cell wall lipids. At fungistatic levels, the main effect is inhibition of ergosterol synthesis but at higher concentrations, there is an additional mechanism of membrane damage unrelated to sterol synthesis.
Microbiology: In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candida sp, including Candida albicans. Using an in vitro (mouse and mouse kidney homogenate) testing system, clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans.
Strains of fungi having a natural resistance to clotrimazole are rare. Only a single isolate of Candida guilliermondi has been reported to have primary resistance to clotrimazole.
No single- or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans and Trichophyton mentagrophytes. No appreciable change in sensitivity was detected after successive passages of isolates of C. albicans, C. krusei or C. pseudotropicalis in liquid or solid media containing clotrimazole. Also, resistance could not be developed in chemically-induced mutant strains of polyene-resistant isolates of C. albicans.
Following topical administration, clotrimazole appears to be minimally absorbed.
Indications/Uses
Dermatomycosis caused by dermatophytes, yeast, Candida sp, moulds and other fungi, eg: Tinea cruris (jock itch, occurs on the medial and upper parts of the thighs and the pubic area); tinea pedis (athlete's foot or ringworm of the feet); tinea capitis (on the scalp); tinea versicolor; tinea corporis; tinea unguium (onychomycosis); tinea barbae (barber's itch or ringworm of the beard); candidiasis of the skin and nails.
Clotrimazole also has some actions against gram-positive bacteria, so it may be used in mycosis secondarily infected with such bacteria.
Dosage/Direction for Use
Apply continuously 2-3 times daily for 10-14 days.
Tinea pedis (Athlete's Foot): 1 month of regular and persistent medication is needed.
Overdosage
Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.
Contraindications
Patients known to be hypersensitive to clotrimazole.
Special Precautions
Discontinue application if sensitivity reactions or irritations occur.
Avoid direct contact with eyes.
If there is no improvement within 1 month, consult a doctor.
Laboratory Test: If there is lack of response to clotrimazole, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.
For external use only.
Use in children: Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.
Side Effects
Erythema, stinging, vesication, pruritus, urticaria and general irritation of the skin.
Storage
Store in a cool and dry place.
ATC Classification
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Cream 10 mg x 5 g.
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