McNeil Consumer Products
Action And Clinical Pharmacology: Miconazole exhibits broad spectrum in vitro fungistatic activity; e.g., against species of the genus Candida. Studies with C. albicans indicate that at low concentrations, miconazole acts primarily on the yeast cell membrane resulting in selective inhibition of the uptake of precursors of RNA and DNA (purines) and mucopolysaccharide (glutamine).
In addition, in vitro antibacterial activity has been reported with Gram-positive bacilli and cocci.
Indications And Clinical Uses: Topical treatment of dermatophytes and Candida infections and lesions caused by mixed infections involving susceptible organisms e.g., tinea pedis (athlete’s foot), tinea cruris, tinea corporis and tinea versicolor caused by dermatophytes.
Miconazole is also effective in cutaneous candidiasis, excluding moderate to severe candidal paronychia. Among the organisms against which miconazole has been found to be effective are T. rubrum, T. mentagrophytes, T. interdigitale, E. floccosum, M. canis, M. gypseum, and species of Candida (including C. albicans) and M. furfur.
Contra-Indications: Sensitivity to any of the components.
Precautions: If irritation occurs, or there is no improvement following the full treatment period (see Dosage), discontinue use and see a doctor. Avoid contact with the eyes; if this happens, rinse thoroughly with water. For external use only. Do not use in children under 2 years of age unless directed by a doctor. Do not use for infections of the nails.
Adverse Reactions: Rarely, mild pruritus, irritation and burning at the site of application have been reported.
Dosage And Administration: Cleanse skin with soap and water and dry thoroughly. Apply (or spray) a thin layer over the affected area morning and night for the full treatment period. If there is no improvement within 2 weeks, consult a doctor. Otherwise, continue treatment for 1 to 2 weeks after symptoms have disappeared, up to a maximum of 4 weeks. Jock itch and ringworm usually require 2 weeks to resolve, while athlete’s foot may require 4 weeks.
When treating athlete’s foot, pay special attention to the spaces between toes; wear well-fitting, ventilated shoes and cotton socks.
The cream should be applied sparingly and smoothed in well to avoid maceration effects. Massage treated area gently until Micatin disappears.
Early clinical improvement (1 to 2 weeks) has been seen in the treatment of infections caused by dermatophytes and Candida species and in mixed infections, but resistant lesions may take longer to clear. If a patient shows no clinical improvement after 30 days of treatment, reconsider the diagnosis.
Availability And Storage: Cream: Each tube of cream contains: miconazole nitrate 2% in a water miscible, white to off-white cream base. Nonmedicinal ingredients: benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate and purified water. Tubes of 15 and 30 g.
Spray: Each 90 or 120 g can contains: miconazole nitrate 2% (as a percent of nonvolatile ingredients). Nonmedicinal ingredients: alcohol, hydrocarbon propellant, stearalkonium hectorite, sorbitan sesquioleate and talc.
MICATIN® McNeil Consumer Products Miconazole Nitrate Topical Antifungal