PHARMACOLOGICAL ACTION Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. It is a broad spectrum anti-fungal agent. In vitro, low concentrations of miconazole nitrate are fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g. Saprolegnia, Candida, Cryptococcus, Aspergillus, Dermatophytes, Phialophora, Sporotrichum), and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum. Trichophyton interdigitale and Microsporum canis.
Miconazole nitrate also possesses some anti-bacterial activity against Gram-positive organisms.
INDICATIONS Dermatomycoses, e.g.:
Tinea pedis (Athletes foot)
Tinea corporis (Tinea circinata)
Tinea cruris due to:
Infections of the skin (e.g. intertrigo)
Stomatitis angularis (cheilitis, perlêche)
CONTRA-INDICATIONS Miconazole nitrate is contra-indicated in those patients who have shown hypersensitivity to miconazole.
DOSAGE AND DIRECTIONS FOR USE
For external use only. Miconazole nitrate should be applied to the lesions twice daily and thoroughly rubbed into the skin. When all lesions have disappeared (usually after 2 to 5 weeks), treatment should be continued for a further 10 to 14 days to prevent relapse.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Minimal absorption of the active ingredient takes place through the skin and systemic side-effects are therefore most unlikely to arise.
Local irritation and sensitivity reactions may occur with miconazole nitrate. The safety of use during pregnancy has not been established.
INTERACTIONS Systemic absorption of miconazole, although low after topical administration, may potentiate the activity of warfarin
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Poisoning or overdosage is unlikely to occur owing to the limited extent to which miconazole nitrate is absorbed. If it does occur treatment should be symptomatic and supportive.
IDENTIFICATION Homogenous, white to off-white cream
PRESENTATION Miconazole nitrate is supplied in a tube containing 25g cream.
STORAGE INSTRUCTIONS Store below 25°C
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER 34/13.9.2/0182
NAME AND BUSINESS ADDRESS OF THE APPLICANT Hexal Pharma (SA) (PTY) Ltd
10 Fangio Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT 20/09/2002
Updated on this site: September 2005
Source: Pharmaceutical Industry