INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DERMAZOLE™ cream

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DERMAZOLE™ cream

COMPOSITION
Miconazole nitrate 20 mg/g.
Preservative: Benzoic acid 0,2 % m/m and butylhydroxyanisole as anti-oxidant.

PHARMACOLOGICAL CLASSIFICATION
A.13.9.2 Dermatological preparations: fungicides.

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 (Athlete’s foot)
- Tinea corporis (Tinea circinata)
- Tinea manuum
Tinea cruris due to:
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Microsporum audouinii
- Epidermophyton floccosum
Candidial infections:
Infections of the skin (e.g. intertrigo)
Perianal infections
Stomatitis angularis (cheilitis, perlêche)
Balanoposthitis

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
Mahogany Ridge
Westmead, 3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT
20/09/2002

MICTP1

Updated on this site: September 2005
Source: Pharmaceutical Industry

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