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

Logo DAKTARIN® cream

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

DAKTARIN® cream

COMPOSITION:
Miconazole nitrate 20 mg/g.
Preservative: benzoic acid 0,2% m/m.

PHARMACOLOGICAL CLASSIFICATION:
A 13.9.2 Dermatological preparations: fungicides.

PHARMACOLOGICAL ACTION:
Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. 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.
Thus DAKTARIN cream is a broad-spectrum anti-fungal agent. As yet there is no evidence of drug resistance developing to miconazole nitrate.
Miconazole nitrate also possesses some anti-bacterial activity against Gram-positive organisms.
In addition DAKTARIN cream has a very rapid alleviating effect on the pruritis which frequently accompanies infection.

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 floccosumCandidial infections:
Infections of the skin (e.g. intertrigo)
Perianal infections
Stomatitis angularis (cheilitis, perlèche)
Balanoposthitis

CONTRA-INDICATIONS:
DAKTARIN cream is contra-indicated in those patients who have shown hypersensitivity to miconazole.

DOSAGE AND DIRECTIONS FOR USE:
For external use only.
DAKTARIN cream 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:
DAKTARIN cream is excellently tolerated and leaves no stain on skin or clothes. 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 DAKTARIN cream.
Drug interaction
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 along conventional lines.

IDENTIFICATION:
A smooth white cream, miscible with water.

PRESENTATION:
DAKTARIN cream is supplied in a tube containing 30 g of cream.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
G/13.9.2/106.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg No. 1980/11122/07)
15th Road
HALFWAY HOUSE, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
10 May 1974.
                        Code No.: 022937
                        2002B
® Trademark
Updated on this site: November 2002       
Source: Pharmaceutical Industry

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