DAKTARIN® tincture

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

DAKTARIN® tincture

SCHEDULING STATUS:
Schedule 2.

PROPRIETARY NAME
(and dosage form):

DAKTARIN^® tincture

COMPOSITION:
Miconazole 20 mg/mL in alcoholic film forming solution.

PHARMACOLOGICAL CLASSIFICATION:
A.13.9.2. Dermatological preparations. Fungicides.

PHARMACOLOGICAL ACTION:
Miconazole is a synthetic 1-phenethylimidazole derivative. In vitro, low concentrations of miconazole are fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g. Saprolegnia, Candida, Cryptococcus, Aspergillus, Phialophora, Sporotrichum) and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum, Trichophyton interdigitale and Microsporum canis.

Miconazole is a broad-spectrum antifungal agent. As yet there is no evidence of drug resistance developing to miconazole.

Miconazole also possessed some antibacterial activity against gram positive organisms.

INDICATIONS:
Fungal infections of the skin, hair and nails caused by dermatophytes, yeasts and various other fungi, especially when a covering effect over a lesion is desired.

–	Onychomycosis
–	Dermatomycoses, e.g.:
	Tinea pedis (Athletes foot)
	Tinea corporis (Tinea circinata)
	Tinea manuum
	Tinea cruris
	due to:
	Trichophyton mentagrophytes
	Trichophyton rubrum
	Microsporum audouinii
	Epidermophyton floccosum
–	Candidial infection, e.g.:
	Infection of the skin (e.g. intertrigo)
–	Pruriginous fungal infections.

CONTRA-INDICATIONS:
DAKTARIN tincture is contra-indicated in persons who have shown hypersensitivity to the medicine.

DOSAGE AND DIRECTIONS FOR USE:
For external use only
DAKTARIN tincture should be applied to the lesion twice daily. When lesions have disappeared treatment should be continued for a further 10 to 14 days to prevent relapse. Treatment of onychomycosis should continue until mycological cure is achieved - this is usually achieved in ± 6 months.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
DAKTARIN tincture is well 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 topical administration of miconazole.

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 SPECIFIC TREATMENT:
Poisoning or overdosage is unlikely to occur owing to the very limited extent to which miconazole is absorbed. If it does present, treatment should be along conventional lines.

IDENTIFICATION:
Colourless to faintly yellow solution.

PRESENTATION:
DAKTARIN tincture is supplied in an amber glass bottle containing 30 mL of tincture.

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

REGISTRATION NUMBER:
L/13.9.2/180.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN –CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 80/11122/07)
15th Road, Halfway House, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28 February 1990

Code No: 022103
96E