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

Logo GYNO-DAKTARIN® Vaginal Tampons

SCHEDULING STATUS:
Schedule 4.

PROPRIETARY NAME
(and dosage form):

GYNO-DAKTARIN® Vaginal Tampons

COMPOSITION:
Each vaginal tampon contains 100 mg of the active substance
miconazole nitrate.

PHARMACOLOGICAL CLASSIFICATION:
A.18.6 Medicines acting on genito-urinary system. Vaginal preparations.

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 the GYNO-DAKTARIN* (miconazole nitrate) Vaginal Tampon is a broad-spectrum antifungal 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.

INDICATIONS:
Infections due to a wide range of fungi (esp. Candida spp.) presenting as:
–vulvovaginitis.

DOSAGE AND DIRECTIONS FOR USE:
In Candida vulvovaginitis, 1 tampon should be inserted intravaginally each morning and evening, i.e. giving a dose of 100 mg twice a day for 5 days. It may be used during menstruation.
A second course may be given if the patient is not mycologically cured after the first course.
Although symptomatic relief may be experienced within the first few days, the patient must complete the full course of treatment.
When GYNO-DAKTARIN* (miconazole nitrate) Vaginal Tampons are used during pregnancy, it should be under the strict supervision of a doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
No systemic side-effects have been reported in the treatment of patients suffering from a variety of gynaecological conditions. A few cases of local burning or itching have occurred.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Application of GYNO-DAKTARIN* (miconazole nitrate) Vaginal Tampon is characterised by practically no systemic absorption, hence overdosage does not arise.

IDENTIFICATION:
White tampon with a retractable string, partially coated with a suppository mass.

PRESENTATION:
Cardboard carton containing one or more blister strips of 5 GYNO-DAKTARIN* (miconazole nitrate) Vaginal Tampons each.

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

REGISTRATION NUMBER:
M/18.6/93

APPLICANT:
Janssen Pharmaceutica (Pty) Ltd
(Reg. No. 80/11122/07)
15th Road,
HALFWAY HOUSE,
1685

DATE OF PUBLICATION:
13 October, 1980.        Code No.: 022120
90E0690
Cilag       
a division of
JANSSEN
PHARMACEUTICA

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