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

Logo TERAZOL® 5 Cream

SCHEDULING STATUS:
Schedule 4.

PROPRIETARY NAME
(and dosage form):

TERAZOL® 5 Cream

COMPOSITION:
Terconazole 8 mg/g.
Preservatives:
Propylene glycol 20% m/m.
Butylated hydroxyanisole 0,025% m/m.

PHARMACOLOGICAL CLASSIFICATION:
A 18.6 Vaginal preparations.

PHARMACOLOGICAL ACTION:
Terconazole is a synthetic triazole fungicide. It is believed to interfere with triglyceride synthesis in the yeast cell wall.
Following intravaginal administration, small amounts of terconazole are absorbed. Absorption appears to be dose-related. Terconazole is active in vitro against various strains of Candida albicans and topically in vivo.
Its inhibitory effects are both medium and strain dependent. At fungistatic concentrations, terconazole inhibits the transformation of yeast cells into their mycelial form and inhibits the uptake of 14C into yeast cell membrane sterols. Terconazole does not disturb the vaginal flora of lactobacilli which is necessary to maintain the optimum vaginal pH.

INDICATIONS:
Terconazole is indicated for the local treatment of vulvo-vaginal candidiasis (moniliasis).

CONTRA-INDICATIONS:
Known hypersensitivity to this medicine.
Since small quantities of vaginal applications are absorbed it should not be used in pregnancy since the safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
One applicatorful (40 mg/5g dose) of TERAZOL 5 must be introduced high into the vagina once daily at bedtime on five consecutive nights.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
During clinical studies with terconazole, vulvovaginal burning, itching and irritation has been reported.
Discontinue using the medicine if sensitization or irritation is reported during use.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of terconazole in humans has not been reported. Treatment is symptomatic.

IDENTIFICATION:
White to off-white soft cream.

PRESENTATION:
Aluminium tube with screw cap closure containing 30 g of cream and an applicator, packed in a carton.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
T/18.6/31

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 July 1986

© Jph (Pty) Ltd. SA 1986
                                Code No.: 022899
                                        96C

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