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

Logo SULTRIN*

SCHEDULING STATUS:
Schedule 2.

PROPRIETARY NAME
(and dosage form):

SULTRIN*
vaginal cream

COMPOSITION:
Sulphathiazole 34,2 mg/g, sulphacetamide 28,6 mg/g, sulphabenzamide 37 mg/g and urea 6,4 mg/g.
Preservatives: Propylparaben 0,1% m/m and methylparaben 0,1% m/m

PHARMACOLOGICAL CLASSIFICATION:
A.18.6 Vaginal preparations.

PHARMACOLOGICAL ACTION:
The three sulphonamides exert optimal bacteriostatic and bactericidal action at different specific pH levels, as follows:
Sulphathiazole         pH 7,04
Sulphacetamide         pH 5,20
Sulphabenzamide         pH 4,60
Urea neutralises sulpha-inhibitors, acts as a debriding agent, promotes granulation, and neutralises malodorous discharge.

INDICATIONS:
SULTRIN vaginal cream is indicated in the treatment of vaginitis and cervicitis, due to Haemophilus vaginalis, as well as non-specific bacterial vaginitis and cervicitis, secondary bacterial invasion in vaginal trichomoniasis and candidiasis, the prevention of bacterial complications and the promotion of more rapid healing following cervical cauterization or conization, plastic vaginal surgery and vulvectomy after radiation therapy of the cervix and vagina.
SULTRIN vaginal cream is also indicated as a post-partum anti-infective, and in the treatment of condyloma acuminatum.

CONTRA-INDICATIONS:
Sulphonamide sensitivity and kidney disease.

DOSAGE AND DIRECTIONS FOR USE:
One applicator full of cream (5g) is applied intra-vaginally twice daily i.e. 12 hourly for 4 to 6 days. Thereafter the dosage may be reduced to one-half or one-quarter.
The applicator is filled by screwing it onto the SULTRIN vaginal cream tube, after the cap has been removed. The base of the tube is then depressed until the applicator is full. After use, the applicator must be washed thoroughly and stored in a clean place.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In rare cases where a patient is allergic to the cream, the reaction is generally almost immediate and locally confined. SULTRIN vaginal cream should be used by pregnant women only if clearly needed since it is not known whether SULTRIN vaginal cream can cause foetal harm or effect reproductive capacity. The safety and effectiveness of SULTRIN vaginal cream in children has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage have not been reported. Treatment would be symptomatic if necessary.

IDENTIFICATION:
A smooth, white to off-white, non-staining, water dispersable cream.

PRESENTATION:
SULTRIN vaginal cream is supplied in tubes containing 40g and 78g of cream. The pack includes the measured dose applicator.

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

REFERENCE NUMBER:
H.1787 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN-CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
15th Road
HALFWAY HOUSE
1685
www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 April 1983.

* Trademark       
                        Code No. : 024415
                        2003H
                Britepak

Updated on this site: October 2003
Source: Pharmaceutical Industry

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