(and dosage form):
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
A.18.6 Vaginal preparations.
The three sulphonamides exert optimal bacteriostatic and bactericidal action at different specific pH levels, as follows:
Urea neutralises sulpha-inhibitors, acts as a debriding agent, promotes granulation, and neutralises malodorous discharge.
|| pH 7,04|
|| pH 5,20|
|| pH 4,60|
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.
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.
A smooth, white to off-white, non-staining, water dispersable cream.
SULTRIN vaginal cream is supplied in tubes containing 40g and 78g of cream. The pack includes the measured dose applicator.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
H.1787 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 April 1983.
Code No. : 024415
Updated on this site: October 2003
Source: Pharmaceutical Industry
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