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

Logo BETADINE* VAGINAL GEL

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BETADINE* VAGINAL GEL

COMPOSITION:
Each gram contains:
Povidone-iodine 100 mg, equivalent to 10 mg available iodine in an inert water-soluble base.

PHARMACOLOGICAL CLASSIFICATION:
A. 18.6 Vaginal Preparations

PHARMACOLOGICAL ACTION:
Povidone-iodine is a multivalent broad spectrum local antiseptic having bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Many viruses, protozoa, yeasts, cysts and spores are also susceptible.

INDICATIONS:
Vaginitis due to: -
1. Candida albicans
2. Trichomonas vaginalis
3. Mixed infections
4. Non-specific infections.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. This product is spermicidal and should not be used when conception is desired. Patients with a non-toxic nodular colloid goitre should not use povidone-iodine.

WARNINGS:
1. Not to be used by persons who are allergic to iodine.
2. Not to be used in pregnancy or by lactating women.

DOSAGE AND DIRECTIONS FOR USE:
One applicatorful (withdraw to four gram mark) of BETADINE* VAGINAL GEL is inserted each night to be followed by morning douching for two weeks, or as directed by the physician. If further therapy is required, the prescribed regimen should be continued through the next two menstrual cycles, the patient being seen every two weeks. To ensure prompt relief of the presenting symptoms, it is recommended that the vagina and cervix are swabbed with BETADINE* DOUCHE (undiluted) on initial examination and on subsequent examinations.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Povidone-iodine sensitivity may develop in certain individuals. If irritation, redness, swelling or other signs of sensitivity occur, the patient should discontinue use and consult her physician. This product is spermicidal and should not be used when conception is desired. Alkalis will reduce the activity of this preparation. Absorption of povidone-iodine may interfere with thyroid function tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic effects include metabolic acidosis, hypernatraemia and renal impairment. Treatment is symptomatic and supportive.

IDENTIFICATION:
BETADINE* VAGINAL GEL
is a golden-brown, pleasantly perfumed gel.

PRESENTATION:
Tubes of 90 g with applicator.

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

REGISTRATION NUMBER:
C/18.6/144

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston
2152

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 January 1987

Under licence from:
Mundipharma AG, Switzerland

* BETADINE is a Registered Trade Mark

New addition to this site: April 2004
Source: Pharmaceutical Industry

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