BETADINE Vaginal Douche Bactericidal, fungicidal, protozoacidal and deodorising
Composition:
Each 100 ml Contains :
Active ingredients: Povidone iodine (Mundidone) 10 g.
Inactive ingredients: legpal Co-71O. Bouquet T 8114 purified. Purified water.
Pharmaceutical form :
Solution.
Pharmacological action:
-BETADINE vaginal douche has the broad microbicidal spectrum of iodine. but is free of the undesirable features and disadvantages associated with elemental iodine.
-BETAOINE vaginal douche is lethal to gram-positive and gram negative bacteria, fungi. protozoa, spores and viruses.
-BETAOINE vaginal douche is active against antibiotic-resistant microorganisms. No resistance 10 8ETADINE vaginal douche from microorganisms has been observed.
-BETADINE vagjnat douche has an immediate onset and prolonged duration of action. Its activity is not affected b)’ blood or pu
-BETADINE vaginal douche is avaginal cleanser with a broad spectrum of activity. It rapidly eliminates all vaginal pathogens, drastically reduces the risk of infection and prevents recurrence of symptoms.
-BETADINE vaginal douche has a low surface tension auewtng penetration even into small vaginal crypts .
– BETADINE vaginal douche is non-irritating to the vaginal mucosa.
Pharmacokinetics:
-Pcvldcne iodine complex releases iodine on contact with skin or mucous membranes.
-The activity is thought to be due to the oxidizing properties of free molecular iodine and mal’ also be due to the combination of free iodine with cell protein.
Indications:
For unspecific vaginitis, mixed vaginal infections, candidal vaginitis, trichomonal vaginitis or preoperative preparation of the vagina.
Dosoge & administration :
– For the treatment of vaginitis:
As vaginal douche once a day for 14 days, two tablespoonful added to one liter of lukewarm water before bedtime, but throughout the menstrual cycle external washing is enough If further therapy is required, douching should be continued through the next two cycles.
– For routine vaginal douching: One tablespoonful added to one liter of lukewarm water once or twice a week.
– N.B. : Carefully insert the nozzle of the applicator high into the vagina without causing discomfort. Expel as much cleansing liquid as possible allowing solution to run freely from the vagina. Repeat until all liquid has been used.
Contraindications:
-Discourtnuc in rare cases or local sensitivity, or patients with hypersensitivity to iodine,
-Preterm nconate gestational age under 32 weeks.
-Avold regular use in patients with thyroid disorders or those receiving lithium therapy.
Side effects :
Rarely sensitivity; may interfere with thyroid fundicn tests.
Drug interactions:
-Compound benzoin tincture.
-Hydrogen peroxide.
Pregnancy and Lactation:
Used with caution in pregnancy as sufficient iodine may be absorbed 10 affect the fetal thyroid.
lactation: The use of BETADINE’vaginal douch by breast feeding “omen result in elevated iodine concentration in the breast milk.
Precautions and warnings:
-If swancwed, get medical help or contact Poison Control Center right away.
-In rare instances of local irritation or sensitivity. or if irritation and redness develop, discontinue use.
-Do not heat prior to apptlcauon.
Package and storage:
-Cartcn box contains plastic bottle of 120 ml + inner leaflet.
-Store al temperature not exceeding 30°C and keep away from light.
Instructions to patients:
-Keep out of reach of children.
-Prolonged exposure may cause irritation or rarel) se,’ere skin reaction.
Manufactured by :
EL- NILE Co. for Pharmaceuticals and
Chernicallndustries – Cairo -A.R.E. R.C.C.
Licensed by Mundipharma AG – Beset . Switzerland.
