Betadine Vaginal Douche

Betadine Vaginal Douche

povidone iodine

Manufacturer:

Mundipharma

Distributor:

Zuellig
Full Prescribing Info
Contents
Povidone-iodine.
Description
Each mL contains povidone-iodine 100 mg equivalent to 10 mg available iodine.
POVIDONE-IODINE (BETADINE) vaginal douche contains povidone-iodine 10% (100 mg/mL) w/v as the active ingredient. Povidone-Iodine is an antiseptic. Antiseptics are chemicals that kill or prevent the growth of micro-organisms (bacteria, fungi and viruses).
It does not stain the skin and can be washed off if spill on to clothing.
Indications/Uses
POVIDONE-IODINE (BETADINE) vaginal douche is used as a vaginal cleanser for the treatment of vaginitis due to candidal, trichomonal, bacterial, non-specific or mixed infections and for pre-operative disinfection of the vagina.
For better hygiene, effective cleansing, deodorizing (not recommended during pregnancy) and washing out accumulations of normal secretions, washing out vaginal medications, removing contraceptive creams and jellies, cleansing the vaginal vault after sexual intercourse and for fresh and clean feeling.
Dosage/Direction for Use
Use POVIDONE-IODINE (BETADINE) vaginal douche as prescribed by the doctor or follow the instructions as follows: For the treatment of vaginitis use once daily in the morning for 14 days including days of the menstrual cycle.
For personal hygiene, use twice weekly.
How to Douche: Therapeutic Douche: Pour POVIDONE-IODINE (BETADINE) vaginal douche into the squeezable syringe bottle up to the FIRST-FILL-LINE (15 mL). Add lukewarm water up to the WATER-FILL-LINE (approximately 300 mL). Attach nozzle to douche bottle and shake gently to mix, holding bottle straight until ready to use.
Note: Whatever douche or douching apparatus used, be sure to let the first few drops run out before inserting the nozzle, to prevent any possible air bubble from entering. This applies to all douches.
Gently insert nozzle about three inches into the vagina. Hold douche bottle so as to provide proper flow of contents.
Squeeze douche bottle gently on both sides. Use sustained even pressure so solution can flow in gently. Do not release pressure and continue squeezing until most of the solution is used up. Discard the small amount left in the douche bottle.
Make a second identical dilution and repeat the procedure.
Rinse out the douche bottle and nozzle, and let them drain dry.
Routine Cleaning Douche: Pour POVIDONE-IODINE (BETADINE) vaginal douche squeezable douche bottle up to halfway (½) the FIRST-FILL-LINE.
Add lukewarm water up to the WATER-FILL-LINE (approximately 300 mL). Attach nozzle to douche bottle and shake gently to mix, holding bottle straight until ready to use.
Then, follow directions from insertion of the douche into the vagina until rinsing of the douche bottle and nozzle as previously mentioned in Therapeutic Douche procedure.
Where to Douche: The multiple creases and folds of the vaginal canal make it necessary to wash the walls of the vaginal canal thoroughly with douche solution. Therefore, the most effective results are obtained by reclining in the bath tub with knees drawn up, permitting more effective irrigation (Patient may take the chill off the tub by running in some warm water and then draining it out).
Patient may prefer douche while sitting back on the toilet or in the shower, wherever it helps to feel relaxed while douching.
Overdosage
Signs & Symptoms: In the unlikely event the patient experiences any of the following symptoms: stomach pain, unable to pass urine, loss of appetite, weakness, nausea and vomiting, coughing up blood, excessive sweating, difficulty in breathing, metabolic acidosis, anxiety and pale skin, immediately consult the doctor.
Treatment is symptomatic and supportive.
Contraindications
POVIDONE-IODINE (BETADINE) vaginal douche should not be used: If the patient is allergic to iodine or povidone; If the patient has overactive thyroid gland (hyperthyroidism) or any thyroid diseases; If the patient is on lithium therapy;
Before and after a specific medical treatment involving the use of radioactive iodine.
If the patient experienced an allergic reaction, stop using POVIDONE-IODINE (BETADINE) vaginal douche and inform the doctor or pharmacist immediately.
Special Precautions
In pre-operative preparation, avoid pooling beneath the patient. In pre-operative preparation, avoid pooling beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. Chemical burns of skin due to pooling may occur. In instances of skin irritation, contact dermatitis or hypersensitivity, discontinue use.
Do not heat POVIDONE-IODINE (BETADINE) vaginal douche prior to use.
Avoid getting POVIDONE-IODINE (BETADINE) vaginal douche in the eyes. Avoid solutions containing detergent if treating open wounds with povidone-iodine.
BETADINE VAGINAL DOUCHE is intended FOR EXTERNAL USE ONLY. Not for use on extensive body areas and should not be used over a long period of time unless strictly indicated.
Patients with goiter, thyroid nodules or other non-acute thyroid diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) from the administration of large amounts of iodine. In this patient population, povidone-iodine should not be applied for an extended period of time and to large areas of the skin unless strictly indicated. Even after the end of the treatment one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored.
It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
Newborns and small infants are at increased risk of developing hypothyroidism from the administration of large amounts of iodine. Because of the permeable nature of the skin and their increased sensitivity to iodine, the use of povidone-iodine should be kept to the absolute minimum in newborns and small infants. A check of their thyroid function (e.g. T4 levels and TSH levels) may be necessary.
Avoid use in patients with renal impairment.
It is a spermicidal and not recommended when conception is desired.
Use In Pregnancy & Lactation
During pregnancy and lactation, POVIDONE-IODINE (BETADINE) vaginal douche should be used if strictly prescribed by the doctor and its use should be kept to the absolute minimum.
Adverse Reactions
All medicines can have side effects. Sometimes they are serious, most of the time they are not. Patient may need medical attention if the patient gets some of the side effects.
The side effects listed as follows may not include all of the side effects reported. For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE) vaginal douche, consult the doctor or pharmacist.
Note that the side effects related to the use of POVIDONE-IODINE (BETADINE) vaginal douche occur rarely.
Rarely, hypersensitive/allergic skin reaction may occur, which can appear in the form of: Itchiness; redness; small blisters.
Very rarely, acute generalized allergic reactions have been reported with: Drop in blood pressure; difficulty in breathing; swelling of the skin and mucosa.
If the patient notices any side effects, consult the doctor or pharmacist.
The long term use of the product, not in accordance with the usage instructions mentioned in Dosage & Administration, may lead to possible absorption of iodine into the body. This may lead to: Overactive thyroid gland function if the patient has a history of thyroid problems, rapid heartbeat (tachycardia) and restlessness; imbalance of electrolytes; abnormal blood concentration (osmolarity); abnormal kidney function (renal impairment).
Drug Interactions
Do not apply other medications to the same affected areas to treat with POVIDONE-IODINE (BETADINE) vaginal douche, unless the doctor has told to do so.
It is not likely that other drugs taken orally or injected will have an effect on POVIDONE-IODINE (BETADINE) vaginal douche.
The concomitant use of other externally applied wound healing medicines/preparations may alter the effect of POVIDONE-IODINE (BETADINE) vaginal douche or both. Products containing enzymatic component, alkali, acetylsalicylic acid, bismuth, mercury, silver, hydrogen peroxide, tannic acid and taurolidine may interact with povidone-iodine and should not be used concomitantly.
Povidone-Iodine products when used concomitantly or immediately after application of octenidine containing antiseptics in the same or adjacent sites may lead to transient dark discolorations in the areas involved.
Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive lab results (e.g., tests with toluidine or gum guaiac for the determination of hemoglobin or glucose in the stool or the urine).
Absorption of iodine from povidone-iodine may interfere with thyroid function tests.
Do not start a new treatment medication without telling the doctor.
For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE) vaginal douche, consult the doctor or pharmacist.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
G01AX11 - povidone-iodine ; Belongs to the class of other antiinfectives and antiseptics. Used in the treatment of gynecological infections.
Presentation/Packing
Vag douche 10% x 120 mL (with kit) 1's.
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