Betadine Gargle & Paint/Betadine Throat Spray

Betadine Gargle & Paint/Betadine Throat Spray

povidone iodine

Manufacturer:

Mundipharma

Distributor:

Zuellig
Full Prescribing Info
Contents
Povidone-iodine.
Description
Gargle: Each mL of Betadine Gargle contains povidone-iodine 10 mg equivalent to available iodine 1 mg.
Paint: Each mL of POVIDONE-IODINE (BETADINE) contains 100 mg povidone-iodine equivalent to 10 mg available iodine.
POVIDONE-IODINE (BETADINE) paint is an antiseptic. It contains the broad spectrum germicide povidone-iodine which retains all the advantages of elemental iodine without staining or sensitizing.
POVIDONE-IODINE (BETADINE) paint is effective in killing all pathogens, including bacteria, viruses, fungi, protozoa and spores.
POVIDONE-IODINE (BETADINE) paint provides rapid, prolonged and complete antiseptic power and is fully effective in the presence of blood, pus, serum and dead tissue. Betadine Gargle & Paint is a powerful germicidal solution that rapidly kills harmful microorganisms in the mouth. It is active even in the presence of blood or pus. Its dark amber color indicates a potent iodine germ-killing power.
Betadine Gargle & Paint is refreshing, well-tolerated and does not stain teeth.
Throat Spray: Each mL contains: Povidone-Iodine, EP 4.5 mg (equivalent to 0.45 mg available iodine).
POVIDONE-IODINE (BETADINE) throat spray is a powerful antiseptic scientifically proven to eliminate numerous types of harmful microorganisms like bacteria, viruses and fungi.
POVIDONE-IODINE (BETADINE) throat spray contains the broad spectrum antiseptic povidone-iodine which retains all the advantages of elemental iodine without staining or sensitizing.
Indications/Uses
Gargle: Oral germicide for fast and soothing relief of sore throat and mouth sores. Breath freshener, where excessive bacteria in the mouth is present. Mouthwash for oral hygiene of postoperative or bedridden patients. Oral antiseptic before and after dental operations or tooth extractions. Ideal degerming soak for dentures and toothbrushes.
Paint: As a general topical and quick-drying antiseptic in the treatment and prevention of infection. It is ideal for mouth sores (aphthous ulcers), herpes simplex, herpes zoster (shingles), herpes labialis (cold sores), grazes, abrasions, cuts and wounds, or any break in the skin which requires protection from infection.
BETADINE paint is effective in the treatment of dermal infections caused by bacteria, viruses and fungi.
Throat Spray: POVIDONE-IODINE (BETADINE) throat spray is indicated for the treatment of acute mucosal infections of the mouth and pharynx including stomatitis, gingivitis, aphthous ulcers, pharyngitis, tonsillitis, monilial infections, common colds and influenza.
For oral hygiene prior to, during and after dental and oral surgery.
For fast and soothing relief of sore throat.
Dosage/Direction for Use
Gargle: For sore throat and mouth infections, pour 15 mL (3 tsp) into glass and gargle for 30 seconds. Repeat for 2-4 times daily or as required. As a mouth wash, use 15 mL (3 tsp) Betadine oral antiseptics full strength or diluted with an equal amount of water. Gargle for 30 seconds. Repeat as directed.
Paint: Use POVIDONE-IODINE (BETADINE) paint as prescribed by the doctor or apply undiluted to the affected area and allow to dry. Use twice daily.
The plastic applicator provided with POVIDONE-IODINE (BETADINE) paint is for ease of application to minor wounds and infections. It facilitates treatment of herpetic conditions such as cold sores and shingles. Rinse the plastic applicator thoroughly with clean water after use. Once the plastic applicator has been used in the mouth, never use it on other parts of the body and vice versa.
If there are further questions on the use of POVIDONE-IODINE (BETADINE) paint, ask the doctor or pharmacist.
Throat Spray: Spray to the mucous membrane of the throat several times a day (every 3-4 hours) or as directed by the doctor.
Overdosage
Signs & Symptoms: In the unlikely event to experience 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) should not be used: If the patient is allergic to iodine or povidone.
If the patient has an 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) and inform the doctor or pharmacist immediately.
Throat Spray: POVIDONE-IODINE (BETADINE) throat spray should not be used: Before and after radioiodine therapy for hyperthyroidism, until a lasting cure has been obtained; not be used for 4 weeks prior to radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma; if the patient has goiter, thyroid nodules, or other thyroid diseases.
Not to be used in children below 6 years old.
Special Precautions
If mouth and throat soreness persist, consult physician.
Use in Children: Do not give to children <3 years.
Paint: 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 the POVIDONE-IODINE (BETADINE) paint prior to use.
Avoid getting POVIDONE-IODINE (BETADINE) paint in the eyes. Avoid solutions containing a detergent if treating open wounds with povidone-iodine.
POVIDONE-IODINE (BETADINE) paint 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.
If symptoms persist, consult the doctor.
Use in Pregnancy and Lactation: During pregnancy and lactation, POVIDONE-IODINE (BETADINE) should only be used if strictly prescribed by the doctor and its use should be kept to the absolute minimum. Seek medical advice from the doctor or pharmacist.
Use In Pregnancy & Lactation
During pregnancy and lactation, POVIDONE-IODINE (BETADINE) should only be used if strictly prescribed by the doctor and its use should be kept to the absolute minimum. Seek medical advice from the doctor or pharmacist.
Side Effects
All medicines can have side effects. Sometimes they are serious, most of the time they are not. The patient may need medical attention if he/she 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), please consult the doctor or pharmacist.
Note that the side effects related to the use of POVIDONE-IODINE (BETADINE) 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 under Dosage & Administration, may lead to possible absorption of iodine into the body. This may lead to: Overactive thyroid gland function if there is 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 treated with POVIDONE-IODINE (BETADINE), unless the doctor has told so.
It is not likely that other drugs the patient takes orally or inject will have an effect on externally applied POVIDONE-IODINE (BETADINE).
The concomitant use of other externally applied wound healing medicines/preparations may alter the effect of POVIDONE-IODINE (BETADINE). Products containing enzymatic component, alkali, 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), please consult the doctor or pharmacist.
Storage
Store at temperatures not exceeding 30°C.
Paint: Discard when preparation is no longer golden-brown.
MIMS Class
Preparations for Oral Ulceration & Inflammation
ATC Classification
D08AG02 - povidone-iodine ; Belongs to the class of iodine product antiseptics. Used in the treatment of dermatological diseases.
R02AA15 - povidone-iodine ; Belongs to the class of antiseptics used in throat preparations.
Presentation/Packing
Betadine Gargle: Gargle 1% (mint-flavor) x 60 mL, 120 mL, 240 mL, 500 mL. Betadine Paint: Paint 10% x 10 mL. Betadine Throat Spray: Throat spray 0.45% x 50 mL x 1's.
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