Each gram contains 25 mg POVIDONE-IODINE (BETADINE) equivalent to 2.5 mg available iodine.
POVIDONE-IODINE (BETADINE) dry powder spray is a pressurized aerosol spray for use as a skin antiseptic. It is available in 30 g and 55 g pressurized aerosol aluminum monobloc container.
Pharmacology: Pharmacodynamics: POVIDONE-IODINE (BETADINE) dry powder spray is an organic-solvent formulation, containing povidone-iodine, indicated for treatment and prevention of skin infections in wounds including ulcers, burns, cuts, abrasions and other minor injuries.
It provides an effective barrier to bacteria, viruses, fungi, spores and protozoa allowing wounds to heal without further infection. In addition to its antiseptic properties, the preparation had a tanning effect that prevented early, undesired decomposition of skin that had been burnt. Thus, surgical removal of necrotic tissue could be delayed until the overall condition of the patient was improved. Furthermore, surgical procedures would be facilitated by the clear demarcation of affected tissue from non-affected tissue, resulting from the tanning of the dead layers of skin.
POVIDONE-IODINE (BETADINE) dry powder spray is well tolerated for the skin, mucous membranes and wounds. It is effective against a broad spectrum of human pathogens (e.g. gram-positive and gram-negative bacteria, acid-fast bacteria, spores, fungi, viruses, protozoa and other microorganisms). It has also been proven effective on highly resistant bacteria (e.g. MRSA).
POVIDONE-IODINE (BETADINE) dry powder spray kills bacteria, viruses, fungi, spores and protozoa.
POVIDONE-IODINE (BETADINE) dry powder spray is indicated for treatment and prevention of infection of minor wounds (cuts and abrasions), ulcers, burns and superficial lesion.
Shake well before using POVIDONE-IODINE (BETADINE) dry powder spray. Spray evenly onto the wound area from a distance of 15-25 cm for 3 seconds. Apply twice a day until the wound has healed. If necessary, cover with a dressing.
If there are further questions on the use of POVIDONE-IODINE (BETADINE) dry powder spray, ask the doctor or pharmacist.
Missed Dose: If dose is missed, use it as soon as remembered. Follow the usage instructions.
Signs & Symptoms: In the unlikely event of deliberate or accidental ingestion of large quantities of povidone-iodine acute iodine toxicity is experienced with any of the following symptoms: stomach pain, unable to pass urine, circulatory failure, edema of glottis resulting asphyxia, pulmonary edema, metabolic abnormalities, 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.
POVIDONE-IODINE (BETADINE) dry powder spray 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, as well as 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 nodular colloid goiter, endemic goiter, Hashimoto's thyroiditis.
If the patient is on lithium therapy. In pre-pubertal children.
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) dry powder spray and inform the doctor or pharmacist immediately.
Not for use on children under 2 years of age.
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.
It is a spermicidal and not recommended when conception is desired.
Do not heat POVIDONE-IODINE (BETADINE) dry powder spray prior to use.
Avoid inhaling or spraying into the eyes. Avoid solutions containing a detergent if treating open wounds with povidone-iodine. POVIDONE-IODINE (BETADINE) dry powder spray is intended FOR EXTERNAL USE ONLY.
Not for use on extensive body areas and should not be used over a long period of time (e.g. not to more than 10% of the total body surface and for not longer than 14 days) unless strictly indicated. Even after the end of the treatment (up to 3 months) one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored.
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. 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) dry powder spray should 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.
During pregnancy and lactation, POVIDONE-IODINE (BETADINE) dry powder spray should 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.
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) dry powder spray, consult the doctor or pharmacist.
Note that the side effects related to the use of POVIDONE-IODINE (BETADINE) dry powder spray 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).
Do not apply other medications to the same affected areas treated with POVIDONE-IODINE (BETADINE) dry powder spray, unless the doctor has told so.
The PVP-Iodine complex is effective at pH of between 2.0 and 7.0. It has to be expected that the complex will react with protein and other unsaturated organic compounds, leading to impairment of its effectiveness.
The concomitant use of other externally applied wound healing medicines/preparations may alter the effect of POVIDONE-IODINE (BETADINE) dry powder spray 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.
Using this treatment may interfere with tests on thyroid function and can make a planned treatment of the thyroid with iodine impossible. After the end of the treatment an interval of at least 1-2 weeks should be allowed before a new scintigram is carried out.
Contamination with povidone-iodine of several types of tests for the detection of occult blood in feces or blood in urine may produce false-positive results.
It is not likely that other drugs taken orally or inject will have an effect on externally applied POVIDONE-IODINE (BETADINE) dry powder spray.
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 solution may lower the iodine uptake of the thyroid can lead to interference with various investigations (thyroid scintigraphy, determination of PBI (protein-bound iodine), radioiodine diagnostics and can make a planned treatment of the thyroid with iodine (radioiodine therapy) impossible. After the end of the treatment, an appropriate interval should be allowed before a new scintigram is carried out.
Do not start a new treatment medication without telling the doctor. For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE) dry powder spray, please consult the doctor or pharmacist.
Store at temperatures not exceeding 30°C.
Protect the pressured container from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even when empty. Do not spray on a naked flame or on any incandescent material.
D08AG02 - povidone-iodine ; Belongs to the class of iodine product antiseptics. Used in the treatment of dermatological diseases.
Betadine Dry Powder Spray 2.5% w/w
55 g x 1's (P254/box)