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The dose is proportionate to the size of the area to be treated.
Spray once or multiple times daily on the area to be treated until this is visibly covered with the golden-brown coloured povidone-iodine powder.
In the event the Betadine Topical Spray becomes discoloured, it may be reapplied.
New-borns and infants under 6 months: Betadine Topical Spray may only be used in new-borns and infants up to the age of 6 months after a thorough risk-benefit analysis has been carried out by the doctor, and applied only to a very limited extent.
Route of administration: Betadine Topical Spray is intended for external use.
Betadine Topical Spray forms a dry film on the treated area and can be washed
Shake the spray can well before use, hold upright and spray from a distance of 15 cm on the area to be treated. The propellant evaporates immediately and the cold sensation experienced when the product is sprayed on quickly disappears.
If necessary, a dressing can then be applied on top.
Duration of administration: Betadine Topical Spray should continue to be administered for as long as there is evidence of an infection or a clear risk of infection. Should an infection recur after treatment with Betadine Topical Spray has been discontinued, then treatment may be reinitiated at any time.
As antiseptic for prevention and treatment of infections associated with burns, cuts and scrapes, and for preventive treatment of wounds at risk of infection, e.g. after placement of a suture for wound treatment or after surgery.
Hypersensitivity to the active ingredient or to one of the other excipients.
Hyperthyroidism or other manifesting thyroid diseases.
Dermatitis herpetiformis (Duhring’s disease).
Use in conjunction with products containing mercury.
Use in conjunction with octenidine-based antiseptics.
Before and after radioactive iodine therapy (until the treatment is concluded).
Before radioactive iodine scintigraphy for thyroid testing.
Before radioactive iodine treatment for thyroid cancer.
Due to the texture and sensitivity of the skin of new-borns and infants up to the age of 6 months to iodine, povidone-iodine may only be used after strict diagnosis, as the risk of hyperthyroidism (particularly if larger quantities are applied) cannot be completely excluded. If applicable, the thyroid function (e.g. T4 and TSH values) should be monitored.
Infants and small children must be prevented from ingesting povidone iodine.
In the case of latent thyroid function disorder (particularly in elderly patients and patients with goitre or thyroid nodules) Betadine Topical Spray should only be used over an extended period (more than 14 days) or over a large surface area (more than 10% of the surface of the body) after a thorough risk-benefit analysis, to avoid the risk of subsequent hyperthyroidism. It is necessary, to be vigilant in these patients for early symptoms of hyperthyroidism and, if applicable, to monitor thyroid function, even after the treatment has been discontinued (for up to 3 months).
Caution, do not inhale spray mist and do not spray into eyes or near the eye area.
Propellants are flammable. The spray mist can ignite. Caution is therefore advised in the vicinity of open flames. Do not undertake electrocautery until the spray mist has completely dissipated.
Immune system disorders: Rare: Hypersensitivity. Very rare: Anaphylactic reaction frequently accompanied by hypotension, dizziness, nausea and possible respiratory distress.
Endocrine disorders: Very rare: Iodine-induced hyperthyroidism in predisposed individuals (sometimes accompanied by the symptoms of tachycardia or anxiety; Unknown: Hypothyroidism.
Metabolism and nutrition disorders: Unknown: Electrolyte imbalance, metabolic acidosis.
Skin and Subcutaneous Cell Tissue Disorders: Rare: Hypersensitivity reactions of the skin (for example delayed contact allergy reactions, which may manifest in the form of, for example, pruritus, erythema, blisters or similar.) Very rare: Angioedema.
Renal and urinary disorders: Unknown: acute kidney failure, anomalous osmolarity of the blood.
See prescribing information for full details.
Concomitant use of povidone-iodine and hydrogen peroxide, enzymatic wound
treatment agents or those containing silver or taurolide, or antiseptics may lead to mutually reduced efficacy.
The use of Betadine Topical Spray in conjunction with taurolidine should be avoided, as taurolidine may metabolise to formic acid, which causes intense burning.
Povidone-iodine may not be used in conjunction with products containing mercury, as caustic mercury iodide may form.
Povidone-iodine may not be used in conjunction with octenidine-based antiseptics, as this may result in temporary dark discolorations.
The povidone-iodine complex is active at a pH value between 2.0 and 7.0. It is
anticipated that povidone-iodine may react with protein and various other organic substances such as blood and pus constituents for example, which may impair its efficacy; this can be compensated for with a higher dose of povidone-iodine.
Longer-term application, particularly over a large surface area should be avoided in patients undergoing lithium therapy, as larger quantities of iodine may be absorbed.
Influence on diagnostic tests: The use of Betadine Topical Spray can reduce iodine uptake by the thyroid; this can lead to problems during various tests (thyroid scintigraphy, PBI (protein-bound iodine) determination and radioactive iodine diagnostics), and can make planned radioactive iodine therapy impossible. An interval of 1-2 weeks after discontinuation of povidone-iodine treatment should be observed.
Due to the oxidising effect of povidone-iodine, various diagnostic agents can deliver false-positive results (including toluidine and guaiacum resin for determining haemoglobin or glucose in stools or urine).
Pregnancy and Lactation
Povidone-iodine is not teratogenic.
Use in pregnant women and during lactation should be strictly indicated and povidone-iodine used to an extremely limited extent. In pregnant women or during lactation, monitoring of the thyroid function in the mother and the infant respectively is indicated. Povidone-iodine may induce temporary hypothyroidism (elevated TSH).
Iodine passes through the placental barrier and into the breast milk. In addition, iodine is present in higher concentrations in breast milk compared with the serum.
Accidental oral intake of Betadine Topical Spray by the infant as the result of contact with the treated area of the body of the breastfeeding mother must be avoided.
Symptoms of an overdose: Symptoms of intoxication have been reported in the literature in relation to an intake exceeding 10 g povidone-iodine. These symptoms are: abdominal pain and cramping, nausea, vomiting, diarrhoea, dehydration, hypotension with tendency tocollapse, glottic oedema, tendency to bleed (mucous membranes, kidneys), cyanosis, kidney damage culminating in anuria, paraesthesia, fever and pulmonary oedema.
Prolonged, excessive intake of iodine may result in symptoms of hyperthyroidism, tachycardia, anxiety, tremor, or headache.
Therapy for overdose: Immediate administration of foodstuffs containing starch and protein (for example, corn-starch stirred into water or milk), if necessary gastric lavage with 5% sodium thiosulphate solution (or 10 ml 10% sodium thiosulphate solution i.v.) at 3-hourly intervals. After absorption has already taken place, toxic serum-iodine levels can be reduced by means of peritoneal dialysis or haemodialysis.
Furthermore, the thyroid function must be subject to careful clinical monitoring to facilitate exclusion or early detection of possible hyperthyroidism.
Further treatment is determined based on any other presenting symptoms such as metabolic acidosis and renal function disorders for example.
Storage: Easily flammable. Store below 25ºC. Do not expose to temperatures above 50°C. Keep away from potential sources of inflammation.
Incompatibilities: Povidone-iodine is incompatible with reducing agents, alkaloid salts, tannic acid, salicylic acid, silver, mercury and bismuth salts, taurolidine, hydrogen peroxide, and octenidine.