Betadine Throat Spray

BETADINE u00ae 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.
• oral hygiene prior, during and after dental and oral surgery, e.g. after tonsillectomy and dental procedures.

Posology

For oromucosal use only.

Paediatric Population

Not to be used in children below 6 years of age.

Method of administration

Adult and children aged 6 years and above: one spray onto the back of the throat or affected area every 3 u2013 4 hours as needed, up to 3 sprays per day for a maximum of 7 days.

1. Remove the cap from the nozzle.
2. Please note that the pump has to be completely pushed down before spraying.
3. Tilt your head back slightly, open your mouth and aim the nozzle towards the back of the throat.
4. Hold your breath and press the pump down to spray. Do not breathe in the spray.
5. Wipe the nozzle and place the cap back after use.

• Hypersensitivity to iodine or povidone or to any of the excipients listed in section 6.1.
• Not to be used in hyperfunction of the thyroid (hyperthyroidism) or other manifest thyroid diseases.
• Not to be used 4 weeks before, during or 4 weeks after radioiodine administration (see section 4.4 Special warning and precautions).
• Not to be used in patients on concurrent lithium therapy.
• Children under 6 years of age.

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism from the administration of large amounts of iodine. In this patient population povidone-iodine should not be used for an extended period of time (e.g., for no 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.

It should not be used prior to or after radioiodine scintigraphy or radioidine treatment of thyroid carcinoma until a lasting cure has been obtained. After the end of the treatment, 4 weeks should be allowed before a new scintigram or radioiodine treatment is carried out (see section 4.3).

In oropharyngeal use, precautions should be taken to prevent aspiration of BETADINE u00ae THROAT SPRAY into the respiratory tract as this may cause complications such as pneumonitis. This may particularly occur in intubated patients.

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.

Newborns and small infants are at increased risk of developing hypothyroidism from the administration of large amounts of iodine. Because of 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 the childu2019s thyroid function (e.g. T4 levels and TSH levels) may be necessary. Any possible oral ingestion of the product by the infant must be absolutely avoided.

In instances of local irritation or sensitivity, discontinue use.

BETADINE u00ae THROAT SPRAY contains 40 mg of alcohol (ethanol) in each dose (spray). The amount in each dose (spray) of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in BETADINE u00ae THROAT SPRAY will not have any noticeable effects.

Flammable, contains alcohol: keep away from open flames or heat. Do not heat prior to application. For mouth and throat only.

The PVP-iodine complex is effective at pH values 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.

Use should be avoided in patients receiving concomitant lithium therapy (see Section 4.3). The concomitant use of wound-treatment preparations containing enzymatic components leads to a weakening of the effects of both substances. Products containing mercury, silver, hydrogen peroxide and taurolidine may interact with povidone-iodine and should not be used concomitantly. Simultaneous use with mercury products may lead to the formation of a substance, which can damage the skin.

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.

Effects on diagnostic tests

Absorption of iodine from BETADINE u00ae THROAT SPRAY may interfere with thyroid function tests or radioiodine therapy. During the use of BETADINE u00ae THROAT SPRAY the iodine uptake of the thyroid can be lowered; this 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, 4 weeks should be allowed before a new scintigram is carried out.

Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive laboratory results (e.g. tests with toluidine or gum guaiac for the determination of haemoglobin or glucose in the stool or the urine).

During pregnancy and lactation, BETADINE u00ae THROAT SPRAY, should only be used if strictly indicated and its use should be kept to the absolute minimum. Because of the ability of iodine to pass through the placenta and be secreted in breast milk. and because of the increased sensitivity of the foetus and newborn to iodine, large amounts of BETADINE u00ae THROAT SPRAY should not be administered during pregnancy and lactation. Moreover, iodine is concentrated in the breast milk, as compared with the serum. Povidone-iodine use may induce transient hypothyroidism with elevation of TSH (thyroid stimulating hormone) in the foetus or in the newborn. A check of the newbornu2019s thyroid function may be necessary, especially in areas known for endemic low dietary iodine and high prevalence of goitre. Any oral ingestion of the solution by the newborn or infant must be avoided.

Fertility

No data is available.

BETADINE u00ae THROAT SPRAY has no influence on the ability to drive and use machines.

Respiratory, thoracic and mediastinal disorders

Frequency unknown: Pneumonitis

Immune system disorders

Less frequent: Hypersensitivity, anaphylactic reaction

Endocrine disorders

Less frequent: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness)

Frequency unknown: Hypothyroidism

Metabolism and nutrition disorders

Frequency unknown: Electrolyte imbalance *, metabolic acidosis *

Skin and subcutaneous tissue disorders

Less frequent: Contact dermatitis (with symptoms such as urticaria, erythema, small blisters and pruritus), angioedema

Renal and urinary disorders

Frequency unknown: Acute renal failure*, Blood osmolarity abnormal *

Injury, poisoning and procedural complications

Frequency unknown: Chemical burn of skin

* May occur following uptake of large amounts of povidone-iodine (e.g. in the treatment of burns)

** Hypothyroidism following prolonged or extensive use of povidone-iodine

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 Alternatively report to: [email protected]

Signs and Symptoms

In the case of deliberate or accidental ingestion of large quantities of povidone-iodine acute iodine toxicity is manifested by abdominal symptoms, anuria, circulatory failure, oedema of glottis resulting in asphyxia, or pulmonary oedema and metabolic abnormalities.

Systemic toxicity may result in renal impairment (including anuria), tachycardia, hypotension, circulatory failure, oedema of glottis resulting in asphyxia, or pulmonary oedema, seizures, fever and metabolic acidosis. Hyperthyroidism or hypothyroidism may also develop.

Treatment

The overdose effects that can occur are due to iodine toxicity and often require specialised treatment in a hospital setting. For severe hypotension, intravenous fluid should be administered; vasopressors should be added if necessary. Endotracheal intubation may be required if caustic injury to the upper airway results in significant swelling and oedema. Vomiting should not be induced. Patient should be maintained in a position to keep the airways open and prevent aspiration (in case of vomiting). If the patient is not vomiting and can tolerate oral feeding, then ingestion of starchy food (e.g. potato, flour, starch, bread) may help convert iodine to less toxic iodide. Haemodialysis effectively clears iodine and should be employed in severe cases of iodine poisoning particularly if renal failure is present. Continuous venovenous haemodiafiltration is less effective than haemodialysis. In case of thyroid dysfunction, treatment with povidone-iodine should be discontinued.