Betadine Gargle and Mouthwash/Betadine Sore Throat Spray

Betadine Gargle and Mouthwash/Betadine Sore Throat Spray

povidone iodine

Manufacturer:

Mundipharma

Distributor:

DKSH
Full Prescribing Info
Contents
Povidone-iodine.
Description
Betadine Sore Throat Spray: Betadine Sore Throat Spray may also contain the following excipients: Glycerol, menthol, eucalyptus oil, potassium iodide, purified water.
Action
Pharmacology: Betadine Gargle and Mouthwash: Numerous studies have established the rapid microbicidal activity of povidone-iodine contained in Betadine germicides, both in vitro and in vivo.
Povidone-iodine is active in the presence of serum, blood, purulent exudate and necrotic tissue. It can be used for the preparation of skin and mucous membranes and for burn and wound disinfection without the risk of systemic toxicity.
Povidone-iodine, as contained in Betadine germicides, is not inactivated by soap.
Betadine Sore Throat Spray: Pharmacodynamics: Povidone-iodine is a complex of the polymer polyvinylpyrrolidone with iodine (povidone-iodine) which, after application, continues to deliver iodine over a period of time. Elemental iodine ( I2 ) has long been known as a highly effective microbicidal agent that rapidly kills in vitro. Two (2) mechanisms are involved: Free iodine rapidly causes microbial killing, whereas iodine bound to the polymer serves as a reservoir. As the preparation comes in contact with the skin and mucous membranes, more and more iodine dissociates from the polymer. The free iodine reacts with oxidizable –SH or –OH groups of the amino acids in the enzymes and structural proteins of microorganisms thereby inactivating and killing these enzymes and proteins. Most vegetative microorganisms are killed in less than a minute in vitro, with many destroyed within 15-30 sec. During this process, iodine is decolorized, thus, the intensity of brown coloration serves as indicator of its effectiveness. Repeated dosing may be required upon discoloration. Resistance has not been reported.
Pharmacokinetics: Absorption: In normal individuals, topical application results in very little systemic iodine absorption. Betadine Sore Throat Spray is intended for local use to the mouth and throat.
Povidone (PVP): Absorption and, in particular, renal elimination of povidone depend on the (mean) molecular weight (of the mixture). For molecular weights of >35,000-50,000, retention must be expected.
Iodine: The behavior of absorbed iodine or iodide in the organisms is largely similar to that of iodine taken up by other routes. The volume of distribution corresponds to approximately 38% of body weight in kg.
Elimination is almost exclusively by renal route with a clearance of 15-60 mL plasma/min depending on serum iodine level and creatinine clearance.
Toxicology: Preclinical Safety Data: Acute Toxicity: In experimental animal investigations (mouse, rat rabbit, dog), acutely toxic effects were found after systemic administration (oral, IP, IV) only with excessively high doses that are of no significance for the local use of povidone-iodine.
Chronic Toxicity: Subchronic and chronic tests for toxicity were carried out on rats, among other animals, in the form of the admixture of povidone-iodine (10% available iodine ) into the feed in dosages of between povidone-iodine 75 and 750 mg/day and kg body weight for up to 12 weeks. After the povidone-iodine addition was stopped, only the practically completely reversible and dose-dependent rises in protein-bound iodine in the serum and non-specific histopathologic changes in the thyroid gland were observed. Similar changes also occurred in the control group, which received potassium iodide in iodine-equivalent amounts instead of povidone-iodine.
Mutagenic and Tumor-Inducing Potential: A mutagenic action for povidone-iodine can be ruled out. No carcinogenicity studies have been conducted, no information is, therefore, available.
Reproductive Toxicity: Because of the ability of iodine to pass through the placenta and the sensitivity of the foetus to pharmacologic doses of iodine, no larger amounts of iodine should be absorbed during pregnancy. The use of povidone-iodine in obstetrics may lead to a significant rise in serum iodine concentration in the mother and to transient hypofunction of the thyroid gland with elevation of thyroid-stimulating hormone concentration in the neonate. Moreover, iodide is concentrated in the milk, as compared with the serum.
Indications/Uses
Betadine Gargle and Mouthwash: Oral hygiene, inflammatory conditions of the mouth, sore throat.
Betadine Sore Throat Spray: For protection and symptomatic relief of sore throat and mouth ulcers.
For oral hygiene prior to, during and after dental and oral surgery.
Dosage/Direction for Use
Betadine Gargle and Mouthwash: Gargle or rinse for 30 sec. Repeat every 2-4 hrs.
Betadine Sore Throat Spray: Spray to the mucous membrane of the throat several times a day (every 3-4 hrs).
Overdosage
Betadine Gargle and Mouthwash: In cases of deliberate or accidental ingestion of large quantities, provide supportive and symptomatic treatment. Thyroid function should be monitored.
Betadine Sore Throat Spray: 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, edema of glottis resulting in asphyxia, or pulmonary edema and metabolic abnormalities.
Treatment is symptomatic and supportive.
Contraindications
Betadine Sore Throat Spray: Hypersensitivity to iodine or povidone or any other of the excipients (see Description) of Betadine Sore Throat Spray.
Not to be used in hyperfunction of the thyroid (hyperthyroidism), other manifest thyroid diseases, as well as before and after radioiodine therapy for hyperthyroidism, until a lasting cure has been obtained. It should not be used for 4 weeks prior to radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma. Patients with goiter, thyroid nodules, or other thyroid diseases (especially elderly patients) are at risk of developing thyroid hyperfunction (hyperthyroidism) from the administration of large amounts of iodine.
Not to be used in patients on concurrent lithium therapy.
Use in children: Not to be used in children <6 years.
Special Precautions
Betadine Gargle and Mouthwash: A patch test should be performed in rare cases of iodine sensitivity. In the case of thyroid dysfunction, careful monitoring is advised.
Betadine Sore Throat Spray: Povidone-iodine should not cover for a long period large areas of the skin (eg, not to >10% of the total body surface and for not >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 preexisting renal insufficiency.
For mouth and throat only.
In instances of local irritation or sensitivity, discontinue use.
Effects on the Ability to Drive or Operate Machinery: None known.
Use in pregnancy & lactation: During pregnancy and lactation, Betadine Sore Throat Spray should only be used if strictly prescribed by the physician and its use should be kept to the absolute minimum, as absorbed iodine can cross the placental barrier and can be secreted in breast milk. Povidone-iodine use may induce transient hypothyroidism in the foetus or in the newborn. Povidone-iodine should be avoided in such situations. In these cases, a check of the child’s thyroid function is necessary, especially in areas known for endemic low dietary iodine and tendency to goiter. Also, any possible ingestion of the throat spray by the infant must be absolutely avoided.
Use In Pregnancy & Lactation
During pregnancy and lactation, Betadine Sore Throat Spray should only be used if strictly prescribed by the physician and its use should be kept to the absolute minimum, as absorbed iodine can cross the placental barrier and can be secreted in breast milk. Povidone-iodine use may induce transient hypothyroidism in the foetus or in the newborn. Povidone-iodine should be avoided in such situations. In these cases, a check of the child’s thyroid function is necessary, especially in areas known for endemic low dietary iodine and tendency to goiter. Also, any possible ingestion of the throat spray by the infant must be absolutely avoided.
Adverse Reactions
Betadine Gargle and Mouthwash: Local irritation may be experienced.
Betadine Sore Throat Spray: May produce mucous irritation of the mouth as well as hypersensitivity reaction. In instances of local irritation on sensitivity, discontinue use.
Drug Interactions
Betadine Sore Throat Spray: The PVP-iodine complex is effective at pH values of between 2 and 7. 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 products containing enzymatic component, hydrogen peroxide, silver and taurolidine lead to a weakening effect of both substances.
Simultaneous use with mercury products may lead to the formation of a substance, which can damage the skin.
Using this treatment may interfere with tests or 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 faeces or blood in urine may produce false-positive results.
Incompatibilities: The activity of povidone-iodine is reduced in the presence of alkali, hydrogen peroxide, taurolidine, tannic acid, acetylsalicylic acid, all silver, bismuth and mercury salts.
Storage
Store at or below 25°C.
Shelf-Life:
3 years.
ATC Classification
R02AA15 - povidone-iodine ; Belongs to the class of antiseptics used in throat preparations.
Presentation/Packing
Betadine Gargle and Mouthwash: 1% x 100 mL, 190 mL, 1 L. Betadine Sore Throat Spray: 0.45% x 50 mL.
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