BETADINE * 10GARZE IMPREGN 10x10
Betadine 10% Cutaneous, alcoholic solution: Disinfection and cleaning of damaged skin (wounds, sores). Betadine 1% Mouthwash: Disinfection of the oral mucosa. Betadine 10% Gel: Disinfection of damaged skin (wounds, sores). Betadine 10% Impregnated gauze: Disinfection of damaged skin (wounds, sores).
Dosage and method of use
Betadine 10% Cutaneous, alcoholic solution: It is applied directly to the skin for disinfection before, during and after surgery. The part can be covered with gauze and adhesive bandages. Apply a layer of the brown solution 2 times a day until a medium intensity color is obtained; a surface film is formed which does not stain. A quantity of 5 ml of solution (containing 50 mg of iodine) is sufficient to treat an area of about 15 cm per side. DO NOT EXCEED THE RECOMMENDED DOSE. The alcohol solution is highly flammable: it must dry completely before any devices (especially high frequency surgical devices) are applied. In pre-operative preparation, avoid accumulation under the patient, as chemical skin burns may occur. Prolonged exposure to moisture conditions related to the solution may cause irritation or, rarely, severe skin reactions. Betadine 1% Mouthwash: Dilute to your taste, only when necessary, bearing in mind that the effectiveness is maintained at the dilution of 1 part of Betadine for 2 parts of water, and gargle 2-3 times a day. DO NOT EXCEED THE RECOMMENDED DOSE. Betadine 10% Gel: Apply a light layer of gel directly to the affected area twice a day as needed. 3 g of gel equal to about 15 cm (containing 30 mg of iodine) are sufficient to treat an area of 10 cm per side. DO NOT EXCEED THE RECOMMENDED DOSE. Betadine 10% Impregnated gauze: Apply 1 gauze, 1-3 times a day. DO NOT EXCEED THE RECOMMENDED DOSE.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Hyperthyroidism Do not use in children less than 6 months of age. The mouthwash should not be used in children under 6 years of age.
Undesirable effects are classified according to their frequency: Very common (≥ 1/10) Common (> 1/100 a Immune system disorders Rare Hypersensitivity Very rare Anaphylactic reaction Endocrine pathologies Very rare Hyperthyroidism * (sometimes with symptoms such as tachycardia or agitation) Not known Hypothyroidism *** Metabolism and nutrition disorders Not known Electrolyte imbalance ** Metabolic acidosis ** Respiratory, thoracic and mediastinal disorders Not known Pneumonia ***** (only when using Betadine 1% mouthwash) Skin and subcutaneous tissue disorders Rare Contact dermatitis (with symptoms such as erythema, microvesicles and pruritus) Very rare Angioedema Not known Exfoliative dermatitis Dry skin ^^ (only when using Betadine 10% cutaneous solution, alcoholic) Renal and urinary disorders Not known Acute renal failure ** Abnormal blood osmolarity ** Injury, poisoning and procedural complications Not known Chemical skin burn **** Thermal burn ^ (only when using Betadine 10% cutaneous solution, alcoholic) * In patients with a history of thyroid disease (see section Warnings and special precautions for use) following high iodine uptake, e.g. after long-term use of povidone-iodine solution for the treatment of wounds and burns on large skin areas. ** May occur following uptake of high amounts of povidone iodone (e.g. in the treatment of burns) *** Hypothyroidism following prolonged or extensive use of povidone iodone **** Following "buildup" behind the patient during preoperative preparation ***** Complications due to inhalation - see section 4.4 ^ Due to high flammability, Povidone-iodine alcohol solution must dry completely before devices (especially HF surgical devices) can be used ^^ May occur after repeated applications due to the high alcohol content in the solution; the risk is higher for the genital area (e.g. scrotum) Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Do not use for prolonged treatments. Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on damaged skin. For external use only. The use especially if prolonged can give rise to sensitization phenomena. In this case, stop the treatment and adopt suitable therapeutic measures. Patients with goiter, thyroid nodules or other acute and non-acute thyroid disorders are at risk of developing thyroid hyperfunction (hyperthyroidism) following administration of large amounts of iodine. In this patient population, povidone iodine solution should not be used for an extended period of time and on large body surfaces unless strictly indicated. Even after the end of treatment, the early symptoms of possible hyperthyroidism should be sought and, if necessary, thyroid function should be monitored. Do not use at least 10 days before performing a scintigraphy or after radioactive iodine scintigraphy or in the treatment with radioactive iodine of thyroid cancer. The pediatric population has an increased risk of developing hypothyroidism following applications of high doses of iodine. Due to the permeability of the skin and their high sensitivity to iodine, the use of povidone iodine should be minimized in children. The child's thyroid function may need to be checked (for example, T4 and TSH levels). Any oral ingestion of povidone iodine by the child should be avoided. In pediatric age use only under strict supervision and in cases of real need. The accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal consequences. Avoid contact with eyes Betadine 10% cutaneous, alcoholic solution: Alcoholic solution is highly flammable: it must dry completely before any devices (especially HF surgical devices) are applied. In pre-operative preparation, avoid accumulation under the patient, as chemical skin burns may occur. Prolonged exposure to moisture conditions related to the solution may cause irritation or, rarely, severe skin reactions. In case of skin irritation, contact dermatitis or hypersensitivity, discontinue use. Do not heat before application. Betadine 1% Mouthwash: Care should be taken with oropharyngeal use to avoid inhalation of Betadine 1% mouthwash through the respiratory tract as it can cause complications such as pneumonia. This can particularly occur in intubated patients.
Pregnancy and breastfeeding
During pregnancy and lactation, povidone iodine solution should only be used if strictly necessary and at the lowest possible dose, due to the ability of iodine to cross the placenta and to be secreted into breast milk and the high sensitivity of the fetus and of the newborn to iodine. Furthermore, iodine is more concentrated in breast milk than in serum, therefore it can cause transient hypothyroidism with increased TSH (thyroid stimulating hormone) in the fetus or newborn.
Expiration and retention
Betadine 1% Mouthwash: store at a temperature not exceeding 25 ° C. Betadine 10% Cutaneous, alcoholic solution: store at a temperature not exceeding 25 ° C Betadine 10% Gel and Betadine 10% Impregnated gauze: store at a temperature not exceeding 30 ° C
Interactions with other drugs
Avoid simultaneous use of other antiseptics and detergents. The polyvinylpyrrolidone-iodine complex is effective and stable at pH values between 2.0 and 7.0. It is possible that the complex reacts with proteins or other unsaturated organic compounds, resulting in a reduction in its effectiveness. The concomitant use of preparations with enzymatic components for the treatment of wounds leads to a weakening of the effects of both substances. Povidone iodine should not be used at the same time as products containing mercury salts or benzonium compounds, carbonates, tannic acid, alkalis, hydrogen peroxide, taurolidine and silver. The use of povidone-containing products concomitantly with other antiseptics containing octedin in the same or adjacent sites may cause a momentary darkening of the affected areas. The oxidative effect of povidone-iodine preparations may cause false positive results of some diagnostic laboratory tests (e.g. toluidine or guaiac gum tests for the determination of hemoglobin or glucose in faeces or urine). Avoid habitual use in patients concomitantly treated with lithium Absorption of iodine from povidone-iodine solution may reduce thyroid iodine uptake. This can interfere with various tests (thyroid scintigraphy, determination of iodine-binding proteins, radioactive iodine diagnostics) and can make a planned treatment of the thyroid with iodine (radioactive iodine therapy) impossible. After the end of the treatment, an adequate period of time must elapse before performing a new scintigraphy.
In case of intentional or accidental overdose (highly unlikely for pharmaceutical forms such as gauze) hypothyroidism or hyperthyroidism may occur. Systemic absorption of iodine after repeated applications of the product on extensive wounds or severe burns can produce a range of symptoms such as: metallic taste, increased salivation, burning or stinging in the mouth and throat, irritation or swelling of the eyes, fever, rash skin, diarrhea and gastrointestinal disturbances, hypotension, tachycardia, metabolic acidosis, hypernatremia, renal failure, pulmonary edema and shock. In case of accidental ingestion of large quantities of product, institute symptomatic and supportive treatment with particular attention to the electrolyte balance and renal and thyroid function.
Betadine 10% Cutaneous, alcoholic solution: 100 ml contain: Active ingredient: Iodopovidone (al 10% of iodine) g 10. Betadine 1% Mouthwash: 100 ml contain: Active ingredient: Iodopovidone (al 10% of iodine) g 1.0. Betadine 10% Gel: 100 g of gel or gel contain: Active ingredient: Iodopovidone (al 10% of iodine) g 10. Betadine 10% Impregnated gauze 1 gauze tablet of 1 dm² of 3 g contains: Active ingredient: Iodopovidone (al 10% of iodine) g 0.25. For the full list of excipients, see section 6.1.
Betadine 10% Cutaneous, alcoholic solution: Isopropyl alcohol, Citric acid, Dibasic sodium phosphate, Purified water. Betadine 10% Gel: Polyethylene glycol 400, Polyethylene glycol 4000, Polyethylene glycol 6000, Purified water. Betadine 1% Mouthwash: Ethanol, Glycerol, Eucalyptol, Menthol, Sodium saccharin, Citric acid monohydrate, Dibasic sodium phosphate dihydrate, Potassium iodate Purified water. Betadine 10% Impregnated gauze: Polyethylene glycol 400, Polyethylene glycol 4000, Polyethylene glycol 6000, Purified water.