BETADINE 10% SKIN SOLUTION

023907052
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023907052
12 Items

BETADINE 10% SKIN SOLUTION

Therapeutic indications

Disinfection and cleaning of damaged skin (wounds, sores, etc.).

Dosage and method of use

It is applied twice a day directly on small wounds and skin infections. A quantity of 5 ml of solution (containing 50 mg of iodine) is sufficient to treat an area of about 15 cm per side. For skin antisepsis: apply a protective layer of the brown solution until a medium intensity color is obtained: a surface film is formed that does not stain.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hyperthyroidism. Do not use in children under six months of age.

Side effects

Undesirable effects are classified according to their frequency: Very common (≥ 1/10); Common (> 1/100 a Disorders of the immune system. 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 **. Skin and subcutaneous tissue disorders. Rare Contact dermatitis (with symptoms such as erythema, microvesicles and pruritus) Very rare: Angioedema; Not known: Exfoliative dermatitis. Renal and urinary disorders. Not known: Acute renal failure **, Abnormal blood osmolarity **. * 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-iodine (e.g. in the treatment of burns) *** Hypothyroidism following prolonged or extensive use of povidone-iodone 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-reazioneavversa.

Special warnings

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, 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 (eg 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 and sometimes fatal consequences. Avoid contact with eyes.

Pregnancy and breastfeeding

During pregnancy and lactation, povidone-iodine solution should only be used when 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. In addition, iodine is more concentrated in breast milk than serum, therefore it can cause transient hypothyroidism with increased TSH (thyroid stimulating hormone) in the fetus or newborn.

Expiration and retention

Betadine 10% cutaneous solution: store at a temperature not exceeding 25 ° C.

Interactions with other drugs

Avoid simultaneous use of other antiseptics and detergents. The polyvinylpyrrolidone-iodine complex is effective 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 simultaneously with products containing mercury salts or benzoin compounds, carbonates, tannic acid, alkali, 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 temporary dark coloration of the affected areas. The oxidative effect of povidone-iodine preparations may cause false positive results of some diagnostic laboratory tests (for example, 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.

Overdose

In the event of an overdose, whether intentional or accidental, 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 disorders, 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.

Active principles

Betadine 10% 100 ml cutaneous solution contain: Active principle: Povidone iodine (al 10% iodine) 10 g. For the full list of excipients, see section 6.1.

Excipients

Betadine 10% cutaneous solution: Glycerol, Macrogol lauryl ether, Dibasic sodium phosphate dihydrate, Citric acid monohydrate, Sodium hydroxide, Purified water.

023907052
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