BETADINE SOLUTION CUT 125ML 10%

BETADINE 10% CUTANEA DEVELOPMENT

active ingredients

Betadine 10% cutaneous solution 100 ml contain: Active ingredient: Iodopovidone (to 10% iodine) g 10 For full list of excipients, see paragraph 6.1.

Excellent

Betadine 10% cutaneous solution: Glycerol, Macrogol lauriletere, Sodium bibasic phosphate, Monohydrate citric acid, Sodium hydroxide, Purified water.

Therapeutic indications

Disinfection and cleansing of the skin (small surface wounds, decubited sores with limited interest to the epidermis).

Contraindications

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

Population

Betadine 10% cutaneous solution: It applies 2 times a day directly on small wounds and skin infections. A quantity of 5 ml solution (containing 50 mg of iodine) is sufficient to treat an area of about 15 cm on the side. For skin antisepsis: apply a protective layer of the brown solution to obtain a medium intensity coloring: a surface film that does not stain is formed.

Conservation

Betadine 10% skin solution: Store at a temperature not exceeding 25°C

Warnings

Only for external use. This medicine should not be applied on severely injured skin and on extended surfaces. Do not use for prolonged treatments: use of species if prolonged can give rise to awareness phenomena. In this case, the treatment must be stopped and a clinical evaluation must be carried out. Particular caution should be used in patients with pre-existing kidney failure that need regular Betadine applications on skin lesa (see paragraph 5.2). Patients with goiter, thyroid nodules or other acute and non-acute thyroid pathologies are at risk of developing thyroid hyperfunction (hyperthyroidism) as a result of administration of large amounts of iodine. In this population of patients, the solution of iodopovidone should not be used for a prolonged period of time and extensive body surfaces. Even after the end of the treatment it is necessary to seek the early symptoms of possible hyperthyroidism and to monitor the thyroid function. Do not use at least 10 days before making a scintigraphy or after scintigraphy with radioactive iodine or in treatment with radioactive iodine of thyroid carcinoma. The pediatric population is more likely to develop hypothyroidism as a result of high doses of iodine. Due to the permeability of the skin and their high sensitivity to iodine, the use of ioodopovidone must be reduced to the minimum indispensable in children. A control of the thyroid function of the child may be necessary (e.g. levels of T4 and TSH). Any oral ingestion of hypopovidone by the child must be avoided. In pediatric age use only under strict control and in cases of actual need. Ingestion or accidental inhalation of some disinfectants may have serious consequences sometimes fatal. Avoid contact with eyes.

Interactions

Avoid the contemporary use of other antiseptics and detergents. The polyvinylpyrrolidone-idine 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, and that this determines a reduction of its effectiveness. The concomitant use of preparations with enzyme components for the treatment of wounds causes a weakening of the effects of both substances. Hyodopovidone should not be used at the same time as mercury salts or benzoin compounds, carbonates, tannic acid, alkali, hydrogen peroxide, taurolidine and silver. The use of products containing iodopovidone in conjunction with other antiseptics containing octedine in the same locations or in adjacent locations can cause a momentary dark coloring of the affected areas. The oxidative effect of the preparations based on hypopovidone can cause false positive results of some laboratory diagnostic tests (e.g. tests with toluidine or gum of sheath for the determination of hemoglobin or glucose in feces or urine). Avoid regular use in patients in contemporary treatment with lithium. The absorption of iodine from the solution of iodopovidone can reduce thyroid captation of iodine. This can interfere with different examinations (thyroid science, iodine binding protein determination, diagnostic with radioactive iodine) and can make a planned treatment of thyroid with iodine impossible (radioactive iodine therapy). After the end of the treatment, before performing a new scintigraphy it is necessary to spend an appropriate period of time.

Effects

Undesirable effects are classified according to their frequency: Very common (≥ 1/10); Common (> 1/100 to Immune System Disorders. Rare: Hypersensitivity; Very rare: Anaphylactic reaction. Endocrine diseases. Very rare: Hyperthyroidism* (sometimes with symptoms such as tachycardia or agitation); Notable: Hypothyroidism. Disorders of metabolism and nutrition. Notable: Electrolytic imbalance **, metabolic acidosis **. Pathologies of skin and subcutaneous tissue. Raro: Contact dermatitis (with symptoms such as erythema, microvescicles and itching); Very rare: Angioedema; Notable: Exfoliatory dermatitis. Kidney and urinary pathologies. Notable: Acute renal insufficiency**, abnormal blood osmolarity*. *In patients with history of thyroid pathologies (see paragraph Warnings and special precautions of use) following high iodine caption, for example after long-term use of hypopovidone solution for the treatment of wounds and burns on extended skin areas. **It may occur as a result of high amounts of iodopovidone (e.g. in the treatment of burns). Hypothyroidism following prolonged or extended use of hypopovidone. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

In case of overdose, intentional or accidental, hypothyroidism or hyperthyroidism may occur. Systemic absorption of iodine after repeated applications of the product on extended wounds or severe burns can produce a number of symptoms such as: metallic flavor, increased salivation, burning or pungent pain in the mouth and throat, irritation or swelling in the eyes, fever, skin rash, diarrhea and gastrointestinal disorders, hypotension, tachycardia, metabolic acidosis, hypernatriemia, kidney function failure, pulmonary edema and shock. In case of accidental ingestion of high quantities of product establish a symptomatic and support treatment with particular attention to the electrolytic balance and renal and thyroid function.

During pregnancy and breastfeeding, the solution of iodopovidone should only be used if strictly necessary and at the minimum possible dose, due to the ability of iodine to cross the placenta and to be secreted in breast milk and for the high sensitivity of the fetus and the newborn to iodine. Iodine also concentrates more in breast milk than serum, therefore it can cause transient hypothyroidism with increase of TSH (the thyroid stimulating hormone) in the fetus or in the newborn

Source: Farmadati