Solution for external and local use "Betadine®" is used for the following indications:
- disinfection of hands and antiseptic treatment of mucous membranes, for example, before surgery, gynecological and obstetric procedures, bladder catheterization, biopsy, injections, punctures, blood sampling, as well as first aid in case of accidental contamination of the skin with infected material;
- antiseptic treatment of wounds and burns;
- hygienic and surgical hand disinfection.
Compound
The active substance is povidone-iodine (1 ml of the solution contains 100 mg of povidone-iodine).
Excipients: glycerin (85%), nonoxynol 9, anhydrous citric acid, anhydrous sodium hydrogen phosphate, sodium hydroxide, purified water.
Contraindications
- hypersensitivity to iodine or suspicion of it or to other components of the drug;
- patients with impaired thyroid function (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis);
- patients with hyperthyroidism or other acute thyroid disorders;
- before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma;
- dermatitis herpetiformis Dühring;
- kidney failure.
Mode of application
The drug is intended for external use in dissolved and undissolved form.
Do not mix the drug with hot water. Only short-term heating to body temperature is permissible.
Dosages
An undiluted solution of Betadine® is used to treat hands and skin before surgery, bladder catheterization, injections, punctures, and the like.
Solutions can be applied 2-3 times a day.
Hygienic disinfection of hands: 2 times 3 ml undiluted solution - each dose of 3 ml remains on the skin for 30 seconds.
Surgical hand disinfection: 2 times 5 ml undiluted solution - each dose of 5 ml remains on the skin for 5 minutes.
For skin disinfection, the undiluted solution is left to dry after application.
According to the above indications, the solution can be used after dilution with tap water. During operations, as well as during antiseptic treatment of wounds and burns, 0.9% sodium chloride solution or Ringer's solution should be used for dilution.
The solution should be diluted immediately before use.
Application features
pregnant
Povidone-iodine should be used in cases strictly prescribed by a doctor, but in the smallest doses. Iodine crosses the placental barrier and may pass into breast milk, so there may be a risk of fetal or newborn hypersensitivity to iodine. The level of povidone-iodine is higher in breast milk than in blood serum. Therefore, the drug can cause hyperthyroidism or elevated levels of thyroid hormone in the fetus or newborn. There is a need to check the function of the thyroid gland in children. The drug is contraindicated after the 2nd month of pregnancy and during lactation. At the time of treatment it is necessary to stop breastfeeding.
Children
Newborns and children under one year of age can use povidone-iodine only under strict indications. High doses of iodine should be avoided in newborns and young children, as the skin is more permeable and they are more likely to be hypersensitive to iodine, which increases the risk of developing hyperthyroidism. In such patients, povidone-iodine should be used in small doses. If necessary, monitor thyroid function in children.
Overdose
In acute iodine intoxication, the following symptoms are characteristic: a metallic taste in the mouth, increased salivation, a burning sensation or pain in the mouth or throat; irritation and swelling in the eyes; skin reactions; gastrointestinal disorders and diarrhea; impaired renal function and anuria; circulatory failure; laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.
Treatment: Symptomatic and supportive therapy should be carried out with particular attention to electrolyte balance, renal and thyroid function. As well as the immediate use of starch- and protein-containing products (for example, a solution of starch in water or milk). Gastric lavage with 5% sodium thiosulfate solution (or 10% sodium thiosulfate solution intravenously) at intervals of 3 hours, if necessary. Also, clinical monitoring of thyroid function to exclude or identify symptoms of the onset of early iodine-induced hyperthyroidism.
Side effects
From the immune system: hypersensitivity, anaphylactic reactions.
From the side of the kidneys and urinary system: impaired renal function, acute renal failure.
From the skin and subcutaneous tissues: local skin hypersensitivity reactions, such as contact dermatitis with the formation of psoriasis-like red small bullous formations; allergic reactions, including itching, redness, rash, angioedema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.
From the endocrine system: hyperthyroidism (sometimes with symptoms such as tachycardia or anxiety); hypothyroidism.
Metabolism and eating disorders: electrolyte imbalance; metabolic acidosis.
Long-term use of povidone-iodine can lead to the absorption of large amounts of iodine.
Storage conditions
Store in the original packaging at a temperature not exceeding 25°C, out of the reach of children.
Shelf life - 3 years.
