Betadine solution for external and local use 10% in a bottle with a dropper 30 ml

The active substance is povidone-iodine (1 ml of solution contains 100 mg of povidone-iodine).

Excipients: glycerin (85%), nonoxynol 9, citric acid anhydrous, sodium hydrogen phosphate anhydrous, sodium hydroxide, purified water.

• hypersensitivity to iodine or suspected hypersensitivity to it or to other components of the drug;
• patients with thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto’s thyroiditis);
• patients with hyperthyroidism or other acute thyroid disorders;
• before and after treatment and radioactive iodine scintigraphy in patients with thyroid carcinoma;
• During’s dermatitis herpetiformis;
• renal failure.

The drug is intended for external use in dissolved and undissolved form.

Do not mix the drug with hot water. Only briefly warm it to body temperature.

Dosage

Undiluted Betadine solution is used to treat hands and skin before surgery, bladder catheterization, injections, punctures, etc.

Solutions can be used 2-3 times a day.

Hygienic hand disinfection: 2 times 3 ml of undiluted solution – each dose of 3 ml remains on the skin for 30 seconds.

Surgical hand disinfection: 2 times 5 ml of undiluted solution – each dose of 5 ml remains on the skin for 5 minutes.

To disinfect the skin, 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 for 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.

Pregnant women

PVPiodine should be used in cases strictly prescribed by a doctor, but in the smallest doses. Iodine penetrates the placental barrier and can penetrate into breast milk, so there may be a risk of hypersensitivity of the fetus or newborns to iodine. The level of PVPiodine is higher in breast milk than in blood serum. Therefore, the drug may cause hyperthyroidism or an increased level of thyroid hormone in the fetus or newborn. It is necessary to check the thyroid gland function in children. The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Breastfeeding must be discontinued during treatment.

Children

Povidone-iodine should only be used in neonates and children under one year of age if strictly indicated. High doses of iodine should be avoided in neonates and young children, as their skin is highly permeable and they are more likely to be hypersensitive to iodine, which increases the risk of developing hyperthyroidism. Povidone-iodine should be used in small doses in such patients. If necessary, monitor thyroid function in children.

Acute iodine intoxication is characterized by the following symptoms: metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat; irritation and swelling in the eyes; skin reactions; gastrointestinal disorders and diarrhea; renal dysfunction and anuria; circulatory failure; laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Treatment: symptomatic and supportive therapy should be carried out with special attention to electrolyte balance, renal function and thyroid gland. As well as immediate use of starch- and protein-containing products (e.g. starch solution in water or milk). Gastric lavage with 5% sodium thiosulfate solution (or 10% sodium thiosulfate solution intravenously) at 3-hour intervals, if necessary. Also clinical monitoring of thyroid function to exclude or detect symptoms of early iodine-induced hyperthyroidism.

Immune system disorders: hypersensitivity, anaphylactic reactions.

Renal and urinary disorders: renal dysfunction, acute renal failure.

Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with the formation of psoriasis-like red small bullous lesions; allergic reactions including itching, redness, rash, angioedema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.

Endocrine system: hyperthyroidism (sometimes with symptoms such as tachycardia or anxiety); hypothyroidism.

Metabolism and nutrition disorders: electrolyte imbalance; metabolic acidosis.

Prolonged use of povidone-iodine may result in the absorption of large amounts of iodine.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 3 years.