Iod-KA^® (Solution) Instructions for Use

Marketing Authorization Holder

Gens, LLC (Russia)

Manufactured By

Snezhfarm, OJSC (Russia)

ATC Code

D08AG02 (Povidone-iodine)

Active Substance

Povidone-iodine (BAN)

Dosage Form

Iod-KA®

Topical and external use solution 10%: 10 mL, 25 mL, or 50 mL bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use dark brown in color, with the odor of iodine.

Excipients : glycerol (calculated as anhydrous substance) – 1.05 g, citric acid (calculated as dry substance) – 0.071 g, sodium hydrogen phosphate (calculated as dry substance) – 0.15 g, sodium hydroxide solution 10% – to pH 3.0-6.0, purified water – to 100 ml.

10 ml – glass bottles (1) with a cap with a spatula – cardboard packs.
25 ml – glass bottles (1) with a sprayer – cardboard packs.
50 ml – glass bottles (1) with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic and disinfectant. When released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial cell proteins, coagulates them, and causes the death of microorganisms.

It has a rapid bactericidal effect on gram-positive and gram-negative bacteria (except for Mycobacterium tuberculosis). It is effective against fungi, viruses, and protozoa.

Pharmacokinetics

When applied topically, iodine is almost not absorbed.

Indications

Treatment and prevention of wound infections in surgery, traumatology, combustiology, and dentistry; treatment of bacterial, fungal, and viral skin infections, prevention of superinfection in dermatological practice; treatment of bedsores, trophic ulcers, diabetic foot; disinfection of the skin and mucous membranes of patients in preparation for surgical interventions, invasive studies (including punctures, biopsies, injections); disinfection of the skin around drains, catheters, probes; disinfection of the oral cavity during dental operations; disinfection of the birth canal, during “minor” gynecological operations (including artificial termination of pregnancy, insertion of an IUD, coagulation of erosion and polyp). For hygienic hand treatment of surgeons and medical personnel.

ICD codes

Dosage Regimen

Apply the solution topically or externally. Use the appropriate packaging for the specific application: sprayer for large areas, dropper for precise application, or standard bottle cap.

For surgical hand disinfection, apply 5 ml to moistened hands and forearms. Rub for 5 minutes. Repeat the procedure.

For pre-operative skin preparation, apply the solution generously to the surgical site. Allow it to dry completely.

For treatment of wounds, burns, trophic ulcers, and bedsores, apply to the affected area. Use a sterile dressing soaked in the solution or apply the solution directly to the wound 2-3 times daily.

For disinfection of mucous membranes in gynecology and dentistry, apply undiluted or as a diluted rinse/gargle. Use the sprayer or dropper for targeted application.

For treatment of skin infections (bacterial, fungal), apply a small amount to the affected skin 1-2 times daily.

For hygienic hand treatment of medical personnel, apply 3 ml to the hands. Rub until completely dry.

Avoid occlusive dressings after application. Do not apply to large areas of damaged skin for prolonged periods.

Discontinue use immediately if signs of local irritation or hypersensitivity (redness, itching, swelling) occur.

Adverse Reactions

It is possible that with frequent application to a large area of the wound surface and mucous membranes, systemic resorption of iodine may occur, which may affect tests of thyroid functional activity. Hypersensitivity reactions, manifestations of an allergic reaction (hyperemia, burning, itching, swelling, pain) are possible, which requires discontinuation of povidone-iodine.

Contraindications

Hypersensitivity to iodine; thyroid dysfunction (hyperthyroidism); thyroid adenoma; Duhring’s herpetiform dermatitis; simultaneous use of radioactive iodine; premature and newborn infants.

With caution

Chronic renal failure, pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

The use of povidone-iodine is not recommended from the 3rd month of pregnancy and during lactation (breastfeeding). If necessary in these cases, treatment is possible under individual medical supervision.

Use in Renal Impairment

Caution should be exercised with regular application to damaged skin in patients with chronic renal failure.

Pediatric Use

Contraindication: premature and newborn infants.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

In case of thyroid dysfunction, the use of the drug is possible only under strict medical supervision.

Caution should be exercised with regular application to damaged skin in patients with chronic renal failure.

A colored film forms at the application site, which persists until the entire amount of active iodine is released, which means the cessation of the active substance’s action.

The coloration on the skin and tissues is easily washed off with water.

Do not use for insect bites, domestic and wild animal bites.

Drug Interactions

Incompatible with other antiseptic agents, especially those containing alkalis, enzymes, and mercury.

In the presence of blood, the bactericidal effect may decrease; however, with an increase in the concentration of the active substance, bactericidal activity may be increased.

Storage Conditions

Store at 8°C (46°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.