Aquazan^® (Solution) Instructions for Use

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Iodine Technologies And Marketing, LLC (Russia)

ATC Code

D08AG02 (Povidone-iodine)

Active Substance

Povidone-iodine (BAN)

Dosage Form

Aquazan®

Solution for topical and external use 10%: fl. 10 ml, 50 ml, 100 ml, 500 ml or 1 l

Dosage Form, Packaging, and Composition

10 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
500 ml – dark glass bottles (1) – cardboard packs.
1 l – dark glass bottles (1) – 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

With topical application, almost no absorption of iodine occurs.

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 10% concentration for all indications.

For wound treatment and infection prevention, irrigate or apply to the affected area. Use 1-2 times daily or as directed by a physician. Apply a sufficient amount to cover the entire affected surface.

For pre-operative skin disinfection, apply to the intended surgical site and allow to dry.

For mucous membrane disinfection (oral, vaginal), apply as a rinse or swab. Use a 1:10 dilution with water for vaginal irrigation.

For hygienic hand treatment of medical personnel, apply 3-5 ml to hands and rub until dry.

Do not use on deep, open wounds or severe burns over large body surface areas due to risk of iodine absorption.

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

The brown coloration indicates active iodine presence. Loss of color signifies reduced antiseptic activity.

Adverse Reactions

Possibly 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 the lactation (breastfeeding) period. If necessary in these cases, treatment is possible under individual medical supervision.

Use in Renal Impairment

Caution should be exercised with regular use on 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 use on 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 color 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 2°C (36°F) to 30°C (86°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.