Betoiodin (Solution) Instructions for Use

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Iodine Technologies And Marketing, LLC (Russia)

Or

Samaramedprom, OJSC (Russia)

ATC Code

D08AG02 (Povidone-iodine)

Active Substance

Povidone-iodine (BAN Accepted Name in the United Kingdom)

Dosage Form

Betoiodin

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

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a dark brown film-forming liquid, odorless or with a faint specific odor, miscible with water in all proportions.

* in the form of iodopovidone 30/06 or PVP-iodine – 105 g.

Excipients: saturated trisodium phosphate solution – to pH 2.3-3.5, purified water – to 1000 ml.

10 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
250 ml – bottles.
500 ml – polyethylene terephthalate 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 agent. It is iodine in the form of a polyvinylpyrrolidone iodine complex. The concentration of active iodine is from 0.1% to 1%. It has a broad spectrum of antimicrobial action.

It is active against bacteria (including Mycobacterium tuberculosis), fungi, viruses, and protozoa. Polyvinylpyrrolidone iodine belongs to iodophors, which bind iodine. Upon contact with the skin and mucous membranes, iodine is gradually and evenly released, exerting a bactericidal effect on microorganisms.

A thin colored layer remains at the site of application of povidone-iodine preparations, which persists until all the iodine is released, after which its action ceases.

Indications

For external and topical use: treatment and prevention of wound infections in surgery, traumatology, combustiology, 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.

For vaginal use: acute or chronic vaginitis (mixed, nonspecific infection); bacterial vaginosis (caused by Gardnerella vaginalis); candidiasis; Trichomonas vaginalis infection; vaginal infections after therapy with antibiotics or steroid drugs; prevention before surgical or diagnostic interventions in the vagina.

ICD codes

Dosage Regimen

Apply the solution topically or externally as required for the specific indication and affected area.

For wound treatment and skin disinfection, apply a sufficient amount to cover the area and allow to dry.

For pre-operative skin preparation, apply thoroughly to the surgical site using a sterile applicator.

For vaginal use, administer 5-10 ml once or twice daily, typically for 7-14 days, or as directed by a physician.

For hand hygiene of medical personnel, apply 3-5 ml to hands and rub for at least 1 minute.

For oral mucosa disinfection in dentistry, apply undiluted or as a rinse with a diluted solution for 30 seconds.

Avoid contact with eyes. Discontinue use if signs of hypersensitivity such as itching or redness occur.

Adverse Reactions

A local manifestation of hypersensitivity to iodine (itching, hyperemia) is possible, which requires discontinuation of treatment.

Contraindications

Hyperthyroidism, thyroid adenoma, renal failure, pregnancy, lactation (breastfeeding), hypersensitivity to iodine. Should not be used for treating the skin of premature and newborn infants.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Should not be used for treating the skin of premature and newborn infants.

Geriatric Use

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

Special Precautions

Povidone-iodine solution should not be used in combination with other antiseptic agents or enzymatic ointments.

Before systematic use of povidone-iodine preparations, a trial application is advisable.

In the presence of blood, the bactericidal action of povidone-iodine may decrease.

Avoid contact of povidone-iodine preparations with the eyes.

Drug Interactions

Pharmaceutically incompatible with disinfectants containing mercury; oxidizing agents, alkali salts, and substances with an acidic reaction.

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.