Povidon JOD (Solution) Instructions for Use

Marketing Authorization Holder

Zorka Pharma (Serbia)

ATC Code

G01AX11 (Povidone-iodine)

Active Substance

Povidone-iodine (BAN)

Dosage Forms

	Povidon JOD	Concentrated solution for topical use 8.5%: 50 ml bottle
		Vaginal suppositories 200 mg: 14 pcs.
		Ointment for external use 10% (10 g/100 g): 40 g tube
		Foaming solution for external use 7.5% (7.5 g/100 ml): 500 ml or 5 L bottle
		Solution for external use 10% (10 g/100 ml): 100 ml, 500 ml or 5 L bottle

Dosage Form, Packaging, and Composition

Solution for external use 10% is a dark brown liquid with a characteristic odor of iodine.

Excipients: nonoxynol, glycerol, disodium hydrogen phosphate 12-hydrate, citric acid, sodium hydroxide, demineralized water.

100 ml – plastic bottles.
500 ml – plastic bottles.
5 L – plastic canisters.

Foaming solution for external use 7.5% is a dark brown liquid with a characteristic odor of iodine; foams when shaken.

Excipients: diethanolamide of lauric acid, ammonium nonylphenol ethoxylate sulfonic acid, sodium phosphate 12-hydrate, citric acid, demineralized water.

500 ml – plastic bottles.
5 L – plastic canisters.

50 ml – plastic bottles.

Ointment for external use 10% is dark brown, homogeneous, with a characteristic odor of iodine.

Excipients: macrogol 4000, purified water.

40 g – aluminum tubes (1) – cardboard packs.

7 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in gynecology

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic and disinfectant drug. 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).

Also active against fungi, viruses, protozoa.

It has a longer duration of action compared to a solution of inorganic iodine.

Pharmacokinetics

When applied externally, the reabsorption of iodine from the surface of the skin or mucous membrane or wounds is extremely insignificant.

Indications

Solution for external use 10%

• 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 intrauterine device, coagulation of erosion and polyp).

Foaming solution for external use 7.5%

• Disinfecting baths – for complete and partial treatment of the patient before operations;
• Hygienic treatment of patients;
• Hygienic hand treatment when in contact with infected patients;
• Treatment of instruments (non-metallic) and patient care items.

Concentrated solution for topical use 8.5%

• For mouth and throat rinsing.

Ointment for external use 10%

• Bacterial and fungal skin infections;
• Burns;
• Trophic ulcers;
• Bedsores;
• Infectious dermatitis;
• Abrasions;
• Wounds.

Vaginal suppositories

• Candidiasis;
• Trichomoniasis;
• Non-specific vaginitis.

ICD codes

Dosage Regimen

Solution for external use 10%

For treatment of the skin and mucous membranes, it is used undiluted for lubrication, irrigation or as a wet compress.

For use in drainage systems, the solution is diluted from 10 to 100 times.

Foaming solution for external use 7.5%

For disinfection of the hands of surgical personnel, 5 ml of undiluted solution is applied to pre-washed hands and evenly distributed up to the elbows, rubbing for 2.5 minutes with palms or a brush until foam forms (the foam is washed off with sterile water or removed with a sterile napkin); then the treatment is repeated.

For disinfection of the skin of the operating field, the drug is applied to the shaved and moistened with water skin and rubbed in to form foam. 1 ml of the drug is sufficient for application to a skin surface of 50-70 cm² by rubbing for 5 minutes. The foam is removed with a sterile gauze pad soaked in water, after which the skin is lubricated with undiluted solution and dried.

Concentrated solution for topical use 8.5%

For mouth and throat rinsing, 1 teaspoon of the solution is diluted in 1/4 glass of water. Rinsing is carried out several times a day.

Ointment for external use 10%

The ointment is applied in a thin layer to the affected area 2-3 times a day, it can be used under an occlusive dressing.

Vaginal suppositories

Prescribed 1-2 pcs./day. The duration of treatment is 14 days or as directed by a doctor. Before using vaginal suppositories, sanitary treatment is necessary.

Adverse Reactions

Possible allergic reactions.

Local reactions in some cases allergic reactions to iodine – hyperemia, burning, itching, swelling, pain (drug withdrawal is required).

Systemic reactions when applied to a large area of the wound surface and mucous membranes, systemic reabsorption of iodine is possible, which can cause neutropenia, as well as change the results of thyroid function tests; with long-term use (more than 7-10 days) phenomena of iodism are possible (including metallic taste in the mouth, increased salivation, swelling of the eyelids or larynx).

Contraindications

• Hyperthyroidism;
• Thyroid adenoma;
• Heart failure;
• Chronic renal failure;
• Dermatitis herpetiformis Duhring;
• Simultaneous use of radioactive iodine;
• Premature and newborn infants;
• Children under 8 years of age (ointment for external use);
• Pregnancy;
• Lactation;
• Hypersensitivity to iodine and other components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

The drug is contraindicated in children under 8 years of age.

Special Precautions

If side effects develop, drug withdrawal is required.

The presence of blood and pus may reduce the antimicrobial effect of the drug.

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

The patient should be warned about the need to consult a doctor if systemic reactions occur.

It is necessary to ensure that no excess solution remains under the patient.

A colored film is formed at the application site, which persists until the entire amount of active iodine is released, i.e., its disappearance means the cessation of the drug’s action. The color on the skin and tissues is easily washed off with water.

Do not heat before use.

Overdose

Symptoms local irritation, allergic reactions.

Treatment reducing the frequency of application or complete discontinuation of the drug.

Drug Interactions

Povidone iodine is incompatible with other disinfectants and antiseptics, especially those containing alkalis, enzymes and mercury.

In an acidic environment, the activity of the drug decreases.

Storage Conditions

List B. Solutions should be stored in a place protected from light, tightly closed, at a temperature from 0°C (32°F) to 25°C (77°F).

The ointment should be stored in the original packaging at a temperature from 0°C (32°F) to 25°C (77°F).

Shelf Life

The shelf life of the drug in the form of a solution for external use 10%, ointment for external use 10% and vaginal suppositories is 3 years.

The shelf life of the foaming solution for external use 7.5% and the concentrated solution for topical use 8.5% is 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.