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Iovidox (Solution, Ointment, Suppositories) Instructions for Use

ATC Code

D08AG02 (Povidone-iodine)

Active Substance

Povidone-iodine (BAN accepted for use in the United Kingdom)

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptics and disinfectants; iodine preparations

Pharmacological Action

Antiseptic and disinfectant agent. 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, 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

ICD-10 code Indication
A60 Anogenital herpesviral infection [herpes simplex]
B00 Herpesviral [herpes simplex] infections
B01 Varicella [chickenpox]
B35.2 Mycosis of hands
B35.3 Tinea pedis
B35.4 Tinea corporis
B35.6 Tinea cruris
B37.2 Candidiasis of skin and nails
E10.5 Insulin-dependent diabetes mellitus with peripheral circulatory complications (including ulcer, gangrene)
E11.5 Non-insulin-dependent diabetes mellitus with peripheral circulatory complications (including ulcer, gangrene)
L01 Impetigo
L02 Cutaneous abscess, furuncle and carbuncle
L03 Cellulitis
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
L30.3 Infectious dermatitis (infectious eczema)
L89 Decubitus ulcer and pressure area
L98.4 Chronic skin ulcer, not elsewhere classified
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1 Open wound of unspecified body region
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
Z93 Artificial opening status
ICD-11 code Indication
1A94.Z Anogenital herpes simplex virus infection without further specification
1B70.1 Streptococcal cellulitis of the skin
1B70.2 Staphylococcal cellulitis of the skin
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0 Bullous impetigo
1B72.1 Nonbullous impetigo
1B72.Z Impetigo, unspecified
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1B7Y Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44 Non-pyogenic bacterial infections of skin
1E90.Z Varicella, unspecified
1F00.Z Infections due to herpes simplex virus, unspecified
1F23.1Z Candidiasis of skin or mucous membranes, unspecified
1F28.2 Dermatophytosis of foot
1F28.3 Genitofemoral dermatophytosis
1F28.Y Other specified dermatophytosis
5A10 Type 1 diabetes mellitus
5A11 Type 2 diabetes mellitus
EA40 Tropical phagedenic ulcer
EA50.3 Staphylococcal scarlet fever
EA88.0Z Infectious dermatitis, unspecified
EB21 Pyoderma gangrenosum
EF60 Ischemic ulceration of the skin
EH90.Z Pressure ulcer of unspecified degree
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
EM0Z Unspecified skin disorder
ME60.2 Ulcerative skin lesion of unspecified nature
ND56.0 Superficial injury of unspecified body region
ND56.1 Open wound of unspecified body region
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified
QB61.Z Presence of artificial opening, unspecified
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the Solution topically for wound management, skin disinfection, and mucous membrane treatment.

Use a sufficient volume to cover the affected area; apply as needed.

For pre-operative skin disinfection, apply and allow to dry completely.

For hygienic hand treatment of medical personnel, wash hands with the solution.

Apply the Ointment topically to the affected skin areas one to several times daily.

Use a thin layer; cover with a dressing if indicated.

Administer Suppositories intravaginally, one suppository once or twice daily.

The duration of treatment is individual and depends on the clinical indication and response.

Do not discontinue suppository use during menstruation.

For all formulations, the frequency and duration of application are determined by the severity of the condition.

Avoid application to large wound surfaces or extensive areas of damaged skin for prolonged periods.

Discontinue use immediately if signs of hypersensitivity or local irritation occur.

Adverse Reactions

Possible with frequent application to a large area of the wound surface and mucous membranes, systemic resorption of iodine may occur, which may affect thyroid function tests. 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 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Iovidox Solution for topical and external use 10%: fl. 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml or 100 ml

Dosage Form, Packaging, and Composition

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

100 ml
Povidone-iodine 10 g,
   Equivalent to active iodine content 10.25 mg

Excipients : glycerol – 1.275 g, nonoxinol 9 – 0.312 g, sodium phosphate dibasic dodecahydrate – 0.32 g, citric acid monohydrate – 0.1 g, sodium hydroxide – 0.117 g, purified water – up to 100 ml.

5 ml – bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
35 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
45 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
55 ml – bottles (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs.
65 ml – bottles (1) – cardboard packs.
70 ml – bottles (1) – cardboard packs.
75 ml – bottles (1) – cardboard packs.
80 ml – bottles (1) – cardboard packs.
85 ml – bottles (1) – cardboard packs.
90 ml – bottles (1) – cardboard packs.
95 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Iovidox Ointment for external use 10%: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g, or 200 g

Dosage Form, Packaging, and Composition

Ointment for external use brown in color, homogeneous, with a faint odor of iodine.

100 g
Povidone-iodine 10 g,
   Equivalent to active iodine content 1.025 g

Excipients : sodium bicarbonate – 0.335 g, macrogol 400 – 41.465 g, macrogol 4000 – 20.25 g, macrogol 1000 – 10.76 g, macrogol 1500 – 7.19 g, purified water – up to 100 g.

10 g – tubes (1) – cardboard packs.
15 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
45 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
55 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
65 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
75 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
85 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
95 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
110 g – tubes (1) – cardboard packs.
120 g – tubes (1) – cardboard packs.
130 g – tubes (1) – cardboard packs.
140 g – tubes (1) – cardboard packs.
150 g – tubes (1) – cardboard packs.
160 g – tubes (1) – cardboard packs.
170 g – tubes (1) – cardboard packs.
180 g – tubes (1) – cardboard packs.
190 g – tubes (1) – cardboard packs.
200 g – tubes (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Iovidox Vaginal suppositories 200 mg: from 1 to 100 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories from brown to dark brown in color, homogeneous, torpedo-shaped.

1 supp.
Povidone-iodine 0.2 g

Excipients : macrogol 1000 – to obtain a suppository weighing 3 g.

1 pc. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
2 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
3 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
4 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
5 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
6 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
7 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
8 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
9 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – contour cell packaging (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.

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