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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
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
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
| 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.
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
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
| 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.
Vaginal suppositories 200 mg: from 1 to 100 pcs.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
| 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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