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Povidone-Iodine (Solution, 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
Antiseptic
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, 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 treatment of the hands of surgeons and medical personnel.
ICD codes
Open the list of 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. |
For solution, apply a sufficient quantity to cover the affected area or wound. Use for preoperative skin disinfection by applying and allowing to dry. For wound irrigation, use as directed. The regimen is individual and depends on the indication and severity.
For chronic wounds or ulcers, irrigate or apply with gauze. For disinfection of mucous membranes in gynecology and dentistry, apply as per procedural guidelines. For hand hygiene, apply 5 ml and rub over all surfaces for the recommended contact time.
For suppositories, administer intravaginally once or twice daily, typically in the morning and evening. The usual course of treatment is 7 to 14 days, but the duration is determined individually based on clinical response.
Continue using the suppositories during menstruation. Insert the suppository high into the vagina while lying down. Adhere strictly to the prescribed frequency and duration to ensure efficacy and prevent recurrence.
Avoid concurrent use with other topical antiseptics or detergents. Do not apply occlusive dressings over the treated area. Discontinue use immediately and consult a physician if signs of local irritation or hypersensitivity, such as redness, itching, or swelling, occur.
Adverse Reactions
Possible with frequent application over 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 herpetiformis 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.
Staining 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, the 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
Povidone-Iodine [Hemofarm, A.D. (Serbia)]
Solution for topical and external use 10% (10 g/100 ml): fl. 500 ml or 5 l
Solution for topical and external use 10% (10 g/100 ml): fl. 500 ml or 5 l
Marketing Authorization Holder
Hemofarm, A.D. (Serbia)
Manufactured By
Hemofarm A.D. Vrsac Branch Plant Sabac (Serbia)
Quality Control Release
HEMOFARM, A.D. (Serbia)
Dosage Form
 |
Povidone-iodine | Solution for topical and external use 10% (10 g/100 ml): fl. 500 ml or 5 l |
Dosage Form, Packaging, and Composition
Solution for topical and external use as a dark brown liquid with a characteristic odor of iodine.
| 1 ml | |
| Povidone-iodine | 100 mg* |
* the amount depends on
Excipients: glycerol 85%, nonoxinol 9, sodium hydrogen phosphate dodecahydrate, citric acid, sodium hydroxide solution 45%, purified water.
500 ml – polyethylene bottles.
5000 ml – polyethylene cans.
Povidone-Iodine [Biopharmkombinat, LLC (Russia)]
Vaginal suppositories 200 mg: 5 or 10 pcs.
Vaginal suppositories 200 mg: 5 or 10 pcs.
Marketing Authorization Holder
Biopharmkombinat, LLC (Russia)
Dosage Form
|
Povidone-iodine | Vaginal suppositories 200 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories from brown to dark brown in color, torpedo-shaped, marbling of the surface is allowed.
| 1 supp. | |
| Povidone-iodine* | 200 mg |
* obtained according to the following formulation: iodine – 20 mg; polyvinylpyrrolidone – 180 mg.
Excipients: macrogol 1500 (polyethylene glycol 1500) – 2.66 g, macrogol 400 (polyethylene glycol 400) – 0.14 g.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
Povidone-Iodine [Tula Pharmaceutical Factory, LLC (Russia)]
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
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
|
Povidone-iodine | 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, |
| Corresponding to the content of active iodine | 10.25 mg |
Excipients: glycerol – 1.275 g, nonoxinol 9 – 0.312 g, sodium hydrogen phosphate 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.
Povidone-Iodine [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Vaginal suppositories 200 mg: 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 pcs.
Vaginal suppositories 200 mg: 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 pcs.
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Povidone-iodine | Vaginal suppositories 200 mg: 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories homogeneous, torpedo-shaped, from brown to dark brown in color.
| 1 supp. | |
| Povidone-iodine | 200 mg, |
| Corresponding to the content of active iodine | 17-24 mg |
Excipients: macrogol 1000 – to obtain a suppository weighing 3000 mg.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (7) – cardboard packs.
5 pcs. – contour cell packs (8) – cardboard packs.
5 pcs. – contour cell packs (9) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
Povidone-Iodine [Pharmaprim, LLC (Republic of Moldova)]
Vaginal suppositories 200 mg: 14 pcs.
Vaginal suppositories 200 mg: 14 pcs.
Marketing Authorization Holder
Pharmaprim, LLC (Republic of Moldova)
Dosage Form
|
Povidone-iodine | Vaginal suppositories 200 mg: 14 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories torpedo-shaped, brown in color, with a specific odor of iodine; on the longitudinal section, the presence of an air rod or a funnel-shaped depression is allowed.
| 1 supp. | |
| Povidone-iodine | 200 mg |
Excipients: macrogol 1000 – 1800 mg.
7 pcs. – contour cell packs (2) – cardboard packs.
Povidone-Iodine [YUGPHARM, LLC (Russia)]
Solution for topical and external use 10%: fl. 10 ml, 15 ml, 30 ml, 50 ml, 100 ml, 120 ml, 250 ml, 400 ml, 450 ml, 500 ml or 1000 ml
Solution for topical and external use 10%: fl. 10 ml, 15 ml, 30 ml, 50 ml, 100 ml, 120 ml, 250 ml, 400 ml, 450 ml, 500 ml or 1000 ml
Marketing Authorization Holder
YUGPHARM, LLC (Russia)
Dosage Form
|
Povidone-iodine | Solution for topical and external use 10%: fl. 10 ml, 15 ml, 30 ml, 50 ml, 100 ml, 120 ml, 250 ml, 400 ml, 450 ml, 500 ml or 1000 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 |
Excipients: glycerol – 1.275 g, nonoxinol 9 – 0.312 g, sodium hydrogen phosphate dodecahydrate – 0.32 g, citric acid monohydrate – 0.1 g, sodium hydroxide – 0.117 g, purified water – up to 100 ml.
10 ml – bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
120 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
450 ml – bottles (1) – cardboard packs.
500 ml – bottles (1) – cardboard packs.
1000 ml – bottles (1) – cardboard packs.
100 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
120 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
250 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
400 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
450 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
500 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
1000 ml – bottles from 4 to 50 pcs. – cardboard boxes (for hospitals).
Povidone-Iodine [YUGPHARM, LLC (Russia)]
Vaginal suppositories 200 mg: 10 pcs.
Vaginal suppositories 200 mg: 10 pcs.
Marketing Authorization Holder
YUGPHARM, LLC (Russia)
Dosage Form
|
Povidone-iodine | Vaginal suppositories 200 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories from brown to dark brown in color, torpedo-shaped, marbling of the surface is allowed.
| 1 supp. | |
| Povidone-iodine* | 200 mg |
* obtained according to the following formulation: iodine – 30 mg; polyvinylpyrrolidone – 180 mg.
With a povidone-iodine activity of 10%: in the case of a different substance activity, the amount of the base is correspondingly decreased or increased.
Excipients: macrogol 1500 (polyethylene glycol 1500) – 2.66 g, macrogol 400 (polyethylene glycol 400) – 0.14 g.
5 pcs. – contour cell packs (2) – cardboard packs.
![Povidone-Iodine [Solution, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Povidone-Iodine [Solution, Suppositories] 2")