Iodinol (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

D08AG03 (Iodine)

Active Substance

Iodine (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Antiseptic for external use

Pharmacotherapeutic Group

Antiseptics and disinfectants; iodine preparations

Pharmacological Action

Elemental Iodine possesses pronounced antimicrobial properties. Preparations of elemental iodine are characterized by a pronounced local irritant effect on tissues, and in high concentrations, a cauterizing effect. The local action is due to the ability of elemental iodine to precipitate tissue proteins. Preparations that release elemental Iodine have a significantly less pronounced irritant effect, while iodides possess local irritant properties only in very high concentrations.

Pharmacokinetics

Upon contact with the skin or mucous membranes, 30% is converted into iodides, and the remainder into active Iodine. It is partially absorbed. The absorbed part penetrates into tissues and organs and is selectively absorbed by the thyroid gland. It is excreted mainly by the kidneys, intestines, sweat, and mammary glands.

Indications

For external use: infectious and inflammatory skin lesions, trauma, wounds, myalgia.

For topical use: chronic tonsillitis, atrophic rhinitis, purulent otitis, trophic and varicose ulcers, wounds, infected burns, fresh thermal and chemical burns of I-II degree.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
H66	Suppurative and unspecified otitis media
I83.2	Varicose veins of lower extremities with ulcer and inflammation
J31.0	Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J35.0	Chronic tonsillitis
L01	Impetigo
L08.0	Pyoderma
M79.1	Myalgia
L08.8	Other specified local infections of skin and subcutaneous tissue
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

ICD-11 code	Indication
1B72.0	Bullous impetigo
1B72.1	Nonbullous impetigo
1B72.Z	Impetigo, unspecified
1B7Y	Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44	Non-pyogenic bacterial infections of skin
AA9Z	Unspecified suppurative otitis media
BD74.Z	Chronic venous insufficiency of lower extremities, unspecified
CA09.0	Chronic rhinitis
CA0F.Y	Other specified chronic diseases of the palatine tonsils and adenoids
EA40	Tropical phagedenic ulcer
EA50.3	Staphylococcal scarlet fever
EB21	Pyoderma gangrenosum
EF60	Ischemic ulceration of the skin
EH92	Dermatoses provoked by friction or mechanical impact
EH92.1	Blister due to friction
EM0Z	Unspecified skin disorder
FB56.2	Myalgia
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

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.

Solution

It is used externally and topically.

For external use, the affected skin areas are treated with the iodine solution.

For topical use, it is used for washing lacunae and supratonsillar spaces, for irrigating the nasopharynx, for instillation into the ear and for washing; in surgical practice and for burns, gauze napkins applied to the affected surface are moistened as needed. The doses, method of application, and duration of treatment are determined depending on the indications.

Adverse Reactions

Rarely skin irritation; with prolonged use on extensive surfaces – iodism (rhinitis, urticaria, angioedema, salivation, lacrimation, acne).

Contraindications

Hypersensitivity to iodine.

For external use: thyrotoxicosis, dermatitis herpetiformis.

Use in Pregnancy and Lactation

Used as indicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Used as indicated.

Use in Renal Impairment

Used as indicated.

Pediatric Use

Used as indicated.

Geriatric Use

Used as indicated.

Special Precautions

Prolonged use may lead to phenomena of iodism.

Drug Interactions

Pharmaceutically incompatible with essential oils, ammonia solutions, white precipitated mercury (forms an explosive mixture).

Alkaline or acidic environment, the presence of fat, pus, blood weaken the antiseptic activity.

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

Iodinol [Begrif, LLC (Russia)]
Solution for topical and external use: 25 ml, 30 ml, 40 ml, 50 ml or 100 ml fl.

Marketing Authorization Holder

Begrif, LLC (Russia)

Dosage Form

Iodinol

Solution for topical and external use: 25 ml, 30 ml, 40 ml, 50 ml or 100 ml fl.

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a dark blue liquid with a characteristic odor, foaming when shaken; traces of foaming in the unfilled part of the bottle are allowed.

	1 L
Iodine	1 g

Excipients: potassium iodide – 3 g, polyvinyl alcohol – 9 g, purified water – up to 1 L.

25 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.
50 ml – dropper bottles (1) – cardboard packs.
0.9 kg – canisters for hospitals.
2.7 kg – canisters for hospitals.
4.5 kg – canisters for hospitals.
9 kg – canisters for hospitals.
19 kg – canisters for hospitals.
20 kg – canisters for hospitals.
30 kg – canisters for hospitals.
45 kg – canisters for hospitals.

Iodinol [Genel RD, LLC (Russia)]
Solution for topical and external use 100 mg/100 ml: 40, 50, 60, 70, 80 or 100 ml fl.

Marketing Authorization Holder

Genel RD, LLC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: 40, 50, 60, 70, 80 or 100 ml fl.

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a dark blue liquid with a characteristic odor, foaming when shaken; traces of foaming in the unfilled part of the bottle are allowed.

	1000 g
Iodine	1 g

Excipients: potassium iodide 3 g, polyvinyl alcohol 9 g, purified water 987 g.

40 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs.
70 ml – bottles (1) – cardboard packs.
80 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Iodinol [Ivanovo Pharmaceutical Factory PJSC (Russia)]
Solution for topical and external use 1 mg/ml: 40 ml, 50 ml, 60 ml, 70 ml, 80 ml or 100 ml fl., 60 ml, 70 ml, 80 ml or 100 ml dropper fl., 3 L, 5 L or 10 L canisters

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 1 mg/ml: 40 ml, 50 ml, 60 ml, 70 ml, 80 ml or 100 ml fl., 60 ml, 70 ml, 80 ml or 100 ml dropper fl., 3 L, 5 L or 10 L canisters

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a dark blue liquid with a characteristic odor, foaming when shaken; traces of foaming in the unfilled part of the bottle are allowed.

	1 L
Iodine	1 g

Excipients: potassium iodide – 3 g, polyvinyl alcohol – 9 g, purified water – up to 1 L.

25 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs.
70 ml – bottles (1) – cardboard packs.
80 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
60 ml – dropper bottles (1) – cardboard packs.
70 ml – dropper bottles (1) – cardboard packs.
80 ml – dropper bottles (1) – cardboard packs.
100 ml – dropper bottles (1) – cardboard packs.
3 L – canisters (for hospitals).
5 L – canisters (for hospitals).
10 L – canisters (for hospitals).

Iodinol [Kazan Pharmaceutical Factory, CJS (Russia)]
Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Marketing Authorization Holder

Kazan Pharmaceutical Factory, CJS (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [Kazan Pharmaceutical Factory, CJS (Russia)]
Solution for external use [alcoholic] 100 mg/100 ml: bottle 100 ml

Marketing Authorization Holder

Kazan Pharmaceutical Factory, CJS (Russia)

Dosage Form

Iodinol

Solution for external use [alcoholic] 100 mg/100 ml: bottle 100 ml

Dosage Form, Packaging, and Composition

Solution for external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [Microgen NPO, JSC (Russia)]
Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)]
Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [Tatkhimpharmpreparaty, JSC (Russia)]
Solution for topical and external use 100 mg/100 ml: 1 pc. bottle

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: 1 pc. bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [Tekhnolog SKB FSUE of the Ministry of Education of Russia (Russia)]
Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Marketing Authorization Holder

Tekhnolog SKB FSUE of the Ministry of Education of Russia (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [Tula Pharmaceutical Factory, LLC (Russia)]
Solution for topical and external use 1 mg/ml: 40 ml, 50 ml, 80 ml or 100 ml fl., 4.5 L bottles

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 1 mg/ml: 40 ml, 50 ml, 80 ml or 100 ml fl., 4.5 L bottles

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a dark blue liquid with a characteristic odor, foaming when shaken; traces of foaming in the unfilled part of the bottle are allowed.

	1 ml
Iodine	1 mg

Excipients: potassium iodide 3 mg, polyvinyl alcohol 9 mg, purified water up to 1 ml.

40 ml – orange glass bottles (1) with screw caps or spray nozzle – cardboard packs.
50 ml – orange glass bottles (1) with screw caps or spray nozzle – cardboard packs.
80 ml – orange glass bottles (1) with screw caps or spray nozzle – cardboard packs.
100 ml – orange glass bottles (1) with screw caps or spray nozzle – cardboard packs.
40 ml – polymer bottles (1) with dropper inserts and caps or spray nozzle – cardboard packs.
50 ml – polymer bottles (1) with dropper inserts and caps or spray nozzle – cardboard packs.
80 ml – polymer bottles (1) with dropper inserts and caps or spray nozzle – cardboard packs.
100 ml – polymer bottles (1) with dropper inserts and caps or spray nozzle – cardboard packs.
40 ml – polyethylene terephthalate bottles (1) with polymer caps or spray nozzle – cardboard packs.
50 ml – polyethylene terephthalate bottles (1) with polymer caps or spray nozzle – cardboard packs.
80 ml – polyethylene terephthalate bottles (1) with polymer caps or spray nozzle – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) – cardboard packs with polymer caps or spray nozzle.
40 ml – orange glass bottles with screw caps or spray nozzle – group packaging.
50 ml – orange glass bottles with screw caps or spray nozzle – group packaging.
80 ml – orange glass bottles with screw caps or spray nozzle – group packaging.
100 ml – orange glass bottles with screw caps or spray nozzle – group packaging.
40 ml – polymer bottles with dropper inserts and caps or spray nozzle – group packaging.
50 ml – polymer bottles with dropper inserts and caps or spray nozzle – group packaging.
80 ml – polymer bottles with dropper inserts and caps or spray nozzle – group packaging.
100 ml – polymer bottles with dropper inserts and caps or spray nozzle – group packaging.
40 ml – polyethylene terephthalate bottles with polymer caps or spray nozzle – group packaging.
50 ml – polyethylene terephthalate bottles with polymer caps or spray nozzle – group packaging.
80 ml – polyethylene terephthalate bottles with polymer caps or spray nozzle – group packaging.
100 ml – polyethylene terephthalate bottles with polymer caps or spray nozzle – group packaging.
4.5 L – polyethylene terephthalate bottles.

Iodinol [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Solution for topical and external use: 10, 15, 20, 25, 30, 40, 50, or 100 ml bottle

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Iodinol

Solution for topical and external use: 10, 15, 20, 25, 30, 40, 50, or 100 ml bottle

Dosage Form, Packaging, and Composition

5% Alcoholic Solution for topical and external use is transparent, of a reddish-brown color, with a characteristic odor.

	100 ml
Iodine	5 g

Excipients: potassium iodide, ethanol 95%.

10 ml – dark glass bottles (1) – cardboard packs.

Iodinol [Phytofarm-Nn, LLC (Russia)]
Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Marketing Authorization Holder

Phytofarm-Nn, LLC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 100 mg/100 ml: fl. 100 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use	100 ml
Iodine	100 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – dark glass bottles (1) – cardboard packs.

Iodinol [YUGPHARM, LLC (Russia)]
Solution for topical and external use 20 mg/20 ml: fl. 100, 250, 1000, 3000, 4500 and 5000 ml

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Iodinol

Solution for topical and external use 20 mg/20 ml: fl. 100, 250, 1000, 3000, 4500 and 5000 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use	20 ml
Iodine	20 mg

Excipients: potassium iodide, polyvinyl alcohol.

100 ml – bottles (1) made of polyethylene terephthalate – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
250 ml – bottles (1) made of polyethylene terephthalate – cardboard packs.
1000 ml – bottles (1) made of polyethylene terephthalate – cardboard packs.
3000 ml – bottles (1) made of polyethylene terephthalate – cardboard packs.
4500 ml – bottles (1) made of polyethylene terephthalate – cardboard packs.
5000 ml – bottles (1) made of polyethylene terephthalate – cardboard packs.
5000 ml – polymer bottles (1) – cardboard packs.

Iodinol [Yaroslavl Pharmaceutical Factory, CJSC (Russia)]
Solution for topical and external use 100 mg/100 ml: fl. 100 ml