Iodinolsept (Solution) Instructions for Use

Marketing Authorization Holder

Lekar, LLC (Russia)

ATC Code

D08AG (Iodine preparations)

Active Substance

Iodine (Ph.Eur. European Pharmacopoeia)

Dosage Form

Iodinolsept

Solution for topical and external use: fl. 25 ml, 30 ml, 50 ml, 100 ml, 150 ml, 200 ml or 250 ml.

Dosage Form, Packaging, and Composition

Solution for topical and external use: a dark blue liquid with a characteristic odor, foaming when shaken. Traces of foaming on the unfilled part of the bottle are allowed.

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

25 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs (with a spray nozzle).
30 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs (with a spray nozzle).
50 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs (with a spray nozzle).
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs (with a spray nozzle).
150 ml – bottles (1) – cardboard packs.
150 ml – bottles (1) – cardboard packs (with a spray nozzle).
200 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs (with a spray nozzle).
250 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs (with a spray nozzle).

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Elemental Iodine has pronounced antimicrobial properties. Preparations of elemental iodine are characterized by a pronounced local irritant effect on tissues, and in high concentrations, by 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 have 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. 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, injuries, 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

Dosage Regimen

It is used externally and topically.

For external use, the damaged areas of the skin are treated with iodine.

For topical use, it is used for washing lacunae and supratonsillar spaces, for irrigating the nasopharynx, for instillation into the ear and 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 large surfaces – iodism (rhinitis, urticaria, angioedema, salivation, lacrimation, acne).

Contraindications

Hypersensitivity to iodine.

For external use: thyrotoxicosis, dermatitis herpetiformis.

Use in Pregnancy and Lactation

It is used according to indications during pregnancy and breastfeeding.

Use in Hepatic Impairment

It is used according to indications.

Use in Renal Impairment

It is used according to indications.

Pediatric Use

It is used according to indications.

Geriatric Use

It is used according to indications.

Special Precautions

With prolonged use, phenomena of iodism are possible.

Drug Interactions

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

An alkaline or acidic environment, the presence of fat, pus, and blood weaken the antiseptic activity.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.