Lugol (Spray) Instructions for Use

Marketing Authorization Holder

Lekar, LLC (Russia)

ATC Code

R02AA20 (Other antiseptics)

Active Substance

Iodine (Ph.Eur. European Pharmacopoeia)

Dosage Form

Lugol

Topical spray 1%: 25 g, 30 g, 50 g, or 60 g bottle with dispenser and sprayer

Dosage Form, Packaging, and Composition

Topical spray in the form of a transparent, viscous red-brown liquid with the odor of iodine.

Excipients: potassium iodide – 2 g, purified water – 3 g, glycerol 85% – 94 g.

25 g – bottles (1) complete with a dispenser and sprayer – cardboard packs.
30 g – bottles (1) complete with a dispenser and sprayer – cardboard packs.
50 g – bottles (1) complete with a dispenser and sprayer – cardboard packs.
60 g – bottles (1) complete with a dispenser and sprayer – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antiseptics

Pharmacological Action

The main active substance is molecular Iodine, which has an antiseptic and locally irritating effect.

It has a bactericidal effect against gram-negative and gram-positive flora, and also acts on pathogenic fungi (including yeasts); Staphylococcus spp. are more resistant to iodine, but with prolonged use of the drug, suppression of staphylococcal flora is noted in 80% of cases; Pseudomonas aeruginosa is resistant to the drug’s action.

When applied to large areas of the skin and mucous membranes, Iodine has a resorptive effect: it participates in the synthesis of T3 and T4.

The potassium iodide included in the composition improves the solubility of iodine in water, and glycerol has a softening effect.

Pharmacokinetics

When the drug is used in the recommended doses, the resorption of iodine through the skin and oral mucosa is insignificant.

Upon contact with mucous membranes, 30% is converted into iodides.

If accidentally swallowed, Iodine is rapidly absorbed.

The absorbed part penetrates well into tissues and organs, accumulating in the tissues of the thyroid gland.

It is excreted by the kidneys (mainly), to a lesser extent with feces and sweat.

It penetrates into the milk of lactating women.

Indications

Infectious and inflammatory diseases of the oral mucosa and pharynx in adults and children.

ICD codes

Dosage Regimen

Use the spray topically for irrigation of the oral mucosa, pharynx, and throat.

Administer 4-6 times per day or as directed by a physician.

Apply by pressing the sprayer head once per application.

Hold your breath during spraying to avoid inhalation.

Direct the spray away from the eyes. Avoid contact with eyes.

In case of accidental eye contact, rinse immediately with copious amounts of water or a sodium thiosulfate solution.

Do not exceed the recommended frequency and duration of use.

Treatment duration is typically short-term; prolonged use increases the risk of adverse effects.

Discontinue use and consult a physician if irritation or signs of iodism (e.g., metallic taste, skin rashes) occur.

Ensure the spray nozzle is clean and functions properly before each use.

Adverse Reactions

Allergic reactions.

With prolonged use – manifestations of “iodism”: rhinitis, urticaria, angioedema, salivation, lacrimation, acne.

If the specified or any other side effect occurs when using the drug, it is necessary to consult a doctor.

Contraindications

Hypersensitivity to iodine or other components of the drug.

Use with caution in patients with decompensated liver and kidney diseases, thyrotoxicosis, dermatitis herpetiformis.

Use in Pregnancy and Lactation

The use of the drug during pregnancy is not recommended.

Use during breastfeeding is possible if the expected benefit to the mother outweighs the potential risk to the child.

It is necessary to consult a doctor.

Use in Hepatic Impairment

Use with caution in patients with decompensated liver diseases.

Use in Renal Impairment

Use with caution in patients with decompensated kidney diseases.

Special Precautions

Sunlight and temperatures above 40°C (104°F) accelerate the decomposition of active iodine.

Overdose

Symptoms: irritation of the upper respiratory tract (burn, laryngobronchospasm); if ingested – irritation of the mucous membranes of the gastrointestinal tract, development of hemolysis, hemoglobinuria; the lethal dose is about 3 g (about 300 ml of the drug).

Treatment: gastric lavage with 0.5% sodium thiosulfate solution, sodium bicarbonate solutions, intravenous administration of 30% sodium thiosulfate – up to 300 ml.

Drug Interactions

Iodine is inactivated by sodium thiosulfate.

The Iodine contained in the preparation oxidizes metals, which can lead to damage to metal objects.

Pharmaceutically incompatible with essential oils, ammonia solutions.

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

Storage Conditions

In a place protected from light at a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

Shelf Life

Shelf life. 3 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.