Maxicold^® LOR (Spray) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

A01AB12 (Hexetidine)

Active Substance

Hexetidine (Rec.INN registered by WHO)

Dosage Form

Maxicold® LOR

Topical spray 0.2%: 40 ml canisters with metering pump and sprayer for oral use

Dosage Form, Packaging, and Composition

Topical spray in the form of an almost colorless liquid with a characteristic menthol odor.

Excipients: sodium saccharin dihydrate – 40 mg, citric acid monohydrate – 70 mg, sodium hydroxide – 19 mg, glycerol (glycerin) – 17000 mg, ethanol (rectified ethyl alcohol) – 4000 mg, lauromacrogol (macrogol lauryl ether) – 1500 mg, cineole (eucalyptol) – 20 mg, levomenthol (L-menthol) – 20 mg, peppermint leaf oil – 10 mg, purified water – up to 100 ml.

40 ml – aluminum canisters (1) with a metering pump and sprayer for oral use – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; antimicrobial agents and antiseptics for the local treatment of diseases in the oral cavity

Pharmacological Action

An antiseptic preparation for topical application. It has antimicrobial, antifungal, analgesic, enveloping, and deodorizing effects.

The antimicrobial effect of Maxicold^® Lor is associated with the suppression of oxidative reactions of bacterial metabolism (Hexetidine is a thiamine antagonist). The drug has a broad spectrum of antibacterial and antifungal action, particularly against gram-positive bacteria and fungi of the genus Candida, however, Maxicold^® Lor can also be effective in the treatment of infections caused by, for example, Pseudomonas aeruginosa or Proteus spp. At a concentration of 100 mg/ml, the drug suppresses most bacterial strains. The development of resistance has not been observed. Maxicold^® Lor has a weak anesthetic effect on the mucous membrane.

Pharmacokinetics

After a single application, the local effect of hexetidine continues for 10-12 hours.

The drug is practically not absorbed from the surface of the mucous membranes and does not have a systemic effect. After a single application of the active substance, its traces are detected on the gum mucosa for 65 hours. In dental plaque, active concentrations persist for 10-14 hours after application.

Indications

• Infectious and inflammatory diseases of the oral cavity and pharynx (tonsillitis, including Plaut-Vincent’s angina, pharyngitis, stomatitis, aphthous ulcers of the oral cavity, glossitis, periodontitis, gingivitis, periodontosis, periodontopathies, alveolitis), bleeding gums;
• For acute respiratory infections – as an auxiliary agent, as part of complex therapy;
• Fungal infections of the oral cavity, pharynx, and larynx (thrush);
• Injuries and surgical interventions in the oral cavity, pharynx, and larynx (both before and after their performance), including prevention of alveolar infection after tooth extraction;
• As an oral hygiene agent to eliminate unpleasant odor (deodorizing effect);
• Prevention of superinfections in disintegrating tumors of the oral cavity and larynx.

ICD codes

Dosage Regimen

Apply topically, after meals or between meals.

Using the spray, treat the affected areas in the oral cavity and pharynx. The frequency of application for adults and children over 3 years is 2-3 times/day. If necessary, more frequent use of the drug is possible. The course of treatment is 5-7 days. For correct use of the drug, it is necessary to perform the following actions:

1. Remove the cap from the canister, install the sprayer into the corresponding hole in the upper part of the canister.
2. During first use, it is necessary to preliminarily make several short presses on the sprayer (to ensure uniform spraying of the canister contents).
3. Introduce the required amount of the drug into the oral cavity by pressing the sprayer all the way down 3-4 times. During the introduction of the drug, you should hold your breath.
4. After use, remove the sprayer, rinse it under running water and dry it at room temperature in a place inaccessible to children.
5. The sprayer should be stored in the packaging together with the drug.

During administration, the canister should be held vertically.

Adverse Reactions

Local reactions: allergic reactions, burning sensation of the oral mucosa.

In case of accidental swallowing: nausea.

With prolonged use: disturbance of taste sensations.

Contraindications

• Atrophic pharyngitis;
• Children under 3 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

There is no information about any adverse effects of hexetidine during pregnancy and breastfeeding. Before prescribing the drug to pregnant or breastfeeding women, the doctor should carefully weigh the benefit of treatment for the mother and the possible risk to the fetus and child, taking into account the lack of sufficient data on the penetration of the drug through the placenta and into breast milk.

Pediatric Use

Contraindicated in children under 3 years of age. Children can use the drug from the age when they do not resist a foreign object (sprayer) in the mouth when using the spray and are able to hold their breath when the drug is sprayed.

Special Precautions

Children can use the drug from the age when they do not resist a foreign object (sprayer) in the mouth when using the spray and are able to hold their breath when the drug is sprayed.

The spray should not be inhaled; avoid getting the drug into the eyes.

After using the spray, the applicator should be rinsed with warm water.

It should be borne in mind that the spray contains ethanol – 24-48 mg in the daily dose.

It should be taken into account that the canister is under pressure. Do not burn, puncture, or open the canister, even if it is empty.

Effect on ability to drive vehicles and mechanisms

In the absence of a general reaction to the drug, performing potentially hazardous activities that require special attention and quick reactions (including driving a car) is not contraindicated.

Overdose

Hexetidine in the indicated dosage is not toxic. Swallowing large amounts of the drug leads to vomiting, so significant absorption is not expected.

No cases of ethanol poisoning due to overdose have been described. Acute alcohol poisoning is very unlikely but theoretically possible if a large dose of the drug is swallowed by a small child.

In any case of overdose, you should immediately consult a doctor.

Treatment is symptomatic: intake of enterosorbents (activated charcoal), gastric lavage, plenty of fluids. Gastric lavage is necessary within 2 hours after swallowing the excessive dose.

Drug Interactions

There are no data on the drug interaction of Maxicold^® Lor.

Storage Conditions

The drug should be stored in a place inaccessible to children at a temperature not exceeding 25°C (77°F). Do not freeze!

Shelf Life

The shelf life is 2 years.

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.