Maxicold Lore spray, instructions for use

Be sure to read these instructions for use of MAXICOLD® ENT and consult a specialist before using this drug.

Registration number: LSR-008791/10

Trade name of the drug : Maxicold® Lor

International nonproprietary name: hexethidine

Dosage form: spray for topical use.

Composition per 100 ml:

Active substance: hexethidine (in terms of 100% substance) – 200 mg (0.2%).

Excipients: sodium saccharinate dihydrate – 40 mg, citric acid monohydrate – 70 mg, sodium hydroxide (sodium hydroxide) – 19 mg, glycerol (glycerol) – 17000 mg, ethanol (rectified ethyl alcohol) 95% – 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 100.0 ml.

Description: a transparent, colorless or yellowish liquid with a characteristic menthol odor, located in an aluminum container with a dosing pump, equipped with a spray for oral use with a protective cap. Opalescence is allowed.

Pharmacotherapeutic group: antiseptic

ATX code: A01AB12

Pharmacological properties

Pharmacodynamics

Antiseptic for topical use for application to mucous membranes. 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 (hexethidine is a thiamine antagonist). The drug has a wide spectrum of antibacterial and antifungal action, in particular against gram-positive bacteria and fungi of the genus Candida, however, Maxicold® Lor can also have an effect in the treatment of infections caused, for example, by Pseudomonas aeruginosa or Proteus. At a concentration of 100 mg/ml, the drug inhibits most strains of bacteria. No development of resistance was observed. Maxicold® Lor has a weak anesthetic effect on the mucous membrane.

The drug has an antiviral effect against influenza A viruses, respiratory syncytial virus (RS virus), and herpes simplex virus type 1, which affect the respiratory tract.

Pharmacokinetics

After a single application, the local effect of hexethidine lasts 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 use of the active substance, traces of it are found on the gum mucosa for 65 hours. In dental plaques, active concentrations remain for 10-14 hours after application.

Maxicold ENT 0.2% 40ml spray for topical use

pharmachologic effect

Antiseptic.

Composition and release form Maxicold ENT 0.2% 40ml spray for topical use

Spray - 100 ml:

Active substance: hexetidine (in terms of 100% substance) - 200 mg (0.2%);
Excipients: sodium saccharinate dihydrate - 40 mg, citric acid monohydrate - 70 mg, sodium hydroxide (sodium hydroxide) - 19 mg, glycerol (glycerol) - 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 100.0 ml.

40 ml in aluminum cylinders (with internal protection), equipped with dosing pumps, sprayers for oral use with protective caps.

Each cylinder, along with a protective cap, a spray for oral use and instructions for use, is placed in a cardboard pack.

Description of the dosage form

An almost colorless liquid with a characteristic menthol odor, located in an aluminum container with a dosing pump, equipped with a spray for oral use with a protective cap.

Directions for use and doses

Locally.

Adults and children over 6 years of age: treat the affected areas while holding your breath 2 times a day.

Children from 3 to 6 years old: use of the drug is possible after consultation with a medical professional.

Hexethidine adheres to the mucous membrane and due to this gives a lasting effect. In this regard, the drug should be used after meals.

General recommendations for administration.

The drug is sprayed into the mouth or throat. Using the spray, you can easily and quickly treat the affected areas.

You need to do the following:

Remove the cap from the cylinder, install the sprayer in the corresponding hole in the upper part of the cylinder.
When using for the first time, you must first make several short presses on the sprayer (to ensure uniform spraying of the contents of the container).
Introduce the required amount of the drug into the oral cavity by pressing the sprayer all the way 3-4 times. During the administration of the drug, you should hold your breath.
After use, remove the sprayer, rinse it in running water and dry it at room temperature out of the reach of children.
The sprayer should be stored in the packaging along with the drug. The balloon should be held vertically during insertion.

The course of treatment is 5-7 days.

If longer use is necessary, the duration of treatment is determined by the doctor.

Pharmacodynamics

Antiseptic for topical use for application to mucous membranes. It has antimicrobial, antifungal, analgesic, enveloping and deodorizing effects. The antimicrobial effect of the drug MAXICOLD® ENT is associated with the suppression of oxidative reactions of bacterial metabolism (hexethidine is a thiamine antagonist). The drug has a wide spectrum of antibacterial and antifungal action, in particular against gram-positive bacteria and fungi of the genus Candida, however, MAXICOLD® ENT can also have an effect in the treatment of infections caused, for example, by Pseudomonas aeruginosa or Proteus. At a concentration of 100 mg/ml, the drug inhibits most strains of bacteria. No development of resistance was observed. MAXICOLD® ENT has a weak anesthetic effect on the mucous membrane. The drug has an antiviral effect against influenza A viruses, respiratory syncytial virus (RS virus), and herpes simplex virus type 1, which affect the respiratory tract.

Pharmacokinetics

Indications for use Maxicold ENT 0.2% 40ml spray for topical use

Infectious and inflammatory diseases of the oral cavity and pharynx (tonsillitis, including Plaut-Vincent angina, pharyngitis, stomatitis, aphthous ulcers of the oral cavity, glossitis, periodontitis, gingivitis, periodontal disease, periodontopathies, alveolitis), bleeding gums. For acute respiratory infections - as an adjuvant, as part of complex therapy.
Fungal infections of the mouth, pharynx and larynx (thrush).
Injuries and surgical interventions in the oral cavity, pharynx and larynx (both before and after them), incl. prevention of infection of the alveoli after tooth extraction.
As a means of oral hygiene to eliminate unpleasant odors (deodorizing effect).
Prevention of superinfections in collapsing tumors of the oral cavity and larynx.

Contraindications

Hypersensitivity, atrophic pharyngitis, children under 3 years of age.

Application of Maxicold ENT 0.2% 40ml spray for topical use during pregnancy and breastfeeding

There are no reports of any adverse effects of hexethidine during pregnancy or breastfeeding. Before prescribing the drug to pregnant or lactating women, the doctor must carefully weigh the benefits of treatment for the mother and the possible risk to the fetus and child, given the lack of sufficient data on the penetration of the drug through the placenta and into breast milk.

special instructions

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

The spray should not be inhaled; Avoid contact of the drug with 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 per daily dose. In the absence of a general reaction to. Taking the drug and performing potentially dangerous activities that require special attention and quick reactions (including driving) are not contraindicated. Attention! The cylinder is under pressure. Do not burn, puncture or open, even if the container is empty.

Impact on the ability to drive vehicles and operate machinery

The drug does not have a negative effect on driving vehicles and performing potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Hexethidine in the indicated dosage is non-toxic. Ingestion of large quantities of the drug results in vomiting, so significant absorption is not expected.

There have been no cases of ethanol poisoning due to overdose. 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, consult your doctor immediately.

Treatment is symptomatic: taking enterosorbents (activated carbon), gastric lavage, drinking plenty of fluids. Gastric lavage is necessary within 2 hours after ingestion of an excess dose.

Side effects Maxicold ENT 0.2% 40ml spray for topical use

Allergic reactions; burning of the oral mucosa; in case of accidental ingestion - nausea; Long-term use may result in disturbance of taste sensations.

If any of the side effects indicated in the instructions get worse, or you notice other adverse reactions not listed in the instructions, tell your doctor.

Drug interactions

Currently, there is no information on interactions with other drugs.

Indications for use

Infectious and inflammatory diseases of the oral cavity and pharynx (tonsillitis, including Plaut-Vincent angina, pharyngitis, stomatitis, aphthous ulcers of the oral cavity, glossitis, periodontitis, gingivitis, periodontal disease, periodontopathies, alveolitis), bleeding gums. For acute respiratory infections - as an adjuvant, as part of complex therapy.

Fungal infections of the mouth, pharynx and larynx (thrush).

Injuries and surgical interventions in the oral cavity, pharynx and larynx (both before and after them), incl. prevention of infection of the alveoli after tooth extraction.

As a means of oral hygiene to eliminate unpleasant odors (deodorizing effect).

Prevention of superinfections in collapsing tumors of the oral cavity and larynx.

Maxicold ENT

Maxicold ENT (hexethidine) is an antiseptic in the form of a spray for use in otorhinolaryngological and dental practice. Shows antibacterial, antimycotic, analgesic, enveloping effects. Prevents the formation of, eliminates or weakens unpleasant odors from the oral cavity. The antibacterial effect of the drug is due to its ability to inhibit the oxidative reactions of the metabolism of microorganisms. Maxicold ENT is endowed with a wide antimicrobial and antimycotic therapeutic range, which extends, among other things, to staphylococci, streptococci, corynebacteria, listeria, bacilli, clostridia, enterococci, candida, pseudomonas, and protea. The development of resistance to the drug was not observed. Slightly suppresses the excitability of the terminal apparatus of the sensory nerves innervating the mucous membrane of the oral cavity and oropharynx. After using a single dose, the local effects of the drug are maintained at a clinically significant level for 10-12 hours. Hexethidine is absorbed only to a minimal extent in the mucous membrane of the oral cavity and oropharynx, without causing systemic side effects. After using a single dose, traces of the active component of the drug are detected on the surface of the gums for up to 65 hours. In dental plaques, clinically significant concentrations of the active substance are maintained for 10-14 hours after spraying a single dose. Maxicold ENT is indicated for inflammation of the palatine tonsils, mucous membrane of the pharynx, oral cavity, painful shallow ulcers (wounds) on the oral mucosa, inflammation of the tongue, root membrane of the tooth and adjacent tissues, inflammation of the gums without compromising the integrity of the dentogingival junction, dystrophic diseases of periodontal tissues , diffuse inflammatory damage to the final parts of the respiratory tract, bleeding gums, fungal infections of the oral cavity and oropharynx (including candidiasis), traumatic injuries (including

including as a result of surgical interventions) of the oral cavity, oropharynx, larynx, as a deodorizing agent for bad breath, and also as a means of prevention during re-infection with a new infectious disease in conditions of an incomplete infectious disease as a result of the destruction of tumors localized in the oral cavity. Use topically after meals or in between meals. The spray is sprayed onto the affected areas of the oral cavity and oropharynx. The frequency of use for patients over three years of age is 2-3 times a day. According to indications, with the consent of the doctor, it is possible to increase the frequency of dosing of the drug. The duration of the medication course is 5-7 days. Possible side effects: allergic manifestations, irritating sensation of heat on the oral mucosa. If the spray accidentally enters the digestive tract, nausea will occur. With prolonged use - hypogeusia. In pediatric practice, Maxicold ENT is used after the patient reaches the age of three. The criterion for the admissibility of prescribing the drug to a child is the absence of resistance on his part to the spray bottle placed in the oral cavity and his ability to hold his breath when spraying the spray. The drug is not prescribed for atrophic pharyngitis, as well as for individual intolerance to the active or auxiliary components of the drug. Pregnancy and lactation are not direct contraindications to the use of Maxicold ENT, but special care should be taken when prescribing the drug during this period. When spraying the spray, you should hold your breath. After use, the sprayer is washed with water. When using Maxicold ENT, it is necessary to take into account that the drug contains ethanol as an auxiliary component. The cylinder should be protected from accidental puncture, because its contents are under pressure.

General recommendations for administration

The drug is sprayed into the mouth or throat. Using the spray, you can easily and quickly treat the affected areas.

You need to do the following:

1. Remove the cap from the cylinder, install the sprayer in the corresponding hole in the upper part of the cylinder.

2. When using for the first time, you must first make several short presses on the sprayer (to ensure uniform spraying of the contents of the container).

3. Introduce the required amount of the drug into the oral cavity by pressing the sprayer all the way 3-4 times. During the administration of the drug, you should hold your breath.

4. After use, remove the sprayer, rinse it in running water and dry it at room temperature out of the reach of children.

5. The sprayer should be stored in the packaging along with the drug.

During insertion, the balloon should be held vertically (see picture)!

The course of treatment is 5-7 days.

If longer use is necessary, the duration of treatment is determined by the doctor.

Maxicold Lor spray for local approx. 0.2% 40ml (balloon)

Registration Certificate Holder

OTCPHARM (Russia)

Dosage form

Medicine - Maxicold® ENT (Maxicold LOR)

Description

Topical spray

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

100 ml

hexethidine 200 mg

Excipients

: sodium saccharinate dihydrate - 40 mg, citric acid monohydrate - 70 mg, sodium hydroxide (sodium hydroxide) - 19 mg, glycerol (glycerol) - 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 cylinders (1) with a dosing pump and a spray for oral use - cardboard packs.

Indications

infectious and inflammatory diseases of the oral cavity and pharynx (tonsillitis, including Plaut-Vincent angina, pharyngitis, stomatitis, aphthous ulcers of the oral cavity, glossitis, periodontitis, gingivitis, periodontal disease, periodontopathies, alveolitis), bleeding gums;
for acute respiratory infections - as an adjuvant, as part of complex therapy;
fungal infections of the mouth, pharynx and larynx (thrush);
injuries and surgical interventions in the oral cavity, pharynx and larynx (both before and after them), incl. prevention of infection of the alveoli after tooth extraction;
as a means of oral hygiene to eliminate unpleasant odors (deodorizing effect);
prevention of superinfections in decaying tumors of the oral cavity and larynx.

Contraindications for use

atrophic pharyngitis;
children under 3 years of age;
hypersensitivity to the components of the drug.

pharmachologic effect

Antiseptic drug for local use. 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 (hexethidine is a thiamine antagonist). The drug has a wide spectrum of antibacterial and antifungal action, in particular against gram-positive bacteria and fungi of the genus Candida, however, Maxicold® Lor can also have an effect in the treatment of infections caused, for example, by Pseudomonas aeruginosa or Proteus spp. At a concentration of 100 mg/ml, the drug inhibits most strains of bacteria. No development of resistance was observed. Maxicold® Lor has a weak anesthetic effect on the mucous membrane.

Drug interactions

There is no data on drug interactions with Maxicold® Lor.

Dosage regimen

Apply topically, after meals or between meals.

Using a spray, treat the affected areas in the mouth and throat. Frequency of use for adults and children over 3 years of age

— 2-3 times/day. If necessary, more frequent use of the drug is possible. The course of treatment is 5-7 days. To use the drug correctly, you must perform the following steps:

1. Remove the cap from the cylinder, install the sprayer in the corresponding hole in the upper part of the cylinder.

2. When using for the first time, you must first make several short presses on the sprayer (to ensure uniform spraying of the contents of the container).

3. Introduce the required amount of the drug into the oral cavity by pressing the sprayer all the way 3-4 times. During the administration of the drug, you should hold your breath.

4. After use, remove the sprayer, rinse it in running water and dry it at room temperature out of the reach of children.

5. The sprayer should be stored in the packaging along with the drug.

During insertion, the balloon should be held vertically.

Overdose

Hexethidine in the indicated dosage is non-toxic. Ingestion of large quantities of the drug results in vomiting, so significant absorption is not expected.

There have been no cases of ethanol poisoning due to overdose. 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, consult your doctor immediately.

Treatment

symptomatic: taking enterosorbents (activated carbon), gastric lavage, drinking plenty of fluids. Gastric lavage is necessary within 2 hours after ingestion of an excess dose.

Side effect

Local reactions:

allergic reactions, burning of the oral mucosa.
If accidentally swallowed:
nausea.

With long-term use:

disturbance of taste sensations.

special instructions

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

The spray should not be inhaled; Avoid contact of the drug with 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 per daily dose.

It should be taken into account that the cylinder is under pressure.
Do not burn, puncture or open the container, even if it is empty. Effect on the ability to drive vehicles and operate machinery
In the absence of a general reaction to taking the drug, performing potentially dangerous activities that require special attention and quick reactions (including driving) is not contraindicated.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Do not freeze!

Best before date

Shelf life: 2 years.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution. There is no information about any adverse effects of hexethidine during pregnancy and breastfeeding. Before prescribing the drug to pregnant or lactating women, the doctor must carefully weigh the benefits of treatment for the mother and the possible risk to the fetus and child, given the lack of sufficient data on the penetration of the drug through the placenta and into breast milk.

Use in children

Restrictions for children - With caution.

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

Terms of sale

The drug is approved for use as a means of OTC.

Contacts for inquiries

OTCPHARM PJSC (Russia)

OTCPHARM P

JSC

123317 Moscow, Testovskaya st. 10 Tel., 221-18-00

Overdose

Hexethidine in the indicated dosage is non-toxic. Ingestion of large quantities of the drug results in vomiting, so significant absorption is not expected.

Treatment is symptomatic: taking enterosorbents (activated carbon), gastric lavage, drinking plenty of fluids. Gastric lavage is necessary within 2 hours after ingestion of an excess dose.

special instructions

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

The spray should not be inhaled; Avoid contact of the drug with 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 per daily dose.

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

Attention! The cylinder is under pressure. Do not burn, puncture or open, even if the container is empty.