Xylometazoline, 1 piece, 10 ml, 0.1%, nasal spray

Xylometazoline spray is intended for the treatment of acute respiratory diseases with symptoms of rhinitis (runny nose); acute allergic rhinitis, sinusitis, hay fever, otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa); preparing the patient for diagnostic procedures (rhinoscopy). Xylometazoline belongs to the group of local vasoconstrictors (decongestants), causes a narrowing of the blood vessels of the nasal mucosa, thus eliminating swelling and hyperemia of the nasal mucosa, restores the patency of the nasal passages, and facilitates nasal breathing.
The effect of the drug begins a few minutes after use and lasts up to 10 hours.

Method of administration and dose. Intranasally (inside the nasal cavity).

Clean your nasal passages before use.

Adults and children over 6 years old : 1 injection of 0.1% xylometazoline solution into each nasal passage 2-3 times a day.

Children aged 2 to 6 years use 0.05% xylometazoline solution, 1 injection into each nasal passage 1-2 times a day.

The drug should not be used more than 3 times a day. Do not use the drug without a break for more than 3-5 days.

Release form . Nasal spray 0.05% and 0.1%. 10 ml in neutral glass bottles, sealed with a crimp microspray, spray nozzle and protective cap.

Conditions for dispensing from pharmacies . Over the counter.

Contraindications . Hypersensitivity to xylometazoline, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, thyrotoxicosis, surgical interventions on the meninges (history), children under 2 years of age for using a 0.05% solution and up to 6 years for 0. 1% solution.

Do not use during therapy with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants.

Use with caution: coronary heart disease (angina pectoris III-IV functional class), prostatic hyperplasia, diabetes mellitus, pregnancy, lactation.

Side effects . With frequent and/or prolonged use - irritation and/or dryness of the nasopharyngeal mucosa, burning, paresthesia, sneezing, hypersecretion; rarely - swelling of the nasal mucosa, palpitations, tachycardia, arrhythmia, increased blood pressure, vomiting, headache, insomnia, blurred vision, depression (with long-term use of high doses).

Features and advantages of XYLOMETAZOLINE spray with microspray (dosing pump):

Spray form - more precise dosage of the drug:

The spray provides a much more accurate dosage of the drug compared to conventional nasal drops, which cannot be dosed, which is why most of the injected solution immediately flows down the bottom of the nasal cavity into the pharynx, and not only the necessary therapeutic effect is not achieved, but it may also pose a threat drug overdose.

If we compare the form of a spray with “sprayers”, then when using such “sprayers”, the drug is extracted from the bottle through a small hole when the polymer bottle is compressed (the “syringe” principle), and at the same time there is an uncontrolled release of liquid from the bottle. The nature of the spray depends on the force, duration of pressing on the bottle, and the position of the bottle. When the bottle deviates from the vertical position, the medicine is not even partially sprayed, but is supplied in a stream. Contamination of the drug in the bottle occurs.

Possibility of carrying out a full course of treatment at home, at work, in transport:

The compactness of the packaging allows you to carry the drug with you all the time.

Visual inspection of the drug in the package:

The transparent bottle allows you to see both the quantity and quality of the drug in the package.

Best before date . 3 years. Do not use the drug after the expiration date indicated on the package.

Storage conditions . Store at a temperature from 0°C to 25°C, protected from light, out of reach of children.

Xylometazoline drops

intended for the treatment of acute respiratory diseases with symptoms of rhinitis (runny nose); acute allergic rhinitis, sinusitis, hay fever, otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa); preparing the patient for diagnostic procedures (rhinoscopy).

Xylometazoline

belongs to the group of local vasoconstrictors (decongestants), causes a narrowing of the blood vessels of the nasal mucosa, thus eliminating swelling and hyperemia of the nasal mucosa, restores the patency of the nasal passages, and facilitates nasal breathing.

The effect of the drug begins a few minutes after use and lasts up to 10 hours.

Method of administration and dose.

Intranasally (inside the nasal cavity). Clean your nasal passages before use.

Adults and children over 6 years old

1-2 drops of 0.1% xylometazoline solution in each nasal passage 2-3 times a day.

Children aged 2 to 6 years

use a 0.05% solution of xylometazoline, 1-2 drops in each nasal passage 1-2 times a day.

The drug should not be used more than 3 times a day. Do not use the drug without a break for more than 3-5 days.

Release form

. Nasal drops 0.05% and 0.1%. 10 or 15 ml in polyethylene bottles, hermetically sealed with dropper stoppers and screw caps.

Conditions for dispensing from pharmacies

. Over the counter.

Contraindications

. Hypersensitivity to xylometazoline and other components of the drug, children under 2 years of age for using a 0.05% solution and up to 6 years for a 0.1% solution, pregnancy, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, thyrotoxicosis, condition after transsphenoidal hypophysectomy, surgical interventions on the meninges (history), do not use during therapy with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, as well as with other drugs that increase blood pressure.

Side effects

. With frequent and/or prolonged use - irritation and/or dryness of the nasopharyngeal mucosa, burning, paresthesia, sneezing, hypersecretion; rarely - swelling of the nasal mucosa, palpitations, tachycardia, arrhythmia, increased blood pressure, vomiting, headache, insomnia, blurred vision, depression (with long-term use of high doses).

Impact on driving vehicles and machinery:

in therapeutic doses does not affect the ability to drive a car or operate machinery.

Visual inspection of the drug in the package:

The transparent bottle allows you to see both the quantity and quality of the drug in the package.

Best before date

.
3 years.
Do not use the drug after the expiration date indicated on the package.

Storage conditions

. Store at a temperature from 2°C to 25°C, protected from light, out of reach of children.

pharmachologic effect

The mucous membrane of the nasal cavity is penetrated by many small blood vessels. Two parts of the nervous system are responsible for their tone. Parasympathetic dilates blood vessels, increases blood flow to tissues and stimulates mucus secretion. The sympathetic part activates α(alpha)-adrenergic receptors, located in the walls of blood vessels and responding to adrenaline. When they are stimulated, vasoconstriction occurs, blood flow accelerates and nasal secretion decreases3.

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What are xylometazoline preparations used for?

Decongestants are drugs that can eliminate swelling of the mucous membrane and nasal congestion, and restore nasal breathing4. Xylometazoline belongs to this category of drugs. It has a stimulating effect on α-adrenergic receptors, constricts the blood vessels of the nasal mucosa and limits blood flow to it, thereby helping to reduce swelling and facilitate breathing through the nose1,2.

Difficulty in nasal breathing not only affects well-being and quality of life. It can disrupt normal aeration - the natural exchange of air between the nasal cavity, paranasal sinuses and middle ear. The worse the cavities are “ventilated”, the more mucus is formed in them and the slower its outflow occurs. Stagnation of mucus, in turn, promotes the proliferation of microorganisms and often leads to inflammatory diseases - sinusitis, sinusitis and otitis media. In addition, nasal congestion and mouth breathing aggravate respiratory infections. If the air does not pass through the “nasal filter,” pathogens easily penetrate the lower respiratory tract and lungs, causing inflammation – bronchitis and pneumonia.

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Indications

The main cause of nasal congestion is rhinitis3. Proper, controlled use of decongestants prevents complications of rhinitis and speeds recovery3,4.

According to the instructions for use2, xylometazoline can help with the following diseases:

• acute respiratory infectious diseases accompanied by inflammation of the nasopharynx (runny nose);
• acute sinusitis (inflammation of the paranasal sinuses, sinusitis);
• seasonal allergic rhinitis (hay fever);
• otitis (inflammation of the middle ear).

Xylometazoline can also be prescribed by otolaryngologists before diagnostic and therapeutic procedures to reduce swelling of the nasal mucosa2.

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Application, dosage regimen

Xylometazoline preparations are intended for intranasal administration - instillation into the nose. The dose and frequency of use of the drug depend on the chosen dosage form, the concentration of the active substance and the age of the patient.

In the pharmacy chain you can find sprays and drops for the common cold containing xylometazoline in the following concentrations:

• 0.05% (500 mg of substance in 1 ml of solution);
• 0.1% (1 mg in 1 ml).

The first is more often prescribed to children, the second to adults1,2.

Before using xylometazoline drops/spray, it is necessary to clear the nasal passages of mucus and crusts. You can rinse your nose with a syringe or remove mucus with an aspirator. Then drip/inject the medicine into both nostrils.

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Standard dosage regimen

Adults and children over 6 years of age: one injection or 2-3 drops of a 0.1% xylometazoline solution into each nasal passage. To reduce nasal congestion, the procedure should be repeated 3 times during the day5.

For symptomatic treatment of children from 2 to 6 years old, a 0.05% xylometazoline solution is used. For rhinitis and other indications, the drug is injected once or instilled 1-2 drops 1-2 times a day5.

Important! The optimal dosage regimen for xylometazoline preparations is determined by the doctor. During treatment, it is necessary to follow its recommendations on the choice of dosage form, dosage and duration of use of the drug. To relieve nasal congestion and reduce the risk of side effects, the drug should be used for no more than 5-7 days in a row2,5.

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Xylometazoline nasal spray 0.05% vial with spray. 10ml nozzle

Registration Certificate Holder

ATOLL (Russia)

Dosage form

Medicine - Xylometazoline

Description

Nasal spray 0.05%

in the form of a colorless or slightly colored transparent liquid with a weak characteristic odor.

1 ml

xylometazoline hydrochloride 0.5 mg

Excipients

: benzalkonium chloride - 0.15 mg, disodium edetate - 0.5 mg, potassium dihydrogen phosphate - 3.63 mg, sodium dihydrogen phosphate dihydrate - 3.54 mg, sodium chloride - 7 mg, eucalyptus oil - 0.5 mg, sorbitol - 8 mg, glycerol - 4 mg, macrogol glyceryl hydroxystearate - 3.4 mg, purified water - up to 1 ml.

10 ml - bottles with a spray (1) - cardboard packs. 20 ml - bottles with a spray (1) - cardboard packs.

Indications

To reduce swelling of the mucous membrane of the nasopharynx and discharge in acute allergic rhinitis, acute respiratory infections with symptoms of rhinitis, sinusitis, hay fever, otitis media; preparing the patient for diagnostic procedures in the nasal passages.

Contraindications for use

Hypersensitivity to xylometazoline; atrophic rhinitis, thyrotoxicosis; inflammatory diseases of the skin or mucous membrane of the nasal vestibule; condition after transsphenoidal hypophysectomy; patients with severe cardiovascular diseases (for example, coronary artery disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis); patients with a history of surgical interventions on the meninges; patients receiving MAOI or other drugs that can cause an increase in blood pressure; patients with increased intraocular pressure, especially with angle-closure glaucoma; during therapy with tricyclic and tetracyclic antidepressants, other local vasoconstrictors (decongestants); pregnancy; children's age - depending on the dosage form.

Carefully:

patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with pheochromocytoma, porphyria; patients with endocrine diseases (for example, hyperthyroidism, diabetes mellitus); patients with prostatic hyperplasia; during lactation (breastfeeding).

pharmachologic effect

Vasoconstrictor for local use in ENT practice. Alpha adrenergic agonist. When applied to the mucous membranes, it causes a narrowing of the blood vessels of the nasal mucosa, thus eliminating swelling and hyperemia of the nasal mucosa, and restores the patency of the nasal passages. For rhinitis, it facilitates nasal breathing.

Drug interactions

It is possible to enhance the systemic effect of xylometazoline with simultaneous use of MAO inhibitors and tricyclic antidepressants. The simultaneous use of xylometazoline with tetracyclic antidepressants, other local vasoconstrictors (decongestants), as well as other drugs that increase blood pressure is incompatible.

Dosage regimen

Use intranasally. The dose depends on the dosage form used and the age of the patient.

Side effect

From the immune system:

uncommon - hypersensitivity reactions (angioedema, skin rashes, itching).

From the digestive system:

rarely - nausea, vomiting.

From the nervous system: rarely - headache; very rarely - insomnia, anxiety, fatigue, hallucinations and convulsions (mainly in children).

From the side of the organ of vision:

very rarely - blurred vision.
From the cardiovascular system:
rarely - palpitations, increased blood pressure, tachycardia; very rarely - arrhythmia.

Local reactions:

often - irritation and/or dryness of the nasopharyngeal mucosa, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the nasal mucosa; infrequently - swelling of the nasal mucosa, nosebleeds, withdrawal syndrome. Possible increased swelling of the nasal mucosa (reactive hyperemia).

special instructions

Long-term use (more than 7 days) and overdose of sympathomimetics that have a decongestive effect can lead to reactive hyperemia of the nasal mucosa. As a result, difficulty in nasal breathing occurs, which leads to the patient starting to use xiometazoline repeatedly or even constantly. This can lead to chronic swelling (medicinal rhinitis), and eventually even to atrophy of the nasal mucosa (ozena).

In milder cases, to improve the patient's condition, you can first stop injecting the sympathomimetic into one nostril, and after the complaints have subsided, continue to inject it into the other nostril to at least partially ensure nasal breathing.

Recommended doses should not be exceeded, especially in children and elderly patients.
Effect on the ability to drive vehicles and operate machinery.
With long-term treatment or when using xylometazoline in higher doses, the possibility of its systemic effect cannot be excluded. If systemic side effects develop, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - With caution. Contraindicated for use during pregnancy. During lactation, use is possible only as prescribed by a doctor, after a careful assessment of the ratio of the expected benefit for the mother to the potential risk for the child. Exceeding recommended doses is not allowed.

Use in elderly patients

Restrictions for elderly patients - Use with caution.

Do not exceed recommended doses in elderly patients.

Use in children

Restrictions for children - With caution.

It can be used in children according to indications, in doses and dosage forms recommended according to age. It is necessary to strictly follow the instructions in the instructions for xylometazoline preparations regarding contraindications for the use of specific dosage forms of xylometazoline in children of different ages. Do not exceed recommended doses in children.

Side effects

When applied topically, the drug is practically not absorbed into the blood and is not determined in the body by analytical methods1. However, in rare cases due to xylometazoline preparations:

• the nasal mucosa swells;
• heart rhythm is disturbed;
• blood pressure increases;
• headache, vomiting, sleep disturbance and blurred vision1.

Depression can occur extremely rarely (with long-term use in high doses)1.

The listed reactions from the drug develop more often if people are predisposed to them or if xylometazoline is used incorrectly2. In most cases, its side effects are limited to local reactions to the active component2.

Xylometazoline can cause irritation and dryness of the mucous membrane, burning and tingling in the nose, which causes sneezing attacks and excessive discharge of liquid mucus from the nose2.

With prolonged and frequent use of drops or spray, the development of rebound syndrome and tachyphylaxis is possible2,3. The rebound effect may occur several hours after using the decongestant. The reason for the reaction is the activation of b-adrenergic receptors. When they are stimulated, the blood vessels dilate, swelling of the mucous membrane occurs and nasal breathing becomes difficult3.

The “rebound” syndrome encourages the patient to use the medicine more often and in larger doses, which causes addiction. Over time, the sensitivity of adrenergic receptors decreases, and this contributes to the development of tachyphylaxis - a noticeable decrease in the effectiveness of the drug3.

Frequent and long-term use of a decongestant can lead to changes in the mucous membrane of the nasal cavity - its thinning, death of ciliated epithelial cells and the development of drug-induced rhinitis2,3.

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Side effects

• burning in the nose and throat;
• irritation of the mucous membrane;
• dryness of the nasopharyngeal mucosa;
• sneezing;
• headache;
• dizziness;
• swelling of the nasal mucosa;
• insomnia;
• heart rhythm disturbance;
• tachycardia;
• increased blood pressure ;
• increased excitability ;
• visual impairment;
• vomit;
• depression.

Contraindications

Xylometazoline is contraindicated in the following diseases:

• arterial hypertension;
• tachycardia (rapid heartbeat);
• severe atherosclerotic damage to the arteries;
• glaucoma (increased intraocular pressure);
• atrophic rhinitis (thinning of the nasal mucosa);
• hyperthyroidism (high levels of thyroid hormones)2.

Other contraindications include hypersensitivity to the active substance of the drug and previous surgical interventions on the meninges.

Xylometazoline should be used with caution in severe angina, diabetes mellitus and prostatic hyperplasia, as well as during pregnancy and lactation2.

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Use in children

Decongestants are included by the Russian Association of Otorhinolaryngologists in federal clinical guidelines for the treatment of rhinitis and rhinosinusitis4. The FDA (Food and Drug Administration) approves their use in children over 6 years of age4. At the same time, it is important to select medications specifically intended for the treatment of young patients, strictly follow the recommendations of the attending physician and not exceed the doses and duration of therapy set out in the instructions4.

Important! For children from 2 to 6 years old, xylometazoline preparations are intended at a concentration of 0.05%; for children over 6 years old, a 0.1% solution can be used2.

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Xylometazoline analogues

Level 4 ATX code matches:
Xymelin Eco

Xymelin

Nazivin

Galazolin

Lazorin

Nazivin Sensitive for children

Otrivin

Naphthyzin

Sanorin

Knoxprey

For the nose

Lazolvan Rino

Afrin

Rhinorus

Eucazoline Aqua

Rinazolin

Grippostad Reno

Farmazolin

Nazol Advance

Nazol Baby

Analogues: Farmazolin, Farmazolin N, Galazolin, Xylo-mefa, Meralis, Otrivin, Otrivin with menthol and eucalyptus, Tizin Xylo .

Differences between Xylometazoline and Oxymetazoline

Xylometazoline and Oxymetazoline belong to the group of imidazolines, acting on α1 and 2 adrenergic receptors and have a longer effect than drugs of the phenylephrine : 10 hours of action.

For long-acting drugs, the effect does not occur immediately, but after 10–15 minutes. The long-term vasoconstrictive effect allows them to be used 1-2 times a day, provides restful sleep, but causes a greater risk of damage to the mucous membrane, including atrophy. However, if you do not exceed the period of continuous use (3-4 days), the risk is reduced.

The difference between Xylometazoline and Oxymetazoline is only in the duration of action. Xylometazoline is a drug with an average duration of action of 8-10 hours. Known preparations of xylometazoline: Xylen, Rinostop, Galazolin, Xymelin, Otrivin, Farmazolin, Dlyanos, Tizin-Xylo . Oxymetazoline is a long-acting drug - up to 12 hours. Preparations based on it: Nazivin, Rinazolin, Nazol, Noxprey . To prolong the vasoconstrictor effect, high-molecular prolongators (cellulose ethers, alginates) are added to the composition.

TIZIN® - xylometazoline preparation

The TIZIN® line includes several drugs. TIZIN® Classic spray in the form of a 0.05% xylometazoline solution is intended for children from 2 to 6 years old, 0.1% solution for adults5.

The drug can begin to act within 2-5 minutes5, reduces swelling of the nasal mucosa and helps fight nasal congestion for 10 hours6,8.

TIZIN® Expert spray is also available in dosages for children from 2 to 6 years old and for children over 6 years old and adults7. In addition to xylometazoline, it contains hyaluronic acid, which helps moisturize the nasal mucosa and helps it recover6,7. The drug does not contain preservatives. The spray is equipped with a special SILVER TURBO spiral with silver ions, which prevents bacteria from penetrating inside. Thanks to this, the medicinal solution remains sterile throughout the entire period of use.

The information in this article is for reference only and does not replace professional advice from a doctor. To make a diagnosis and prescribe treatment, consult a qualified specialist.

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Literature

1. Xylometazoline. Active ingredients // Radar of Russia - https://www.rlsnet.ru/mnn_index_id_111.htm
2. Description of the drug Xylometazoline, based on the officially approved instructions for use of the drug // Vidal Directory - 2011. — https://www.vidal.ru/drugs/molecule/1121
3. Evdokimova A.I., Miroshnichenko N.A., Ovchinnikov A.Yu. Topical decongestants: myths and reality // Medical Council. - No. 12. – 2022. – pp. 40-43.
4. Karneeva O. V., Garashchenko T. I., Karpova E. P., Ryazantsev S. V., Nikiforova G. N., Geppe N. A., Gorelov A. V., Malakhov A. B., Kondurina E. G., Bakradze M.D., Kolosova N.G. Current trends and safety problems in the use of decongestants in childhood. Resolution of the expert council. Pediatrics (Appendix to the journal Consilium Medicum). 2018; 1:32-35. DOI: 10.26442/2413-8460_2018.1.32-35.
5. Instructions for medical use of the drug TIZIN® Classic.
6. Malakhov A.B. et al. Topical decongestants in the complex therapy of acute respiratory infections in children // Medical Council. - No. 14. — 2015
7. Instructions for medical use of the drug TIZIN® Expert.
8. Official website TIZIN ®, description of the drug TIZIN ® Expert.

Instructions for use of Xylometazoline (Method and dosage)

All forms of the drug are used intranasally.

Xylometazoline nasal drops 0.1% are used in adults, 1-2 drops at each turn three times a day.

The 0.1% spray is used in adults with 1 pump (corresponding to 0.1 mg) per stroke. The applicator is inserted, maintaining the vertical position of the bottle, and injected three times a day after 8-10 hours.

Gel 0.1% is used by adults, 2-3 drops of gel 3 times a day.

Considering the possibility of systemic adsorption and the occurrence of adverse reactions, the instructions for use of Xylometazoline must be strictly followed. Use the drug in any form of release for no more than 3-5 days. Should not be used for a long time or for chronic rhinitis. If crusts appear in the nose, it is better to use the drug in gel form. If a dose is missed, the next dose will not be doubled.