Tizin xylo got into the eye. Tizin - instructions for use. Restrictions on use

Tizin Xylo, use, indications, contraindications, side effects

Tizin Xylo is available in the form of nasal drops and spray, and is intended for the treatment of chronic and acute rhinitis, as well as subsequent possible complications in the form of rhinitis, sinusitis, pharyngitis, etc. This medication is also used as a medicine for hay fever, as well as to relieve swelling of the mucous membranes of the nasopharynx and diagnostic measures.

There are certain contraindications, which include individual intolerance to the components of the drug in the patient, the presence of dry rhinitis. There are also restrictions on the age category - Tizin is not recommended for use in children under 2 years of age.

When using the drug Tizin, the following side effects are possible: reactive hyperemia, the appearance of a burning sensation, if the drug is used for a sufficiently long time, swelling of the nasal mucosa may occur. Headaches, sweating, weakness, increased blood pressure, increased heart rate (palpitation), body tremors are quite rare.

Overdose of Tizin, symptoms, remedies

In cases of overdose, the following symptoms may occur: nausea, bluish discoloration of the skin (cyanosis), fever. The pupils of the eyes expand, convulsions, tachycardia and arrhythmia appear, which can lead to cardiac arrest. Pulmonary edema, hypertension are possible, respiratory activity is disturbed, mental disorders also appear. Treatment is usually symptomatic, otherwise it is necessary to use activated charcoal for gastric lavage, the introduction of antipyretic and anticonvulsant drugs, oxygen therapy. With increased blood pressure, 5 mg of phentolamine based on saline is administered or 100 mg is taken orally.

Tizin drops. Description, method of application, dosage

The active substance of the drug is Tetryzoline (tetrizoline hydrochloride), as auxiliary substances are used: benzyl alcohol, disodium edetate, benzalkonium chloride, sorbitol, sodium citrate, hydrochloric acid, polyoxyethyleneglycerol trihydroxystearate 40, methylhydroxypropyl cellulose, perfume oils and purified water.

The drug is a nasal drops placed in a special dropper bottle with a capacity of 10 ml, a concentration of 0.1%. The dropper, in turn, is packed in a cardboard box.

Apply drops, instilling each nostril with the head tilted back a little, the dosage is: for adult patients and for children aged 6 years, 2-3-4 drops (concentration 0.1%); for children aged 2 to 6 years - 2 or 3 drops (0.05% concentration). It should be remembered that the tool is strong enough, and you should not abuse it. Instillation should be carried out no more than once every 4 hours, and this dosage is more than acceptable, since often the effect of the drug can last up to 8 hours. The drug works perfectly during the whole night's sleep, if used immediately before it, without requiring any additional applications and without being a source of insomnia.

The use of the drug should be limited to a period of three to five days, in cases where it is necessary to extend the period of use, a preliminary consultation with the attending physician is required.

The drug must be stored out of the reach of children, at a temperature not exceeding 30 ° C. If the storage conditions are observed, the shelf life of the drug is 5 years.

Tizin spray. Description, method of application, dosage

The main component of Tizin in the spray is xylometazoline, which, acting on the mucous membranes, reduces their swelling. Accordingly, normal nasal breathing is restored, mucous secretion decreases. The beneficial effect is manifested within 5-10 minutes after taking the drug.

Tizin-spray is used as an auxiliary drug for acute and chronic rhinitis of various origins, for sinusitis and otitis media, as well as for allergic diseases.

The drug Tizin Xylo Spray is available in special 10 ml bottles, the concentration is 0.05% and 0.1%.

Tizin spray 0.05% is intended for the children's group aged 2 to 6 years, Tizin spray 0.1% is used to treat children from 6 years and adult patients. For children from 2 to 6 years old, the dosage of 0.05% spray is 1 injection into each nostril three times a day, for children from 6 years old and adult patients, the dosage of 0.1% spray is 1 injection into each nasal passage three times a day.

The treatment period should not exceed 3-5 days. If it is necessary to re-treat, a break in its application should be at least a few days. Treatment of chronic rhinitis with Tizin in a spray should be carried out under the supervision of the attending physician due to the possibility of atrophy of the mucous tissues of the nasal cavity.

Tizin for children

Parents using Tizin as a drug for the treatment of children should remember that there is no Tizin for the age group under 2 years of age. Drops and spray Tizin for children from 2 to 6 years old has a concentration of 0.05% and is used only after consultation with the attending physician. Despite the speed of action (5-10 minutes) and undoubted effectiveness, it is necessary to take into account the fact that a sufficiently long-term use of Tizin can contribute to the occurrence of atrophic rhinitis, which limits the allowable period of taking the drug to 7 days.

Use of Tizin during pregnancy

Studies on the effect of Tizin on pregnant women have not been conducted, however, it should be remembered that the drug can affect the tone of the muscles of the uterus, which, in turn, can lead to miscarriage. Even if such catastrophic consequences do not occur, the embryo, when Tizin is used by the mother, is subject to hypoxia, which is fraught with abnormal development.

As for the use of Tizin during lactation, it should be recommended to use it during this period only if absolutely necessary in small doses and at low concentrations. In this case, the child's condition should be under the supervision of a pediatrician.

Tizin, price

The cost of the drug Tizin in drops and spray in pharmacies of Ukraine ranges from 25.83 UAH. up to UAH 28.77 - depending on the region and distributor.

In viral and allergic diseases, a runny nose often appears, to eliminate which drugs from the group of vasoconstrictors are used. It is to such medicines that Tizin belongs. This medicine helps to ease breathing and eliminate nasal congestion. In what dosage forms is it produced and is it prescribed for children? How to use "Tizin" correctly so as not to harm the health of the child?

Composition and form

Under the brand name "Tizin", which is owned by Johnson & Johnson, several drugs for the common cold are offered. Initially, the drug with this name contained tetrizoline and was produced in the form of nasal drops. Such a product is common abroad, and in Russia, Tizin brand medicines are represented by several types of nasal sprays.

• "Tizin Classic". This drug was previously called "Tizin Xylo". Its main component is xylometazoline hydrochloride. Depending on the concentration of such a compound, Tizin Classic is isolated for children (in 1 ml of such an agent there is 0.5 mg of the active substance, that is, a 0.05% solution) and a more concentrated preparation for adults (it is 0.1% - ny, because each milliliter contains 1 mg of xylometazoline). Among the excipients in the Classic preparation, you can see sodium hydrogen phosphate, sodium chloride, benzalkonium chloride and other components.
• "Tizin Expert". Such a medication was previously called "Tizin Xylo Bio". It is also presented in two dosages, like the "Classic", and is intended for the same age categories (0.05% medication is called children's). The main difference of this drug is the presence of the second active substance - hyaluronic acid in the form of sodium hyaluronate. In addition, the "Expert" line does not contain a preservative, which in the preparations "Classic" is benzalkonium chloride.

• "Tizin Alergi". This medication differs from the previous ones in the active substance, since it does not contain xylometazoline, but levocabastin. Such a substance in the form of hydrochloride is presented in 1 ml of a solution in an amount of 0.5 mg, and one spray dose contains it in a dosage of 50 mcg. Additionally, the preparation contains hypromellose, propylene glycol, sterile water and some other compounds.

According to their physical characteristics, all preparations are a colorless (sometimes yellowish) solution, in which there are no suspensions or inclusions. The medicine may have a slight characteristic odor. All medicines are sold in bottles made of brown glass ("Tizin Classic") or dense white polyethylene ("Tizin Expert" and "Tizin Alergy").

Inside one vial is 10 ml of solution. The vials have a dosing device and a polyethylene cap. Since all sprays are dosed, the 0.05% preparation contains 140 doses of the drug, and inside the 0.1% preparation there are at least 70 doses. One bottle of "Tizin Alergi" is the source of 100 doses of the drug.

A feature of the preparations of the Expert line is also the presence inside the pump of a special filter system and a spiral with silver ions. Thanks to this unique design, bacteria cannot get inside the vial.

Operating principle

According to their mechanism of action, the drugs "Classic" and "Expert" belong to alpha-adrenergic agonists. They affect alpha-type adrenergic receptors, as a result of which the vessels contract, the amount of discharge from the nose decreases, and the swelling disappears. The therapeutic effect after xylometazoline enters the nasal cavity develops within 5-10 minutes. At the same time, the active component of the spray is almost not absorbed, but acts only at the site of the medication.

The presence of hyaluronic acid in the preparations "Expert" gives such solutions an additional moisturizing effect. Thanks to this component, after treatment with a spray, the nasal mucosa recovers faster.

Levocabastin, which provides the action of Tizin Alergi, is a histamine receptor blocker. The consequence of its selective effect on these receptors will be the elimination of itching in the nose, sneezing and other symptoms of an allergic rhinitis. Like other products of this brand, such a spray relieves the condition of patients 5 minutes after application and lasts up to 12 hours.

Indications

Taking into account the mechanism of action, "Tizin Allergy" is prescribed to patients who have been diagnosed with a year-round or seasonal rhinitis of an allergic nature. Preparations from the "Expert" and "Classic" lines can also be used for allergic rhinitis, but are also prescribed in other situations:

• if you need to eliminate congestion and swelling with a runny nose, provoked by SARS or pathogenic bacteria;
• if you want to facilitate the secretion of sinusitis;
• if the child has inflammation of the middle ear;
• if a small patient is to undergo some kind of manipulation in the nasopharynx.

At what age is it prescribed?

All types of "Tizin" are contraindicated for the treatment of children under two years of age. Preparations "Classic" and "Expert" for children with a content of xylometazoline at a concentration of 0.05% are prescribed at the age of 2-6 years, and solutions with a concentration of 0.1% are prescribed to patients older than six years. Spray "Alerji" can be used from the age of six.

Contraindications

The only reason to refuse to use "Tizin Allergy" in a child with an allergic rhinitis is hypersensitivity to any ingredient in the spray. In addition, children with kidney disease require caution in the treatment of this drug.

Other means of the brand "Tizin" do not prescribe:

• with atrophic rhinitis;
• with glaucoma;
• with intolerance to the main or auxiliary ingredient;
• with tachycardia or high blood pressure;
• during surgery on the membranes of the brain in the past.

Doctor's supervision when using the "Classic" and "Expert" preparations is needed for thyrotoxicosis, pheochromocytoma, porphyria or diabetes mellitus.

Side effects

After treatment of the nasopharynx with drugs from the "Expert" or "Classic" lines, a burning sensation, increased discharge from the nose, or frequent sneezing may occur. In some patients, the use of a spray does not eliminate puffiness, but only increases it. Occasionally, after the use of these drugs, fatigue, insomnia, tachycardia, an increase in blood pressure, arrhythmia, and other negative symptoms occur. In such situations, a medical examination is required.

Unnecessarily long treatment with "Tizin", the composition of which includes xylometazoline, can provoke the appearance of a drug-induced rhinitis. Due to the development of the phenomenon of recoil, nasal congestion increases, which is why the medicine has to be used even longer. The result of such "addiction" will be chronic swelling of the nasopharynx or even atrophy of the mucous membrane.

The use of "Tizin Alergi" is sometimes the cause of nausea, burning in the nose, sinusitis, headache, pain in the nose, drowsiness, nosebleeds, sore throat, shortness of breath and other ailments. If such symptoms appear, it is recommended to show the patient to a doctor and choose another therapy.

Instructions for use

Before using any Tizin spray for the first time, you need to remove the protective cap from the bottle and make a few clicks so that a cloud of medicine particles appears. Only after these actions can you start using the dosage prescribed by your doctor. One press on the nebulizer corresponds to one dose of medication.

When administering the drug into the nasal cavity, the vial should be placed vertically. Do not point the sprayer down or sideways. Before using the spray, it is important to clear the mucosa from excess secretions, and during the injection, the child must breathe through the nose. After spraying, the bottle is closed with a cap and cleaned out of the reach of children.

A single dose of medicines "Expert" and "Classic" is one injection. For a child under six years of age, 0.05% medicine is sprayed once or twice a day. For children over six years old, the use of a 0.1% spray is allowed up to three times during the day.

The duration of the use of these drugs should not exceed 5-7 days, because a longer treatment threatens with the appearance of addiction and adverse reactions. If you want to use the medicine for longer, you should take a break for a few days, and then continue therapy after consulting your doctor.

The drug "Alergy" must be used twice a day, two doses in each nostril, which corresponds to a dosage of 200 mcg (100 mcg in one stroke). If the symptoms of rhinitis are very severe, the doctor may advise more frequent use - up to 4 times a day. The duration of treatment with such a drug is determined individually, since it is injected until the signs of allergy are eliminated.

Overdose

If the "Classic" and "Expert" preparations were used at a higher dose, or the child accidentally drank the solution from the bottle, then the overdose will be manifested by tachycardia, fever, nausea, respiratory failure, dilated pupils or other negative symptoms. In severe poisoning, drowsiness, bradycardia, pulmonary edema, cardiac arrest and other dangerous phenomena occur. If an overdose is detected, gastric lavage should be performed immediately and medical attention should be sought.

An overdose of the drug "Alergi" when used in the nose usually does not occur. If the patient accidentally drinks such a medicine, a sedative effect develops, the heart rate accelerates and blood pressure decreases. In such a situation, drinking plenty of water is indicated so that the active substance of the solution is quickly excreted in the urine.

Drug interaction

"Tizin Classic", like "Tizin Expert", is incompatible with some antidepressants, since their combined use can adversely affect the cardiovascular system. The use of Alergy spray is not recommended along with oxymetazoline preparations, as they will impair the absorption of levocabastine.

Terms of sale

Any of the Tizin brand sprays can be freely bought at a pharmacy, since all these medicines are over-the-counter. The average price of a bottle of children's "Tizina Classic" is 100 rubles. For a 0.05% drug "Expert" you need to pay about 200 rubles, and the cost of the spray "Alergy" varies from 290 to 370 rubles.

Storage conditions

The shelf life of the spray "Classic" is 3 years, and the drug "Alergy" - 2 years. Means of the "Expert" line, if they have not yet been opened, due to the lack of a preservative, it is permissible to store only 2 years from the date of manufacture. In addition, unlike other Tizin sprays, their shelf life after opening is reduced to 1 year from the date of first use.

The optimal temperature regime for storing any of the sprays is called the range from +10 to +25 degrees.

Preparations should be placed in a place inaccessible to children, where sunlight or moisture does not fall.

Tizin: instructions for use and reviews

Tizin is an alpha-adrenomimetic, anticongestive drug for topical use in otolaryngology with a vasoconstrictive, anti-edematous effect.

Release form and composition

Dosage forms:

• nasal drops 0.05%: opalescent colorless liquid with a transparent structure (10 ml each in a dark-colored glass dropper bottle, 1 bottle in a cardboard box);
• nasal drops 0.1%: opalescent colorless liquid with a transparent structure (10 ml each in a dark-colored glass dropper bottle, 1 bottle in a cardboard box).

The active substance of Tizin is tetrizoline, in 1 ml its content is:

• drops 0.05%: 0.5 mg;
• drops 0.1%: 1 mg.

Auxiliary components of drops 0.05% and 0.1%: hypromellose, 70% sorbitol (non-crystallizing), sodium citrate, benzyl alcohol, benzalkonium chloride (17% solution), perfume oil (No. 25768), disodium edetate, cremophor 40 (macrogol glycerylhydroxystearate), concentrated hydrochloric acid (37%), purified water.

Pharmacological properties

Pharmacodynamics

Tetrizoline promotes narrowing of small arterioles localized in the nasal passages, which ensures the elimination of swelling and hyperemia of the mucous membranes and a decrease in secretion. The drug restores the patency of the nasal passages and facilitates nasal breathing. The effect of the drug appears 1 minute after its application and lasts up to 8 hours.

Pharmacokinetics

When applied topically, tetrizoline is practically not absorbed, so its content in the blood plasma is negligible.

Indications for use

According to the instructions, Tizin is indicated to reduce swelling of the nasal mucosa with sinusitis, rhinitis, pharyngitis, hay fever, and for therapeutic or diagnostic measures.

Contraindications

• angle-closure glaucoma;
• dry rhinitis;
• hypersensitivity to the components of the drug.

Application in pediatrics: drops of 0.05% Tizin are contraindicated for children under 2 years old, drops of 0.1% for children under 6 years old.

With extreme caution, after carefully comparing the benefits of therapy and the possible risk to the patient, Tizin should be prescribed for severe cardiovascular pathologies (including arterial hypertension, coronary heart disease, arrhythmia, pheochromocytoma, aneurysm), metabolic disorders (including diabetes mellitus, hyperthyroidism), concomitant use of monoamine oxidase inhibitors (MAO) and other drugs that increase blood pressure; during pregnancy and breastfeeding.

Instructions for use Tizin: method and dosage

Tizin drops are intended for instillation into the nasal passage, the procedure is carried out in each nostril.

The effect of the drug lasts up to 8 hours, so more than 1 time in 4 hours should not be instilled.

• drops of 0.05%: children aged 2-6 years - 2-3 drops 3-4 times a day;
• drops 0.1%: patients older than 6 years - 2-4 drops 3-5 times a day.

Duration of treatment: children - no more than 3 days, adults - up to 5 days.

After a few days of interruption, the course of therapy can be repeated.

Side effects

• systemic disorders: weakness, headache, nausea, insomnia, sweating, tremor, increased blood pressure (BP), palpitations, allergic reactions;
• local disorders: burning sensation of the nasal mucosa, reactive hyperemia; against the background of long-term use - chronic swelling of the nasal mucosa, dry rhinitis; frequent use in high doses - dryness of the nasal mucosa, the development of reactive edema, drug-induced rhinitis.

Overdose

Overdose or accidental oral administration of Tizin drops can lead to symptoms such as depression of the respiratory center, dilated pupils, increase or decrease in blood pressure, heart rhythm disturbance, nausea, vomiting, headache, severe dizziness, fever, shortness of breath, increased sweating, cyanosis , convulsive seizures, collapse, coma. Also, in some cases, there are signs of CNS depression.

As therapeutic measures, gastric lavage, activated charcoal, artificial respiration, accompanied by the introduction of oxygen, are recommended. To reduce blood pressure, phentolamine is slowly injected intravenously at a dose of 5 mg in saline, or it is taken in tablet form at a dose of 100 mg.

special instructions

Tizin should be used for a short time.

Nasal congestion all night relieves a single application of drops before going to bed. Because tetrizoline has central nervous system (CNS) effects, its use at bedtime may cause insomnia.

Ingestion of drops increases the risk of systemic side effects in young children.

Excessive systemic absorption of the drug can cause CNS depression, manifested by a decrease in body temperature, drowsiness, hypotension, bradycardia, apnea, coma.

Influence on the ability to drive vehicles and complex mechanisms

With long-term treatment with Tizin, or its use in doses higher than recommended, the risk of developing a systemic effect of tetrizoline cannot be excluded. In the case of diagnosing systemic side effects, it is necessary to avoid driving and performing other potentially hazardous work that requires increased concentration and immediate psychomotor reactions.

Use during pregnancy and lactation

The use of Tizin in pregnant and lactating women is allowed only if the intended benefit of treatment significantly outweighs the potential risks to the fetus or child.

Application in childhood

Tizin contraindications for children: 0.05% drops for children under 2 years old, 0.1% drops for children under 6 years old.

drug interaction

Tetrizoline potentiates the vasoconstrictive effect of MAO inhibitors and tricyclic antidepressants, therefore, with simultaneous use in a patient, an increase in blood pressure is possible.

Analogues

Terms and conditions of storage

Keep away from children.

Store below 25°C.

Shelf life - 5 years.

Vasoconstrictor drug for local use in ENT practice

Active substance

Release form, composition and packaging

◊ Dosed nasal spray 0.05%

Excipients: - 200 mcg, sorbitol 70% - 20 mg, sodium chloride - 4.16 mg, sodium dihydrophosphate dihydrate - 3.38 mg, disodium hydrogen phosphate dihydrate - 2.08 mg, disodium edetate - 1 mg, purified water - a sufficient amount.

10 ml (not less than 140 doses) - brown hydrolytic glass bottles (class III) (1) with a dosing device and a "pull-off" polyethylene screw cap - packs of cardboard.

◊ Dosed nasal spray 0.1% in the form of a clear, colorless solution, odorless or with a slight characteristic odor.

Excipients: benzalkonium chloride - 200 mcg, sorbitol 70% - 20 mg, - 4.16 mg, sodium dihydrophosphate dihydrate - 3.38 mg, disodium hydrogen phosphate dihydrate - 2.08 mg, disodium edetate - 1 mg, purified water - a sufficient amount.

10 ml (not less than 70 doses) - brown hydrolytic glass bottles (class III) (1) with a dosing device and a polyethylene screw cap of the "pull-off" type - packs of cardboard.

pharmachologic effect

Vasoconstrictor drug for local use in ENT practice. Xylometazoline (an imidazole derivative) is an alpha-agonist. It has a vasoconstrictive effect, reduces swelling of the nasal mucosa.

The drug facilitates nasal breathing by reducing swelling and hyperemia of the mucous membrane, and also improves the discharge of secretions.

The effect of the drug occurs in 5-10 minutes.

Pharmacokinetics

When applied topically, xylometazoline is practically not absorbed, its blood concentrations are so low that they cannot be determined by modern analytical methods.

Indications

- to reduce swelling of the mucous membrane of the nasopharynx and secretions in acute allergic rhinitis, acute respiratory infections with rhinitis, sinusitis, hay fever, otitis media;

- preparation of patients for diagnostic manipulations in the nasal passages.

Contraindications

- simultaneous use of MAO inhibitors or other drugs that increase blood pressure;

- arterial hypertension;

- tachycardia;

- severe atherosclerosis;

- glaucoma;

- atrophic rhinitis;

- surgical interventions on the meninges (in history);

- children's age up to 6 years (for nasal spray 0.1%);

- children's age up to 2 years (for nasal spray 0.05%);

- Hypersensitivity to the components of the drug.

WITH caution the drug should be prescribed for ischemic heart disease (angina pectoris), prostatic hyperplasia, thyrotoxicosis, diabetes mellitus, pheochromocytoma.

Dosage

In the form of a nasal spray 0.05% is prescribed children aged 2 to 6 years 1 dose in each nasal passage 1-2 times / day.

Xylo in the form of a nasal spray 0.1% is prescribed adults and children over 6 years old 1 dose in each nasal passage 3 times / day.

The dose depends on the individual sensitivity of the patient and the clinical effect.

Do not use the drug for more than 5-7 days without a doctor's recommendation.

After completion of therapy, the drug can be re-administered only after a few days.

The duration of the drug in children is determined by the doctor.

Rules for the use of the drug

Remove protective cap. Before the first use, press the spray nozzle several times until a uniform cloud of "fog" appears. The bottle is ready to use. When applying, press 1 time. The drug is inhaled through the nose. Keep the spray bottle upright if possible. Do not spray horizontally or downwards. After use, the bottle should be closed with a cap.

Side effects

Local reactions: burning sensation, paresthesia, sneezing, hypersecretion, in some cases - reactive hyperemia; with frequent and / or prolonged use or use in high doses - dryness of the nasal mucosa, burning sensation, reactive stagnation with the development of drug-induced rhinitis (this effect can be observed even 5-7 days after completion of treatment). With prolonged use, the development of dry rhinitis (irreversible damage to the nasal mucosa with the formation of crusts) is possible.

From the nervous system: very rarely - headache, insomnia, fatigue, depression (with prolonged use in high doses).

System reactions: in isolated cases - palpitations, tachycardia, arrhythmias, increased blood pressure, visual impairment.

Overdose

Symptoms: mydriasis, nausea, vomiting, cyanosis, fever, spasms, tachycardia, arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory disorders, mental disorders, suppression of the central nervous system, accompanied by drowsiness, decrease in body temperature, bradycardia, shock-like hypotension, apnea, coma.

Treatment: gastric lavage, the appointment of activated charcoal, if necessary, artificial respiration with the introduction of oxygen. To lower blood pressure - phentolamine (dissolved in saline) IV slowly at a dose of 5 mg or orally at a dose of 100 mg.

Vasopressors are contraindicated. If necessary, use antipyretic and anticonvulsants.

drug interaction

With the simultaneous use of the drug Tizin Xylo and MAO inhibitors such as tranylcypromine and tricyclic antidepressants, an increase in blood pressure is possible.

special instructions

Prolonged use of the drug and overdose can lead to reactive hyperemia of the nasal mucosa.

The rebound phenomenon can cause airway obstruction, which leads to the fact that the patient begins to use the drug repeatedly or even permanently. This can lead to chronic swelling (drug-induced rhinitis) and sometimes even to atrophy of the nasal mucosa (ozena).

In chronic rhinitis, the use of the drug is possible only under the supervision of a physician, given the risk of developing atrophy of the nasal mucosa.

The drug should not be used in the presence of hypersensitivity to benzalkonium chloride, which is part of the drug as a preservative.

Influence on the ability to drive vehicles and control mechanisms

With prolonged treatment or when used in doses exceeding those recommended, the possibility of a systemic effect on the cardiovascular system cannot be excluded. In these cases, the ability to drive vehicles or equipment may be reduced.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Shelf life - 3 years.

INSTRUCTIONS
on the medical use of the drug

Registration number:

P N014038/01-250608

Tradename

Tizin ® Xylo

International non-proprietary name:

xylometazoline.

Dosage form:

dosed nasal spray

Compound

1 ml of solution contains:
active substance:
xylometazoline hydrochloride 0.5 mg (0.05%) or 1.0 mg (0.1%); the amount of the active ingredient in one dose for 0.05% - 0.035 mg xylometazoline hydrochloride; for 0.1% - 0.14 mg xylometazoline hydrochloride;
Excipients:
benzalkonium chloride - 0.2 mg, sorbitol 70% - 20.0 mg, sodium chloride - 4.16 mg, sodium dihydrophosphate dihydrate - 3.38 mg, disodium hydrogen phosphate dihydrate - 2.08 mg, disodium edetate - 1.0 mg , purified water - a sufficient amount.

Description: clear, colorless solution, odorless or with a slight characteristic odor.

Pharmacotherapeutic group

anticongestive agent - vasoconstrictor (alpha-adrenergic agonist).

ATX code– R01AA07.

Pharmacodynamic properties

Xylometazoline (an imidazole derivative) is a sympathomimetic drug with alpha-adrenergic activity. It has a vasoconstrictive effect and reduces swelling of the mucous membrane.
The action usually begins within 5-10 minutes. The drug facilitates nasal breathing by reducing swelling and hyperemia of the mucous membrane, and also improves the discharge of secretions.

Pharmacokinetic properties

When applied topically, it is practically not absorbed, plasma concentrations are so small that they cannot be determined by modern analytical methods.

Indications for use

To reduce swelling of the mucous membrane of the nasopharynx and secretions in acute allergic rhinitis, acute respiratory infections with rhinitis, sinusitis, hay fever, otitis media.
Preparation of the patient for diagnostic manipulations in the nasal passages.

Contraindications

Hypersensitivity to any of the components of the drug, simultaneous use of monoamine oxidase inhibitors (MAO) or other drugs that can cause an increase in blood pressure; arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, surgical interventions on the meninges (history), children's age (up to 6 years - for a dosage of 0.1%, up to 2 years - for a dosage of 0.05%).

Carefully- IHD (angina pectoris), prostatic hyperplasia, thyrotoxicosis, diabetes mellitus, pheochromocytoma, in patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness.

Pregnancy and lactation

Pregnancy
Carefully controlled and appropriate studies in pregnant women have not been conducted. The drug should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the developing fetus.
Lactation
It is not known whether xylometazoline or its metabolites pass into breast milk, so the drug should not be used during breastfeeding.

Dosage and administration

Children aged 2-6 years
Unless otherwise prescribed, one dose of Tizin Xylo in the form of a 0.05% nasal spray dosed into each nasal passage 1-2 times a day.
Adults and children of school age (over 6 years old)
3 times a day, one dose of Tizin Xylo is administered in the form of a 0.1% nasal spray dosed into each nostril. The dose depends on the individual sensitivity of the patient and the clinical effect.
Xylometazoline nasal metered spray should not be used for more than 5-7 days, unless the doctor has recommended a different duration of treatment.
After completion of therapy, the drug can be re-administered only after a few days.
Always consult your doctor regarding the duration of use in children.

General recommendations for administration
Remove protective cap. Before the first application, press the spray nozzle several times (Fig. 1) until a uniform cloud of "fog" appears. The bottle is ready for further use. When applying, press once (Fig. 2). The drug is inhaled through the nose. Keep the spray bottle upright if possible. Do not spray horizontally or downwards. After use, close the bottle with a cap.

Side effect

Tizine Xylo may cause transient mild nasal irritation (burning), paresthesia, sneezing, and hypersecretion in susceptible individuals.
In some cases, after the use of the drug, there may be increased swelling of the nasal mucosa (reactive hyperemia).
Prolonged or frequent use of xylometazoline or its use in high doses can lead to burning in the nose or dryness of the mucous membrane, as well as reactive congestion with the development of drug-induced rhinitis. This effect can be observed even 5-7 days after the completion of treatment, and with prolonged use it can cause irreversible damage to the mucous membrane with the formation of crusts (dry rhinitis).
In very rare cases, headache, insomnia or fatigue, depression may occur (with prolonged use in high doses).
In isolated cases, local intranasal use of sympathomimetics may be accompanied by systemic effects, such as palpitations, tachycardia, arrhythmias, increased blood pressure, visual impairment.

Overdose

Symptoms of intoxication
Overdose or accidental ingestion of the drug inside can lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmias, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory failure, mental disorders.
In addition, the following symptoms may be observed: suppression of the function of the central nervous system, accompanied by drowsiness, a decrease in body temperature, bradycardia, shock-like hypotension, apnea and coma.
Treatment of intoxication
The use of activated charcoal, gastric lavage, artificial respiration with the introduction of oxygen. To lower blood pressure, phentolamine 5 mg in saline is used slowly intravenously or 100 mg orally.
Vasopressors are contraindicated. If necessary, use antipyretic and anticonvulsants.

Interaction with other drugs

The simultaneous use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants can lead to an increase in blood pressure due to the cardiovascular effects of these substances.

special instructions

Prolonged use and overdose of sympathomimetics that have a decongestant effect can lead to reactive hyperemia of the nasal mucosa.
The rebound phenomenon can cause airway obstruction, which leads to the fact that the patient begins to use the drug repeatedly or even permanently. This can lead to chronic swelling (drug-induced rhinitis), and eventually even to atrophy of the nasal mucosa (ozena).
In the case of chronic rhinitis, the drug Tizin ® Xylo 0.05% and 0.1% can only be used under medical supervision, given the risk of atrophy of the nasal mucosa.
Tizin ® Xylo should not be used in the presence of hypersensitivity to benzalkonium chloride, which is part of the drug as a preservative.
Recommended doses should not be exceeded, especially in children and the elderly.

Influence on the ability to drive a car and use machinery

With prolonged treatment or the use of the drug Tizin Xylo in higher doses, the possibility of its systemic effect on the cardiovascular system cannot be ruled out, which may impair the ability to drive and use machinery.

Release form

Spray nasal dosed 0.05% and 0.1%.
10 ml of the drug in a brown hydrolytic glass bottle (class III) with a dosing device and a pull-off polyethylene screw cap.
One bottle with instructions for use in a pack of cardboard.
Number of doses in a vial: for 0.05% at least 140 doses, for 0.1% at least 70 doses.

Best before date

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

Storage conditions

Store at a temperature not exceeding 25°C.
Keep out of the reach of children.

Terms of dispensing from pharmacies

Released without a prescription.

Manufacturer

Famar Orleans, France.
Legal address: Famar Orleans, 5 avenue de Concyr, 45071 Orleans Cedex 2, France
Organization receiving claims: LLC "Johnson & Johnson", Russia, 121614, Moscow, st. Krylatskaya, 17, building 2.