Tyzine Xylo nasal drops 0.05% 10 ml — Made in France — Free Delivery

Pharmacological properties

Xylometazoline hydrochloride, an imidazole derivative, is a sympathomimetic active ingredient with α-adrenergic action. the preparation has a vasoconstrictor effect, as a result of which the edema of the mucous membrane decreases.

The onset of action is usually observed after 5-10 minutes and lasts up to 10 hours; the preparation facilitates nasal breathing, reducing swelling of the mucous membrane and improving the excretion of secretions.

With nasal administration, the absorbed amount of the preparation may sometimes be sufficient to cause systemic effects, in particular from the central nervous system and the cardiovascular system.

Indications

To reduce the severity of symptoms of nasal congestion in acute rhinitis associated with colds and flu, sinusitis, allergic and non-allergic rhinitis.

Application

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

Unless otherwise prescribed, children aged 2-6 years are recommended 1-2 drops of Tyzine ® Xylo (0.05% solution) in each nasal passage up to 3 times a day. Children aged 6-12 years are prescribed 2-3 drops of Tyzine ® Xylo (0.05% solution) in each nasal passage up to 3 times a day. Children over the age of 12 - 2-3 drops of Tyzine ® Xylo (0.1% solution) in each nasal passage up to 3 times a day, depending on the need.

Mode of application. To use the preparation Tyzine ® Xylo nasal drops, solution 0.05 and 0.1%, you should tilt your head back slightly. Do not release the rubber stopper before removing the pipette from the nose to avoid getting nasal secretions into the vial. Wipe off the dosing pipette after each use.

Duration of treatment. Tyzine ® Xylo should not be used for more than 7 days in a row, except when recommended by a doctor.

Reapplication should be started only after a break for several days and after consulting a doctor. The duration of preparation treatment in children is determined by the doctor individually.

In the case of chronic rhinitis due to the risk of atrophy of the nasal mucosa, prolonged use of Tyzine ® Xylo is possible only under the supervision of a physician.

Contraindications

Tyzine ® xylo should not be used in the following cases: hypersensitivity to the active substance xylometazoline hydrochloride or any of the excipients of the preparation; dry inflammation of the nasal mucosa with the formation of crusts (dry rhinitis); atrophic or vasomotor rhinitis; simultaneous treatment with MAO inhibitors, treatment with MAO inhibitors for 2 weeks before starting the use of Tyzine ® xylo or other preparations that can increase blood pressure; after hypophysectomy or surgery on the dura mater; angle-closure glaucoma; acute coronary diseases; coronary asthma; hyperthyroidism.

Due to the use of benzalkonium chloride as a preservative in the composition of Tyzine ® Xylo, it should not be used in case of established hypersensitivity to this substance.

Side effects

The frequency of adverse events was categorized as follows: very common: 1/10; often: 1/100 - 1/10; infrequently: 1/1000 - 1/100; rarely: 1/10 000 - 1/1000; very rare: 1/10 000.

Unknown: Cannot be determined from the available data.

On the part of the respiratory system, chest and mediastinum: Tyzine ® Xylo may cause temporary weak signs of irritation (burning sensation or dryness of the nasal mucosa), especially in sensitive patients, pain in the nose and throat; often - reactive hyperemia; infrequently - nosebleeds, sneezing.

Prolonged or frequent use of high doses of xylometazoline hydrochloride can cause burning, tingling, itching, dryness, tenderness or irritation of the nasal mucosa, as well as reactive congestion and rhinitis medicamentosa. This effect can occur already after 7 days of treatment and after prolonged use can lead to irreversible damage to the nasal mucosa with the formation of crusts (dry rhinitis).

Sometimes nausea, headache, and temporary visual impairment may occur.

Reversibility of nasal congestion was noted after discontinuation of treatment, especially after prolonged use of xylometazoline.

From the nervous system: rarely - headache, dizziness, ricochet effect, insomnia, increased fatigue; very rarely - hallucinations, mainly in children.

From the side of the cardiovascular system: infrequently - systemic effects of sympathomimetics (tachycardia, accelerated pulse, increased blood pressure); very rarely - arrhythmia.

From the musculoskeletal system and connective tissue: very rarely - convulsions, especially in children.

From the immune system: infrequently - hypersensitivity reactions (angioedema, rash, itching).

Post-marketing data. There were such side effects, which were spontaneously reported: a burning sensation of the mucous membrane, dryness in the nose, long-term treatment can lead to the opposite effect.

Special instructions

With topical application of xylometazoline hydrochloride, systemic absorption is minimal, however, Tyzine ® xylo should be used only after careful assessment of the benefits / risks in patients:

with severe cardiovascular diseases (for example, ischemic heart disease, hypertension);

with pheochromocytoma;

with metabolic disorders (for example, diabetes mellitus);

with prostatic hyperplasia.

Long-term use and overdose of sympathomimetic decongestants can provoke reactive hyperemia of the nasal mucosa. Such a reaction can lead to obstruction of the airways, which, in turn, forces the preparation to be repeatedly or even constantly used, which threatens with chronic edema (medication rhinitis), and as a result - atrophy of the nasal mucosa and ozena.

In milder cases, you can stop using sympathomimetics, first in one nasal passage, and after reducing complications, continue treatment using the preparation in the other nasal passage in order to keep nasal breathing at least half.

Tyzine ® Xylo contains benzalkonium chloride. This compound can irritate the nasal mucosa.

The preparation should be prescribed with caution to patients who, when using adrenergic preparations , have such pronounced side effects as insomnia, dizziness, tremors, cardiac arrhythmia, increased blood pressure.

During pregnancy and breastfeeding. Pregnancy. Xylometazoline hydrochloride should not be used during pregnancy, since there are no adequate studies on the effects of the preparation  on the fetus.

Lactation. The preparation Tyzine ® Xylo should not be used during breastfeeding, since it is not known whether the active substance penetrates into breast milk.

Children. Tyzine ® Xylo 0.05% is intended for the treatment of children aged 2–12 years. Tyzine ® Xylo 0.1% is intended for the treatment of adults and children over the age of 12 years.

Influence on the ability to drive vehicles and work with mechanisms. Usually, Tyzine ® Xylo does not affect the ability to drive vehicles and work with complex mechanisms when used in recommended doses, but the likelihood of adverse reactions from the central nervous system and the organ of vision should be taken into account.

Interactions

The simultaneous use of Tyzine ® Xylo with inhibitors of the maoranylcypramine type or tricyclic antidepressants, as well as preparations that increase blood pressure, can lead to ages due to the effect of these preparations on the cardiovascular system.

Due to the low systemic absorption of xylometazoline with intranasal administration, interaction with preparations used in other ways is considered unlikely.

Overdose

Symptoms with nasal administration, systemic exposure is unlikely due to local vasoconstriction, which suppresses absorption. in the case of systemic absorption, it can be expected that xylometazoline, as an α2-adrenergic agonist, can have an effect similar to clonidine: a short increase in blood pressure followed by longer arterial hypotension and sedation.

Symptoms of intoxication with imidazole derivatives may be clinically unclear, since periods of stimulation can alternate with periods of depression of the central nervous system and cardiovascular system. Symptoms of CNS stimulation include anxiety, agitation, hallucinations, and seizures. Symptoms of CNS depression include a decrease in body temperature, lethargy, drowsiness, and coma. Such additional symptoms are also possible: miosis, mydriasis, increased sweating, nausea, cyanosis, fever, pallor of the skin, central nervous system paralysis, sedation, dry mouth, arrhythmia, tachycardia, bradycardia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, violation breathing and apnea.

Overdose, especially in children, can lead to a significant effect on the central nervous system, causing spasms, coma, bradycardia, apnea and hypertension, which can be replaced by arterial hypotension.

Treatment. Severe overdose requires treatment in a hospital setting. Since xylometazoline hydrochloride is rapidly absorbed, you should immediately take activated charcoal (adsorbent), sodium sulfate (laxative), or resort to gastric lavage (for large amounts). A decrease in blood pressure can be achieved with the help of non-selective blockers of α-adrenergic receptors. Vasoconstrictor preparations are contraindicated. If necessary, use antipyretic and anticonvulsant preparations, as well as mechanical ventilation.

Storage conditions

At a temperature not exceeding 25 ° C, out of the reach of children. do not freeze!