Pharmacological properties
Xylometazoline hydrochloride, an imidazole derivative, is a sympathomimetic active substance with α-adrenergic action. The drug has a vasoconstrictor effect, as a result of which swelling of the mucous membrane is reduced.
The onset of action is usually observed after 5-10 minutes and lasts up to 10 hours; the drug facilitates nasal breathing, reducing swelling of the mucous membrane and improving secretion removal.
With nasal use, the absorbed amount of the drug may sometimes be sufficient to cause systemic effects, particularly on the CNS and cardiovascular system.
Indication
For the relief of symptoms of nasal congestion in acute rhinitis associated with colds and flu, sinusitis, allergic and non-allergic rhinitis.
Application
Dosage: The dosage depends on the individual sensitivity of the patient and the clinical effect.
Unless otherwise prescribed, children aged 4-6 years are recommended to instill 1-2 drops of Tizin ® Xylo (0.05% solution) in each nostril up to 3 times a day. Children aged 6-12 years are prescribed 2-3 drops of Tizin ® Xylo (0.05% solution) in each nostril up to 3 times a day. Children over 12 years old - 2-3 drops of Tizin ® Xylo (0.1% solution) in each nostril up to 3 times a day, depending on the need.
Method of application. To use the drug Tizin ® Xylo nasal drops, solution 0.05 and 0.1%, you should slightly tilt your head back. Do not release the rubber stopper before removing the pipette from the nose to avoid nasal secretions from entering the bottle. Wipe the dosing pipette after each use.
Duration of treatment. Tizin ® Xylo should not be used for longer than 7 consecutive days, unless recommended by a doctor.
Repeated use should be started only after a break of several days and after consultation with a doctor. The duration of treatment with the drug in children is determined by the doctor individually.
In case of chronic rhinitis, due to the risk of atrophy of the nasal mucosa, long-term use of the drug Tizin ® Xylo is possible only under the supervision of a physician.
Contraindication
Tizin® Xylitol should not be used in the following cases: hypersensitivity to the active substance xylometazoline hydrochloride or any of the excipients of the drug; dry inflammation of the nasal mucosa with crusting (dry rhinitis); atrophic or vasomotor rhinitis; simultaneous treatment with MAO inhibitors, treatment with MAO inhibitors for 2 weeks before starting the use of Tizin® Xylitol or other drugs that can increase the risk of developing pharyngitis; after hypophysectomy or surgical intervention on the dura mater; angle-closure glaucoma; acute coronary disease; coronary asthma; hyperthyroidism.
Due to the use of benzalkonium chloride as a preservative in the preparation, Tizin® Xylo cannot be used in cases of established hypersensitivity to this substance.
Side effects
The frequency of adverse events was distributed according to the following categories: very common: 1/10; common: 1/100 - 1/10; uncommon: 1/1000 - 1/100; rare: 1/10,000 - 1/1000; very rare: 1/10,000.
Unknown: cannot be determined from available data.
On the part of the respiratory system, chest and mediastinum: Tyzin® Xylo may cause temporary mild 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 may cause a burning sensation, tingling, itching, dryness, sensitivity or irritation of the nasal mucosa, as well as reactive congestion and rhinitis medicamentosa. This effect may occur after as little as 7 days of treatment and after prolonged use may lead to irreversible damage to the nasal mucosa with the formation of crusts (rhinitis sicca).
Sometimes nausea, headache and temporary visual impairment may occur.
Reversibility of nasal congestion has been noted after discontinuation of treatment, especially after prolonged use of xylometazoline.
From the nervous system: rarely - headache, dizziness, rebound effect, insomnia, increased fatigue; very rarely - hallucinations, mainly in children.
From the cardiovascular system: infrequently - systemic effects of sympathomimetics (tachycardia, increased pulse, increased blood pressure); very rarely - arrhythmia.
Musculoskeletal and connective tissue disorders: very rarely - convulsions, especially in children.
On the part of the immune system: infrequently - hypersensitivity reactions (angioedema, rash, itching).
Post-marketing data. The following side effects have been noted, which were spontaneously reported: burning sensation of the mucous membrane, dryness in the nose, prolonged treatment may lead to the opposite effect.
Special instructions
With topical application of the hydrochloride, systemic absorption is minimal, however, Tizin® Xylitol should only be used after a careful benefit/risk assessment in patients:
Prolonged use and overdose of sympathomimetic decongestants can provoke reactive hyperemia of the nasal mucosa. Such a reaction can lead to airway obstruction, which, in turn, forces repeated or even constant use of the drug, which threatens with chronic edema (rhinitis medicamentosa), and ultimately - atrophy of the nasal mucosa and ozena.
In milder cases, you can stop using sympathomimetics first in one nasal passage, and after the complications have subsided, continue treatment by using the drug in the other nasal passage to maintain nasal breathing at least half.
Tizin ® Xylo contains benzalkonium chloride. This compound may cause irritation of the nasal mucosa.
The drug should be prescribed with caution to patients who experience severe side effects such as insomnia, dizziness, tremor, cardiac arrhythmia, and increased blood pressure when using adrenergic drugs.
Pregnancy and breast-feeding. Pregnancy. Xylometazoline hydrochloride should not be used during pregnancy, as there are no adequate studies on the effect of the drug on the fetus.
Breastfeeding. The drug Tizin ® Xylo should not be used during breastfeeding, since it is not known whether the active substance penetrates into breast milk.
Children. Tizin ® Xylo 0.05% is intended for the treatment of children aged 4-12 years. Tizin ® Xylo 0.1% is intended for the treatment of adults and children over 12 years of age.
Effect on the ability to drive and use machines. Usually, Tyzin® Xylo does not affect the ability to drive and use machines when used in recommended doses, but the possibility of adverse reactions from the central nervous system and the organ of vision should be taken into account.
Interactions
The simultaneous use of Tizin® Xylitol with MAO inhibitors of the tranylcypromine type or tricyclic antidepressants, as well as drugs that increase blood pressure, may lead to arrhythmias due to the effect of these drugs on the cardiovascular system.
Due to the low systemic absorption of xylometazoline when administered intranasally, interactions with drugs administered by other routes are considered unlikely.
Overdose
Symptoms. With nasal administration, systemic effects are unlikely due to local vasoconstriction, which inhibits absorption. In the case of systemic absorption, it can be expected that xylometazoline as an α2-adrenergic agonist may have an effect similar to clonidine: a short-term increase in blood pressure followed by more prolonged hypotension and sedation.
Symptoms of intoxication with imidazole derivatives may be clinically ambiguous, as periods of stimulation may alternate with periods of depression of the central nervous system and cardiovascular system. Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations and convulsions. Symptoms of central nervous system depression include hypothermia, lethargy, drowsiness and coma. Additional symptoms may include miosis, mydriasis, hyperhidrosis, 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, respiratory failure and apnea.
Overdose, especially in children, can lead to significant effects on the central nervous system, causing spasms, coma, bradycardia, apnea and hypertension, which may progress to hypotension.
Treatment. Severe overdose requires hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent), sodium sulfate (laxative) or gastric lavage (for large amounts) should be administered immediately. Blood pressure can be reduced with non-selective α-adrenoceptor blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants, as well as mechanical ventilation, are used.
Storage conditions
At a temperature not exceeding 25 °C, out of the reach of children. Do not freeze!
