Xylo-Teva nasal spray is indicated for:
In the symptomatic treatment of rhinitis of various origins. As a drainage of secretions in diseases of the paranasal sinuses. As an adjunct in the combined therapy of otitis media to relieve swelling of the nasal mucosa. In diagnostic interventions (rhinoscopy).
Composition
Active ingredient: xylometazoline hydrochloride;
1 dose of 0.5 mg/ml spray contains 0.045 mg of xylometazoline hydrochloride;
1 dose of 1 mg/ml spray contains 0.09 mg of xylometazoline hydrochloride;
Excipients: citric acid monohydrate, sodium; glycerin 85% water for injections.
Contraindication
Hypersensitivity to the active substance or to any component of the drug. Angle-closure (congestive) glaucoma. Dry inflammation of the nasal mucosa (rhinitis sicca) or atrophic rhinitis. Transsphenoidal hypophysectomy or other surgical interventions on the dura mater. Acute coronary disease. Coronary asthma. Hyperthyroidism. Concomitant treatment with MAO inhibitors (MAOIs) and within 2 weeks after stopping their use.
Method of application
Remove the protective cap. Before using for the first time, shake the bottle several times until the contents are homogeneous. When reusing, the metered spray is ready for use. Insert the tip of the bottle into the nostril and press firmly once on the base of the dispenser; pull out the tip without stopping pressing. It is necessary to inhale carefully through the nose to ensure optimal distribution of the spray in the nasal cavity. After use, close the bottle with the protective cap.
Unless otherwise prescribed, children aged 2 to 6 years should be given 1 spray of Xylo-Teva 0.5 mg/ml nasal spray into each nostril up to 3 times a day. Children aged 6 years and older and adults should be given 1 spray of Xylo-Teva 1 mg/ml nasal spray into each nostril up to 3 times a day.
The treatment period is 3-5 days, except when recommended by a doctor.
Application features
Pregnant women
Not recommended for use.
Children
Xylo-Teva, nasal spray, solution 0.5 mg/ml, is intended for use in children aged 2 to 6 years.
Xylo-Teva, nasal spray, solution 1 mg/ml, is intended for use in children aged 6 years and older.
Overdose
With nasal administration, systemic effects are unlikely due to local vasoconstriction, which inhibits absorption. In the case of systemic absorption, xylometazoline as an α2-adrenergic agonist can be expected to have effects 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 vague, 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 seizures.
Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.
The following symptoms may also occur: miosis, mydriasis, sweating, nausea, vomiting, cyanosis, fever, pallor of the skin, tachycardia, palpitations, bradycardia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory failure, ataxia and apnea.
Overdose, especially in children, can lead to significant effects on the central nervous system, causing spasms, coma, bradycardia, apnea and arterial hypertension, which may progress to hypotension.
Severe overdoses require hospital treatment.
Side effects
Respiratory, thoracic and mediastinal: temporary weak signs of irritation (burning sensation or dryness of the nasal mucosa), especially in sensitive patients; reactive hyperemia, epistaxis; sneezing. Psychiatric: nervousness, insomnia, drowsiness. Nervous system: headache, increased fatigue, agitation, dizziness, hallucinations (mainly in children). Vision: temporary visual impairment. Gastrointestinal tract: nausea. Musculoskeletal and connective tissue: convulsions (mainly in children). Cardiovascular: systemic effects of sympathomimetics (sensation of rapid heartbeat, tachycardia, increased blood pressure), arrhythmia.
Interaction
Xylometazoline may enhance the effects of MAO inhibitors and induce hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAO inhibitors within the last two weeks.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Shelf life - 3 years.
After first opening the bottle - 1 year.
