Composition, form of production and packaging
? Spray nasal dosed 0.05% in the form of a clear, colorless solution, odorless or with a weak characteristic odor.
1 ml 1 dose
xylometazoline hydrochloride 500 Ојg 35 Ојg
[PRING] benzalkonium chloride - 200 mcg, sorbitol 70% - 20 mg, sodium chloride - 4.16 mg, sodium dihydrogen phosphate dihydrate - 3.38 mg, disodium hydrogen phosphate dihydrate - 2.08 mg, disodium edetate - 1 mg, purified water - enough.
10 ml (not less than 140 doses) - bottles of brown hydrolytic glass (class III) (1) with a dosing device and a polyethylene screw cap of the "pull-off" type - packs of cardboard.
? Spray nasal dosed 0.1% in the form of a clear, colorless solution, odorless or with a weak characteristic odor.
1 ml 1 dose
xylometazoline hydrochloride 1 mg 140 Ојg
[PRING] benzalkonium chloride - 200 mcg, sorbitol 70% - 20 mg, sodium chloride - 4.16 mg, sodium dihydrogen phosphate dihydrate - 3.38 mg, disodium hydrogen phosphate dihydrate - 2.08 mg, disodium edetate - 1 mg, purified water - enough.
10 ml (not less than 70 doses) - bottles of brown hydrolytic glass (class III) (1) with a dosing device and a polyethylene screw cap of the "pull-off" type - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Vasoconstrictive drug for topical application in ENT practice. Xylometazoline (an imidazole derivative) is an alpha-adrenomimetic. Has vasoconstrictive effect, reduces edema of the nasal mucosa.
The drug facilitates nasal breathing by reducing the swelling and hyperemia of the mucosa, and improves the flow of discharge.
The effect of the drug comes in 5-10 minutes.
PHARMACOKINETICS
With topical application, xylometazoline is practically not absorbed, its concentrations in the blood plasma are so small that they can not be determined by modern analytical methods.
INDICATIONS
- to reduce edema of the nasopharyngeal mucosa and secretions in acute allergic rhinitis, ARI with rhinitis, sinusitis, pollinosis, otitis media;
- preparation of patients for diagnostic manipulations in the nasal passages.
DOSING MODE
Tysin Xylo in the form of nasal spray 0.05% is prescribed for children aged 2 to 6 years , 1 dose per each nasal route 1-2 times / day.
Tizin Xylo in the form of nasal spray 0.1% is prescribed for adults and children over 6 years for 1 dose in each nostril 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.
Application rules
Remove the protective cap. Before the first application, press the spray nozzle several times until a uniform cloud of "fog" appears. The bottle is ready for use. When using, press 1 time. The drug is inhaled through the nose. If possible, keep the spray bottle vertically. Do not spray horizontally or downward. After use, the bottle should be closed with a cap.
SIDE EFFECT
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 rhinitis (this effect can be observed even after 5-7 days after completion of treatment). With long-term 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).
Systemic reactions: in single cases - palpitations, tachycardia, arrhythmias, increased blood pressure, impaired vision.
CONTRAINDICATIONS
- simultaneous administration of MAO inhibitors or other drugs that increase blood pressure;
- arterial hypertension;
- tachycardia;
- severe atherosclerosis;
- glaucoma;
- Atrophic rhinitis;
- surgical interventions on the meninges (in the anamnesis);
- Children under 6 years of age (for nasal spray 0.1%);
- Children's age under 2 years (for nasal spray 0.05%);
- Hypersensitivity to the components of the drug.
With caution should prescribe the drug with coronary artery disease (angina), prostatic hyperplasia, thyrotoxicosis, diabetes, pheochromocytoma.
PREGNANCY AND LACTATION
Xylometazoline should not be used during pregnancy; Effects of this drug on the fetus have not been studied.
It is not known whether xylometazoline is excreted in breast milk. Therefore, it is not recommended to prescribe the drug during the period of breastfeeding.
APPLICATION FOR CHILDREN
Nasal spray 0.1% is contraindicated in children under 6 years of age, nasal spray 0.05% is contraindicated in children under 2 years of age.
SPECIAL INSTRUCTIONS
Prolonged use of the drug and an overdose can lead to reactive hyperemia of the nasal mucosa.
The recoil phenomenon can cause airway obstruction, which leads to the patient starting to use the drug repeatedly or even constantly. This can lead to chronic swelling (drug rhinitis), and sometimes even to atrophy of the mucous membrane of the nose (ozona).
With chronic rhinitis, the drug can be used only under the supervision of a doctor, taking into account the risk of atrophy of the nasal mucosa.
The drug should not be used in the presence of hypersensitivity to benzalkonium chloride, which is a part of the drug as a preservative.
Impact on the ability to drive vehicles and manage mechanisms
With long-term treatment or when used in doses exceeding the recommended ones, one can not exclude the possibility of systemic influence on the cardiovascular system. In these cases, the ability to drive vehicles or equipment can be reduced.
OVERDOSE
Symptoms: mydriasis, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory disorders, mental disorders, suppression of CNS function, accompanied by drowsiness, lower 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 reduce blood pressure - phentolamine (dissolved in physiological solution) iv slowly in a dose of 5 mg or inside at a dose of 100 mg.
Vasopressor agents are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.
DRUG INTERACTION
With the simultaneous use of Tysin Xylo and MAO inhibitors such as tranylcypromine and tricyclic antidepressants, an increase in blood pressure is possible.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
