Producer: LLC Pharmtekhnologiya Republic of Belarus
Code of automatic telephone exchange: R01AA07
Release form: Liquid dosage forms. Drops are nasal.
General characteristics. Structure:
Active ingredient: 0,5 mg or 1 mg of xylomethazolinum of a hydrochloride in 1 ml of solution.
Excipients: benzyl alcohol, a benzalkoniya chloride, dinatrium phosphate 12-water, sodium dihydrophosphate a dihydrate, sodium chloride, sorbitol solution uncrystallizable, Acidum hydrochloricum concentrated the water purified.
The nasal drug reducing the inflammatory process and exudation removing hypostasis and a hyperemia mucous a nose, facilitating nasal breath.
Pharmacodynamics. Xylomethazolinum is alpha адреномиметиком non-selective action. Stimulates in low concentration α2-адренорецепторы, in high concentration has a promoting effect on α1-адренорецепторы. Possesses direct action on mucous a nose and it is used locally in the ENT SPECIALIST to practice for the purpose of reduction of vessels, weakening of inflammatory process and exudation. Reduces or eliminates a hyperemia and hypostasis mucous a nose and facilitates nasal breath at rhinitises.
Effect of drug comes within several minutes after use and continues till 10 o'clock. It is well transferred even by patients with a sensitive mucous membrane and does not break function of a ciliate epithelium.
Pharmacokinetics. At topical administration drug is practically not soaked up therefore its concentration in a blood plasma is very small and is not defined by modern analytical methods.
Indications to use:
— rhinitis of different types;
— diseases of adnexal bosoms of a nose (for simplification of a drainage);
— average otitis (as a part of a combination therapy for reduction of hypostasis of a mucous nasopharynx);
— for simplification of carrying out a rinoskopiya.
Route of administration and doses:
The xylean is applied intranazalno, digging in him in a nose by means of the nozzle which is available on a bottle.
Solution with concentration of 0,5 mg / 1 ml appoint according to the recommendation of the doctor to children aged from 2 up to 6 years on 1-2 drops in each nasal course 1-2 times a day. It is not necessary to use drug more than 3 times a day.
/ 1 ml appoint solution with concentration of 1 mg to adults and children 6 years on 2-3 drops in each nasal course 3-4 times a day are more senior. The course of treatment makes usually 5–7 days. Implementation of the procedure of an instillation: before use of drug and in 5 min. after its use it is necessary to clear the nasal courses. To uncover a bottle before use. To reject the head back in a sitting position or to lay down, to enter a tip of a nozzle of the bottle turned upside down accurately into one of half of a nose, to dig drug in each half of a nose, to accurately incline the head here and there several times. After use to clear a nozzle tip, to close a cover a bottle.
The bottle has to be used only by one person because of risk of transmission of infection.
Features of use:
The xylean as well as all vasoconstrictive drugs should be used with care at patients, with arterial hypertension, cardiovascular diseases, a hyperthyroidism, a diabetes mellitus or having the hypersensitivity to vasoconstrictive drugs which is shown in the form of sleeplessness, dizziness, etc. Duration of treatment should not exceed more than 7 days. At chronic rhinitis Ksilin's use is possible only after consultation with the doctor, considering risk of development of medicamentous rhinitis.
Xylean, 0,5 mg/ml of a drop from 2 to 6 years, nasal for children, it is necessary to use only according to the recommendation of the doctor and under observation of adults.
Influence on ability to drive the car or other moving mechanisms. The xylean in the dosages which are not exceeding recommended does not influence ability to driving or the equipment. However after prolonged use of Ksilin in the dosages exceeding recommended it is impossible to exclude the general influence on cardiovascular system and the central nervous system. In these cases ability to manage the vehicle or mechanisms can be broken.
Pregnancy and lactation. Considering existence at xylomethazolinum of vasoconstrictive properties, it is necessary to avoid from reasons of precaution of use of medicine Ksilin at pregnancy and in the period of a lactation. However if the advantage for mother exceeds potential risk for a fruit or the child, use of drug at pregnancy and in the period of a lactation (breastfeeding) is admissible without exceeding of the recommended therapeutic doses.
From respiratory system. Short-term irritation (burning or xeromycteria). In rare instances increase in hypostasis of a mucous membrane, strengthening of allocations from a nose and emergence of feeling of "congestion" at the expense of a reactive hyperemia.
Long or frequent use of high doses of Ksilin can lead to burning, dryness, and also developing of reactive rhinitis. This effect can be observed even in 5-7 days after completion of treatment and can lead to irreversible injuries of a mucous membrane and developing of dry rhinitis.
From a nervous system. In rare instances there are a headache, sleeplessness, fatigue.
From cardiovascular system. Seldom: heartbeat, increase of pulse, increase in arterial pressure.
From immune system. Seldom: allergic reactions, asthma, Quincke's disease.
Interaction with other medicines:
At Ksilin's appointment in the recommended doses system effects are practically not observed.
At co-administration of tricyclic or tetracyclic antidepressants, MAO inhibitors increase in arterial pressure is possible. Joint purpose of other vasoconstrictive medicines increases risk of development of side effects.
- hypersensitivity to xylomethazolinum and other components of drug;
- dry rhinitis;
- a transsphenoidal hypophysectomy or other operative measure with disturbance of integrity of a meninx;
- surgical interventions on a meninx (in the anamnesis);
- children's age: up to 2 years - solution with concentration of 0,5 mg / 1 ml.
up to 6 years - solution with concentration of 1 mg / 1 ml.
Symptoms: About cases of overdose of drug at adults it was not reported. In rare instances, at an accidental proglatyvaniye of drug (is more often at children), in a clinical picture such symptoms as tachycardia, arrhythmia, increase in arterial pressure, drowsiness, confusion of consciousness, respiratory depression or irregular breath prevailed.
Treatment: the reception termination, adrenoblockers, symptomatic therapy (angiotonic means are contraindicated).
To store in the place protected from light at a temperature from 15 °C to 25 °C. To store in the place, unavailable to children. Period of validity 2 years.
On 10,0 ml or 20,0 ml in the bottles corked by a nozzle sprayer like "nozzle" or a cover screw with a safety ring and an insert - a dropper, placed together with a leaf insert for the consumer in packs from a cardboard.