Producer: LLC Pharmtekhnologiya Republic of Belarus
Code of automatic telephone exchange: R01AA07
Release form: Liquid dosage forms. Spray nasal.
General characteristics. Structure:
Active ingredient: 0,5 mg or 1 mg of xylomethazolinum of a hydrochloride.
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 vessels, weakening inflammatory process and exudation and which is actively applied in the LOR-expert.
Pharmacodynamics. Xylomethazolinum is alpha адреномиметиком non-selective action. In low concentration works on α2-адренорецепторы, in high concentration has 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 processes 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:
Apply at acute respiratory diseases with the phenomena of rhinitis (cold);
- acute allergic rhinitis, sinusitis;
- at average otitis (as a part of a combination therapy for reduction of hypostasis of a mucous nasopharynx);
- for simplification of carrying out a rinoskopiya and other manipulations in a nasopharynx.
Route of administration and doses:
Medicine Ksilin is applied intranazalno, during a superficial breath. The bottle with medicine when spraying has to be in vertical position. Before use it is necessary to make 2-3 pressing a nasal nozzle before emergence of a dispersive stream of medicine.
To adults and children 12 years – on 1 injection of 1 mg/ml of solution in each nasal course 2-4 times a day are more senior.
To children from 2 to 12 years - on 1 injection of 0,5 mg/ml of solution in each nasal course 1-3 times a day.
Medicine use duration – no more than 5 days.
Features of use:
It is longer not necessary to use drug 5 days in a row. Continuous use of drug can cause converse effect.
It is necessary to appoint with care drug to patients with warmly - vascular diseases, arterial hypertension and the complicated urination.
Patients who at use of adrenergic drugs have the strong reactions which are shown in the form of sleeplessness, dizzinesses, a shiver, arrhythmias, the increased arterial pressure should appoint drug with care.
The preservative (a benzalkoniya chloride) which is contained in sprays nasal, especially at prolonged use can cause hypostasis of a mucous membrane of a nasal cavity. If there is a suspicion concerning emergence of such reaction (a long congestion of a nose), it is whenever possible necessary to use medicine for nasal use without preservative.
If other means without preservative is unavailable to nasal use, then it is necessary to pay attention to other dosage form.
Not to exceed the recommended dose, especially to children and people of advanced age.
For hygienic reasons and in order to avoid infection only one person can use a bottle of spray.
Use at pregnancy and a lactation. Considering existence at xylomethazolinum of vasoconstrictive properties, it is necessary to avoid from reasons of precaution of use of medicine Ksilin during pregnancy and a lactation. However if the advantage for mother exceeds potential risk for a fruit or the child, use of drug is admissible without exceeding of the recommended therapeutic doses.
Special instructions. Long treatment (more than 5 days) and overdose of xylomethazolinum can increase risk of decrease in its efficiency and probability of developing of a mucosal atrophy of a nose and its reactive hyperemia with the phenomena of medicamentous rhinitis. The bottle is used only by one person (risk of transmission of infection).
Influence on ability to drive the car and to work with mechanisms. Xylomethazolinum in the dosages which are not exceeding recommended does not influence ability to manage the vehicle or the equipment.
Local reactions: at frequent and/or prolonged use - irritation and/or dryness of a mucous membrane of a nasopharynx, burning, a pricking, sneezing, hypersecretion, decrease in therapeutic effect – "ricochet" puffiness of a mucous membrane of a nose (strengthening of allocations from a nose and emergence of feeling of "congestion" at the expense of a reactive hyperemia).
Interaction with other medicines:
At use of spray of Ksilin in the recommended doses system effects are practically not observed. However, at simultaneous use of tricyclic or tetracyclic antidepressants, Maprotilinum, other adrenomimetik or monoamine oxidase inhibitors of manifestation of systemic action of xylomethazolinum can amplify, especially in cases of its overdose.
Adrenoblockers and antagonists of calcium weaken action of xylomethazolinum.
- hypersensitivity to xylomethazolinum and other components of drug;
- arterial hypertension, tachycardia, the expressed atherosclerosis;
- closed-angle form of glaucoma;
- atrophic rhinitis;
- diabetes mellitus;
- surgical interventions on a meninx (in the anamnesis);
- a concomitant use of MAO inhibitors and the period from 10 to 14 days after the end of their use;
- children's age up to 2 years.
The clinical picture of intoxication can be greased as phases of stimulation can change phases of oppression of the central nervous and is warm – vascular systems. Especially children after overdose often have dominating central nervous effects with spasms and a coma, bradycardia, an apnoea, and also arterial hypertension, can change arterial hypotension. Symptoms of stimulation of the central nervous system is the concern (feeling of fear / alarm), excitement, hallucinations and spasms. Symptoms owing to oppression of the central nervous system is a decrease in body temperature, slackness, drowsiness and a coma.
There can be following additional symptoms: narrowing of pupils (miosis), expansion of pupils (mydriasis), heat, sweating, pallor, bluish coloring of skin owing to reduction of content of oxygen in blood (cyanosis), tachycardia, disturbance of breath and an apnoea, nausea and vomiting, psychogenic disturbances, increase or a lowering of arterial pressure, cardiac arrhythmia, the accelerated / slowed down cordial rhythm.
At intoxication it is necessary to see a doctor at once, hospitalization and observation is necessary.
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 storage 2 years.
On 10,0 ml or 25,0 ml in the bottles corked by the nozzle spraying nasal, placed together with a leaf insert for the consumer in packs from a cardboard.