Producer: Ratiopharm, GmbH (Ratiofarm) Germany
Code of automatic telephone exchange: R01AA07
Release form: Liquid dosage forms. Spray nasal.
General characteristics. Structure:
Active agent: Xylomethazolinum hydrochloride of 10,0 mg
Citric acid monohydrate, sodium citrate a dihydrate, глицерол 85%, water for injections.
Transparent colourless solution.
Xylomethazolinum is alpha адреномиметиком, used for topical administration in the LOR-expert.
At topical administration xylomethazolinum causes narrowing of arterioles that leads to reduction of a hyperemia and hypostasis of mucous membranes of a nasopharynx and reduction of the separated secret. Clear local effect of drug comes to light already in a few minutes and remains within several hours (till 6-8 o'clock), being shown in recovery of passability of the nasal courses, openings of bosoms and Eustachian tubes. Recovery of air passability of a nasopharynx improves health of patients and reduces danger of the possible complications caused by stagnation of a mucous secret.
Pharmacokinetics. At topical administration xylomethazolinum is practically not absorbed therefore concentration in a blood plasma are very small (analytically are not defined).
Indications to use:
As a symptomatic treatment at the following diseases and states:
• acute viral or bacterial rhinitis;
• acute allergic rhinitis;
• acute sinusitis or exacerbation of chronic sinusitis;
• acute average otitis (for reduction of hypostasis of a mucous membrane of an Eustachian tube);
• training of patients for diagnostic procedures in the nasal courses.
Route of administration and doses:
To adults and children 10 years are more senior:
on 1 dose (one pressing the piston device) in each nasal course no more than 3 times a day (the maximum dose should not exceed 7 times a day). The interval between administration of drug should not be less than 6 hours.
1 dose = 0,14 ml of solution.
In order to avoid complications in the form of resuming of symptoms of a disease, duration of continuous use of drug should not exceed 7 days.
Before Rinonorm's use it is recommended to exempt the nasal course from a secret, and during administration of drug it is necessary to make an easy breath through a nose.
For use for children from 2 to 10 years it is necessary to use Rinonorm, spray nasal dosed [for children].
Features of use:
Influence on ability of driving of transport and on control of cars and mechanisms is noted.
Burning sensation and dryness of a mucous membrane of a nasal cavity;
in rare instances - irritation of a mucous membrane of a nose, an oral cavity and a throat, a headache and nausea;
extremely seldom (<1/10000) - arrhythmia, increase in arterial pressure, a hyperexcitability, skin reactions.
Interaction with other medicines:
The concomitant use three - or tetracyclic antidepressants can increase system influence of xylomethazolinum. At a concomitant use of drug with monoamine oxidase inhibitors (MAO) the risk of increase in arterial pressure is possible.
• hypersensitivity to xylomethazolinum or other components of drug;
• inflammation of skin, mucous membrane of a nose and crusting (dry rhinitis);
• use after a hypophysectomy;
• use for children up to 10 years;
• closed-angle glaucoma;
• reception of monoamine oxidase inhibitors (MAO) and tricyclic antidepressants.
To apply with care at patients with arterial hypertension, serious heart diseases, a hyperthyroidism, a diabetes mellitus and accepting Bromocriptinum.
Use during pregnancy and during feeding by a breast:
Drug should not be accepted during pregnancy. To take with caution during breastfeeding.
In rare instances overdoses, arising preferential at children, can be observed the following symptoms: irregular pulse, increase in arterial pressure, in certain cases - a loss of consciousness. At overdose the symptomatic treatment under observation is shown.
In serious cases non-selective alpha adrenoblockers can be applied to a lowering of arterial pressure, and also an intubation and artificial ventilation of the lungs. Vasoconstrictive drugs are contraindicated. At accidental reception of a moderate or large amount of drug inside, it is necessary to accept absorbent carbon (adsorbent) and sodium sulfate (purgative), to make a gastric lavage.
To store at a temperature not above 25 °C to Store in the place, unavailable to children! Period of validity: 3 years, after opening of a bottle - 1 year. Not to apply after expiry date!
Spray nasal dosed 0,1%.
On 10 ml or 15 ml in a bottle of dark glass with the portioning device for spraying, a nozzle for a nose and a protective cap.
On 1 bottle together with the application instruction in a cardboard pack.