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Halazolinum

Препарат Галазолин. Polpharma/Medana Pharma S. A. («Польфарма»/ Медана Фарма С. А.) Польша


Producer: Polpharma/Medana Pharma S. A. (Polfarm / Medan of Pharm S.A.) Poland

Code of automatic telephone exchange: R01AA07

Release form: Liquid dosage forms. Drops are nasal.

Indications to use: Acute otitis. Average otitis. Allergic rhinitis (cold). Chronic sinusitis. Acute sinusitis. Acute rhinitis (cold).


General characteristics. Structure:

Active agent: xylomethazolinum hydrochloride of 0,5 mg/ml

Other ingredients: sodium chloride, sodium hydrophosphate dodecahydrate, sodium dihydrophosphate monohydrate, dinatrium эдетат, a chloride benzalkoniya solution, sorbite (E 420), the water purified.

Active agent: xylomethazolinum hydrochloride of 1 mg/ml

Other ingredients: sodium chloride, sodium hydrophosphate dodecahydrate, sodium dihydrophosphate monohydrate, dinatrium эдетат, a chloride benzalkoniya solution, sorbite (E 420), the water purified.

Active agent: xylomethazolinum hydrochloride of 0,5 mg/ml

Other ingredients: sodium chloride, sodium hydrophosphate dodecahydrate, sodium dihydrophosphate monohydrate, dinatrium эдетат, a benzalkoniya chloride, sorbite (E 420), hydroxyethylcellulose, glycerin, the water purified.

Active agent: xylomethazolinum hydrochloride of 1 mg/ml

Other ingredients: sodium chloride, sodium hydrophosphate dodecahydrate, sodium dihydrophosphate monohydrate, dinatrium эдетат, a benzalkoniya chloride, sorbite (E 420), hydroxyethylcellulose, glycerin, the water purified.




Pharmacological properties:

Pharmacodynamics. Xylomethazolinum — derivative imidazoline, has sympathomimetic effect, is a direct antagonist α2-адренорецепторов. Causes narrowing of blood vessels of a mucous membrane of a nasal cavity, eliminates its hyperemia and hypostasis, reduces exudation.
Long use of drug (> 2 weeks) can lead to secondary expansion of blood vessels (medicamentous rhinitis) which cause braking of release of noradrenaline from nerve terminations by excitement presynaptic α2-адренорецепторов can be.

Pharmacokinetics. Effect of drug develops in 5–10 min.; its effect lasts for 5–6 h, however vasoconstriction remains during 8–12 h. When drawing on a mucous membrane drug causes local narrowing of blood vessels and is practically not soaked up in a blood stream and has no systemic action. In case of hit of a significant amount of xylomethazolinum in a digestive tract (it is generally possible at children), note excessive sedation.


Indications to use:

Treatment of acute rhinitis of a virus or bacterial origin; acute or exacerbations of chronic sinusitis; allergic rhinitis; acute average otitis (for recovery of passability of acoustical pipes).


Route of administration and doses:

Drops nasal 0,05% (1 drop contains 0,025 mg of xylomethazolinum of a hydrochloride).
To children aged from 4 months up to 2 years each 8–12 h dig in on 1 drop 0,05% of solution in each nasal course; to children at the age of 2–12 years — on 2–3 drops of 0,05% of solution in each nasal course each 8–10 h.
Drops nasal 0,1% (1 drop contains 0,05 mg of xylomethazolinum of a hydrochloride).
To adults and children 12 years are aged more senior each 8–10 h dig in 2–3 drops in each nasal course.
Drug in a form 0,05 and 0,1 of % of nasal gel is applied on a mucous membrane of a nasal cavity by bystry one-time pressing of the doser of a bottle.
Every time before use of drug it is necessary to remove a nozzle and to press the doser of 3-5 times until emergence of drug (gel).
Gel for a nose of 0,05% (one pressing contains 0,05 mg of xylomethazolinum of a hydrochloride).
Children at the age of 3–12 years: gel for a nose of 0,05%: usually each 8–10 h do one pressing in each nasal course.
Gel for a nose of 0,1% (one pressing contains 0,1 mg of xylomethazolinum of a hydrochloride).
Children are aged more senior than 12 years and adults: usually each 8–10 h appoint one pressing in each nasal course.
The course of treatment usually makes 3–5 days and anyway should not exceed 2 weeks.


Features of use:

The bottle needs to be used individually; it is not necessary to transfer him for use to other persons for prevention of possible spread of an infection.
Drug in the form of nasal drops should not be used at children aged up to 4 months. Drug in the form of nasal gel should not be used at children under 3 years.
With care apply at patients with an ischemic heart disease, arterial hypertension, a diabetes mellitus, a prostatauxe, a hyperthyroidism. Not to use drug during treatment by MAO inhibitors or tricyclic antidepressants.
It is possible to use drug during pregnancy only if the expected therapeutic effect for mother exceeds potential risk for a fruit.
There are no data that Halazolinum is allocated with breast milk, however it is not recommended to use drug during feeding by a breast. If use of drug is necessary, it is necessary to stop breastfeeding.
Ability to influence speed of response at control of vehicles or work with other mechanisms.
Drug does not exert a negative impact on ability to control of vehicles and work with potentially dangerous mechanisms.


Side effects:

Locally in some cases there can be an irritation, burning, unpleasant feeling of a xeromycteria, sneezing. Very seldom there is systemic action — a headache, drowsiness, weakness, tachycardia, sedative action (after overdose). In case of use of very high dose or wrong use of a drop it is possible to swallow that leads to absorption of active ingredient in a GIT. Such cases note generally at children, at the same time the main side effect is excessive sedation.


Interaction with other medicines:

Because medicine in the minimum quantity gets to a system blood stream, its interaction with other applied means is improbable. Noted separate cases of interaction of drug with tricyclic antidepressants therefore drug is not used during treatment by tricyclic antidepressants and MAO inhibitors.


Contraindications:

Hypersensitivity to drug components; closed-angle glaucoma; a state after a hypophysectomy or other operative measures which are carried out with a section of a firm meninx. To children aged up to 4 months — in the form of drops.


Overdose:

The considerable overdose of drug or its accidental oral administration, especially children, can cause development of sedation, vision disorder, a headache, irritability, disturbances of a heart rhythm, sleeplessness. Prolonged use of drug can lead to development of the secondary medicamentous rhinitis steady against therapy. Treatment at overdose symptomatic.


Storage conditions:

In the place protected from light at the room temperature of 15−25 °C.


Issue conditions:

Without recipe


Packaging:

Cap. nazat. 0,05% фл. - капельн. 10 ml, with counter. openings
Cap. nazat. 0,05% фл. - капельн. 10 ml

Cap. nazat. 0,1% фл. - капельн. 10 ml, with counter. openings
Cap. nazat. 0,1% фл. - капельн. 10 ml

Gel nazat. 0,05% фл. 10 g, with the doser, No. 1

Gel nazat. 0,1% фл. 10 g, with the doser, No. 1.



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