Галазолин®

General characteristics. Structure:

Active ingredient: 0,5 mg or 1 mg of xylomethazolinum of a hydrochloride.

Excipients: dihydrophosphate sodium monohydrate, hydrophosphate sodium dodecahydrate, sodium chloride, sorbitol, dinatrium эдетат, a benzalkoniya chloride, solution of 50%, a gietelloza, глицерол, the water purified.

Pharmacological properties:

Pharmacodynamics. Xylomethazolinum is derivative imidazoline with an alpha adrenomimeticheskim action. Directly stimulates alpha and adrenergic receptors. At use on a mucous membrane of a nose causes narrowing of blood vessels, reduces a hyperemia and hypostasis of a mucous membrane of a nasopharynx, reduces the number of allocations from a nose, facilitates nasal breath at rhinitises.

Pharmacokinetics. Action of xylomethazolinum begins in 5-10 minutes and keeps within 10 hours.

Impurity use it is practically not absorbed, concentration in plasma are so small that they cannot be determined by modern analytical methods.

Indications to use:

Symptomatic treatment:

- acute rhinitis of a virus or bacterial origin;

- acute sinusitis or in a phase of an exacerbation of chronic sinusitis;

- allergic rhinitis;

- acute average otitis;

- for recovery of passability of an Eustachian tube.

Route of administration and doses:

Every time before to use drug it is necessary to remove a protective nozzle. Before the first use of new capacity, after removal of a nozzle, it is necessary to press the doser 3-5raz, until emergence of gel.

Gel of nasal 0,05%. One dose at introduction by means of the portioning device contains 0,05mg hydrochloride xylomethazolinum.

Children aged from the 3rd up to 12 years: the average dose makes single introduction to each nasal course every 8-10 hours.

It is not necessary to exceed the specified doses. Drug use duration - no more 3-5dny.

Features of use:

Children should not appoint the drug Galazolin® of gelnazalny 0,05% up to 3 years, and gel of nasal 0,1% children should not appoint Galazolin® up to 12 years. The drug Galazolin® of gelnazalny 0,1% and 0,05%, as well as other sympathomimetics, with extra care patients should appoint with hypersensitivity to adrenomimetika, the shown sleeplessness, dizziness, a tremor, disturbance of a cordial rhythm and increase in the arterial pressure (AP).

It is not necessary to appoint drug to patients with chronic or vasculomotor rhinitis as they observe a tendency to drug use longer, than 5 days. Drug use longer than is recommended, can lead to secondary expansion of blood vessels and in an effect to secondary medicamentous rhinitis (rhinitis medicamentosa). Most likely, suspension of release of noradrenaline from nerve terminations by stimulation of presynaptic alfa2-receptors is the reason of this disease. It is not necessary to apply doses above recommended, especially at children and elderly people.

Use during pregnancy and during breastfeeding. It is not necessary to use drug during pregnancy. There are no data on allocation of xylomethazolinum with breast milk. It is necessary to appoint with care drug to women in the period of a lactation.

Influence on ability to control of vehicles and to service of moving mechanisms. Drug does not influence ability to control of vehicles and service of moving mechanisms if it is applied in the recommended dose and during not long time.

At prolonged use or use in high doses undesirable effects from the blood circulatory system and the central nervous system can appear. In case of development of side effects drug can exert impact on ability to manage vehicles and mechanisms.

Side effects:

Local reactions: a xeromycteria, irritation of a mucous membrane of a nose, burning sensation in a nose and in a throat, sneezing.

Symptoms of system-wide action are very seldom noted: nausea, a headache, weakness, fatigue, drowsiness, vision disorders, allergic reactions (suffocation, vasculomotor hypostasis), palpitation, a heart consciousness, increase in arterial pressure (especially streets with blood circulatory system diseases).

Drug use longer, than is recommended and (or) in the doses exceeding recommended can lead to development of medicamentous rhinitis.

Interaction with other medicines:

Cases of interaction of xylomethazolinum with tricyclic antidepressants MAO inhibitors are noted, it is not necessary to use drug during treatment by these medicines.

It is necessary to avoid simultaneous use of a simpatikomimetikama (for example: ephedrine, pseudoephedrine) considering potentiation of actions.

Contraindications:

- hypersensitivity to any of drug components;
- surgical intervention on a meninx (in the anamnesis);
- atrophic rhinitis;
- children's age up to 3 years (for 0,05%gelya), children's age do12 years (for 0,1%gelya);
- concomitant use of inhibitors of a monoaminooxidase (MAO) and tricyclic antidepressants;
- arterial hypertension;
- glaucoma;
- tachycardia;
- the expressed atherosclerosis.

With care:

- stenocardia;
- diabetes mellitus;
- prostate hyperplasia 
- lactation period;
- hyperthyroidism.

Overdose:

Cases of overdose of medicine at adults are noted. The overdose at children is noted in rare instances. After overdose or inadvertent administration of drug inside, especially at children, there can come the following symptoms: the accelerated ineritmichny heartbeat, the increased arterial pressure, drowsiness, respiratory depression or spasmodic breath, consciousness disturbances.

At children there can come excess sedation.

There is no specific treatment. Carrying out a symptomatic treatment is recommended.

Storage conditions:

In the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 3 years. A period of storage after the first opening of a bottle-12 of weeks. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

Gel of nasal 0,05% and 0,1%. 10 g of drug place in white bottles from polyethylene of high density corked by an aluminum cap with the pump, with the doser from polyethylene, polypropylene, elastomer and the applicator with a safety nozzle from polyethylene and polypropylene place 1 bottle with the application instruction in a cardboard pack.