Galazolin - instructions for use, dose, side effects, contraindications

Excipients: sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, benzalkonium chloride solution, sorbitol, purified water.

Description:

Colorless or almost colorless transparent liquid.

Pharmacotherapeutic group:The anticongestive agent is a vasoconstrictor (alpha-adrenomimetic)

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:Xylometazoline is an imidazole derivative with a sympathomimetic effect. At low concentrations, it acts on α₂-adrenoceptors, and in high concentrations has an effect on α₁-adrenoceptors.

With topical application xylometazoline causes narrowing of the blood vessels of the mucous membrane, which leads to a reduction in edema and hyperemia of the mucous membranes of the nasopharynx, a decrease in the amount of discharge, and relief of nasal breathing.

Pharmacokinetics:

With topical application is practically not absorbed, plasma concentrations are so small that they can not be determined by modern analytical methods. Action comes through 5-10 minutes, and lasts for 5-6 hours.

Indications:

- acute rhinitis of viral or bacterial origin;

- allergic rhinitis;

- acute or chronic sinusitis;

- Pollinosis;

- otitis media in order to reduce edema of the nasopharyngeal mucosa.

Contraindications:

- hypersensitivity to the components of the drug;

- atrophic rhinitis;

- angle-closure glaucoma;

- arterial hypertension;

- severe atherosclerosis;

- tachycardia;

- hyperthyroidism;

- pregnancy;

- surgical interventions on the meninges (in the anamnesis);

- children under 6 years (for 0,1 % solution) and up to 2 years (for 0.05 % solution);

- simultaneous administration of monoamine oxidase inhibitors (MAO) and up to 14 days after the end of their use.

Carefully:

- lactation period;

- diabetes;

- angina pectoris III - IV functional class;

- hyperplasia of the prostate;

- pheochromocytoma.

Pregnancy and lactation:

Dosing and Administration:

0.05% nasal drops

Children aged 2 to 6 years: the average dose is 1 - 2 drops in each nasal passage 1-2 times a day.

0.1% nasal drops

Adults and children over 6 years of age: the average dose is 2-3 drops in each nasal passage 2-3 times a day.

Do not use the drug more than 3 times a day.

Duration of the drug - no more than 3-5 days.

Side effects:

With frequent and / or prolonged use - irritation and / or dryness of the nasal mucosa, burning and paresthesia nasal mucous membrane, sneezing, hypersecretion of mucous membrane of the nasal cavity.

Rarely - edema of the mucous membrane of the nasal cavity, palpitations, tachycardia, arrhythmias, increased blood pressure, headache, vomiting, insomnia, impaired vision; depression (with prolonged use in high doses).

Overdose:

There were no cases of drug overdose in adults.

In the case of too large a dose or misuse, drops may be ingested and the active substance absorbed from the gastrointestinal tract,intestinal tract. Such situations, in general, were observed in children. In this case, the main side effect was a pronounced sedative effect.

If you accidentally swallow the drug (more often in children), there is tachycardia, arrhythmia, increased blood pressure, drowsiness, confusion, respiratory depression, or irregular breathing. Treatment is symptomatic.

Interaction:

Incompatible with MAO inhibitors and tricyclic antidepressants.

Special instructions:

Before application, it is necessary to clean the nasal passages.

Do not use the drug in patients with chronic or vasomotor rhinitis, because they have a tendency to use the drug for more than 2 weeks.

Prolonged use of the drug (more than 2 weeks) can lead to a secondary expansion of the blood vessels and subsequently to iatrogenic rhinitis (rhinitis medicamentosa). The cause of this disease is the inhibition of norepinephrine release from the nerve endings by excitation of presynaptic α₂receptors.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to drive vehicles and service moving machinery.

Form release / dosage:Nasal drops 0.05% and 0.1%.

Packaging:10 ml of the drug is placed in a polyethylene bottle with a built-in dropper and a screw-on lid or a screw cap with the first opening control.

The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children.

Shelf life:

4 years. Shelf life after the first opening of the bottle is 12 weeks. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014423 / 01

Date of registration:16.09.2008 / 22.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

WARSAW PHARMACEUTICAL WORK POLFA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp12.03.2017

Illustrated instructions

Instructions

Galazolin® (Galazolin®)