GALAZOLIN

Active material: Ksilometazolin
When ATH: R01AA07
CCF: Vasoconstrictor drugs for local application in an ENT-practice
ICD-10 codes (testimony): H66, H68, J00, J01, J30.1, J30.3, J32
When CSF: 24.05.01
Manufacturer: WARSAW PHARMACEUTICAL WORK POLFA S.A. (Poland)

Pharmaceutical form, composition and packaging

Nasal gel 0.05%1 g
Xylometazoline hydrochloride500 g

Excipients: sodium chloride, sodium hydrogen phosphate, sodium dihydrogen, disodium edetate, benzalkonium chloride, sorbitol, hydroxyethyl, glycerol (glycerol), Purified water.

10 g – plastic bottles with dispenser (1) – packs cardboard.

Nasal gel 0.1%1 g
Xylometazoline hydrochloride1 mg

Excipients: sodium chloride, sodium hydrogen phosphate, sodium dihydrogen, disodium edetate, benzalkonium chloride, sorbitol, hydroxyethyl, glycerol (glycerol), Purified water.

10 g – plastic bottles with dispenser (1) – packs cardboard.

Nasal drops 0.05%1 ml
Xylometazoline hydrochloride500 g

Excipients: sodium chloride, sodium hydrogen phosphate, sodium dihydrogen, sorbitol, disodium edetate, benzalkonium chloride, Purified water.

10 ml – dropper bottle plastic (1) – packs cardboard.
10 ml – bottles (1) – packs cardboard.

Nasal drops 0.1%1 ml
Xylometazoline hydrochloride1 mg

Excipients: sodium chloride, sodium hydrogen phosphate, sodium dihydrogen, sorbitol, disodium edetate, benzalkonium chloride, Purified water.

10 ml – dropper bottle plastic (1) – packs cardboard.
10 ml – bottles (1) – packs cardboard.

 

Pharmacological action

Vasoconstrictor drugs for local application in an ENT-practice.

Alpha-agonists from the group of imidazoline derivatives. At low concentrations, it acts on α2-adrenoreceptory, in high concentration has an effect on α1-adrenoreceptory. When applied topically, causes narrowing of the blood vessels, which leads to a reduction of edema and hyperemia of the mucous membranes of the nasopharynx and reduce the number of discharge.

Against the background of galazolin restored patency of the nasal passages, holes sinuses and eustachian tube.

When topically applied therapeutic concentrations not irritate the nasal mucosa, It does not cause congestion.

Preparation action begins 5-10 minutes and lasts for 5-6 no, then vasoconstriction persists until 8-12 no.

 

Pharmacokinetics

In applying the drug in recommended doses ksilometazolin hardly exposed systemic absorption, concerning data missing Pharmacokinetics Galazolin.

 

Testimony

- Coryza (viral, bacterial, allergic);

- Sinusitis;

- Evstahiit;

- Otitis media.

 

Dosage regimen

Galazolin in the form of a nasal gel 0.05% are applied by spraying children aged 3 to 6 years by 1 dose (1 spraying) in each nostril 1-2 times / day. Children aged 6 to 12 years appoint an average of 1-2 dose (1-2 spray) in each nostril 2-3 times / day.

When spraying with a metering device 1 dose nasal gel 0.05% It contains 50 micrograms xylometazoline.

Galazolin in the form of a nasal gel 0.1% are applied by spraying adults and children over 12 years by 1 dose (1 spraying) in each nostril 2-3 times / day.

When spraying with a metering device 1 dose nasal gel 0.1% It contains 100 micrograms xylometazoline.

Before using the nasal gel every time you need to remove the nozzle, then press the dispenser 3-5 just before the advent of cloud content bottle.

Galazolin the drop 0.05% appointed children aged 2 to 6 years by 1-2 drops in each nostril 1-2 times / day.

Galazolin the drop 0.1% appointed adults and children over 6 years by 2-3 drops in each nostril 2-3 times / day.

Do not use the drug in the form of a nasal gel or drops more 3 time / day. The course of treatment is not more than 3-5 days. The maximum duration of use – 2 of the week.

 

Side effect

Local reactions: sometimes – burning, xeromycteria, chikhaniye; rarely – reaktivnaя giperemiя (strongly expressed feeling of nasal congestion after, how the effect of the drug).

Other: sometimes with local overdose – tachycardia, increased blood pressure; rarely – anxiety, insomnia, fatigue, headache, nausea.

 

Contraindications

- Increased intraocular pressure;

- Zakrыtougolynaya glaucoma;

- Atrophic rhinitis;

- Arterial hypertension;

- Expressed atherosclerosis;

- Tachycardia;

- Hyperthyroidism;

- Diabetes;

- Pheochromocytoma;

- Simultaneous reception of MAO inhibitors and the period 14 days after their application;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

The drug should be used only after assessment of the risks and benefits to the fetus and mother.

It is not allowed to exceed the recommended dose during pregnancy and lactation (breast-feeding).

 

Cautions

Long-term use of the drug leads to a weakening of its action, atrophy of the nasal mucosa and the reactive hyperemia with drug rhinitis.

Effects on ability to drive vehicles and management mechanisms

After prolonged use of funds from the cold, containing xylometazoline, doses, exceeding recommended, It can not be excluded overall effect on the cardiovascular system and CNS. In these cases, the ability to drive vehicles or equipment may be reduced.

 

Overdose

Symptoms: Accidental ingestion of the drug (more children) marked tachycardia, arrhythmia, increased blood pressure, confusion.

Treatment: symptomatic therapy.

 

Drug Interactions

With simultaneous use of xylometazoline (an overdose or accidental ingestion) tricyclic antidepressants or MAO inhibitors (incl. and to use xylometazoline) there is an increase in blood pressure.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature from 15 ° to 25 ° C. Shelf life of nasal drops – 4 year, nasal gel – 3 year.

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