Composition, form of production and packaging
? Nasal drops 0.05% as a colorless or almost colorless, clear liquid.
1 ml
xylometazoline hydrochloride 0.5 mg
Additives: sodium hydrogen phosphate dodecahydrate 2.5 mg, sodium dihydrogen phosphate monohydrate 3.68 mg, sodium chloride 3.3 mg, disodium edetate 0.2 mg, benzalkonium chloride 50% 0.2 mg, sorbitol 20 mg, purified water up to 1 ml.
10 ml - polyethylene bottles (1) with a built-in dropper and a screw cap - packs of cardboard.
10 ml - polyethylene bottles (1) with a built-in dropper and screw cap with control of the first opening - packs cardboard.
? Nasal drops 0.1% in the form of a colorless or almost colorless, clear liquid.
1 ml
xylometazoline hydrochloride 1 mg
Additives: sodium hydrogen phosphate dodecahydrate 2.5 mg, sodium dihydrogen phosphate monohydrate 3.68 mg, sodium chloride 3.3 mg, disodium edetate 0.2 mg, benzalkonium chloride 50% 0.2 mg, sorbitol 20 mg, purified water up to 1 ml.
10 ml - polyethylene bottles (1) with a built-in dropper and a screw cap - packs of cardboard.
10 ml - polyethylene bottles (1) with a built-in dropper and screw cap with control of the first opening - packs cardboard.
? Nasal gel 0.05% as a colorless or almost colorless, transparent or slightly opalescent, viscous liquid.
1 g
xylometazoline hydrochloride 0.5 mg
Auxiliary substances: sodium dihydrogen phosphate monohydrate - 3.68 mg, sodium hydrogen phosphate dodecahydrate 2.5 mg, sodium chloride 3.3 mg, sorbitol 20 mg, disodium edetate 0.2 mg, benzalkonium chloride (solution 50%) 0.2 mg, hyethelose 14 mg, Glycerol - 40 mg, purified water - up to 1 g.
10 g - polyethylene bottles (1), sealed with an aluminum cap with a pump, with a dispenser and an applicator with a protective packing - packs of cardboard.
? Nasal gel 0.1% in the form of a colorless or almost colorless, transparent or slightly opalescent, viscous liquid.
1 g
xylometazoline hydrochloride 1 mg
Auxiliary substances: sodium dihydrogen phosphate monohydrate - 3.68 mg, sodium hydrogen phosphate dodecahydrate 2.5 mg, sodium chloride 3.3 mg, sorbitol 20 mg, disodium edetate 0.2 mg, benzalkonium chloride (solution 50%) 0.2 mg, hyethelose 14 mg, Glycerol - 40 mg, purified water - up to 1 g.
10 g - polyethylene bottles (1), sealed with an aluminum cap with a pump, with a dispenser and an applicator with a protective packing - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Vasoconstrictive drug for topical application in ENT practice. Alpha-adrenomimetic from the group of imidazole derivatives. In low concentrations acts on? 2-adrenoreceptors, in high concentrations has an effect on? 1- adrenoreceptors.
When topical application causes narrowing of blood vessels, which leads to a reduction in edema and hyperemia of the mucous membranes of the nasopharynx, reduces the amount of discharge from the nose, facilitates nasal breathing in rhinitis.
The drug starts in 5-10 minutes and lasts for 5-6 hours when applied in the form of nasal drops and for 10 hours when applied in the form of a nasal gel.
PHARMACOKINETICS
When the drug is used in recommended doses, xylometazoline practically does not undergo systemic absorption, plasma concentrations are so small that they can not be determined by modern analytical methods.
INDICATIONS
- acute rhinitis of viral or bacterial origin;
- Allergic rhinitis;
- Acute sinusitis;
- chronic sinusitis in the phase of exacerbation;
- Pollinosis;
- otitis media (to reduce edema of the nasopharynx mucous membrane and restore the patency of the Eustachian tube).
DOSING MODE
Galazoline В® in the form of drops 0.05% prescribed to children aged 2 to 6 years 1-2 drops in each nostril 1-2 times / day.
Galazoline В® in the form of drops 0.1% is prescribed for adults and children over 6 years 2-3 drops in each nostril 2-3 times / day.
Galazolin В® in the form of nasal drops should not be used more than 3 times / day.
Galazoline В® in the form of nasal gel 0.05%: children aged 3 to 12 years, on average, 1 injection into each nostril every 8-10 hours.
When administered with a dosing device 1, a dose of 0.05% nasal gel contains 50 Ојg xylometazoline.
Galazoline В® in the form of nasal gel 0.1%: adults and children over 12 years of age, on average, 1 injection into each nostril every 8-10 h.
When administered with a dosing device 1, a 0.1% nasal gel dose contains 100 Ојg of xylometazoline.
Before applying the nasal gel each time, remove the nozzle, then press the dispenser 3-5 times until the appearance of the gel.
Do not exceed these doses. The course of treatment is no more than 3-5 days. The maximum duration of application is 2 weeks.
SIDE EFFECT
Local reactions: with frequent and / or prolonged use - irritation and / or dryness of the mucous membrane of the nasopharynx, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the mucous membrane of the nasal cavity; rarely - edema of the mucous membrane of the nasal cavity.
Systemic reactions: rarely - palpitations, tachycardia, palpitation, arrhythmia, increased blood pressure (especially in patients with cardiovascular diseases), headache, nausea, vomiting, insomnia, weakness, fatigue, drowsiness, visual impairment, allergic reactions (choking, vasomotor edema); at long application and-or at application in high doses - depression, a medicamental rhinitis.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- Atrophic rhinitis;
- an angle-closure glaucoma;
- arterial hypertension;
- severe atherosclerosis;
- tachycardia;
- hyperthyroidism (for drops of nasal);
- surgical intervention on the meninges (in the anamnesis);
- simultaneous administration of MAO inhibitors and a period of 14 days after the end of their use;
- simultaneous reception of tricyclic antidepressants;
- Pregnancy;
- Children under 6 years of age (for 0.1% of nasal drops) and up to 2 years (for 0.05% of nasal drops);
- Children's age under 12 years (for 0.1% of nasal gel) and up to 3 years (for 0.05% of nasal gel).
Caution should be used during lactation, diabetes, with angina pectoris III-IV functional class, prostatic hyperplasia, pheochromocytoma (for nasal drops), with hyperthyroidism (for nasal gel).
PREGNANCY AND LACTATION
Contraindicated in pregnancy.
Data on the isolation of xylometazoline with breast milk is not available. It is necessary to prescribe with caution the drug to women during lactation (breastfeeding).
APPLICATION FOR CHILDREN
Contraindications: children under 6 years of age (for 0.1% of nasal drops) and up to 2 years (for 0.05% of nasal drops); Children under 12 years of age (for 0.1% of nasal gel) and up to 3 years (for 0.05% of nasal gel).
SPECIAL INSTRUCTIONS
Before application, it is necessary to clean the nasal passages.
Galazolin В®, like other sympathomimetics, should be used with extreme caution in patients with hypersensitivity to adrenomimetics, manifested by insomnia, dizziness, tremor, cardiac rhythm disturbances and increased blood pressure.
Do not use the drug in patients with chronic or vasomotor rhinitis, as they tend to use the drug for more than 5 days.
Prolonged use of the drug (more than 2 weeks) can lead to a secondary expansion of the blood vessels and subsequently to secondary medicamentous rhinitis . The cause of this disease is the inhibition of the release of norepinephrine from the nerve endings through the excitation of presynaptic ones? 2 receptors.
Do not exceed the recommended dose, especially in children and elderly patients.
The drug contains benzalkonium chloride, so it can cause irritation of the nasal mucosa.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and service moving mechanisms, if used at the recommended dose and for a short time.
With prolonged use or application in high doses, undesirable effects from the cardiovascular system and the central nervous system may occur. In the case of side effects, the drug may affect the ability to drive vehicles and mechanisms.
OVERDOSE
There were no cases of overdose in adults. In case of application of too large a dose or incorrect application, it may occur the ingestion of drops and absorption of the active substance from the digestive tract. This happens mainly in children. In this case, a pronounced sedative effect is observed.
Symptoms: with accidental ingestion of the drug (more often in children), there is tachycardia, arrhythmia, increased blood pressure, drowsiness, confusion, respiratory depression, or irregular breathing.
Treatment: conduct symptomatic therapy.
DRUG INTERACTION
Incompatible with MAO inhibitors and tricyclic antidepressants.
With the simultaneous use of xylometazoline with other sympathomimetics (for example, ephedrine, pseudoephedrine), potentiation of the action occurs. Use this combination with caution.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 В° C. The shelf life of drops of nasal - 4 years, gel nasal - 3 years.
Shelf life after the first opening of the bottle with gel nasal - 12 weeks.
