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

Excipients: sodium dihydrogen phosphate monohydrate 3.68 mg, sodium hydrogen phosphate dodecahydrate 2.5 mg, sodium chloride 3.3 mg, sorbitol 20.0 mg, disodium edetate 0.2 mg, benzalkonium chloride, a solution of 50% of 0.2 mg, hyethelose 14, 0 mg, glycerol 40.0 mg, water purified to 1.0 g.

Description:

Colorless or almost colorless, transparent or slightly opalescent viscous liquid.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline is a derivative of imidazoline with an alpha-adrenomimetic effect. Directly stimulates the alpha-adrenergic receptors. When applied to the mucous membrane of the nose causes narrowing of the blood vessels, reduces flushing and swelling of the mucous membrane of the nasopharynx, reduces the amount of discharge from the nose, facilitates nasal breathing in rhinitis.

Pharmacokinetics:

The effect of xylometazoline begins through 5-10 minutes and held for 10 hours.

With topical application is practically not absorbed, plasma concentrations are so small that they can not be determined by modern analytical methods.

Indications:

Symptomatic treatment:

- acute rhinitis of viral or bacterial origin;

- acute sinusitis or in the phase of exacerbation of chronic sinusitis;

- allergic rhinitis;

- acute otitis media - to restore the patency of the Eustachian tube.

Contraindications:

- hypersensitivity to any of the components of the drug;

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

- atrophic rhinitis;

- children under 3 years (for 0.05 % gel), children under 12 years (for 0.1 % gel);

- simultaneous administration of monoamine oxidase (MAO) inhibitors and tricyclic antidepressants;

- arterial hypertension;

- glaucoma;

- tachycardia;

- severe atherosclerosis.

Carefully:

- angina pectoris;

- diabetes;

- hyperplasia of the prostate;

- lactation period;

- hyperthyroidism.

Pregnancy and lactation:

Do not use the drug during pregnancy.

There is no data on the isolation of xylometazoline with breast milk. It is necessary to prescribe with caution the drug to women during lactation.

Dosing and Administration:

Each time before applying the drug, remove the protective cap. Before the first use of the new container, after removing the nozzle, you should press the dispenser 3-5 times, until the appearance of the gel.

Nasal gel 0.05%

One dose, when administered with a dosing device, contains 0.05 mg of xylometazoline hydrochloride.

Children between the ages of 3 and 12: the average dose is a single injection into each nasal passage every 8-10 hours.

Do not exceed these doses.

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

Nasal gel 0.1%

One dose, when administered with a dosing device, contains 0.1 mg of xylometazoline hydrochloride.

Adults and children over 12 years of age: The average dose is a single injection into each nasal passage every 8-10 hours.

Do not exceed these doses.

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

Side effects:

Local reactions: dryness of the nasal mucosa, irritation of the nasal mucosa, burning sensation in the nose and throat, sneezing.

Very rarely symptoms of systemic action are noted: nausea, headache, weakness, fatigue, drowsiness, visual impairment, allergic reactions (choking, vasomotor edema), palpitation, palpitation, increased blood pressure (especially in people with diseases of the circulatory system). The use of the drug longer than recommended and (or) in doses exceeding the recommended can lead to the development of drug rhinitis.

Overdose:

There were no cases of drug overdose in adults.

Overdose in children is noted in rare cases.

After an overdose or unintentional intake of the drug inside, especially in children, the following symptoms may occur: accelerated and irregular heartbeat, high blood pressure, drowsiness, respiratory depression or irregular breathing, impaired consciousness.

Children may experience excessive sedation.

Specific treatment is not. Symptomatic treatment is recommended.

Interaction:

There have been cases of interaction of xylometazoline with tricyclic antidepressants and MAO inhibitors, do not use the drug during treatment with these drugs.

It should avoid the simultaneous use of xylometazoline with other sympathicomimetics (for example: ephedrine, pseudoephedrine), Considering potentiation of actions.

Special instructions:

The drug Galazolin® gel nasal 0.05% should not be administered to children under 3 years of age, and Galazoline® gel nasal 0.1 % should not be administered to children under 12 years of age.

The drug Galazolin® gel nasal 0.1% and 0.05%, like other sympathomimetics,with extreme caution should be given to patients with hypersensitivity to adrenomimetics, manifested by insomnia, dizziness, tremor,

violation of the heart rate and increased blood pressure (BP).

Do not prescribe the drug to patients with chronic or vasomotor rhinitis, as they tend to use the drug for longer than 5 days. The use of the drug longer than recommended, can lead to a secondary dilatation of the blood vessels and subsequently to secondary medical rhinitis (rhinitis medicamentosa). The cause of this disease, most likely, is the suspension of the release of norepinephrine from the nerve endings by stimulation of presynaptic alpha 2 receptors.

Do not use doses above recommended, especially in children and elderly people.

Preparation Galazolin® gel nasal 0.05% and 0.1% should not be prescribed during treatment with monoamine oxidase inhibitors and tricyclic antidepressants. The preparation contains benzalkonium chloride, therefore can cause irritation of the nasal mucosa.

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

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 use in high doses, undesirable effects from the circulatory 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.

Form release / dosage:

Nasal gel 0.05% and 0.1%.

Packaging:

10 g of the drug is placed in white high-density polyethylene bottles densities, ukuporennye an aluminum cap with a pump, with a dispenser made of polyethylene, polypropylene, elastomer and applicator with a safety packing made of polyethylene and polypropylene.

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

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Shelf life after the first opening of the bottle is 12 weeks.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014423 / 02

Date of registration:18.11.2009 / 27.10.2016

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®)