Tizin Xylo - instructions for use, dose, side effects, contraindications

active substance: xylometazoline hydrochloride 0.5 mg (0.05%) or 1.0 mg (0.1%); quantity active ingredient in a single dose for 0.05 % 0.035 mg of xylometazoline hydrochloride; for 0.1%, 0.14 mg xylometazoline hydrochloride;

Excipients: Benzalkonium chloride 0.2 mg, sorbitol 70% 20.0 mg, sodium chloride 4.16 mg, sodium dihydrogen phosphate dihydrate 3.38 mg, disodium hydrophosphate dihydrate 2.08 mg, disodium edetate 1.0 mg , purified water - enough.

Description:

a clear, colorless solution, odorless or with a weak characteristic odor.

Pharmacotherapeutic group:anticonvulsant - a vasoconstrictor (alpha-adrenomimetic).

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline (an imidazole derivative) is a sympathomimetic drug with alpha-adrenergic activity. It has a vasoconstrictive effect and reduces swelling of the mucous membrane.

The action usually begins within 5-10 minutes. The drug facilitates nasal breathing by reducing the swelling and hyperemia of the mucosa, and improves the flow of discharge.

Pharmacokinetics:

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

Indications:

To reduce the edema of the nasopharyngeal mucosa and secretions in acute allergic rhinitis, acute respiratory disease with phenomena of rhinitis, sinusitis, pollinosis, otitis media.Preparation of the patient for diagnostic manipulation in the nasal passages.

Contraindications:Hypersensitivity to any of the components of the drug, simultaneous administration of monoamine oxidase (MAO) inhibitors or other drugs that can cause high blood pressure; arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, surgical interventions on the meninges (in the anamnesis), children's age (up to 6 years - for a dosage of 0.1%, up to 2 years - for a dosage of 0.05%).

Carefully:

With care - ischemic heart disease (angina pectoris), prostatic hyperplasia, thyrotoxicosis, diabetes mellitus, pheochromocytoma, in patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness.

Pregnancy and lactation:

Pregnancy

Carefully controlled and relevant research requirements in pregnant women were not conducted. The drug should not be used during pregnancy, except when the potential benefit of treating the mother exceeds the possible risk to the developing fetus.
Lactation

It is not known whether the xylometazoline or its metabolites in breast milk, so the drug should not be used during breastfeeding.

Dosing and Administration:

Children aged 2-6 years

- Unless otherwise prescribed, one dose of Tizin Xylo in the form of 0.05% nasal spray spray dosed into each nasal passage 1-2 times per day.

Adults and children of school age (over 6 years)

- 3 times a day, one dose of Tizin Xylo is injected in the form of a 0.1% nasal spray spray dose into each nostril. The dose depends on the individual sensitivity of the patient and the clinical effect.

Xylometazoline in the form of a nasal dosage spray should not be used for more than 5-7 days if the doctor did not recommend a different duration of treatment.

After completion of therapy, the drug can be re-administered only after a few days.

As for the duration of use in children, always consult a doctor.

General recommendations for the introduction.

Remove the protective cap. Before the first use, press the spray nozzle several times until a uniform cloud of "fog" appears. The bottle is ready for further use. When using, press once. The drug is inhaled through the nose. If possible, keep the spray bottle vertically.Do not spray horizontally or downward. After use, close the bottle with a cap.

Side effects:

Tysin Xylo can cause transient mild nasal irritation (burning), paresthesia, sneezing and hypersecretion in susceptible people.

In some cases, after application of the drug, there may be an increased swelling of the nasal mucosa (reactive hyperemia).

Prolonged or frequent use of xylometazoline or its use in high doses can lead to burning in the nose or dryness of the mucosa, as well as reactive stagnation with the development of drug rhinitis. This effect can be observed even after 5-7 days after completion of treatment, and with prolonged use may cause irreversible damage to the mucosa with the formation of crusts (dry rhinitis).

In very rare cases, you may experience headache, insomnia or fatigue, depression (with prolonged use in high doses).

In isolated cases, local intranasal use of sympathomimetics can be accompanied by systemic effects such as palpitations, tachycardia, arrhythmias, increased blood pressure, impaired vision.

Overdose:

Symptoms of intoxication

Overdose or accidental ingestion of the drug inside may lead to the following symptoms: pupil dilating, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmias, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory failure, mental disorders.

In addition, the following symptoms can be observed: suppression of the central nervous system, accompanied by drowsiness, decreased body temperature, bradycardia, shock-like hypotension, apnea and coma.

Treatment of intoxication

The use of activated carbon, gastric lavage, artificial respiration with the introduction of oxygen. To reduce blood pressure apply phentolamine 5 mg in physiological solution intravenously slowly or 100 mg orally.

Vasopressor agents are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.

Interaction:

The simultaneous use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants may lead to an increase in blood pressure due to the cardiovascular effects of these substances.

Special instructions:

Long-term use and overdose of sympathomimetics decoholding action, can lead to reactive hyperemia of the nasal mucosa.

The recoil phenomenon can cause airway obstruction, which leads to the patient starting to use the drug repeatedly or even constantly. This can lead to chronic puffiness (medicamentous rhinitis), and eventually even to the atrophy of the mucous membrane of the nose (ozena).
In the case of chronic rhinitis, the preparation Tysin® Xylo 0.05% and 0.1% can be used only under the supervision of the doctor, taking into account the risk of atrophy of the nasal mucosa. Tysin® Xylo should not be used in the presence of hypersensitivity to benzalkonium chloride, which is part of the drug as a preservative.

Do not exceed recommended doses, especially in children and the elderly.

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

With long-term treatment or the use of Tysin Xylol in higher doses, one can not exclude the possibility of its systemic action on the cardiovascular system, which can worsen the ability to drive and use equipment.

Form release / dosage:

Spray nasal dosed 0.05% and 0.1%.

Packaging:

For 10 ml of the preparation in a bottle of brown hydrolytic glass (class III) with a dosing device and a polyethylene screw cap type "pull- off".

One bottle with instructions for use in a pack of cardboard.

The number of doses in a vial: for 0,05% not less than 140 doses, for 0,1% not less than 70 doses.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014038 / 01

Date of registration:25.06.2008

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

FAMAR ORLEANS France

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp06.06.2014

Illustrated instructions

Instructions

Tysin® Xylo (Tyzine® Xylo)