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

In 1 ml of solution contains:
active substance: xylomethyl ester hydrochloride 0.5 mg (0,05%) or 1 mg (0.1%); the amount of the active ingredient in a single dose for 0.05% to 0.035 mg of xylomethylstasoline hydrochloride; for 0.1 % - 0.14 mg of xylomethylstasoline hydrochloride;
Excipients: glycerol, sorbitol, sodium dihydrogen phosphate dihydrate, sodium chloride, sodium phosphate dihydrate, sodium hyaluronate, purified water.

Description:

transparent or slightly opalescent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:protivocongestive agent vasoconstrictor.

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline (an imidazole derivative) is an alpha-address-stimulator, narrows the blood vessels of the nasal mucosa, eliminating edema and flushing of the mucous membrane. Relieves nasal breathing in rhinitis. Hyaluronic acid, which is part of the drug, has a moisturizing effect when used in nasal medicines due to the ability to maintain mucous membranes in a moistened state and creates optimal conditions for regenerative processes.

The action usually begins within 5-10 minutes.

Pharmacokinetics:

With topical application is practically not absorbed, the plasma concentrations are so small that they can not be determined by modern and traditional women.

In humans, pharmacokinetic studies have not been conducted.

Indications:

- Reduction of swelling of the nasal mucosa in rhinitis, including allergic rhinitis; ORZ with the phenomena of rhinitis, polnnose.

- Relief of discharge of discharge from the nose with paranasal sinusitis and inflammation of the middle ear caused by a cold.

"Tizin® Xylo BIO" 0.05% is intended for children aged 2 to 6 years. "Tizin® Xylo BIO" 0.1% is for adults and children over 6 years.

Contraindications:

- hypersensitivity to any of the components of the drug;

- atrophic rhinitis, thyrotoxicosis;

- newborns and children under 2 years;

- patients with severe cardiovascular diseases (for example: coronary heart disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);

- patients with surgical interventions on the meninges in the anamnesis.

Carefully:

In the following cases, "Tizin® Xylitol BIO" can be used only after carefully weighing the benefits and risks of treatment:

- patients receiving monoamine oxidase (MAO) inhibitors or other drugs that can cause high blood pressure;

- patients with increased intraocular pressure, especially narrow-angle glaucoma;

- patients with pheochromonitoma;

- patients with metabolic diseases (eg: hyperthyroidism, diabetes mellitus);

- patients with prostatic hyperplasia.

Pregnancy and lactation:

Xylometazoline should not be used during pregnancy, since the effect of this drug on the fetus in clinical studies has not been studied. The drug should not be used during breastfeeding, as it is not known whether the active substance is excreted in breast milk.

Dosing and Administration:

Adults and children over 6 years of age - 0,1%

- Up to 3 times a day, administer one dose of the drug in the form. 0.1% of the dispensed spray in each nostril. The dose depends on the individual sensitivity of the patient and the clinical effect.

Children aged 2-6 years -0.95%

- If not otherwise prescribed, then use one dose of the drug in the form 0.05% of the dosed spray in each nostril 1-2 times a day. Xylometazoline in the form of a dosed spray should not be used for more than 5 days, unless the doctor has recommended 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.

In the case of chronic rhinitis, the preparation "Tizin® Xylon BIO" 0.05% and 0.1% can be used only under the supervision of a doctor, given the risk of atrophy of the nasal mucosa.

Mode of application. Crumple protective cap. Before the first several times click on Spray nozzle until a uniform cloud appears "fog". 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:

Airways

"Tizin® Xylo BIO" can cause transient mild nasal irritation (burning sensation) in susceptible people, sneezing.

Often (> 1- <10%) after discontinuation of the drug, there may be increased edema of the nasal mucosa (reactive hyperemia). Prolonged or too frequent use of xylometazole, or its use in high doses can lead to burning in the nose or dryness of the mucosa, as well as reactive nasal congestion, with the development of drug rhinitis, paresthesia, sneezing, hypersecretion.This effect can be observed even after 5-7 days after completion of treatment, and with prolonged use can cause chronic inflammation of the mucous membrane with the formation of crusts (dry rhinitis).
Nervous system
In rare cases (> 0.01% - <1%), headache, insomnia, visual impairment, fatigue and depression may occur (with prolonged use in high doses).
The cardiovascular system
In single cases (0.1% - <1%), local and intranasal use of sympathomimetics may be accompanied by systemic effects such as palpitation, tachycardia, arrhythmia and increased blood pressure.

Overdose:

Symptoms

Overdose or accidental ingestion of the drug inside may lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, arrhythmia, 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, lower body temperature, bradycardia, hypotension, apnea and coma.

Treatment

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

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

Interaction:

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

Special instructions:

Long-term use and overdose of sympathomimetics, which have a doxigestive effect, can lead to reactive hyperemia of the nasal mucosa.

As a result, there is difficulty in nasal breathing, which leads to the fact that the patient begins to use the drug repeatedly or even constantly.

This can lead to chronic swelling (medicamentous rhinitis), and eventually even to the atrophy of the mucous membrane of the nose (ozena).

In more mild cases, in order to improve the patient's condition, one can at first stop the introduction of sympathomimetics into one nostril,and after reducing complaints continue to inject it into another nostril to at least partially provide nasal breathing.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and into the street! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

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

With long-term treatment or the use of the drug "Tizin® Xylon BIO" in higher doses, it is impossible to exclude the possibility of its systemic action on the cardiovascular system. In such cases, the ability to drive and use machinery may be impaired.

Form release / dosage:

Spray nasal dosed 0.05% and 0.1%. 10 ml in a vial of polyethylene of high density of white color with a dosing device and a polyethylene lid. 1 bottle with instructions for use in a cardboard pack.

The number of doses in a 10 ml bottle: not less than 140 doses.

Packaging:polyethylene bottles with dosing device (1) -package cardboard

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years (no more than 1 year after autopsy).

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

Terms of leave from pharmacies:Without recipe

Registration number:LSR-009878/09

Date of registration:04.12.2009

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

Manufacturer: & nbsp

URSAPHARM Arzneimittel, GmbH Germany

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

Information update date: & nbsp25.02.2010

Illustrated instructions

Instructions

Tizin® Xylitol BIO (Tyzine® Kylo BIO)