TIZIN EXPERT 0.1% NASAL SPRAY 10ML

Composition

In 1 ml of solution contains:

active substance: Xylometazoline hydrochloride 0.5 mg (0.05%) or 1 mg (0.1%); the amount of active ingredient in one dose for 0.05% is 0.035 mg of xylometazoline hydrochloride; for 0.1%, 0.14 mg of xylometazoline hydrochloride;

Excipients: glycerol - 8.5 mg, sorbitol - 5 mg, sodium dihydrogen phosphate dihydrate - 4 mg, sodium chloride - 3 mg, sodium phosphate dihydrate - 0.628 mg, sodium hyaluronate - 0.2 mg, water for injection - up to 1 ml.

clear or slightly opalescent, colorless or slightly yellowish solution.

PHARMACOLOGICAL PROPERTIES

Pharmacological group: anti-bong agent - vasoconstrictor.

Pharmacodynamics

Xylometazoline (imidazole derivative) - alpha-adrenostimulyator, constricts the blood vessels of the nasal mucosa, eliminating swelling and hyperemia 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 drugs due to the ability to maintain the mucous membranes in a moist state and creates optimal conditions for recovery processes.
The action usually begins within 5-10 minutes.

Pharmacokinetics

When applied topically, it is practically not absorbed, plasma concentrations are so small that they cannot be determined by modern analytical methods.
In humans, pharmacokinetic studies have not been conducted.

INDICATIONS FOR USE

• Reduction of swelling of the nasal mucosa with rhinitis, including allergic rhinitis, acute respiratory infections with symptoms of rhinitis, pollinosis.
• Relief of nasal discharge from paranasal sinusitis and inflammation of the middle ear caused by a cold.
• Preparation of patients for diagnostic manipulations in the nasal passages.

"Tizin® Expert ", spray nasal dosage of 0.05% is intended for children aged 2 to 6 years.

"Tizin® Expert ”, spray nasal dosage 0.1% is intended for adults and children over 6 years old.

CONTRAINDICATIONS

• Hypersensitivity to any of the components of the drug;
• atrophic rhinitis, thyrotoxicosis;
• newborns and children under the age of 2 years (for a nasal spray dosed 0.05%); children under the age of 6 years (for a nasal spray dosed out 0.1%);
• patients with severe cardiovascular diseases (for example, ischemic heart disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);
• patients with a history of surgery on the meninges;
• patients receiving monoamine oxidase inhibitors (MAO) or other drugs that can cause an increase in blood pressure;
• patients with increased intraocular pressure, especially with angle-closure glaucoma;
• condition after transsphenoidal hypophysectomy.

Carefully

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

• patients with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure;
• pheochromocytoma patients;
• patients with endocrine diseases (eg, hyperthyroidism, diabetes);
• patients with prostatic hyperplasia;
• patients with porphyria.

PREGNANCY AND LACTATION

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

METHOD OF ADMINISTRATION AND DOSES

Adults and children over 6 years old - 0.1%

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

Children aged 2-6 years - 0.05%

• Unless otherwise indicated, use one dose of the drug in the form of a 0.05% 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 5-7 days, if the doctor did not recommend a different duration of treatment.

After completion of therapy, the drug can be reappointed only after a few days.

Always consult with your doctor about the duration of use in children.

In the case of chronic rhinitis, the drug "Tizin® Expert ”0.05% and 0.1% can be used only under the supervision of a physician, given the risk of atrophy of the nasal mucosa.

Mode of application

- Remove the protective cap. Before the first application, repeatedly press the spray nozzle until a uniform cloud of “fog” appears. The bottle is ready for further use.

- When applying, press once. Drug inhale through the nose. If possible, keep the spray bottle upright. Do not spray horizontally or down. After use, close the bottle cap.

SIDE EFFECT

Airways

"Tizin® Expert ”can cause transient slight irritation of the nose (burning) in susceptible people, sneezing.

Often (> 1- <10%) after the cessation of the action of the drug, an increased swelling of the nasal mucosa can be observed (reactive hyperemia).

Prolonged or too frequent use of xylometazoline, or its use in high doses can lead to a burning sensation in the nose or dry mucous membranes, as well as reactive nasal congestion, with the development of medical rhinitis, paresthesia, sneezing, hypersecretion. This effect can be observed even 5-7 days after the completion of treatment, and with prolonged use it can be the cause of chronic inflammation of the mucous membrane with the formation of crusts (dry rhinitis).

Nervous system

In rare cases (> 0.01% - <1%), headache, insomnia, blurred vision, fatigue and depression (with long-term use in high doses) may occur.

The cardiovascular system

In isolated cases (0.1% - <1%), local intranasal use of sympathomimetics may be accompanied by systemic effects, such as palpitations, tachycardia, arrhythmias, and elevated blood pressure.

OVERDOSE

Symptoms

An overdose or accidental ingestion of the drug can 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 may be observed: suppression of the function of the central nervous system, accompanied by drowsiness, a decrease in 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 phentolamine 5 mg in physiological solution intravenously slowly or 100 mg orally.

Vasopressor drugs are contraindicated. If necessary, use antipyretic and anticonvulsant drugs.

INTERACTION WITH OTHER PREPARATIONS AND OTHER FORMS OF INTERACTION

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

INFLUENCE ON THE ABILITY TO MANAGE THE CAR AND USE THE TECHNIQUE

With long-term treatment or use of the drug "Tizin® Expert ”in higher doses can not exclude the possibility of its systemic action on the cardiovascular system. In such cases, the ability to drive and use the technique may be impaired.

Special notes

Prolonged use (more than 7 days) and overdose of sympathomimetics that have a decongestant 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 again or even constantly. This can lead to chronic edema (medical rhinitis), and eventually even atrophy of the nasal mucosa (ozena).

In milder cases, to improve the condition of the patient, you can first stop the introduction of sympathomimetic in one nostril, and after reducing the complaints continue to enter it into the other nostril to at least partially provide nasal breathing.

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

It is not recommended to use the drug in continuous mode for more than 7 days. If the medicinal product has fallen into disrepair or the expiration date has expired - do not throw it into sewage and on the street! Put the medicine in the bag and put it in the trash. These measures will help protect the environment!

SHELF LIFE

Do not use the drug after the expiration date printed on the package.

STORAGE CONDITIONS

Store at a temperature not higher than 25 ° С.

Keep out of the reach of children.

CONDITIONS OF VACATION

It is released without a prescription.