Tizin Expert, spray 0.05% 10 ml

Pharmacodynamics:

Xylometazoline (imidazole derivative) is an alpha-adrenergic stimulator, narrows the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the mucosa. Facilitates nasal breathing in rhinitis.

Hyaluronic acid, a part of the drug, has a moisturizing effect when used in nasal medicines due to its ability to keep mucous membranes moist and creates optimal conditions for regenerative processes.
Action usually begins within 5-10 minutes.

Pharmacokinetics:

In local application it is practically not absorbed, plasma concentrations are so low that they cannot be determined by modern analytical methods.

In humans pharmacokinetic studies have not been conducted.

Indications

Colds, allergies, flu, sneezing, pollinosis, stuffy nose, otitis, sinusitis, runny nose (rhinitis), allergic rhinitis, tonsillitis – Reducing nasal mucous membrane swelling in rhinitis, including allergic rhinitis, acute respiratory diseases with rhinitis phenomena, pollinosis.

– Relief of nasal discharge in paranasal sinusitis and middle ear inflammation caused by colds.

– Preparation of patients for diagnostic manipulations in the nasal passages.

“Tisin® Expert”, nasal spray dosed 0,05 % is intended for children aged from 2 to 6 years.

“Tisin® Expert”, nasal spray dosed 0.1 % is intended for adults and children over 6 years old.

Active ingredient

Xylometazoline

Composition

1 ml of the solution contains:

The active ingredient:

xylometazoline hydrochloride 0.5 mg (0.05 %);

the amount of the active ingredient in one dose for 0.05 % is 0.035 mg of xylometazoline hydrochloride;

excipients:

glycerol – 8.5 mg,

sorbitol – 5 mg,

p> sodium dihydrophosphate 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.

How to take, the dosage

Adults and children over 6 years of age – 0.1%

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

Children aged 2-6 years – 0.05 %

– If not prescribed otherwise, use one dose of the drug in the form of 0.05 % dosed spray in each nostril 1-2 times a day.

Xylometazoline in the form of a metered spray should not be used for more than 5-7 days unless the physician has recommended a different duration of treatment.

After completion of therapy, the drug may be prescribed again only after a few days.

Always consult your physician regarding the duration of use in children.

In case of chronic rhinitis the preparation “Tisin® Expert” 0,05 % and 0,1 % is used only under the control of a physician taking into consideration the risk of nasal mucous membrane atrophy.

How to use

Take off the protective cap. Before the first use, press several times on the spray nozzle until an even cloud of “fog” appears. The bottle is ready for further use.

During the application press once. The drug is inhaled through the nose. Hold the spray bottle vertically if possible. Do not spray horizontally or downwards. Close the bottle with the cap after use.

Interaction

Concomitant use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants may lead to increased blood pressure due to the cardiovascular effects of these substances.

Special Instructions

Prolonged use (more than 7 days) and overdose of sympathomimetics that have a decongestive effect may lead to reactive hyperemia of the nasal mucosa. This results in difficulty in nasal breathing, which causes the patient to start using the drug repeatedly or even continuously. This can lead to chronic swelling (medicated rhinitis) and eventually even atrophy of the nasal mucosa (ozenema).

In milder cases, to improve the patient’s condition, the sympathomimetic injections in one nostril may be stopped first, and once the complaints have subsided, the injections may be continued in the other nostril to provide at least partial nasal breathing.

The recommended doses should not be exceeded, especially in children and the elderly.

The drug should not be used continuously for more than 7 days.

If the medication has expired or is out of date, do not throw it down the drain or into the street! Place the medication in a bag and put it in the trash. These measures will help protect the environment!

Synopsis

Transparent or slightly opalescent, colorless or slightly yellowish solution

Contraindications

– Hypersensitivity to any of the drug components;
– atrophic rhinitis, thyrotoxicosis;
– infants and children under 2 years of age (for 0.05 % nasal spray); Children under 6 years of age (for nasal spray dosage 0,1 %);
– Patients with severe cardiovascular diseases (e.g. coronary heart disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);
– patients with a history of brain surgery;
– patients receiving monoamine oxidase inhibitors (MAOIs) or other drugs that can cause increased blood pressure;
– patients with elevated intraocular pressure, especially with closed-angle glaucoma;
– condition after transsphenoidal pituitaryectomy.

Side effects

Respiratory tract

“Tisin® Expert” may cause transient mild nasal irritation (burning) in susceptible persons, sneezing.

Often (>1-< 10%) after discontinuation of the drug increased nasal mucosal swelling (reactive hyperemia) may be observed.

Prolonged or too frequent use of xylometazoline, or its use in high doses may lead to the appearance of burning in the nose or dry mucous membranes, as well as reactive nasal congestion, with the development of medication-induced rhinitis, paresthesias, sneezing, hypersecretion.

This effect may be observed even 5-7 days after completion of treatment and with prolonged use it may cause chronic inflammation of the mucous membranes with crust formation (dry rhinitis).

Nervous system

In rare cases (>0,01%-< 1%) headache, insomnia, visual disturbances, fatigue and depression may be observed (when prolonged use in high doses).

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 increased blood pressure.

Overdose

Symptoms: overdose or accidental ingestion of the drug may lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, seizures, tachycardia, arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory disorders, mental disorders.

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

Treatment: application of activated charcoal, gastric lavage, artificial respiration with oxygen infusion. Phentolamine 5 mg on saline slowly intravenously or 100 mg orally is used to reduce blood pressure.

Vasopressors are contraindicated. If necessary, antipyretic and anticonvulsants are used.

Pregnancy use

Xylometazoline should not be used during pregnancy, since the effects of this drug on the fetus have not been studied in clinical trials. The drug should not be used during breastfeeding, as it is unknown whether the active ingredient is excreted with the breast milk.

Similarities

Atrivin, Galazolin, Xylen, Snoop, Rinonorm, Xymelin Eco, Rinorus, Rinostop, Rinomaris, Xylometazolin, Tisin Classic, Xymelin Eco Menthol, Asterisk, Xyloct, Cold and Flu, Asterisk for Colds, Quatran xylo