Tizin Classic, 0.1% spray 10 ml

A vasoconstrictor for local use in ENT practice.

Xylometazoline (imidazole derivative) is an alpha-adrenomimetic.

It has a vasoconstrictor effect, reduces nasal mucosal edema.

The drug facilitates nasal breathing by reducing swelling and hyperemia of the mucous membrane and also improves discharge.

The drug takes effect within 5-10 minutes.

Indications

to reduce nasopharyngeal mucous membrane edema and discharge in acute allergic rhinitis, acute cold with rhinitis, sinusitis, pollinosis, otitis media;

preparing patients for diagnostic manipulations in the nasal passages.

Active ingredient

Composition

1 ml of the solution contains:

acting substance:

xylometazoline hydrochloride 1.0 mg (0.1%);

The amount of the active ingredient in one dose for 0.1% is 0.14 mg of xylometazoline hydrochloride;

excipients:

Benzalkonium chloride, 0.2 mg;
sorbitol 70%, 20.0 mg;
sodium chloride, 4.16 mg;
sodium dihydrophosphate dihydrate, 3.38 mg;
disodium hydrophosphate dihydrate – 2,08 mg;
disodium edetate – 1,0 mg;
purified water – sufficient.

How to take, the dosage

Tisin® Classic in the form of 0.1% nasal spray is administered to adults and children over 6 years of age in 1 dose per nasal passage 3 times daily.

The dose depends on the individual patient’s sensitivity and clinical effect.

The drug should not be used for more than 5-7 days without a physician’s recommendation.

The drug can only be reapplied after a few days of therapy.

The duration of use in children is determined by the doctor.

The rules for use of the drug

Take off the protective cap. Before first use, squeeze the spray nozzle several times until an even “mist” cloud appears. The bottle is ready to use. During use press 1 time. The product should be inhaled through the nose. If possible, hold the spray bottle vertically. Do not spray horizontally or downwards. The bottle should be closed with the cap after use.

Interaction

Special Instructions

Long-term use and overdose of sympathomimetics with decongestive effects may result in reactive nasal mucosal hyperemia.

The recoil phenomenon can cause airway obstruction, which leads the patient to use the drug repeatedly or even continuously. This can lead to chronic swelling (medicated rhinitis) and eventually even atrophy of the nasal mucosa (ozenema).

In case of chronic rhinitis Tisin® Classic 0.05% and 0.1% can only be used under medical supervision taking into account the risk of nasal mucosal atrophy.

Tisin® Classic should not be used if there is hypersensitivity to benzalkonium chloride, which is included in the drug as a preservative.

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

Impact on the ability to drive a car and operate machinery

Long-term treatment or use of Tisin® Classic at higher doses cannot exclude its possible systemic effect on the cardiovascular system, which may impair driving ability and use of machinery.

Contraindications

Hypersensitivity to any of the components of the drug, simultaneous use of monoamine oxidase inhibitors (MAOIs) or other drugs that may cause an increase in blood pressure; Arterial hypertension, tachycardia, expressed atherosclerosis, glaucoma, atrophic rhinitis, brain surgery (in anamnesis), children (under 6 years – for 0.1% dosage, under 2 years – for 0.05% dosage).

With caution – CHD (angina pectoris), prostatic hyperplasia, thyrotoxicosis, diabetes, pheochromocytoma, in patients with hypersensitivity to adrenomimetics accompanied by symptoms of insomnia, dizziness.

Side effects

Tisin® Classic may cause transient mild nasal irritation (burning), paraesthesias, sneezing and hypersecretion in susceptible persons.

In some cases, increased nasal mucosal swelling (reactive hyperemia) may occur after use.

Long-term or frequent use of xylometazoline or use in high doses may result in nasal burning or dry mucous membranes and reactive congestion with the development of medically-induced rhinitis. This effect may be observed even 5-7 days after completion of treatment, and with prolonged use it may cause irreversible mucosal damage with formation of crusts (dry rhinitis).

In very rare cases headache, insomnia or fatigue, depression (with long-term use in high doses) may be observed. In isolated cases, topical intranasal use of sympathomimetics may be accompanied by systemic effects such as palpitations, tachycardia, arrhythmias, increased blood pressure, and visual disturbances.

Overdose

Symptoms of Intoxication

Overdose or accidental ingestion may cause the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmias, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory problems, and psychiatric disorders. In addition, the following symptoms may be observed: suppression of central nervous system function accompanied by somnolence, decreased body temperature, bradycardia, shock-like hypotonia, apnea and coma.

Treatment of intoxication

The use of activated charcoal, gastric lavage, artificial respiration with the administration of oxygen. Phentolamine 5 mg on saline slowly intravenously or 100 mg orally is used to reduce blood pressure.

Vasopressor drugs are contraindicated. If necessary, antipyretics and anticonvulsants are used.

Pregnancy use

Xylometazoline should not be used during pregnancy because the effects of this drug on the fetus have not been studied.

It is not known whether xylomethasoline is excreted with the breast milk.

Therefore, it is not recommended to prescribe the drug while breastfeeding.

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