Tyzine Classic nasal spray 0.1%, 10ml

Composition

1 ml of the solution contains:  

Active ingredient:  

xylometazoline hydrochloride 1.0 mg (0.1%);

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

auxiliary substances:  

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 – a sufficient amount.

Pharmacological action

Vasoconstrictor drug for topical use in ENT practice.

Xylometazoline (an imidazole derivative) is an alpha-adrenomimetic.

It has a vasoconstrictive effect, reduces swelling of the nasal mucosa.

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

The effect of the drug occurs in 5-10 minutes.

Indications

• for reducing edema of the nasopharyngeal mucosa and discharge in acute allergic rhinitis, acute respiratory infections with rhinitis, sinusitis, pollinosis, otitis media;

• preparation of patients for diagnostic manipulations in the nasal passages.

Use during pregnancy and lactation

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

It is not known whether xylometazoline is excreted in breast milk.

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

Contraindications

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

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

Side effects

Tyzine ® Classic may cause transient mild nasal irritation (burning), paresthesia, sneezing, and hypersecretion in susceptible individuals.

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

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

In very rare cases, there may be headache, insomnia or fatigue, depression (with prolonged use in high doses). In isolated cases, local intranasal use of sympathomimetics may be accompanied by systemic effects, such as palpitations, tachycardia, arrhythmias, increased blood pressure, and visual impairment.

Interaction

With simultaneous use of Tyzine Xylo and MAO inhibitors such as tranylcypromine and tricyclic antidepressants, blood pressure may increase.

How to take, course of use and dosage

Tyzine ® Classic in the form of nasal spray 0.1% is prescribed for adults and children over 6 years of age,1 dose in each nasal passage 3 times / day.

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

Do not use the drug for more than 5-7 days without a doctor’s recommendation.

After the end of therapy, the drug can be prescribed again only after a few days.

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

Rules for the use of the drug

Remove the protective cap. Before the first application, you should press the spray nozzle several times until a uniform cloud of “fog” appears. The bottle is ready for use. When applying, press 1 time. The drug should be inhaled through the nose. If possible, hold the spray bottle vertically. Do not spray horizontally or downwards. After application, the bottle should be closed with a cap.

Overdose

Symptoms of intoxication

Overdose or accidental ingestion of the drug can lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmias, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory disorders, mental disorders. In addition, the following symptoms may occur: suppression of central nervous system function, accompanied by drowsiness, decreased body temperature, bradycardia, shock-like hypotension, apnea and coma.

Treatment of intoxication

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

Vasopressors are contraindicated. If necessary, apply antipyretics and anticonvulsants.

Special instructions

Prolonged use and overdose of sympathomimetics that have a decongestive effect can lead to reactive hyperemia of the nasal mucosa.

The recoil phenomenon can cause airway obstruction, which leads to the fact that the patient begins to use the drug repeatedly or even constantly. This can lead to chronic swelling (drug-induced rhinitis), and eventually even to atrophy of the nasal mucosa (ozen).

In the case of chronic rhinitis, Tizin® Classic 0.05% and 0.1% can only be used under the supervision of a doctor, taking into account the risk of atrophy of the nasal mucosa.

Tyzine ® Classic should not be used in the presence of hypersensitivity to benzalkonium chloride, which is included in the preparation as a preservative.

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

IMPACT ON THE ABILITY TO DRIVE AND USE MACHINERY

With prolonged treatment or the use of Tyzine ® Classic in higher doses, it is impossible to exclude the possibility of its systemic effect on the cardiovascular system, which may impair the ability to drive and use machinery.

Product form

Nasal spray dosed 0.1%.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Xylometazoline

Dosage Form

Spray nasal