Description
Release form
Dosage nasal spray 0.1%.
Packaging
10 ml of the drug in a bottle, for 0.1% at least 70 doses.
Pharmacological action
Xylometazoline (an imidazole derivative) is a sympathomimetic drug with alpha-adrenergic activity. It has a vasoconstrictor effect and reduces swelling of the mucous membrane.
Action usually begins within 5 10 minutes.
The drug facilitates nasal breathing by reducing swelling and hyperemia of the mucous membrane, and also improves discharge discharge.
Indications
To reduce swelling of the mucous membrane of the nasopharynx and secretions in acute allergic rhinitis, acute respiratory infections with rhinitis, sinusitis, hay fever, otitis media.
Preparing the patient for diagnostic procedures in the nasal passages.
Contraindications
Hypersensitivity to any component of the drug, concomitant use of monoamine oxidase inhibitors (MAOs) or other drugs that can cause high blood pressure, hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, cerebral surgery , children’s age (up to 6 years – for a dosage of 0.1%, up to 2 years – for a dosage of 0.05%).
Precautions – IHD (angina pectoris), prostatic hyperplasia, thyrotoxicosis, diabetes mellitus, pheochromocytoma, in patients with hypersensitivity to adrenergic agonists, accompanied by symptoms of insomnia, dizziness.
Use during pregnancy and lactation
Pregnancy
Carefully controlled and relevant studies have not been conducted in pregnant women. The drug should not be used during pregnancy unless the potential benefit of treating the mother outweighs the potential risk to the developing fetus.
Lactation
It is not known whether xylometazoline or its metabolites passes into breast milk, so the drug should not be used during breast-feeding.
Special instructions
Long-term use and overdose of sympathomimetics that have a decongestant 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 rhinitis), and as a result, even to atrophy of the nasal mucosa (ozena).
In case of chronic rhinitis, Tizin ® Classic 0.05% and 0.1% can only be used under medical supervision, given the risk of atrophy of the nasal mucosa.
Tizin ® Classic should not be used if hypersensitivity to benzalkonium chloride, which is part of the drug as a preservative.
Do not exceed recommended doses, especially in children and the elderly.
INFLUENCE ON THE ABILITY TO DRIVE A CAR AND USE THE MACHINE
With prolonged treatment or the use of Tizin ® 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 the equipment.
Composition of
In 1 ml of solution contains:
active ingredient:
xylometazoline hydrochloride 1.0 mg (0.1%)
amount of active ingredient in a single dose for 0.1% – 0, 14 mg xylometazoline hydrochloride
excipients:
benzalkonium chloride – 0.2 mg
sorbitol 70% – 20.0 mg
sodium chloride – 4.16 mg
sodium dihydrogen phosphate dihydrate – 3.38 mg
disodium hydrogen phosphate dihydrate 2.0 mg
disodium edetate – 1.0 mg
purified water – a sufficient amount.
Dosage and administration of
Adults and children of school age (over 6 years old)
are administered 3 times a day with one dose of Tizin ® Classic in the form of 0.1% nasal spray dosed into each nostril. The dose depends on the individual sensitivity of the patient and the clinical effect. Xylometazoline in the form of a nasal dosage spray should not be used for more than 5-7 days, unless the doctor has recommended a different duration of treatment.
After completion of therapy, the drug can be prescribed again only after a few days.
Always consult a doctor regarding the duration of use in children.
Side effects
-Tizin ® Classic may cause transient mild nose irritation (burning), paresthesia, sneezing, and hypersecretion in susceptible people.
– In some cases, after the use of the drug, increased swelling of the nasal mucosa (reactive hyperemia) may be observed.
– Prolonged or frequent use of xylometazoline or its use in high doses can lead to a burning sensation in the nose or dry mucous membrane, as well as reactive stasis with the development of drug rhinitis. This effect can be observed even 5-7 days after completion of treatment, and with prolonged use can cause irreversible damage to the mucous membrane with the formation of crusts (dry rhinitis).
– In very rare cases, headache, insomnia or fatigue, depression (with prolonged use in high doses) may occur. 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.
Drug Interactions
The simultaneous use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants can lead to high blood pressure due to the cardiovascular effects of these substances.
overdose
intoxication symptoms
An overdose or accidental intake of the drug can lead to the following symptoms: pupillary enlargement, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmias mental disorders. In addition, the following symptoms can be observed: central nervous system suppression, accompanied by drowsiness, decreased body temperature, bradycardia, shock-like hypotension, apnea and coma.
Treatment of intoxication
Use of activated carbon, gastric lavage, artificial respiration with oxygen administration. To reduce blood pressure, phentolamine is used 5 mg saline intravenously slowly or 100 mg orally.
Vasopressor agents are contraindicated. If necessary, use antipyretic and anticonvulsants.
Storage Conditions
Do not store above 25 ° C. Keep out of reach of children.
Shelf life
3 years.
Deystvuyushtee substance
Xylometazoline
Terms and conditions
without prescription
Dosage form
spray nasal
Possible product names
Tizin Classic Nasal Spray 0.1% 10 ml
