TIZIN KSILO

Active material: Ksilometazolin
When ATH: R01AA07
CCF: Vasoconstrictor drugs for local application in an ENT-practice
ICD-10 codes (testimony): H66, J00, J01, J30.1, J30.3, J31, J32, Z51.4
When CSF: 24.05.01
Manufacturer: JOHNSON & JOHNSON LTD (Russia)

Pharmaceutical form, composition and packaging

◊ Spray nazalynыy dozirovannыy 0.05% as a clear, colorless solution, odorless or with a faint characteristic odor.

Excipients: benzalkonium chloride, disodium эdetat, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium gidrofosfata digidrat, sorbitol, Purified water.

10 ml (no less 140 doses) – brown glass bottles of hydrolytic (Class III) (1) with a metering device and a polyethylene screw-cap type “pull-off” – packs cardboard.

◊ Spray nazalynыy dozirovannыy 0.1% as a clear, colorless solution, odorless or with a faint characteristic odor.

Excipients: benzalkonium chloride, disodium эdetat, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium gidrofosfata digidrat, sorbitol, Purified water.

10 ml (no less 70 doses) – brown glass bottles of hydrolytic (Class III) (1) with a metering device and a polyethylene screw-cap type “pull-off” – packs cardboard.

Pharmacological action

Vasoconstrictor drugs for local application in an ENT-practice. Ksilometazolin (imidazole) is an alpha-agonists. It has a vasoconstrictor effect, reduces swelling of the nasal mucosa.

The product facilitates nasal breathing by reducing the swelling and redness of the mucous membrane, and improves the discharge of secretions.

Effect of the drug comes through 5-10 m.

Pharmacokinetics

When applied topically, xylometazoline practically not absorbed, its concentration in blood plasma so small, that they can not be determined by modern analytical methods.

Testimony

- To reduce the swelling of nasal mucosa and secretions in acute allergic rhinitis, ARI with rhinitis, Sinus, hay fever, otitis media;

- Preparation of patients for diagnostic procedures in the nasal passages.

Dosage regimen

Tizi xylene forms spray nazalynogo 0.05% appointed children aged 2 to 6 years by 1 dose in each nostril 1-2 times / day.

Tizi xylene forms spray nazalynogo 0.1% appointed adults and children over 6 years by 1 dose in each nostril 3 times / day.

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

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

After the completion of drug therapy can be administered to re just a few days.

The duration of the drug in children determined by the physician.

Terms of use of the drug

Remove the protective cap. Before the first application to be pressed several times on the nozzle until a uniform cloud “fog”. The vial is ready for use. In the application, press 1 time. The drug is inhaled through the nose. If possible, keep a spray bottle vertically. Do not spray horizontally or down. After application of the vial should be covered by a cap.

Side effect

Local reactions: burning sensation, paresthesia, chikhaniye, hypersecretion, in some cases – reaktivnaя giperemiя; at frequent and / or prolonged use or use at high doses – xeromycteria, burning sensation, Jet stalemate with the development of medical rhinitis (This effect can be observed even after 5-7 Days after treatment). With prolonged use may develop a dry rhinitis (irreversible damage of the nasal mucosa with formation of crusts).

Systemic reactions: rarely – headache, insomnia, fatigue, depression (long-term use in high doses); in a few cases – heartbeat, tachycardia, Arrhythmia, increased blood pressure, blurred vision.

Contraindications

- Simultaneous reception of MAO inhibitors or other drugs, increase blood pressure;

- Arterial hypertension;

- Tachycardia;

- Expressed atherosclerosis;

- Glaucoma;

- Atrophic rhinitis;

- Surgical interventions in the meninges (history);

- Children up to age 6 years (dlya spray nazalynogo 0.1%);

- Children up to age 2 years (dlya spray nazalynogo 0.05%);

- Hypersensitivity to the drug.

FROM caution should be prescribed the drug for IBS (angina), prostatic hyperplasia, thyrotoxicosis, diabetes, pheochromocytoma.

Pregnancy and lactation

Xylometazoline should not be used during pregnancy, tk. efffekty this drug on the fetus have not been studied.

Unknown, Whether or xylometazoline in breast milk. Therefore it is not recommended to prescribe the drug during breastfeeding.

Cautions

Long-term use of the drug and an overdose can lead to reactive hyperemia and medical rhinitis, eventually – atrophy of nasal mucosa.

In chronic rhinitis drug application is only possible under the supervision of a physician, taking into account the risk of atrophy of the nasal mucosa.

The drug should not be used if high sensitivity to benzalkonium chloride, that is included in the formulation as a preservative.

Effects on ability to drive vehicles and management mechanisms

Prolonged treatment or when used in doses, exceeding recommended, we can not exclude the possibility of systemic effects on the cardiovascular system. In these cases, the ability to drive vehicles or equipment may be reduced.

Overdose

Symptoms: midriaz, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory disorders, mental disorders, the suppression of the central nervous system, accompanied by sleepiness, reduction of body temperature, ʙradikardiej, hypotensive shock-like, apnea, coma.

Treatment: gastric lavage, appointment of activated carbon, if necessary, ventilation. To reduce blood pressure – phentolamine in / slow dose 5 mg oral dose or 100 mg.

Vasopressor agents are contraindicated. If necessary, use antipyretics and anticonvulsants.

Drug Interactions

In an application tizin Xylo and MAO inhibitors (tranylcypromine) and tricyclic antidepressants may increase blood pressure.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.