Ksilen Neo spray 0.1% 15ml

Ksilen Neo instruction

You can buy Ksilen Neo spray on this page

Structure

Active ingredient: xylometazoline hydrochloride - 0,100 g
Excipients; benzyl alcohol - 0.250 g, benzalkonium chloride - 0.010 g, disodium edetate dihydrate (Trilon B) - 0.015 g, racemic camphor (synthetic camphor) - 0.005 g, levomenthol - 0.008 g, povidone K-17 - 0.250 g, microcrystalline cellulose and carmellose sodium - 4,000 g, macrogol 400 - 21,500 g, sodium dihydrogen phosphate dihydrate - 0.750 g, disodium hydrogen phosphate dodecahydrate (in terms of 100% substance) - 0.150 g, purified water - up to 100.0 g.

Description

An opaque, white gel-like or liquid mass with a very slight smell of camphor and menthol and thixotropic properties (thickens at rest and liquefies with shaking), which is located in a bottle corked with a metering pump equipped with a spray nozzle with a protective cap. Ksilen Neo is dispensed from the vial through the nozzle-spray in the form of an aerosol cloud, which is a viscous liquid dispersed in a gaseous medium.

Pharmacodynamics

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity. Ksilen Neo facilitates nasal breathing by reducing swelling and hyperemia of the mucous membrane of the nasal cavity, and also improves discharge discharge. Facilitates nasal breathing in rhinitis.
The action of Ksilen Neo occurs a few minutes after its use. After introduction into the nasal cavity, due to auxiliary substances, its viscosity increases, it lingers on the mucous membrane of the nasal cavity, not spreading to the lower respiratory tract, and remains active. Due to this, Ksilen Neo is valid for up to 24 hours.

Pharmacokinetics

When applied topically, it is practically not absorbed; plasma concentrations are so small that they cannot be determined by modern analytical methods.

Indications for use

Acute respiratory diseases with rhinitis (runny nose), acute allergic rhinitis, sinusitis, hay fever; eustachitis, otitis media (as part of combination therapy to reduce swelling of the mucous membrane of the nasopharynx); preparing the patient for diagnostic manipulations in the nasal passages.

Contraindications

Hypersensitivity to xylometazoline or any other component of Ksilen Neo, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, surgical interventions on the meninges (a history of), inflammatory diseases of the skin or mucous membrane of the nasal vestibule, hyperthyroidism, condition after transsphysenoid hypophytosis, pregnancy , children under 6 years old.
Do not use during therapy with monoamine oxidase inhibitors (MAOs) (including 14 days after their withdrawal), and tricyclic and tetracyclic antidepressants, other local vasoconstrictors (decongestants), as well as with other drugs that increase blood pressure.

Carefully

Diabetes mellitus, prostatic hyperplasia, the period of breastfeeding, diseases of the cardiovascular system, including coronary heart disease (angina pectoris), porphyria, pheochromocytoma, patients with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Use during pregnancy and during breastfeeding

During pregnancy, the use of Ksilen Neo is contraindicated.
During breastfeeding, the use of Ksilen Neo is possible only if the potential benefit to the mother outweighs the potential risk to the baby.

Dosage and administration

Intranasally.
Shake the vial vigorously before each use. Remove the protective cap. Before using the metering device for the first time, press it several times until an aerosol cloud appears. Insert the tip into the nostril and press the metering device, while taking a deep breath with your nose, without having to tilt your head back. Then repeat the procedure by inserting the tip into the other nostril. After use, wipe the tip clean and close the bottle with a safety cap.
Ksilen Neo is prescribed for 1 injection in each nasal passage 1-2 times a day.
Do not use the drug for more than 5-7 days.

Side effect

Classification of the incidence of adverse reactions: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10 000 and <1/1 000), very rarely (<1/10 000).
On the part of the immune system: very rarely - a hypersensitivity reaction (angioedema, rash, itching).
From the nervous system: often - headache; rarely - insomnia, depression (with prolonged use in high doses); very rarely - anxiety, fatigue, hallucinations and cramps (mainly in children).
From the sensory organs: very rarely - a violation of the clarity of visual perception. From the cardiovascular system: rarely - a feeling of palpitations, increased blood pressure; very rarely - tachycardia, arrhythmia.
From the respiratory system: often - irritation and / or dryness of the mucous membrane of the nasopharynx, burning, tingling, sneezing, hypersecretion of the mucous membrane of the nasopharynx; rarely - swelling of the mucous membrane of the nasal cavity, nosebleed.
From the digestive system: often - nausea; rarely - vomiting.
Local reactions: often - burning sensation at the site of use. Benzalkonium chloride, which is part of Ksilen Neo, can cause irritation and swelling of the nasal mucosa.

Overdose

Symptoms: with an overdose or accidental ingestion of the drug, the following symptoms may develop: nausea, vomiting, cyanosis, fever, significant decrease in body temperature, dizziness, increased sweating, headache, bradycardia, tachycardia, arrhythmia, increased blood pressure, after which it may develop decreased blood pressure, shortness of breath, respiratory depression, coma, cramps. In overdose in young children, dominant central effects with convulsions, coma and bradycardia, apnea are often observed.
Treatment: symptomatic, patient monitoring should be within a few hours. In case of accidental ingestion - gastric lavage, intake of activated carbon.

Interaction with other drugs

The simultaneous use of xylometazoline with monoamine oxidase inhibitors (MAOs) and tricyclic and tetracyclic antidepressants can lead to an increase in blood pressure.

special instructions

Before use, it is necessary to clean the nasal passages.
Do not use for more than 5-7 days. Long-term use (more than 7 days) can lead to reactive hyperemia of the nasal mucosa and atrophy of the nasal mucosa. Do not exceed recommended doses. Benzalkonium chloride, which is part of Ksilen Neo, can cause irritation and swelling of the nasal mucosa. Avoid contact with eyes.

Influence on the ability to drive vehicles, mechanisms

When xylometazoline is used in dosages exceeding the recommended ones, visual impairment and the possibility of a systemic effect on the cardiovascular system cannot be ruled out. In this case, a deterioration in the ability to drive vehicles and mechanisms is possible. Caution should be exercised when driving vehicles, mechanisms.

Release form

Nasal spray with aroma of camphor and menthol, 0.1%
On 10 g, 15 g or 20 g in glass bottles from a light-protective glass with a screw mouth.
Each bottle is sealed with a metering pump.

Composition

The parts of the metering pump are made of polyoxymethylene, low density polyethylene, polypropylene and stainless steel. The metering pump is equipped with a spray nozzle for nasal injection of polypropylene with a protective cap of low density polyethylene.
Each bottle with Ksilen Neo, sealed by a metering pump, together with a nozzle-sprayer and a protective cap, as well as instructions for medical use are placed in a pack of cardboard.

Storage conditions

At a temperature of 15 to 25 ° C. Do not refrigerate or refrigerate.
Keep out of the reach of children.
Shelf life - 2 years. Do not use after the expiration date indicated on the package.

Terms of sell

You can buy Ksilen Neo without a prescription.