Xylene Nazal Spray. 0.05 ml of 15%

Description

Composition
Active substance:
1 ml of solution contains: xylometazoline hydrochloride – 0.5 mg or 1.0 mg.
Excipients:
Benzalkonium chloride, based on the anhydrous – 0.15mg, disodium edetate dihydrate (Trilon B) – 0.5 mg, of potassium dihydrogenphosphate – 3.63 mg, disodium hydrogenphosphate dodecahydrate – 7.13 mg Sodium chloride – 9.0 mg purified water – up to 1.0 ml.
Description:
Colorless or slightly colored transparent liquid.
Product form:
Nasal Spray 0.05% and 0.1%.
10, 15, 20 or 30 ml vials dropper polymer with cork-dropper and a plastic tube, the screw-on lid with tamper-evident or polymeric vials for nasal spray with a spray device and a protective cover screwed with the first control opening.
Contraindications
Hypersensitivity to xylometazoline and other ingredients, hypertension, tachycardia, expressed atherosclerosis, glaucoma, atrophic rhinitis, surgical interventions in the meninges (history), children under 2 years – to 0.05% solution (0.0005 g / ml), children under 6 years – to 0.1% solution (0.001 g / ml), hyperthyroidism, post transsphenoidal hypophysectomy, pregnancy. Do not use in the therapy of monoamine oxidase inhibitors and tricyclics (including a period of 14 days after their withdrawal), as well as other drugs that increase blood pressure.
Carefully
Lactation, ischemic heart disease (angina), diabetes, prostatic hyperplasia, hyperthyroidism, porphyria, pheochromocytoma, patients with hypersensitivity to adrenergic drugs accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.
Dosage
0.5 mg / ml
Indications
Acute respiratory illness with symptoms of rhinitis (common cold), acute allergic rhinitis, sinusitis, otitis media (in combination therapy to reduce edema nasopharyngeal mucosa), hay fever, evstahiit to facilitate rinoskopii.
Interaction with other drugs
Simultaneous application Xylometazoline with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants may lead to increased blood pressure.
Overdose
Symptoms: an overdose or accidentally taking the drug inside may develop the following symptoms: nausea, vomiting, cyanosis, fever, a significant decrease in body temperature, shortness of breath, dizziness, increased sweating, headache, bradycardia, arrhythmia, tachycardia, increased blood pressure, followed by may develop blood pressure, respiratory depression, coma, convulsions. Young children are often observed with an overdose of a dominant central effects with seizures, coma, and bradycardia, apnea, and high blood pressure, which is followed by hypotension.
Treatment: symptomatic under the supervision of a physician. Observation of the patient should be within a few hours. Accidental ingestion – gastric lavage, administration of activated charcoal.
pharmachologic effect
Pharmacological group:
Decongestant agent – alpha-agonists.
Pharmacological properties:
Xylometazoline refers to a group of local vasoconstrictive agents (decongestants) with alpha-Adrenomimeticalkie activity. Preparation facilitates nasal breathing by reducing edema and hyperemia of the mucosa, and also improves the discharge of secretions.
Effect of the drug occurs within a few minutes after its application and continues until 10 hours.
Pharmacokinetics:
When applied topically, the drug is practically not absorbed, however, its concentration in the blood plasma is very low (modern analytical methods not determined).
Pregnancy and breast-feeding
Use of the drug during pregnancy is contraindicated. During the period of breast-feeding use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the child.
Conditions of supply of pharmacies
Without recipe.
side effects
With frequent and / or prolonged use – irritation and / or dryness of the nasal mucosa, burning, crawling, sneezing, hypersecretion; rarely – swelling of nasal mucosa, nose bleeds, palpitations, tachycardia, arrhythmia, high blood pressure, nausea, vomiting, headache, insomnia, visual disturbances, depression (with prolonged use of high doses), anxiety, fatigue, hallucination and convulsions (mainly in children), hypersensitivity reactions (angioedema, skin rashes, itching).
Benzalkonium chloride, part of the drug may cause irritation and swelling of the nasal mucosa.
special instructions
Long-term use (more than 7 days) can lead to reactive hyperemia nasal mucosa and atrophy of nasal mucosa. Do not exceed the recommended dose. Benzalkonium chloride, part of the drug may cause irritation and swelling of the nasal mucosa. It is not recommended to apply the preparation in a continuous mode for more than 7 days. Avoid getting product in eyes.
The effect on the ability to operate vehicles, machinery
In the application of xylometazoline in doses exceeding recommended, we can not exclude a violation of view, the possibility of systemic effects on the cardiovascular system. This can lead to a deterioration in the ability to drive a car and activities requiring concentration of attention and speed of psychomotor reactions.
In such cases, you should use caution when driving and mechanisms.
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Intranasally. Before use, clean the nasal passages.
Adults and children over 6 years, 1 injection 0.1% xylometazoline solution in each nostril 2-3 times a day. Do not use more than 5-7 days because xylometazoline can cause swelling of the nasal mucosa, leading to its atrophy.
Children aged 2 to 6 years of use of 0.05% xylometazoline solution 1 injection into each nasal passage 1-2 times a day.
You should not use the drug more than 3 times per day. Long-term use in children determined by the physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist