Xylong nasal spray dispensed 0.1ml/dose+5mg/dose, 15ml

Composition

Per dose: Active ingredients:  

• xylometazoline hydrochloride-0.100 mg,
• dexpanthenol-5,000 mg.

Auxiliary substances:  

• sodium citrate dihydrate – 0,509 mg,
• sodium chloride – 0,250 mg,
• hypromellose – 0,100 mg,
• benzalkonium chloride 0.015 mg,
• citric acid monohydrate – 0,350 mg,
• purified water to 100 µl.

Pharmacological action of

Pharmacodynamically refers to a group of local vasoconstrictor (of decongestants), alpha-adrenomimetic activity, causes constriction of the blood vessels of the mucous membrane of the nasal cavity and restores the patency of the nasal passages, nasal breathing easier. The effect of the drug usually occurs a few minutes after its use and lasts up to 10 hours. Dexpanthenol is a B vitamin derived from pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A (Co-A) and participates in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; it stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. It has regenerating, metabolic and weak anti-inflammatory effects. Pharmacokineticsaxilometazoline when applied topically is practically not absorbed, plasma concentrations are so low that they cannot be determined by modern analytical methods. Dexpanthenol, when applied topically, is rapidly absorbed by the skin and converted to pantothenic acid, binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/l, in the blood serum-100 mcg/l. Pantothenic acid is not metabolized in the body (except for inclusion in Co-A), it is excreted unchanged.

Indications

It is used for acute respiratory diseases with rhinitis, acute allergic rhinitis, vasomotor rhinitis, sinusitis, otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa), to facilitate rhinoscopy, restore disturbed nasal breathing; after surgical interventions in the nasal cavity.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

Contraindications

Hypersensitivity to the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, hypertheriosis, glaucoma, atrophic rhinitis, dry rhinitis, porphyria, prostatic hyperplasia, surgical interventions on the meninges (in the anamnesis), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, pregnancy, breastfeeding, children under 6 years of age.

With caution

Diabetes mellitus, pheochromocytoma, diseases of the cardiovascular system (including coronary heart disease), hypersensitivity to the action of adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Side effects

The adverse events presented below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows:  very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare ( (cannot be estimated based on available data). Nervous system disorders: Very rare:  anxiety, insomnia, headache, fatigue (drowsiness), hallucinations (mainly in children). Disorders of the cardiovascular system: Rarely:  palpitations, tachycardia, increased blood pressure. Very rare:  Arrhythmia Respiratory system disorders: Very rare:  swelling of the nasal mucosa, hypersecretion, nosebleeds. Frequency unknown:  burning and dryness of the nasal mucosa, sneezing. Musculoskeletal disorders: Very rare:  convulsions (especially in children). Immune system disorders: Very rare:  allergic reactions (angioedema, skin rash, pruritus). If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use of MAO inhibitors and tricyclic antidepressants may lead to increased blood pressure due to the effects of these drugs on the cardiovascular system.

How to take, course of use and dosage

Intranasally. Remove the protective cap. The bottle is ready for use. Before the first application or after a long break in the use of the spray, press the dosing nozzle several times until a uniform spray appears. When applying the spray, the bottle must be kept in an upright position. To facilitate accurate dosage of the drug, when pressing the dosing nozzle, it is necessary to lower it down until it stops. During the injection, you need to easily inhale through your nose. One injection in each nasal passage 3-4 times a day. The duration of therapy is 5-7 days. Do not apply for more than 7 days. The duration of use of the drug in children is determined after consultation with a doctor. Repeated use is possible only after a break of several days. If there is no improvement after 5 days of treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

In cases of overdose or accidental oral use, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmia, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, impaired respiratory function, hallucinations. Patients may also experience symptoms of CNS depression, including drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest, and coma. Treatment. Use of activated charcoal, gastric lavage, oxygen ventilation of the lungs. To reduce blood pressure,5 mg of phentolamine in 0.9% sodium chloride solution is prescribed by slow intravenous use or 100 mg of phentolamine orally. Vasoconstrictor drugs are contraindicated. If necessary, apply antipyretics and anticonvulsants.

Special instructions

Before use, it is necessary to clean the nasal passages. The duration of use of the drug in children is determined after consultation with a doctor.

Influence on the ability to drive vehicles and mechanisms

When using the drug, in accordance with these instructions for use, the drug does not affect the ability to drive vehicles, mechanisms, however, if adverse events occur, you should refrain from performing these activities.

Storage conditions

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

Shelf

life is 25 months.

Active ingredient

Xylometazoline, [Dexpanthenol]

Dosage Form

Spray nasal