Pharmacological properties
Pharmacodynamics. Xylometazoline is a sympathomimetic agent (imidazole derivative) acting on α-adrenergic receptors of the nasal mucosa. After nasal administration of xylometazoline, it causes narrowing of blood vessels, thereby reducing swelling of the nasopharyngeal mucosa.
The drug's effect begins within 2 minutes after application and lasts up to 12 hours.
The drug is well tolerated, including by patients with sensitive mucous membranes. The drug reduces mucociliary function. Laboratory studies have shown that xylometazoline reduces the infectious activity of human rhinovirus, which is associated with common acute respiratory viral infections.
Pharmacokinetics. After nasal administration, the amount of substance absorbed may sometimes be sufficient to produce systemic effects, for example, on the CNS and cardiovascular system.
No metabolites or routes of excretion have been identified.
Indication
Symptomatic treatment of nasal congestion due to colds, hay fever, sinusitis, allergic rhinitis;
to facilitate the outflow of secretions from the paranasal sinuses; as an adjunctive therapy in cases of otitis media to eliminate swelling of the nasopharyngeal mucosa; to facilitate rhinoscopy.
Application
Multigrip nasal, nasal drops, 0.05% solution. Children aged 2-12 years. The recommended dose is 1-2 drops 1-2 times a day in each nostril.
Multigrip nasal, nasal drops, 0.1% solution. Adults and children over 12 years of age. The recommended dose is 2-3 drops 2-3 times a day in each nostril.
Do not use in doses exceeding recommended.
Duration of use. The drug should not be used for more than 5 consecutive days, unless otherwise recommended by a doctor.
Before further use of xylometazoline, you should take a break of several days between doses.
Multigrip Nasal, nasal spray, 0.05% solution. Children aged 2 to 12 years. 1 spray in each nostril as needed, but no more than 3 times a day.
Multigrip Nasal, nasal spray, 0.1% solution. Adults and children over 12 years of age. The recommended dose is 1 spray in each nostril 3 times a day.
Do not use in doses exceeding recommended.
Duration of use. Multigrip nasal should not be used for more than 5 consecutive days, unless otherwise recommended by a doctor.
How to use: Remove the protective cap before use. Before first use, press the dosing device 2-3 times to achieve the correct injection dose. The spray is now ready for use.
Before using the nasal spray, the nasal cavity should be thoroughly cleaned. It is recommended to use the last dose of the day before bedtime.
After removing the protective cap, the dispenser opening must be inserted into the nostril and pressed once for easy breathing through the nose.
When using the bottle, it should be in a vertical position. Do not use the bottle horizontally.
After use, close the protective cap.
Contraindication
Hypersensitivity to the active substance or any excipient;
dry rhinitis (when inflammation of the nasal mucosa is not accompanied by secretion); glaucoma; transsphenoidal hypophysectomy or surgical interventions with exposure of the dura mater.
Multigrip nasal, nasal drops and spray, 0.05% solution:
children under 2 years of age;
Multigrip nasal, nasal drops and spray, 0.1% solution:
children under 12 years old.
Side effects
On the part of the immune system: very rarely (1/10,000) - hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system: often (≥1/100-1/10) - headache.
On the part of the organ of vision: very rarely (1/10,000) - transient visual impairment.
Cardiac disorders: very rarely (1/10,000) - arrhythmia or tachycardia.
Respiratory, thoracic and mediastinal disorders: often (≥1/100-1/10) - dryness or discomfort of the nasal mucosa, burning sensation.
From the gastrointestinal tract: often (≥1/100-1/10) - nausea.
General disorders and administration site reactions: often (≥1/100-1/10) - burning sensation at the application site.
Special instructions
Like other sympathomimetics, xylometazoline should be used with caution in patients who experience adverse reactions to adrenergic drugs, such as insomnia, dizziness, tremor, arrhythmias, or increased heart rate.
Patients who require continuous treatment with xylometazoline may use this drug for a longer period only under close clinical supervision, as there is a risk of atrophy of the nasal mucosa.
In case of repeated use of xylometazoline, there is a risk of tachyphylaxis and iatrogenic rhinitis.
Repeated and/or prolonged instillations may cause systemic absorption of xylometazoline in quantities that cause systemic adverse reactions.
Sympathomimetic decongestants may cause reactive hyperemia of the nasal mucosa, especially after prolonged treatment or at high doses. Repeated or continuous use of this drug may lead to a congestive withdrawal syndrome and narrowing of the upper airways. This may manifest as chronic hyperemia of the nasal mucosa (which may subsequently lead to atrophic rhinitis). In cases of moderate disease, the use of the drug in one of the nasal passages may be discontinued or, alternatively, not administered in both nasal passages until the symptoms subside in order to partially preserve the patency of the nasal passages.
Multigrip nasal contains benzalkonium chloride. This is an irritant that may cause adverse reactions.
Multigrip Nasal Spray contains sorbitol. Patients with rare hereditary conditions of fructose intolerance should not use this medicine.
For hygiene reasons and to avoid infections, each bottle should be used by one person only.
Use during pregnancy and breastfeeding. The drug should not be used during pregnancy due to the potential vasoconstrictor effect. There is no evidence of any adverse effects on infants. However, it is not known whether xylometazoline passes into breast milk, so caution should be exercised, and Multigrip nasal should be used during lactation only as directed by a doctor.
Fertility: There are no adequate data on the effect of Multigrip Nasal on fertility. Since systemic exposure to the hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
Children. Multigrip nasal, nasal drops and spray, 0.05% solution. For the treatment of children aged 2-12 years. Contraindicated in children under 2 years of age.
Multigrip nasal, nasal drops and spray, 0.1% solution. For the treatment of children aged 12 years and over. Contraindicated in children under 12 years.
Ability to influence the speed of reaction when driving vehicles or other mechanisms. Long-term treatment or use of xylometazoline in high doses increases the risk of developing adverse reactions from the central nervous system and cardiovascular system. If such effects occur, this may adversely affect the ability to drive vehicles and work with other mechanisms.
Interactions
MAO inhibitors. Xylometazoline may enhance the effects of MAO inhibitors and induce hypertensive crisis. Xylometazoline is not recommended for patients who are taking or have taken MAO inhibitors within the last 2 weeks.
Tri- and tetracyclic antidepressants. With the simultaneous use of tri- or tetracyclic antidepressants and sympathomimetics, the sympathomimetic effect of xylometazoline may be enhanced, therefore the simultaneous use of such agents is not recommended.
Xylometazoline may interfere with the action of some antihypertensive agents, such as β-adrenergic blockers.
Overdose
Excessive topical application of hydrochloride or accidental ingestion may result in severe dizziness, increased sweating, a significant decrease in body temperature, headache, bradycardia, tachycardia, respiratory depression, coma, and convulsions. After an increase in blood pressure, its decrease is possible. Young children are more sensitive to toxicity than adults.
Treatment. All patients with suspected overdose should receive appropriate supportive measures and, if necessary, immediate symptomatic treatment under supervision. Medical care should include observation of the patient for several hours. In the case of severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour.
Storage conditions
In the original packaging to protect from light at a temperature not exceeding 25 °C.
