Pharmacodynamics. Xylometazoline is an α-adrenergic agonist for topical use, an imidazoline derivative. causes a narrowing of the blood vessels of the mucous membrane of the nasal cavity, eliminates its hyperemia and edema, reduces exudation. the effect of xylometazoline develops in 10-15 minutes, the effect lasts 5-6 hours, vasoconstriction persists for another 8-12 hours.
Miramistin is an antiseptic of a group of cationic surfactants - detergents. The mechanism of action of miramistin is based on a direct hydrophobic interaction with the lipids of the membranes of microorganisms, as a result of which the membrane is loosened, its permeability for high-molecular substances increases, the activity of the enzyme systems of the microbial cell is disrupted, which leads to inhibition of the vital activity of microorganisms and their cytolysis. Unlike other antiseptics, miramistin has a high selectivity of action against microorganisms, practically not acting on the membranes of human cells. This is due to a different structure of cell membranes in humans: a significantly longer length of lipid radicals, which sharply limits the possibility of hydrophobic interaction of miramistin with cells.
Miramistin is active against gram-positive and gram-negative, aerobic and anaerobic, spore-forming and asporogenic bacteria in the form of monocultures and microbial associations, including hospital strains with multi-resistance to antibiotics.
It is more effective against gram-positive bacteria (staphylococcus, streptococcus, etc.), has a detrimental effect on sexually transmitted diseases (gonococcus, treponema pallidum, Trichomonas, chlamydia), as well as influenza, herpes, human immunodeficiency viruses and others. Has antifungal effect (on ascomycetes, dermatophytes, yeast, yeast-like and other pathogenic fungi). Under the influence of miramistin, the resistance of microorganisms to antibiotics decreases. Miramistin has an anti-inflammatory and immunoadjuvant effect, enhances local defense reactions, accelerates regeneration processes, activates nonspecific defense mechanisms due to modulation of the cellular and local humoral immune response. Rynomistyn ® has a balanced pH value characteristic of the nasal cavity. Due to the optimal composition of the components, the drops do not cause dryness and irritation of the mucous membrane, facilitate the outflow of mucus and do not suppress the activity of the cilia of the epithelium of the nasal passages.
Pharmacokinetics. When applied to the mucous membrane, xylometazoline causes a local narrowing of blood vessels and is practically not absorbed into the bloodstream, without exerting a systemic effect. There are no data on the possibility of penetration of miramistin into the systemic circulation.
Acute and chronic forms of rhinitis, sinusitis, rhinosinusitis, which are accompanied by nasal congestion and complicated by microbial infection; complex therapy of acute otitis media and eustachitis (in order to restore the patency of the Eustachian tube); prevention of infectious complications during rhinoscopy and other manipulations in the area of the nasopharynx.
Before administration of the preparation, thoroughly cleanse the nasal cavity.
Rynomistyn®, nasal drops 0.05% / 0.01%, is used in children aged 1 to 11 years.
Rynomistyn®, nasal drops 0.1% / 0.01%, is used in adults and children over the age of 12 years.
Nasal drops 0.05% / 0.01%: used in children aged 1 to 5 years (under the supervision of adults), 1-2 drops in each nasal passage 1-2 times a day, but no more than 3 times each nasal passage per day;
used in children aged 6 to 11 years (under the supervision of adults), 2-4 drops in each nasal passage 2-3 times a day.
Apply no more than 3 times in each nasal passage per day.
The duration of treatment depends on the course of the disease, usually 3-5 days and should not exceed 7 days in a row.
Nasal drops 0.1% / 0.01%: used in adults and children over the age of 12 years, 2-4 drops in each nasal passage 3 times a day.
The duration of treatment depends on the course of the disease, usually 3-5 days and should not exceed 10 days in a row.
For the purpose of prophylaxis, 1-2 drops of a solution with a xylometazoline content of 0.1% are used in each nasal passage before the operation, then 1-2 times during the first days after the operation.
Children. Rynomistyn®, nasal drops 0.05% / 0.01%, are not used in children under the age of 1 year.
Use in children aged 1 to 12 years is recommended only under adult supervision.
Rynomistyn, nasal drops 0.1% / 0.01%, are not used in children under 12 years of age.
Contraindications
Rynomistyn®, nasal drops (0.05% / 0.01%), are not used in children under the age of 1 year.
Rynomistyn® nasal drops (0.1% / 0.01%) are not used in children under 12 years of age.
Hypersensitivity to any component of the preparation; acute coronary diseases, coronary asthma, hyperthyroidism, angle-closure glaucoma; a transsphenoidal hypophysectomy and a history of exposure to the meninges. Concomitant treatment with MAO inhibitors and within 2 weeks after the termination of their use.
Side effects
From the immune system: hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system: headache.
From the side of the organ of vision: transient visual impairment.
On the part of the cardiovascular system: irregular or rapid heartbeat.
From the respiratory system: dryness or discomfort on the part of the nasal mucosa, burning sensation.
From the digestive system: nausea.
General disorders and reactions at the injection site: burning sensation at the site of application.
Special instructions
The vial is intended for individual use, should not be passed on for use by others in order to avoid possible spread of infection.
It is used with caution in patients with coronary artery disease, hypertension, diabetes mellitus, prostatic hypertrophy, thyroid diseases, difficulty urinating.
The preparation should be prescribed with caution to patients who, when using adrenergic preparations, experience strong reactions, such as insomnia, dizziness, tremors, cardiac arrhythmias, increased blood pressure.
Do not exceed the recommended dose and duration of treatment for 7-10 consecutive days. Long-term treatment with the preparation can cause the opposite effect.
Use in children aged 1 to 12 years is recommended only under adult supervision.
Do not exceed the recommended dose of the preparation, especially when treating children and elderly patients.
Use during pregnancy and lactation. The preparation should not be used during pregnancy due to the vasoconstrictor effect.
There is no evidence of side effects in breastfed infants. It is not known whether xylometazoline is excreted in breast milk, so caution should be exercised in women who are breastfeeding. It is possible to use the preparation during pregnancy only when, in the opinion of the doctor, the expected therapeutic effect for the mother outweighs the potential risk for the child.
Fertility There are no adequate data on the effect of Rynomistyn® on fertility. Since the systemic exposure of the preparation is very low, the likelihood of an effect on fertility is extremely small.
The ability to influence the reaction rate when driving or operating other mechanisms. Usually, the preparation does not have or has minimal effect on the ability to drive vehicles or work with other mechanisms.
Interactions
The preparation is not used during treatment with tricyclic antidepressants and MAO inhibitors. xylometazoline may interfere with the action of some antihypertensive preparations.
With simultaneous use, the preparation can increase the effectiveness of topical antibiotics.
Overdose
Long-term use of the preparation can lead to the development of secondary rhinitis resistant to therapy (rhinitis medicamentosa). a significant overdose of the preparation or its accidental oral intake, especially by children, can lead to the development of sedation, visual impairment, headache, irritability, heart rhythm disturbances, insomnia, respiratory depression, and sometimes confusion. there is no specific treatment. it is necessary to start appropriate supportive measures, symptomatic treatment is indicated under the supervision of a physician.
Storage conditions
In its original packaging at a temperature not exceeding 30 ° C. freezing is not allowed.