Rinomistin® [Xylometazoline, Miramistin]

Pharmacological properties

xylometazoline is an α-adrenergic agonist for topical use, an imidazoline derivative. causes narrowing of the blood vessels of the nasal mucosa, eliminates its hyperemia and edema, and reduces exudation. the effect of xylometazoline develops after 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 direct hydrophobic interaction with the lipids of the membrane of microorganisms, which results in loosening of the membrane, an increase in its permeability to high molecular weight substances, impaired activity of the microbial cell enzyme systems, which leads to inhibition of the vital activity of microorganisms and their cytolysis. Unlike other antiseptics, miramistin has a high selectivity of action specifically for microorganisms, practically without acting on the membranes of human cells. This is due to a different structure of the cell membranes in humans: a significantly larger length of lipid radicals, which severely 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 antibiotic resistance.

It is more effective against gram-positive bacteria (staphylococci, streptococci, etc.), it has a detrimental effect on pathogens of sexually transmitted diseases (gonococcus, pale treponema, trichomonas, chlamydia), as well as influenza viruses, herpes, human immunodeficiency and others. It has an 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 non-specific defense mechanisms due to modulation of the cellular and local humoral immune response. Rinomistin^® 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 inhibit 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 the blood vessels and is practically not absorbed into the bloodstream without having a systemic effect. There are no data on the possibility of miramistin entering the systemic circulation.

Indications

• 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 of the middle ear and eustachitis (with the goal of restoring patency of the Eustachian tube); prevention of infectious complications with rhinoscopy and other manipulations in the nasopharynx.

Application

Before the introduction of the drug, thoroughly clean the nasal cavity.

Rinomistin^®, nasal drops 0.05% / 0.01%, used in children aged 1 to 11 years.

Rinomistin^®, nasal drops 0.1% / 0.01%, 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 not 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 consecutive days.

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 consecutive days.

For the purpose of prevention, 1-2 drops of a solution with a xylometazoline content of 0.1% in each nasal passage before surgery are used, then 1-2 times during the first day after the operation.

Children. Rinomistin^®, 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 the supervision of adults.

Rinomistin, nasal drops 0.1% / 0.01%, are not used in children under the age of 12 years.

Contraindications

Rinomistin®, nasal drops (0.05% / 0.01%), are not used in children under the age of 1 year.

Rinomistin^®nasal drops (0.1% / 0.01%) are not used in children under the age of 12 years.

Hypersensitivity to any of the components of the drug; acute coronary diseases, coronary asthma, hyperthyroidism, angle-closure glaucoma; transsphenoid hypophysectomy and surgical history with exposure of the meninges in the anamnesis. Concomitant treatment with MAO inhibitors and within 2 weeks after cessation of their use.

Side effects

On the part of the immune system: hypersensitivity reaction, including angioedema, rash, itching.

From the nervous system: headache.

From the side of the organ of vision: transient visual impairment.

From the cardiovascular system: irregular or heart palpitations.

From the respiratory system: dryness or discomfort from the nasal mucosa, burning sensation.

From the digestive system: nausea.

General disorders and reactions at the injection site: burning at the site of application.

special instructions

The bottle is intended for individual use, should not be passed on to other people to avoid the possible spread of infection.

It is used with caution in patients with coronary heart disease, hypertension, diabetes mellitus, prostatic hypertrophy, thyroid disease, and difficulty urinating.

The drug should be used with caution in patients who experience strong reactions when using adrenergic drugs, such as insomnia, dizziness, trembling, cardiac arrhythmia, and increased blood pressure.

Do not exceed the recommended dose and duration of treatment for 7-10 consecutive days. Long-term treatment with the drug can cause the opposite effect.

Use in children aged 1 to 12 years is recommended only under the supervision of adults.

Do not exceed the recommended dose, especially in the treatment of children and elderly patients.

Use during pregnancy and lactation. The drug should not be used during pregnancy due to vasoconstrictor effects.

There is no evidence of side effects in breast-fed infants. It is not known whether xylometazoline is excreted in breast milk; therefore, women who are breast-feeding should be careful. It is possible to use the drug during pregnancy only when, according to the doctor, the expected therapeutic effect for the mother outweighs the potential risk for the baby.

Fertility. Appropriate evidence for the effect of rinomistin^® no fertility. Since the systemic exposure of the drug is very low, the likelihood of affecting fertility is extremely small.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Typically, the drug does not have or has a minimal effect on the ability to drive vehicles or work with other mechanisms.

Interactions

The drug is not used during treatment with tricyclic antidepressants and MAO inhibitors.xylometazoline may affect the action of certain antihypertensive agents.

With simultaneous use, the drug can increase the effectiveness of topical antibiotics.

Overdose

Long-term use of the drug can lead to the development of secondary rhinitis that is resistant to therapy (rhinitis medicamentosa). a significant overdose of the drug or its accidental oral administration, especially by children, can lead to the development of a sedative effect, visual impairment, headache, irritability, heart rhythm disturbance, insomnia, respiratory depression, and sometimes confusion. there is no specific treatment. appropriate supportive measures must be started; symptomatic treatment is indicated under the supervision of a physician.

Storage conditions

In the original packaging at a temperature not exceeding 30 ° C. freezing is not allowed.