Rhinomistin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RYNOMISTYN®

Composition:

Active ingredients: xylometazoline, benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate;

1 ml of solution contains xylometazoline hydrochloride 1 mg, benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate (calculated as anhydrous substance) 0.1 mg;

Excipients: disodium edetate (EDTA); sodium dihydrogen phosphate dihydrate, sodium hydrophosphate dodecahydrate; sorbitol (E 420); purified water.

Pharmaceutical form. Nasal drops, solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group.

Decongestants and other agents for local use in nasal cavity disorders. Sympathomimetics in combination with other agents.

ATC Code R01A B06.

Pharmacological Properties

Pharmacodynamics. Xylometazoline is an α-adrenergic agonist for local use, an imidazoline derivative. It causes vasoconstriction of the nasal mucosa blood vessels, eliminates hyperemia and edema, and reduces exudation. The effect of xylometazoline develops within 10–15 minutes, lasts for 5–6 hours, and vasoconstriction persists for up to 8–12 hours.

Benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate is an antiseptic belonging to the group of cationic surfactants – detergents. Its mechanism of action is based on direct hydrophobic interaction with microbial membrane lipids, resulting in membrane disruption, increased permeability for high-molecular-weight substances, and disturbance of microbial cell enzymatic systems, leading to inhibition of microbial viability and cytolysis.

Unlike other antiseptics, benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate exhibits high selectivity specifically toward microorganisms, with virtually no effect on human cell membranes. This selectivity is due to structural differences in human cell membranes, particularly the significantly longer lipid radicals, which greatly limit the possibility of hydrophobic interaction between this active substance and human cells.

Benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate is active against gram-positive and gram-negative, aerobic and anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains with multidrug resistance to antibiotics.

It is more effective against gram-positive bacteria (staphylococci, streptococci, etc.), and exerts a detrimental effect on pathogens of sexually transmitted diseases (gonococcus, Treponema pallidum, trichomonads, chlamydia), as well as on influenza, herpes, human immunodeficiency viruses, and others. It also demonstrates antifungal activity (against ascomycetes, dermatophytes, yeasts, yeast-like fungi, and other pathogenic fungi). Under its influence, microbial resistance to antibiotics decreases.

Benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate exerts anti-inflammatory and immunoadjuvant effects, enhances local defense reactions and regenerative processes, and activates non-specific defense mechanisms through modulation of cellular and local humoral immune responses.

Rinomistin® has a balanced pH value typical of the nasal cavity. Due to its optimal component composition, the drops do not cause dryness or irritation of the mucous membrane, facilitate mucus drainage, and do not impair ciliary epithelium function in the nasal passages.

Pharmacokinetics. When applied to the mucous membrane, xylometazoline causes local vasoconstriction and is practically not absorbed into the systemic circulation, thus lacking systemic effects.

There are no data available regarding the potential penetration of benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate into the systemic bloodstream.

Clinical characteristics.

Indications.

Acute and chronic forms of rhinitis, sinusitis, rhinosinusitis, accompanied by nasal congestion and complicated by microbial infection.

Complex therapy of acute otitis media and eustachian tube dysfunction (to restore patency of the eustachian tube).

Prevention of infectious complications during rhinoscopy and other procedures in the nasopharyngeal area.

Contraindications.

Hypersensitivity to any component of the medicinal product; acute coronary diseases, coronary asthma, hyperthyroidism, closed-angle glaucoma; dry rhinitis (rhinitis sicca) or atrophic rhinitis; transsphenoidal hypophysectomy and surgical interventions involving exposure of the meninges in medical history. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use.

Interaction with other medicinal products and other types of interactions.

MAO inhibitors: xylometazoline may potentiate the effect of MAO inhibitors and induce a hypertensive crisis. Do not use xylometazoline in patients taking or who have taken MAO inhibitors within the previous 2 weeks.

Tricyclic and tetracyclic antidepressants: concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use of these agents is not recommended.

Concomitant use of xylometazoline with other sympathomimetic agents (e.g., ephedrine, pseudoephedrine) should be avoided due to their combined action.

β-adrenergic blockers: when used concomitantly with β-blockers, may cause bronchospasm or reduced blood pressure.

The drug may increase the efficacy of locally acting antibiotics when used concomitantly.

Special precautions for use.

The bottle is intended for individual use only – do not share it with other individuals to prevent possible transmission of infection.

Use with caution in patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, pheochromocytoma, prostate hyperplasia, or urinary retention.

The medicinal product should be prescribed with caution to patients who experience strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

Patients with prolonged QT interval syndrome who use xylometazoline may have an increased risk of severe ventricular arrhythmias.

Do not exceed the recommended dosage or duration of treatment of 10 consecutive days. Prolonged treatment may lead to rebound effect.

Do not exceed the recommended dose, especially when treating children or elderly patients.

Use during pregnancy or breastfeeding.

The medicinal product should not be used during pregnancy due to its potential vasoconstrictive effect.

There is no evidence of any adverse effects on the infant. It is unknown whether xylometazoline passes into breast milk; therefore, use during breastfeeding is not recommended.

Fertility.

There are no adequate data regarding the effect of Rinomistin® on fertility. Since systemic exposure to the drug is very low, the likelihood of an effect on fertility is extremely small.

Ability to influence reaction speed when driving or operating machinery.

The medicinal product usually has no effect or only a minimal effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Before administering the drug, the nasal cavity should be thoroughly cleaned.

For adults and children aged 12 years and older, administer 2–4 drops into each nostril 3 times daily.

The duration of treatment depends on the course of the disease, usually lasting 3–5 days, and should not exceed 10 consecutive days.

For prophylactic use, administer 1–2 drops of the solution into each nostril before surgery, followed by 1–2 administrations during the first 24 hours after surgery.

Children

This medicinal product must not be used in children under 12 years of age.

Overdose

Prolonged use of the drug may lead to the development of secondary, treatment-resistant rhinitis (rhinitis medicamentosa). Significant overdose or accidental oral ingestion, especially in children, may result in sedative effects, visual disturbances, headache, irritability, cardiac arrhythmias, insomnia, respiratory depression, and occasionally, impaired consciousness. There is no specific antidote. Appropriate supportive measures should be initiated, and symptomatic treatment under physician supervision is indicated.

Adverse Reactions.

Immune system disorders: hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system disorders: headache.

Eye disorders: transient visual disturbances.

Cardiovascular disorders: irregular or rapid heartbeat.

Respiratory system disorders: dryness or discomfort of the nasal mucosa, sensation of burning.

Gastrointestinal disorders: nausea.

General disorders and administration site reactions: burning sensation at the application site.

Shelf life.

3 years. Shelf life after opening the bottle – 28 days.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C. Do not freeze.

Keep out of reach of children.

Packaging.

10 ml in polymer bottles with dropper. One bottle per carton.

Availability.

Over-the-counter (without prescription).

Manufacturers.

1. LLC "VALARTIN PHARMA" (batch release).
2. JSC "FARMAC" (manufacturing, packaging, quality control).

Manufacturers' addresses.

1. 60, Hrushevskoho St., Chayky, Kyiv-Sviatoshyn district, Kyiv region, 08135, Ukraine.
2. 74, Kyrylivska St., Kyiv, 04080, Ukraine.

Marketing Authorization Holder. KNVMP "ISNA".

Address of the Marketing Authorization Holder.

8, Dubrovytska St., bld. 160, Kyiv, 04114, Ukraine.