Rhinostop, 0.05% spray 15 ml

Pharmacotherapeutic group: anticonvulsant – alpha-adrenomimetic

ATX code: R01AA07

Pharmacological properties

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes contraction of the blood vessels of the nasal mucosa, thus eliminating edema and hyperemia of the nasal mucosa, restores nasal passageway, facilitates nasal breathing.

The action of the drug starts within a few minutes after its application and lasts up to 10 hours.

Pharmacokinetics

When applied topically the drug is practically not absorbed, so its concentration in the blood plasma is very low (not determined by modern analytical methods).

Indications

It is used in acute respiratory diseases with rhinitis (runny nose), acute allergic rhinitis, sinusitis, eustachitis, pollinosis, otitis media (to reduce the swelling of the nasopharyngeal mucosa).

Preparing the patient for diagnostic manipulations in the nasal passages.

Active ingredient

Composition

Composition per 1 ml:

How to take, the dosage

Intranasally (into each nasal passage).

The spray is applied after the safety cap has been removed from the nebulizer. The nebulizer is inserted into the nose and pressed down on the base of the nebulizer for 1 second.

For adults and children over 6 years of age (0.1% spray): one spray of nebulizer in each nasal passage; 3-4 sprays daily are usually sufficient; do not use more than 3 times a day.

For children 2 to 6 years of age (0.05% spray), one spray of nebulizer in each nasal passage 1 or 2 times daily; do not use more than 3 times a day.

If another dose is missed, do not double the next dose.

The drug is limited to 7 days; children should always consult their doctor about the length of time.

The bottle should be held with the sprayer up when administering the drug!

Interaction

Special Instructions

Do not use for a long period of time (more than 7 days), e.g. in chronic rhinitis.

Avoid getting the drug in the eyes (it affects vision).

A prolonged use (more than one week) may cause a recurrence of nasal congestion symptoms.

In case of development of systemic side effects (headache, palpitations, increased blood pressure, visual disturbances) one should refrain from driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity to xylometazoline and other components of the drug, arterial hypertension, tachycardia, marked atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism, inflammatory diseases of the nasal anterior skin, Surgical interventions on the meninges (in anamnesis), conditions after transsphenoidal hypophysectomy, children (under 2 years of age – for 0.05% spray, under 6 years for 0.1% spray), pregnancy.

Do not use simultaneously with monoamine oxidase inhibitors (MAOIs), tetra- and tricyclic antidepressants, other local vasoconstrictors (decongestants), as well as drugs that increase blood pressure. When concomitant use with MAO inhibitors or within 14 days after the end of their use, an increase in blood pressure and heart rhythm disturbances are possible.

With caution

Diabetes mellitus, porphyria, pheochromocytoma, diseases of the cardiovascular system (including coronary heart disease), prostatic hyperplasia, breast-feeding period. Hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Side effects

The frequency of adverse drug reactions is classified according to the World Health Organization recommendation: Adverse Reaction Frequency Classification: Very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot estimate frequency based on available data).

Immune system disorders:

infrequent hypersensitivity reactions (angioedema, skin rash, skin itching).

Nervous system disorders:

very rarely – nervousness, anxiety, insomnia, fatigue, drowsiness, lethargy (more often in children), hallucinations and seizures (mainly in children), headache, dizziness, paresthesias (including nasal mucosal paresthesia);

frequency unknown – lethargy, apathy, tingling, depression (with prolonged use of high doses).

Sensory organs:

frequency unknown- visual impairment.

Cardiovascular system disorders:

rarely- sensation of palpitations, tachycardia, increased blood pressure;

very rarely- arrhythmia.

Respiratory system disorders:

often(with frequent and prolonged use) – irritation and/or dryness of nasopharyngeal mucosa, burning of nasal mucosa, sneezing, hypersecretion of nasal mucosa;

infrequent – nasal mucosal swelling, nasal bleeding;

very rarely – apnea in children and infants.

Digestive system disorders:

Overdose

In case of overdose or accidental ingestion the following symptoms may develop: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, shortness of breath, mental disorders, central nervous system depression (drowsiness, decreased body temperature, bradycardia, reduced blood pressure, respiratory arrest and coma).

Pregnancy use

The drug is contraindicated during pregnancy.

Similarities