Rhinostop Extra, drops 0.025% 10 ml

Pharmacodynamics.

The rhinostop ^® Extra (oxymetazoline) has a vasoconstrictor effect. When applied topically to the inflamed nasal mucosa it reduces nasal swelling, nasal congestion and nasal discharge, eliminating the symptoms of rhinitis.

Restores nasal breathing. Elimination of nasal mucous membrane edema restores aeration of paranasal sinuses, middle ear cavity which prevents development of bacterial complications (maxillary sinusitis, sinusitis, otitis media). When used locally intranasally in therapeutic concentrations it does not irritate and does not cause nasal mucous membrane hyperemia.

Glycerol, which is part of Rinostop^® Extra, helps retain moisture, which helps provide hydration to dry or irritated nasal mucosa.

The drug takes effect quickly (within minutes). The duration of action of Rinostop^® Extra is up to 12 hours.

Pharmacokinetics.

In local intranasal administration the drug has no systemic action.

The elimination half-life of oxymetazoline when administered intranasally is 35 h. 2.1% of oxymetazoline is excreted by the kidneys and about 1.1% through the intestine.

Indications

– Treatment of acute respiratory diseases accompanied by rhinitis (runny nose);

– allergic rhinitis;

– vasomotor rhinitis;

– To ease the outflow of nasal sinus fluid due to sinusitis, eustachitis, otitis media;

– to reduce swelling before diagnostic manipulations of the nasal passages.

Active ingredient

Composition

Composition per 1 ml:

Dosage:

0.01%

0.025%

0.05%

Active substance:

oxymetazoline hydrochloride

0.1mg

0.25mg

0.5mg

Excipients:

citric acid monohydrate

0.6093mg

How to take, the dosage

Intranasally.

Adults and children over 6 years of age: – Use 1 to 2 drops of 0.05% solution in each nostril 2 to 3 times a day.

Children between 1 and 6 years of age: Use 1 to 2 drops of the 0.025% solution in each nostril 2 to 3 times a day.

In children under one year of age: up to 4 weeks of age – 1 drop of 0.01 % solution in each nostril 2 – 3 times a day. From the 5th week of life and up to 1 year of age – 1-2 drops in each nostril 2-3 times a day.

Interaction

Delays absorption of local anesthetic drugs (prolongs their effect in surface anesthesia).

The concomitant use of other vasoconstrictor drugs increases the risk of side effects.

Concomitant use of MAO inhibitors (including a period of 14 days after their withdrawal), tricyclic antidepressants, and bromocriptine increases the risk of hypertension.

Special Instructions

Long-term use and overdose of the drug should be avoided, especially in children.

Contacting the drug in the eyes should be avoided.

In order to avoid spreading infection, the drug should be used individually.

Impact on the ability to drive vehicles and machines:

After long-term use of nasal decongestants containing oxymetazoline and in doses greater than recommended, general effects on the cardiovascular system and central nervous system cannot be ruled out.

In these cases, caution is recommended when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

Side effects

Burning or dry mucous membranes of the nasal cavity, dry mucous membranes of the mouth and throat; sneezing; increased nasal secretion; nasal bleeding; after the effect of the drug passes, a feeling of nasal congestion (reactive hyperemia).

Side effects due to the systemic action of the drug (in case of accidental ingestion of the solution): Increased blood pressure, headache, dizziness, palpitations, tachycardia, restlessness, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbance (in children), nausea, insomnia, exanthema, hallucinations, Quincke’s edema, itching, seizures, respiratory arrest (in infants). Visual impairment (in case of eye contact).

Long-term continuous use of vasoconstrictors may lead to tachyphylaxis, nasal mucosal atrophy and recurrent nasal mucosal edema (drug-induced rhinitis).

Overdose

Inadvertent ingestion or overdose may cause the following symptoms: Anxiety, restlessness, hallucinations, seizures, decreased body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitation, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, lower blood pressure, nausea, vomiting, depressed respiration, respiratory arrest.

Treatment: gastric lavage, administration of activated charcoal; symptomatic.

Pregnancy use

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