Rhinostop Extra, spray 0.025% 15 ml

Pharmacodynamics

Oxymetazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic action, causes narrowing of blood vessels of nasal mucosa, thus eliminating edema and hyperemia of nasopharyngeal mucosa.

When applied topically to the inflamed nasal cavity mucosa, it reduces its swelling and associated mucus hypersecretion (nasal discharge) which facilitates nasal passageways drainage. It restores nasal breathing.

The elimination of nasal cavity mucous membrane edema helps restore aeration of the sinus cavity, middle ear cavity, which reduces the likelihood of bacterial complications (maxillary sinusitis, sinusitis, otitis media).

In local intranasal application in therapeutic concentrations it does not irritate and does not cause nasal mucous membrane hyperemia.

The drug takes effect quickly, within a few minutes. The duration of action of the drug is up to 12 hours.

Pharmacokinetics

In local intranasal administration, oxymetazoline has no systemic action. The elimination half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted with urine and about 1.1% with feces.

Indications

Treatment of acute respiratory diseases accompanied by a runny nose;

Allergic rhinitis;

Vasomotor rhinitis;

Active ingredient

Composition

Composition per 1 ml:

Active substance:

How to take, the dosage

Intranasally.

In children aged 1 to 6 years: 1 injection in each nostril 2-3 times a day.The drug is used for 5-7 days. The drug may only be repeated after a few days.

Interaction

The drug slows down the absorption of anesthetic drugs, prolongs their effect.

In concomitant use with monoamine oxidase inhibitors (during the previous 2 weeks and for 2 weeks after their withdrawal), tricyclic antidepressants or other drugs that contribute to increase in blood pressure, there may be increase in blood pressure.

Special Instructions

Glycerol, a component of the excipients of Rinostop® Extra, has the property of binding and retaining water, which contributes to additional moistening of the nasal mucosa.

Avoid contact with the eyes.

The product should be used individually to avoid spreading infection.

Do not exceed the maximum periods and recommended doses when using the drug on its own. If there is no reduction or if there is a worsening of symptoms, a physician should be seen.

Impact on driving and operating ability

After long-term use of rhinitis remedies containing oxymetazoline in doses greater than recommended, general effects on the cardiovascular system and the central nervous system cannot be ruled out. In these cases, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and rapid psychomotor reactions.

Contraindications

– Hypersensitivity to the components of the drug;

– Atrophic (dry) rhinitis;

– Closed angle glaucoma;

– Any condition after transsphenoidal hypophysectomy;

– Surgery on the dura mater (history);

– Child age less than 1 year.

With caution

In case of elevated intraocular pressure, chronic heart failure, arterial hypertension, angina pectoris; arrhythmia; chronic renal failure; In patients with prostatic hyperplasia with clinical symptoms (urinary retention); manifested atherosclerosis; hyperthyroidism; diabetes mellitus; pheochromocytoma; tachycardia; therapy with monoamine oxidase inhibitors (MAO) (includingincluding up to 14 days after their withdrawal/in the preceding 2 weeks and within 2 weeks after their withdrawal) and tricyclic antidepressants and other drugs that increase blood pressure; porphyria.

Side effects

Classification of the frequency of side effects (WHO): very common (with an incidence greater than 1/10), common (with an incidence of at least 1/100 but less than 1/10), infrequent (with an incidence of at least 1/1000 but less than 1/100), rare (with an incidence of at least 1/10000 but less than 1/1000), very rare (with an incidence less than 1/10000, including individual reports), frequency unknown (cannot be determined from the available data).

Disorders of the immune system:

Infrequent: hypersensitivity reactions (angioedema, exanthema, pruritus).

Gastrointestinal tract disorders:

Rarely: nausea.

Nervous system disorders:

Rarely: headache, dizziness, anxiety, irritability, sleep disturbance (in children), insomnia.

Very rare: fatigue, drowsiness, anxiety, hallucinations, seizures.

Cardiac disorders:

Rarely: increased blood pressure, palpitations, tachycardia.

Respiratory system, chest and mediastinum disorders:

Infrequent: burning or dry mucous membranes of the nasal cavity, sneezing, nasal bleeding.

In rare cases: feeling of “stuffy” nose (reactive hyperemia) after the effect of the drug has passed.

Very rare: respiratory arrest (in infants).

Visual disorders:

Rarely:visual impairment (if ingested)

Prolonged continuous use of vasoconstrictors may result in tachyphylaxis, nasal mucosal atrophy, and recurrent nasal mucosal edema (medication-induced rhinitis).

Overdose

The clinical signs of intoxication with imidazole derivatives may be nonspecific and indistinct, as phases of hyperactivity alternate with phases of depression of the central nervous system, cardiovascular and respiratory systems.

Symptoms: anxiety, restlessness, hallucinations, seizures, decreased body temperature, lethargy, sleepiness, coma, constriction or dilation of the pupils, fever, sweating, paleness, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, depressed respiration, respiratory arrest.

In children, overdose may cause central nervous system symptoms such as: agitation, seizures, coma, bradycardia, respiratory arrest, and an increase in blood pressure followed by a possible decrease in blood pressure.

Treatment: gastric lavage, administration of activated charcoal (in case of accidental ingestion of the drug); symptomatic.

In case of severe overdose intensive hospital therapy is indicated. The use of vasoconstrictors is contraindicated.

In case of overdose it is necessary to consult a physician.

Pregnancy use

When used during pregnancy or breastfeeding the recommended dose should not be exceeded. The drug may only be used if the potential benefit to the mother outweighs the potential risk to the fetus or child.

Consult your doctor before using the drug if you are pregnant or think you may be pregnant or are planning to become pregnant.

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