Rhinostop Extra with menthol and eucalyptus nasal spray 22.5mcg/dose bottle, 15ml

Composition

Per dose:

Active ingredient:

oxymetazoline hydrochloride – 22.5 mcg.

Auxiliary substances:  levomenthol (L-menthol) – 18 µg promovideo eucalyptus leaf oil (eucalyptus oil) – 18 µg, disodium edetate dihydrate is 22.5 mcg, sodium hydrogen phosphate, dodecahydrate – 1260 µg, sodium dihydrogen phosphate dihydrate – 562,5 µg, propylene glycol – 4500 mcg, benzyl alcohol – 450 µg, benzalkonium chloride and 6.8 mcg, purified water – up to 0,045 ml.

Pharmacological action

Anticongestive agent-alpha-adrenomimetic: S. 01. G. A. 04 Oxymetazolin Pharmacodynamics :

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

When applied topically to the inflamed nasal mucosa, it reduces its swelling and concomitant hypersecretion of mucus (nasal discharge), which facilitates drainage of the nasal passages and leads to restoration of nasal breathing.

Elimination of edema of the nasal mucosa helps restore aeration of the paranasal sinuses of the nasal cavity, the middle ear cavity, which prevents the development of bacterial complications (sinusitis, sinusitis, otitis media).

When applied topically intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa.

Oxymetazoline begins to act from 25 seconds. The duration of action of the drug is up to 12 hours.

Results of a double-blind placebo-controlled study in patients with acute viral rhinitis aged 12-70 years showed that the use of oxymetazoline 0.05% reduces the median duration of a runny nose from 6 to 4 days.

Pharmacokinetics: When applied topically intranasally, oxymetazoline does not have a systemic effect. The half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted by the kidneys and about 1.1% through the intestines.

Indications

-Treatment of acute respiratory diseases accompanied by a runny nose;

– allergic rhinitis;

– vasomotor rhinitis;

– to restore drainage in case of inflammation of the paranasal sinuses, eustachiitis, otitis media;

– to eliminate edema before diagnostic manipulations in the nasal passages.

Use during pregnancy and lactation

When used during pregnancy or lactation, do not exceed the recommended dosage. The drug can only be used if the potential benefit to the mother exceeds the potential risk to the fetus or child.

Caution should be exercised in the presence of arterial hypertension or signs of decreased placental blood flow. Frequent or prolonged use of the drug in large doses can lead to a decrease in placental blood flow.

Before using the drug, if you are pregnant or think that you might be pregnant, or are planning to become pregnant, you should consult your doctor.

Contraindications

-Hypersensitivity to the components of the drug;

– atrophic (dry) rhinitis;

– angle-closure glaucoma;

– condition after transsphenoidal pituitary

surgery; – dura mater surgery (in the anamnesis);

– children under 6 years of age;

– inflammation of the skin and mucous membrane of the vestibule of the nose.

With caution:

With increased intraocular pressure, chronic heart failure, arterial hypertension, angina pectoris; arrhythmia; chronic renal failure; in patients with prostatic hyperplasia with clinical symptoms (urinary retention); severe atherosclerosis; hyperthyroidism; diabetes mellitus; pheochromocytoma; tachycardia; therapy with monoamine oxidase inhibitors (MAO) (including up to 14 days after their withdrawal) and tricyclic antidepressants, as well as other drugs that increase blood pressure; porphyria; pregnancy, during breastfeeding.

Side effects

The frequency of adverse reactions was determined according to the World Health Organization classification: very common (≥10%), common (≥1% and <10%), infrequent (≥0.1% and <1%), rare (≥0.01% and <0.1%), very rare (

Immune system disorders:

Infrequently: angioedema, pruritus.

Nervous system disorders:

Rare: headache, insomnia.

Very rare: fatigue, drowsiness, anxiety, hallucinations.

Disorders of the cardiovascular system:

Infrequently: tachycardia, increased blood pressure.

Rare: palpitation of the heart.

Respiratory, thoracic and mediastinal disorders:

Often: burning or dryness of the nasal mucosa, sneezing.

Infrequently: a feeling of” stuffy ” nose (reactive hyperemia); nosebleeds.

Very rare: respiratory arrest (in infants).

Musculoskeletal and connective tissue disorders:

Very rare: convulsions.

Side effects due to the systemic action of the drug:  dizziness, anxiety, irritability, sleep disorders (in children), nausea, exanthema, visual disturbances (if in contact with the eyes).

Prolonged or continuous use of vasoconstrictors can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent swelling of the nasal mucosa (drug-induced rhinitis).

Interaction

When used concomitantly with monoamine oxidase inhibitors (for the previous 2 weeks and for 2 weeks after their withdrawal), tricyclic antidepressants or other drugs that contribute to an increase in blood pressure, an increase in blood pressure may occur.

The drug slows down the absorption of local anesthetics, prolongs their effect.

Co-use of other vasoconstrictor drugs increases the risk of side effects

How to take, course of use and dosage

Intranasally.

Adults and children over 6 years of age: 1 injection in each nasal passage 2-3 times a day.

If symptoms worsen or do not improve within 3 days, you should consult your doctor. At the recommended dose, do not use for more than 7 days without consulting a doctor.

With frequent and prolonged use of the drug, the feeling of “stuffy” nose may reappear or worsen. If these symptoms occur, you should stop treatment and consult a doctor.

One 45 ml injection contains 22.5 mcg of oxymetazoline hydrochloride.

Overdose

Clinical signs of intoxication with imidazole derivatives may be non-specific and indistinct, since the phases of hyperactivity are replaced by phases of depression of the central nervous system, cardiovascular and respiratory systems.

Symptoms: anxiety, restlessness, hallucinations, seizures, low body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitation, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.

In children, overdose can cause the development of symptoms from the central nervous system, such as: agitation, convulsions, coma, bradycardia, respiratory arrest, as well as an increase in blood pressure, followed by a possible decrease in blood pressure.

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

In case of severe overdose, intensive care in a hospital setting is indicated. The use of vasoconstrictors is contraindicated.

Description

Colorless or yellowish tint, transparent or opalescent solution with the smell of menthol and eucalyptus.

Special instructions

Avoid contact with the mouth, eyes, or around the eyes.

If the drug gets into the eyes, there may be a visual impairment.

It is recommended not to exceed the maximum time and recommended doses for self-use of the drug, especially in children.

If there is no reduction or if the symptoms of the disease become more severe, you should consult a doctor.

With prolonged use (more than one week), the drug can cause tachyphylaxis, a “rebound” effect and atrophy of the nasal mucosa.

To avoid the spread of infection, it is necessary to use the drug individually.

Influence on the ability to drive vehicles and fur. : After long-term use of cold remedies containing oxymetazoline, in doses exceeding the recommended ones, the overall effect on the cardiovascular system and central nervous system cannot be excluded. In these cases, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Nasal spray dosed with the aroma of menthol and eucalyptus,22.5 mcg / dose.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 2 years.

Do not use after the expiration date.

Active ingredient

Oxymetazoline

Dosage Form

Spray nasal