Rhinostop Extra, spray 0.05% 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;

• to restore drainage in inflammation of the sinuses, eustachitis, otitis media;

• to eliminate swelling before diagnostic manipulations in the nasal passages.

Active ingredient

Oxymetazoline

Composition

Active substance:

• Oxymetazoline hydrochloride – 0.5 mg.

Excipients:

• Citric acid monohydrate – 0.609 mg;
• Sodium citrate dihydrate – 3.823 mg;
• glycerol – 24,348 mg;
• benzalkonium chloride – 0.15 mg;
• purified water – up to 1 ml.

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How to take, the dosage

Intranasally.

Adults and children over 6 years: 1 injection in each nostril 2-3 times a day.

If symptoms worsen or do not improve within 3 days, a physician should be consulted. At the recommended dose without consulting a physician, use for no more than 7 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.

Co-prescription of other vasoconstrictors increases the risk of side effects.

Special Instructions

Avoid getting the drug in the eyes.

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

The drug should be used individually to avoid spreading infection.

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 excluded. 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 ingredients of the drug;

• Atrophic (dry) rhinitis;

• closed-angle glaucoma;

• Post-transsphenoidal pituitaryectomy;

• dura surgery (history);

• children under 6 years of age.

With caution

In high 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) (includingIn the period up to 14 days after their withdrawal) and tricyclic antidepressants, as well as other drugs that increase blood pressure; porphyria; pregnancy, breastfeeding.

Side effects

Infrequently: 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.

Prevalence unknown: dry mucous membranes of the mouth and throat, increased nasal secretion.

Systemic side effects of the drug:

Infrequent: Quincke’s edema, itching.

Rarely: increased blood pressure, headache, dizziness, palpitations, tachycardia, anxiety, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, visual disturbances (in case of eye contact).

Very rare: anxiety, fatigue, drowsiness, sedation, hallucinations, seizures, respiratory arrest (in infants).

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

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

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

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.

Similarities

Afrin, Nasivin, Nasol, Otrivin, Nasol Advance, Nasivin Sensitive, Rinostop, Nesopin, Oxyfrine, Sialor, Rinostop Extra, Cold and Flu, No Time to Be Sick