Rhinostop Extra nasal spray 0,05%, 15ml

Composition

Active ingredient:  

• Oxymetazoline hydrochloride – 0.5 mg.

Auxiliary substances:

• 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

Pharmacological action

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. Restores 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 reduces the likelihood 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.

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

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 in the urine and about 1.1% in the faeces.

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 dose. The drug can only be used if the potential benefit to the mother exceeds the potential risk to the fetus or child.

Before using the drug, if you are pregnant or believe 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.

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

Infrequently: burning or dryness of the nasal mucosa, sneezing, nosebleeds.

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

Frequency unknown: dryness of the mucous membranes of the mouth and throat, increased volume of secretions released from the nose.

Side effects due to the systemic action of the drug:

Infrequently: angioedema, pruritus.

Rare: increased blood pressure, headache, dizziness, palpitation, tachycardia, anxiety, irritability, sleep disturbance (in children), nausea, insomnia, exanthema, visual impairment (in contact with eyes).

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

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

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

Interaction

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

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.

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 nostril 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 contact your doctor.

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.

Special instructions

Avoid contact with eyes.

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

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

Influence on the ability to drive vehicles and mechanisms

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 rapid psychomotor reactions.

Form of production

Nasal drops

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children. Store in the original packaging.

Shelf

life is 2 years.

Active ingredient

Oxymetazoline

Dosage Form

Spray nasal