Rhinostop Extra nasal spray 0,025%, 15ml

Composition

Composition per 1 ml:

Active ingredient:  

• Oxymetazoline hydrochloride – 0.25 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 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 hypophysectomy;

– dura mater surgery (in the anamnesis);

– children under 1 year 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; with hyperthyroidism; diabetes mellitus; pheochromocytoma; tachycardia; therapy with monoamine oxidase inhibitors (MAO)(including up to 14 days after their withdrawal/in the period of during the previous 2 weeks and within 2 weeks after their withdrawal) and tricyclic antidepressants, as well as other drugs that increase blood pressure; porphyria.

If you have one or more of the diseases and conditions listed above, you should consult your doctor before starting treatment.

Side effects

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

Immune system disorders:

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

Disorders of the gastrointestinal tract:

Rare: nausea.

Nervous system disorders:

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

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

Cardiac disorders:

Rarely: increased blood pressure, palpitation, tachycardia.

Respiratory, thoracic and mediastinal disorders:

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).

Very rare: respiratory arrest (in infants).

Visual disturbances:

Rarely: visual impairment (in case of contact with eyes)

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.

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 can be re-prescribed only after a few days.

If symptoms worsen or do not improve within 3 days, you should consult your doctor. Do not use the recommended dose 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 the treatment and consult a 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.

In case of overdose, you should consult a doctor.

Special instructions

Glycerol included in the excipients of Rhinostop® Extra, has the property of binding and retaining water, which contributes to additional hydration of the nasal mucosa.

Avoid contact with eyes.

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

Do not exceed the maximum time and recommended doses for self-use of the drug. If there is no reduction or if the symptoms of the disease become more severe, you should consult a doctor.

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.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of reach of children

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Oxymetazoline

Dosage Form

Spray nasal