Rhinostop, nasal spray 0,05% vial 15ml

Composition

Composition per 1 ml:

Active ingredient:  

• xylometazoline hydrochloride-0.50 mg or 1.00 mg;

excipients:

• disodium edetate dihydrate-0.50 mg,
• sodium chloride-9.00 mg,
• benzalkonium chloride-0.15 mg,
• potassium dihydrogen phosphate -3.63 mg,
• sodium hydrophosphate dodecahydrate-7.13 mg,
• purified water-up to 1 ml

Pharmacological action

Pharmacotherapy group: anticongestive agent-alpha-adrenomimetic

ATX Code: R01AA07

Pharmacological Properties

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, thus eliminating edema and hyperemia of the nasal mucosa, restores patency of the nasal passages, facilitates nasal breathing.

The effect of the drug occurs a few minutes after its application and lasts up to 10 hours.

Pharmacokinetics

When applied topically, the drug is practically not absorbed, so its concentration in blood plasma is very low (it is not determined by modern analytical methods).

Indications

It is used for acute respiratory diseases with rhinitis (runny nose), acute allergic rhinitis, sinusitis, eustachiitis, pollinosis, otitis media (to reduce swelling of the nasopharyngeal mucosa).

Preparation of the patient for diagnostic manipulations in the nasal passages.

Use during pregnancy and lactation

During pregnancy, the use of the drug is contraindicated.

During breastfeeding, the drug should be used only as prescribed by a doctor, after a thorough assessment of the risk-benefit ratio for mother and child. Do not exceed the recommended dosage.

Contraindications

Hypersensitivity to xylometazoline and other components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism, inflammatory diseases of the skin and nasal vestibule, surgical interventions on the meninges (in the anamnesis), conditions after transsphenoidal pituitary surgery, children (up to 2 years – for 0.05% spray, up to 6 years for 0.1% spray), pregnancy.

It should not be used simultaneously with monoamine oxidase inhibitors (MAO), tetra-and tricyclic antidepressants, other local vasoconstrictors (decongestants), as well as drugs that increase blood pressure. When used concomitantly with MAO inhibitors or for 14 days after the end of their use, an increase in blood pressure and a violation of the heart rhythm may occur.

With caution

Diabetes mellitus, porphyria, pheochromocytoma, diseases of the cardiovascular system(including coronary heart disease), prostatic hyperplasia, breast-feeding period. Hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Side effects

The frequency of adverse drug reactions is classified according to the World Health Organization recommendation: Classification of the frequency of adverse reactions: very common (≥1/10), common (≥1/100 – <1/10), infrequent (≥1/1000 – <1/100), rare (≥1/10000 – <1/1000), very rare (

From the immune system:

infrequently – hypersensitivity reaction (angioedema, skin rash, itchy skin).

Nervous system disorders:

very rarely, nervousness, anxiety, insomnia, fatigue, drowsiness, confusion (more common in children), hallucinations, and convulsions (mainly in children), headache, dizziness, paresthesia (including paresthesia of the mucous membrane of the nose);

the frequency is unknown – lethargy, fatigue, tingling, depression (prolonged use of high doses).

From the side of the senses:

frequency unknown – visual impairment.

From the cardiovascular system:

rarely-palpitation, tachycardia, increased blood pressure;

very rarely – arrhythmia.

Respiratory system disorders:

often (with frequent and prolonged use) – irritation and / or dryness of the nasopharyngeal mucosa, burning of the nasal mucosa, sneezing, hypersecretion of the nasal mucosa;

infrequently –swelling of the nasal mucosa, nosebleeds;

very rarely – apnea in children and newborns.

From the digestive system:

rarely–nausea, vomiting.

Interaction

It should not be used simultaneously with monoamine oxidase inhibitors (MAO), tetra-and tricyclic antidepressants, other local vasoconstrictors (decongestants), as well as drugs that increase blood pressure. When used concomitantly with MAO inhibitors or for 14 days after the end of their use, an increase in blood pressure and a violation of the heart rhythm may occur.

How to take, course of use and dosage

Intranasally (in each nasal passage).

Spraying is performed after removing the safety cap from the sprayer. The nebulizer is inserted into the nose and, by pressing on its base, sprayed for 1 second.

For adults and children over the age of 6 years (0.1% spray): one spray injection in each nasal passage, usually 3-4 injections per day are sufficient; do not use more than 3 times a day.

For children aged 2 to 6 years (0.05% spray), one spray injection into each nasal passage 1 or 2 times a day; do not use more than 3 times a day.

If the next dose of the drug was missed, it is forbidden to double the next dose.

The drug is used for no more than 7 days. Always consult your doctor about the duration of use in children.

During the use of the drug, the bottle should be held with the spray bottle up!

Overdose

Overdose or accidental ingestion of the drug may cause the following symptoms: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, shortness of breath, mental disorders, central nervous system depression (drowsiness, decreased body temperature, bradycardia, decreased blood pressure, respiratory arrest and coma).

Treatment: symptomatic therapy, in case of accidental ingestion-use of activated carbon, sodium sulfate (laxative), gastric lavage. In serious cases, non-selective alpha-blockers may be used to lower blood pressure, as well as intubation and artificial ventilation. Vasoconstrictor drugs are contraindicated. There is no specific antidote.

Special instructions

It should not be used for a long time (more than 7 days), for example, in chronic rhinitis.

Avoid contact with the drug in the eyes (the drug has an effect on vision).

With prolonged use (more than one week), the symptoms of nasal congestion may resume.

Influence on the ability to drive vehicles and mechanisms

In case of systemic side effects (headache, palpitation, increased arterial pressure, visual disturbances), it is necessary to refrain from driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and rapid psychomotor reactions.

Form of production

Nasal spray

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C.

Shelf

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

Active ingredient

Xylometazoline

Dosage form

nasal spray

Description

Children’s forms