Rhinostop® (Spray, Drops) Instructions for Use
ATC Code
R01AA07 (Xylometazoline)
Active Substance
Xylometazoline (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Vasoconstrictor drug for topical use in ENT practice
Pharmacotherapeutic Group
Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics
Pharmacological Action
Vasoconstrictor agent for topical use in ENT practice. Alpha-adrenomimetic. When applied to the mucous membranes, it causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasal mucosa, and restores the patency of the nasal passages. In rhinitis, it facilitates nasal breathing.
Pharmacokinetics
When applied topically, it is practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.
Indications
To reduce swelling of the nasopharyngeal mucosa and discharge in acute allergic rhinitis, acute respiratory infections with symptoms of rhinitis, sinusitis, hay fever, otitis media; preparation of the patient for diagnostic procedures in the nasal passages.
ICD codes
| ICD-10 code | Indication |
| H66 | Suppurative and unspecified otitis media |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J06.9 | Acute upper respiratory infection, unspecified |
| J30.1 | Allergic rhinitis due to pollen |
| J30.3 | Other allergic rhinitis (perennial allergic rhinitis) |
| J32 | Chronic sinusitis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| AA9Z | Unspecified suppurative otitis media |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA07.0 | Acute upper respiratory tract infection of unspecified site |
| CA08.00 | Allergic rhinitis due to pollen |
| CA08.03 | Other allergic rhinitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Drops
Administered intranasally. The dose depends on the dosage form used and the age of the patient.
Spray
The drug is administered intranasally. Spraying is performed after removing the protective cap from the sprayer. Insert the sprayer into the nose and, pressing its base, spray for 1 second. During administration, the bottle should be held with the sprayer pointing upwards.
Nasal spray 0.1% is prescribed for adults and children over 6 years of age, 1 spray from the sprayer into each nasal passage. Usually, 3-4 sprays per day are sufficient; the drug should not be used more than 3 times/day.
Nasal spray 0.05% is prescribed for children aged 2 to 6 years, 1 spray from the sprayer into each nasal passage 1-2 times/day; the drug should not be used more than 3 times/day.
The drug should not be used continuously for more than 3-5 days.
Adverse Reactions
Immune system disorders – uncommon: hypersensitivity reactions (angioedema, skin rash, itching).
Gastrointestinal disorders – rare: nausea, vomiting.
Nervous system disorders: rare: headache; very rare: insomnia, anxiety, fatigue, hallucinations and convulsions (mainly in children).
Eye disorders – very rare: blurred vision.
Cardiac and vascular disorders – rare: palpitations, increased blood pressure, tachycardia; very rare: arrhythmia.
Local reactions – common: irritation and/or dryness of the nasopharyngeal mucosa, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the nasal mucosa; uncommon: swelling of the nasal mucosa, nosebleeds, withdrawal syndrome. Increased swelling of the nasal mucosa (reactive hyperemia) is possible.
Contraindications
Hypersensitivity to xylometazoline; atrophic rhinitis, thyrotoxicosis; inflammatory diseases of the skin or mucous membrane of the nasal vestibule; condition after transsphenoidal hypophysectomy; patients with severe cardiovascular diseases (e.g., coronary artery disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis); patients with a history of surgical interventions on the meninges; patients receiving MAO inhibitors or other drugs that can cause increased blood pressure; patients with increased intraocular pressure, especially angle-closure glaucoma; during therapy with tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants); pregnancy; pediatric age – depending on the dosage form.
With caution in patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with pheochromocytoma, porphyria; patients with endocrine diseases (e.g., hyperthyroidism, diabetes mellitus); patients with prostatic hyperplasia; during lactation (breastfeeding).
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy. During lactation, use is possible only as prescribed by a doctor, after a thorough assessment of the expected benefit to the mother versus the potential risk to the child. Exceeding the recommended doses is not allowed.
Pediatric Use
Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the package inserts for xylometazoline preparations regarding contraindications for the use of specific dosage forms of xylometazoline in children of different ages. Recommended doses should not be exceeded in children.
Geriatric Use
Recommended doses should not be exceeded in elderly patients.
Special Precautions
Long-term use (more than 7 days) and overdose of sympathomimetics with a decongestant effect can lead to reactive hyperemia of the nasal mucosa. As a result, nasal breathing difficulty occurs, which leads to the patient using xylometazoline repeatedly or even continuously. This can lead to chronic swelling (medicinal rhinitis), and ultimately even to atrophy of the nasal mucosa (ozena).
In milder cases, to improve the patient’s condition, it is possible to first stop the administration of the sympathomimetic into one nostril, and after the complaints decrease, continue to administer it into the other nostril in order to at least partially ensure nasal breathing.
Recommended doses should not be exceeded, especially in children and elderly patients.
Effect on ability to drive vehicles and operate machinery
With long-term treatment or when using xylometazoline in higher doses, the possibility of its systemic action cannot be excluded. In case of systemic side effects, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Drug Interactions
Enhancement of the systemic action of xylometazoline is possible with simultaneous use of MAO inhibitors and tricyclic antidepressants. Simultaneous use of xylometazoline with tetracyclic antidepressants, other topical vasoconstrictors (decongestants), as well as other drugs that increase blood pressure is incompatible.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Nasal drops 0.05%: 10 ml, 15 ml, or 20 ml dropper bottle
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Lekko, CJS (Russia)
Dosage Form
 |
Rhinostop® | Nasal drops 0.05%: 10 ml, 15 ml, or 20 ml dropper bottle |
Dosage Form, Packaging, and Composition
Nasal drops as a clear, colorless or slightly brownish liquid.
| 1 ml | |
| Xylometazoline hydrochloride | 0.5 mg |
Excipients: disodium edetate dihydrate – 0.5 mg, sodium chloride – 9 mg, benzalkonium chloride, calculated as anhydrous substance – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, purified water – up to 1 ml.
10 ml – dropper bottles (1) with a dosing nozzle/dropper cap – cardboard boxes.
15 ml – dropper bottles (1) with a dosing nozzle/dropper cap – cardboard boxes.
20 ml – dropper bottles (1) with a dosing nozzle/dropper cap – cardboard boxes.
Nasal drops 0.1%: 10 ml, 15 ml, or 20 ml dropper bottle
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Lekko, CJS (Russia)
Dosage Form
|
Rhinostop® | Nasal drops 0.1%: 10 ml, 15 ml, or 20 ml dropper bottle |
Dosage Form, Packaging, and Composition
Nasal drops as a clear, colorless or slightly brownish liquid.
| 1 ml | |
| Xylometazoline hydrochloride | 1 mg |
Excipients: disodium edetate dihydrate – 0.5 mg, sodium chloride – 9 mg, benzalkonium chloride, calculated as anhydrous substance – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, purified water – up to 1 ml.
10 ml – dropper bottles (1) with a dosing nozzle/dropper cap – cardboard boxes.
15 ml – dropper bottles (1) with a dosing nozzle/dropper cap – cardboard boxes.
20 ml – dropper bottles (1) with a dosing nozzle/dropper cap – cardboard boxes.
Nasal spray 0.1%: 15 ml bottle with activator
Nasal spray 0.05%: 15 ml bottle with activator
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Forms
|
Rhinostop® | Nasal spray 0.1%: 15 ml bottle with activator |
| Nasal spray 0.05%: 15 ml bottle with activator |
Dosage Form, Packaging, and Composition
Nasal spray 0.05% as a clear, colorless or slightly colored liquid.
| 1 ml | |
| Xylometazoline hydrochloride | 0.5 mg |
Excipients: disodium edetate dihydrate – 0.5 mg, sodium chloride – 9 mg, benzalkonium chloride – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, purified water – up to 1 ml.
15 ml – plastic bottles (1) complete with an activator with a protective cap – cardboard boxes.
Nasal spray 0.1% as a clear, colorless or slightly colored liquid.
| 1 ml | |
| Xylometazoline hydrochloride | 1 mg |
Excipients: disodium edetate dihydrate – 0.5 mg, sodium chloride – 9 mg, benzalkonium chloride – 0.15 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, purified water – up to 1 ml.
15 ml – plastic bottles (1) complete with an activator with a protective cap – cardboard boxes.
![Rhinostop® [Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Rhinostop® [Spray, Drops] 2")