Instructions for Otrivin nasal spray 0.1%, bottle with sprayer 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains xylometazoline hydrochloride 1 mg;
Excipients: sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; disodium edetate; benzalkonium chloride; sorbitol solution, non-crystallizing (E 420); hypromellose; sodium chloride; purified water.
Dosage form
Nasal spray, metered.
Main physicochemical properties: clear solution from colorless to slightly yellowish.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A07.
Pharmacological properties
Pharmacodynamics
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Xylometazoline, when applied nasally, causes constriction of the blood vessels of the nasal mucosa and paranasal sinuses, thus eliminating edema and hyperemia of the nasal mucosa and nasopharynx, and also reduces the associated increased mucus secretion and facilitates the removal of blocked secretions from the nose, which leads to cleansing of the nasal passages and facilitating nasal breathing.
The drug's effect begins within 2 minutes after application and lasts up to 12 hours.
The drug is well tolerated, including by patients with sensitive mucous membranes, and does not reduce mucociliary function. Laboratory tests have shown that xylometazoline reduces the infectious activity of human rhinovirus, which is associated with the common cold.
Thanks to moisturizing components (sorbitol, hypromellose), Otrivin spray helps with dryness and irritation of the nasal mucosa. The drug has a balanced pH value within the limits characteristic of the nasal cavity.
Pharmacokinetics
When applied topically, the drug is practically not absorbed, the concentrations of xylometazoline in blood plasma are so low that they are practically undetectable (the concentration in blood plasma is close to the detection limit).
Xylometazoline does not have mutagenic properties. Also, in animal studies, no teratogenic effects of xylometazoline were detected.
Indication
Symptomatic treatment of nasal congestion in colds, hay fever, other allergic rhinitis, sinusitis; to facilitate the outflow of secretions in diseases of the paranasal sinuses; adjunctive therapy in cases of otitis media (to eliminate swelling of the mucous membrane); to facilitate rhinoscopy.
Contraindication
Hypersensitivity to xylometazoline or any other component of the drug, angle-closure glaucoma, transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges in history, dry rhinitis (rhinitis sicca) or atrophic rhinitis.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAOIs): Xylometazoline may potentiate the effects of monoamine oxidase inhibitors and induce hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAOIs within the last two weeks.
Tri- and tetracyclic antidepressants: with simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs, the sympathomimetic effect of xylometazoline may be enhanced, therefore the simultaneous use of such drugs is not recommended.
When used together with β-blockers, it may cause bronchial spasm or a decrease in blood pressure.
Application features
The drug should not be used for more than 10 consecutive days. Prolonged or excessive use may lead to the recurrence of nasal congestion and/or atrophy of the nasal mucosa.
The drug, like other sympathomimetics, should be prescribed with caution to patients who have strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure.
The recommended dose of the drug should not be exceeded, especially when treating children and the elderly.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, and should not be used in patients receiving concomitant treatment with MAO inhibitors and within 2 weeks after discontinuation of their use.
The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually has no or negligible influence on the ability to drive or use machines.
Use during pregnancy or breastfeeding
There is no evidence of any adverse effects on the infant. It is not known whether xylometazoline is excreted in breast milk, therefore caution is required and the drug should be used during breastfeeding only as directed by a physician.
Fertility.
There are no adequate data on the effect of Otrivin on fertility. Since the systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
Method of administration and doses
The drug should be used by adults and children over 12 years of age, 1 injection into each nasal passage up to 3 times a day. Apply no more than 3 times in each nasal passage per day. The duration of treatment depends on the course of the disease and should not exceed 10 days in a row.
The dosed spray ensures dosing accuracy and proper distribution of the solution on the surface of the nasal mucosa. With each injection, 0.14 ml of the solution corresponds to 0.14 mg of xylometazoline.
Before use, it is necessary to prepare the dosing device by performing several injection movements until the spray begins to be released into the air. With further use, the dosing device will be ready for immediate use.
The spray should be applied as follows:
thoroughly clean the nose before using the drug
the bottle should be held vertically, supporting the bottom with the thumb and placing the tip between two fingers;
tilt the bottle slightly and insert the tip into the nostril;
inject and at the same time take a light breath through the nose,
after application, before closing the tip with a cap, clean and dry the tip;
in order to prevent infection, only one person can use each vial with the drug.
The last application is recommended immediately before going to bed.
Children
The drug should not be used in children under 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in severe dizziness, excessive sweating, a significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and convulsions. Elevated blood pressure may change to low blood pressure. Young children are more sensitive to toxicity than adults.
All patients with suspected overdose should be given appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include observation of the patient for several hours. In the case of severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour.
Adverse reactions
On the part of the immune system:
rare (<1/10,000): hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system:
common (≥1/100, <1/10): headache.
On the part of the organs of vision:
rare (<1/10,000): temporary visual impairment.
From the cardiovascular system:
rare (<1/10,000): irregular or rapid heartbeat.
Respiratory, thoracic and mediastinal disorders:
Common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa.
From the gastrointestinal system:
common (≥1/100, <1/10): nausea.
General disorders and administration site conditions:
common (≥1/100, <1/10): burning sensation at the application site.
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30°C.
Packaging
10 ml in a polymer bottle with a sprayer. 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
GSK Consumer Helsker S.A. / GSK Consumer Healthcare S.A.
Location of the manufacturer and its business address
Route de l'Etraz 2, 1260 Nyon, Switzerland.
