Otriven

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Otrivin (Otrivin®)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains 1 mg of xylometazoline hydrochloride;

Excipients: disodium dihydrogen phosphate dihydrate; sodium hydrogen phosphate dodecahydrate; disodium edetate; benzalkonium chloride; sorbitol solution, non-crystallizing (E 420); hypromellose; sodium chloride; purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical properties: clear solution ranging from colorless to slightly yellowish.

Pharmacotherapeutic group. Medicinal products used in nasal cavity disorders. Decongestants and other agents for local use in nasal conditions. Simple sympathomimetics. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors.

When applied intranasally, xylometazoline causes vasoconstriction of the blood vessels in the mucous membranes of the nasal cavity and paranasal sinuses, thereby reducing swelling and hyperemia of the nasal and nasopharyngeal mucosa. It also decreases associated excessive mucus secretion and facilitates the removal of blocked secretions from the nose, promoting clearance of the nasal passages and improving nasal breathing.

The effect of the drug 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 impair mucociliary function. Laboratory test results have shown that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold.

Due to its moisturizing components (sorbitol, hypromellose), Otrivin spray helps relieve dryness and irritation of the nasal mucosa. The product has a balanced pH value within the physiological range typical for the nasal cavity.

Pharmacokinetics.

When applied locally, the drug is practically not absorbed, and plasma concentrations of xylometazoline are so low that they are practically undetectable (plasma concentration is close to the limit of detection).

Xylometazoline has no mutagenic properties. In animal studies, xylometazoline showed no teratogenic effects.

Clinical characteristics.

Indications.

Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.

For facilitating drainage of secretions in diseases of the nasal accessory sinuses.

Adjunctive therapy in cases of otitis media (to relieve mucosal swelling).

For facilitating rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline, to any of the excipients, or to other sympathomimetic amines; closed-angle glaucoma, transsphenoidal hypophysectomy, history of surgical procedures involving exposure of the meninges, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Patients receiving concomitant treatment with monoamine oxidase inhibitors (see section "Interactions").

Interaction with other medicinal products and other forms of interactions.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Xylometazoline should not be used in patients taking or who have taken MAO inhibitors within the previous two weeks.

Tricyclic and tetracyclic antidepressants: concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use of these agents is not recommended.

Concomitant use with β-blockers may cause bronchial spasm or reduction in blood pressure.

Special precautions for use

The duration of treatment should not exceed 5 days continuously. Prolonged or excessive use of xylometazoline may cause secondary swelling of the nasal mucosa, with a risk of chronic rhinitis and/or atrophy of the nasal mucosa.

The drug, like other sympathomimetics, should be used with caution in patients who exhibit 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 in children and elderly patients.

The drug should be used with caution in patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, or benign prostatic hyperplasia. It should not be used in patients receiving or who have received treatment with monoamine oxidase inhibitors (MAOIs) within the previous 2 weeks.

Patients with prolonged QT syndrome who receive xylometazoline are at increased risk of serious ventricular arrhythmias. As first-line therapy, nasal irrigation with physiological saline is recommended. Otrivin spray may be used as a second-line medicinal product.

The product contains benzalkonium chloride (0.014 mg benzalkonium chloride per 0.14 mL dose, equivalent to 0.100 mg/mL), which may cause nasal mucosal swelling, particularly with prolonged use.

Rare cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of sympathomimetic agents. Reported symptoms include sudden severe headache, nausea, vomiting, and visual disturbances. In most cases, symptoms resolved or improved within a few days after appropriate treatment. The drug should be discontinued immediately and medical advice sought if signs or symptoms of PRES/RCVS develop.

Use during pregnancy or breastfeeding

The drug should not be used during pregnancy due to its potential vasoconstrictive effects. There is no evidence of any adverse effect on the fetus. It is unknown whether xylometazoline is excreted in breast milk; therefore, caution is advised, and the drug should be used during breastfeeding only under medical supervision. Prolonged use during breastfeeding should be avoided due to the risk of adverse effects in the infant (tachycardia, excitability, increased blood pressure).

Fertility

There are no adequate data on the effect of Otrivin on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.

Effect on the ability to drive or operate machinery

The drug usually has no effect or only a negligible effect on the ability to drive or operate machinery. However, with prolonged use of high doses of xylometazoline, systemic effects with cardiovascular effects cannot be ruled out.

Method of Administration and Dosage

Do not cut off the spray nozzle. The nasal spray is a metered-dose formulation, ready for immediate use.

The medication should be administered to adults and children aged 12 years and older as 1 spray into each nostril, up to 3 times daily. Do not administer more than 3 times per day into each nostril. The interval between administrations should be at least 8–10 hours. The duration of treatment depends on the course of the disease and should not exceed 5 consecutive days.

The metered spray ensures accurate dosing and proper distribution of the solution over the nasal mucosal surface. Each spray delivers 0.14 mL of solution, corresponding to 0.14 mg of xylometazoline.

Before the first use, prime the pump by pressing it 4 times. After this, the spray device will remain ready for use throughout the entire treatment period. If the spray does not dispense when the pump is pressed, or if the spray has not been used for more than 7 days, re-prime the device by spraying 4 times into the air.

How to use the spray:

• thoroughly clear the nose before applying the medication;
• hold the bottle vertically, supporting the bottom with the thumb and positioning the nozzle between two fingers;
• slightly tilt the bottle and insert the nozzle into the nostril;
• administer the spray by pressing the pump while simultaneously taking a gentle nasal inhalation;
• after use, before replacing the cap, clean and dry the nozzle;
• to prevent infection, the bottle should be used by only one person.

The last dose should be administered immediately before bedtime.

Children

The medication should not be used in children under 12 years of age.

Overdose

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to sympatholytic effects, including central nervous system depression (e.g., drowsiness, coma), severe dizziness, excessive sweating, marked decrease in body temperature, pallor, headache, tachycardia, bradycardia, arterial hypertension, respiratory depression, miosis, seizures, ataxia, and agitation. Gastrointestinal symptoms such as nausea and vomiting may also occur. Elevated blood pressure may later shift to hypotension. Impaired consciousness may indicate severe overt intoxication. Younger children are more sensitive to toxicity than adults. Severe symptoms after accidental use have not been commonly observed; however, in newborns (aged 2 weeks), administration of 1 drop of 0.1% solution into each nostril may result in coma. At home, activated charcoal may be administered as an emergency measure prior to hospitalization.

In cases of severe intoxication, hospitalization is required, and emergency symptomatic treatment must be administered under medical supervision. Medical care should include patient monitoring for several hours. There is no specific antidote; atropine may be used in cases of bradycardia. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Adverse Reactions

The adverse reactions listed below are categorized by organ system and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).

Immune system disorders:

Very rare: hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system disorders:

Common: headache; uncommon: insomnia.

Eye disorders:

Very rare: temporary visual disturbances.

Cardiovascular system disorders:

Very rare: irregular or rapid heartbeat, hypertension, arrhythmia.

Respiratory, thoracic and mediastinal disorders:

Common: dryness or discomfort of the nasal mucosa, burning sensation, drug-induced rhinitis; uncommon: epistaxis (nosebleed).

Gastrointestinal disorders:

Common: nausea; uncommon: vomiting.

General disorders and administration site conditions:

Common: burning sensation at the application site.

Reporting of adverse reactions after marketing authorization of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in a place inaccessible to children, at a temperature not exceeding 30 °C.

Packaging. 10 ml in a polymer bottle with a spray pump. 1 bottle per cardboard box.

Supply category. Over-the-counter.

Manufacturer. Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

Manufacturer's address and place of business.

Route de l’Etraz 2, Nyon, 1260, Switzerland / Route de l’Etraz 2, Nyon, 1260, Switzerland.