Otrivin

INSTRUCTIONS for medical use of the medicinal product Otrivin (Otrivin®)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 0.5 mg or 1 mg;

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

Pharmaceutical form. Nasal drops.

Main physicochemical properties: clear solution, from colorless to slightly yellowish, practically odorless.

Pharmacotherapeutic group. Medicines used in nasal cavity disorders. Anti-edematous and other preparations for local use in nasal cavity disorders. 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 nasal mucosa and adjacent areas of the nasopharynx, thereby reducing edema and hyperemia of the nasal and nasopharyngeal mucosa. It also decreases associated excessive mucus secretion, facilitates clearance of blocked nasal secretions, promotes opening of nasal passages, and improves nasal breathing.

The effect of the drug begins within 2 minutes after administration and lasts up to 12 hours.

The product 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 nasal drops help relieve dryness and irritation of the nasal mucosa. The formulation 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 barely detectable (plasma concentration is close to the limit of detection).

Xylometazoline has no mutagenic properties. Animal studies have also shown no evidence of teratogenic effects of xylometazoline.

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 reduce 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 interventions involving exposure of meninges, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Patients receiving concomitant treatment with monoamine oxidase inhibitors (see section "Interaction").

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Do not use xylometazoline 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, simultaneous use of these agents is not recommended.

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

Special precautions for use.

Otrivin, 0.05% nasal drops should not be used in children under 2 years of age.

Use in children aged 2 to 12 years should be under adult supervision.

The product should not be used in children for longer than 5 consecutive days.

Otrivin, 0.1% nasal drops should not be used in children under 12 years of age.

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 product, like other sympathomimetics, should be used with caution in patients who exhibit strong reactions to adrenergic agents, such as insomnia, dizziness, tremor, cardiac arrhythmia, or elevated blood pressure. The recommended dose of the product should not be exceeded, especially when treating children and elderly patients.

The product 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 long 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 nasal drops may be used as a second-line medicinal product.

The product contains benzalkonium chloride (0.0025 mg benzalkonium chloride per 25 mg dose, equivalent to 0.100 mg/mL), which may cause nasal mucosal swelling, particularly with prolonged use.

Isolated cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) have been reported during 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 product should be discontinued immediately and medical advice sought if signs/symptoms of PRES/RCVS develop.

Use during pregnancy or breastfeeding

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

Fertility

There are no adequate data regarding 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.

Ability to affect reaction speed when driving or operating machinery

The product usually has no effect or only a negligible effect on the ability to drive or operate machinery. However, with excessively prolonged use or use at high doses, effects on the cardiovascular system cannot be excluded.

Dosage and Administration.

0.05% Nasal Drops:

For use in children aged 2 to 12 years under adult supervision.

For children aged 2 to 6 years, usually 1–2 drops in each nostril 1–3 times daily are sufficient. For children aged 6 to 12 years, the dose may be 1–4 drops in each nostril 2–3 times daily. The interval between doses should be at least 8–10 hours. Do not administer more than 3 times daily in each nostril.

The duration of treatment depends on the course of the illness and should not exceed 5 consecutive days. One drop of Otrivin 0.05% contains 0.0125 mg of xylometazoline hydrochloride.

0.1% Nasal Drops:

For use in adults and children aged 12 years and older: 2–4 drops in each nostril up to 3 times daily. The interval between doses should be at least 8–10 hours. Do not administer more than 3 times daily in each nostril.

The duration of treatment depends on the course of the illness and should not exceed 5 consecutive days. One drop of Otrivin 0.1% contains 0.025 mg of xylometazoline hydrochloride.

How to use the drops:

• Thoroughly clean the nose before applying the medication;
• Tilt the head back as far as comfortably possible, or lie down and let the head hang slightly over the edge of the bed;
• Instill the drops into each nostril and keep the head tilted back for a short time to allow the medication to spread throughout the nasal cavity;
• After use, clean and dry the dropper cap before closing the bottle;
• To prevent infection, the bottle should be used by only one person.

The last dose should preferably be administered immediately before bedtime.

Children.

Otrivin 0.05% nasal drops must not be used in children under 2 years of age.

Use in children aged 2 to 12 years should only be performed under adult supervision.

Otrivin 0.1% nasal drops must not be used in children under 12 years of age.

Overdose.

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to pronounced dizziness, pallor, sweating, significant decrease in body temperature, headache, bradycardia and tachycardia, arterial hypertension, respiratory depression, miosis, ataxia and restlessness, coma, and seizures. Gastrointestinal symptoms such as nausea and vomiting may also occur. Elevated blood pressure may subsequently decrease. Impaired consciousness may indicate severe intoxication. Younger children are more sensitive to the toxic effects than adults. Severe symptoms have not been observed after accidental use; however, in newborns (aged 2 weeks), administration of 1 drop of the 0.1% solution in each nostril may lead to coma. At home, activated charcoal may be administered as an emergency measure prior to hospitalization.

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

Adverse reactions.

The adverse effects listed below are categorized by organ class and frequency of occurrence: very common (≥ 1/10), common (≥1/100 – <1/10), uncommon (≥ 1/1000 – <1/100), rare (≥ 1/10 000 – < 1/1000), very rare (< 1/10 000).

Immune system disorders:

very rare: hypersensitivity reactions, including angioedema, rash, pruritus.

Nervous system disorders:

common: headache; uncommon: insomnia.

Eye disorders:

very rare: transient 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: nasal bleeding.

Gastrointestinal disorders:

common: nausea; uncommon: vomiting.

General disorders and administration site conditions:

common: burning sensation at the application site.

Reporting of adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy 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 the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Keep out of reach of children and store at a temperature not exceeding 30 °C.

Packaging. 10 ml in a bottle with dropper cap; 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.