Otrivin^® (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

Xylometazoline has an alpha-adrenomimetic effect: it causes constriction of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the nasopharyngeal mucosa.

Xylometazoline also reduces the accompanying hypersecretion of mucus and facilitates the drainage of nasal passages blocked by secretions, thus improving nasal breathing in case of nasal congestion.

Xylometazoline is well tolerated by patients with sensitive mucosa, and its action does not impede the separation of mucus. Xylometazoline has a balanced pH value characteristic of the nasal cavity.

The drug contains inactive components – sorbitol and hypromellose (methylhydroxypropylcellulose), which are moisturizers. Thus, the moisturizing formula helps reduce the symptoms of irritation and dryness of the nasal mucosa that occur with prolonged use of xylometazoline.

In therapeutic concentrations, the drug does not irritate the mucous membrane and does not cause hyperemia.

The effect begins 2 minutes after application and lasts for 12 hours (for example, throughout the night).

In vitro studies have shown that in humans, Xylometazoline suppresses the infectious activity of the rhinovirus that causes the common cold.

Pharmacokinetics

When applied topically in recommended doses, it is practically not absorbed; plasma concentrations are below the detection limit.

Indications

For adults and children aged 6 years and older

• Acute respiratory diseases with symptoms of rhinitis (runny nose);
• Acute allergic rhinitis;
• Hay fever;
• Sinusitis;
• Eustachitis;
• Otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• Preparation of the patient for diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Drops

Apply intranasally. The dose depends on the dosage form used and the age of the patient.

Spray

Adults – 1 spray into each nostril 1-3 times/day. Should not be used more than 3 times/day.

It is not recommended to use the drug for more than 5-7 days.

Children

Should not be used in children aged 0 to 6 years due to the inability to ensure the dosing regimen.

The dosage regimen for children aged 6 years and older coincides with the dosage regimen for adults. The drug in children should be used under adult supervision.

In children aged 6-11 years, the drug should be used on the recommendation of a doctor.

The duration of use in children should be discussed with a doctor.

Method of Application

Intranasally (nasal spray).

Do not cut the tip of the dosing device.

Before the first use of the spray, press the pump dosing device 5 times. During further use, no additional activation of the dosing device is required. If uneven dosing of the spray is observed or the break in using the drug was more than 7 days, it is necessary to activate the dosing device by pressing it 5 times.

Adverse Reactions

The frequency of adverse reactions was determined in accordance with the WHO classification: very common (≥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 (angioedema, rash, itching).

Psychiatric disorders: rare – insomnia, depression (with long-term use in high doses).

Nervous system disorders common – headache.

Eye disorders very rare – blurred vision.

Cardiac disorders rare – palpitations, increased blood pressure; very rare – tachycardia, arrhythmia.

Vascular disorders rare – palpitations, increased blood pressure; very rare – tachycardia, arrhythmia.

Respiratory, thoracic and mediastinal disorders common – irritation and/or dryness of the nasal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa, medicinal rhinitis.

Gastrointestinal disorders common – nausea; rare – vomiting.

Local reactions common – burning at the application site.

Contraindications

• Hypersensitivity to xylometazoline or any of the excipients included in the drug;
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Glaucoma;
• Hyperthyroidism;
• Atrophic rhinitis;
• Inflammatory diseases of the skin or mucous membrane of the nasal vestibule;
• Surgical interventions on the meninges (in history);
• Condition after transsphenoidal hypophysectomy;
• Use of MAO inhibitors (including 14 days after their withdrawal), tricyclic or tetracyclic antidepressants.

With caution

• Diabetes mellitus;
• Severe cardiovascular diseases (including coronary artery disease, angina pectoris);
• Prostatic hyperplasia;
• Pheochromocytoma;
• Porphyria;
• Breastfeeding period;
• With increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure;
• In patients with long QT syndrome.

Use in Pregnancy and Lactation

Pregnancy

The drug should not be used during pregnancy.

Breastfeeding period

During breastfeeding, the drug should be used only after a thorough assessment of the risk-benefit ratio for the mother and infant, under medical supervision. It is not allowed to exceed the recommended dose.

Pediatric Use

Contraindicated in children under 6 years of age.

Geriatric Use

The recommended doses and duration of use of the drug should not be exceeded, especially in elderly patients.

Special Precautions

Rare cases of the development of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) against the background of therapy with sympathomimetic drugs, including xylometazoline, have been described. Symptoms included sudden onset of severe headache, nausea, vomiting, and visual disturbances. In most cases, the condition improved or the phenomenon resolved within a few days after appropriate treatment. If symptoms of PRES or RCVS develop, Otrivin^® should be discontinued immediately and medical attention should be sought.

It is not recommended to use continuously for more than 7 days.

The lowest dose necessary to achieve the effect should be used for the shortest possible period of time.

Do not exceed the recommended doses, especially in children and the elderly.

Long-term (more than 7 days) or excessive use of the drug may cause a rebound effect (medicinal rhinitis) and/or atrophy of the nasal mucosa.

Patients with long QT syndrome using Xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

Benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa.

Effect on the ability to drive vehicles and mechanisms

In case of development of systemic side effects (headache, palpitations, increased blood pressure, visual impairment), it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms Xylometazoline, when applied topically in an excessive dose or when accidentally ingested, can cause severe dizziness, increased sweating, a sharp decrease in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions. Following an increase in blood pressure, a sharp decrease may be observed.

Treatment appropriate supportive measures should be taken for any suspicion of overdose; in some cases, immediate symptomatic treatment under medical supervision is indicated. These measures should include monitoring the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation measures should continue for at least 1 hour.

Drug Interactions

Xylometazoline is contraindicated in patients currently receiving MAO inhibitors, including 14 days after their withdrawal.

Concomitant use of tri- or tetracyclic antidepressants and sympathomimetic drugs may lead to an increase in the sympathomimetic effect of xylometazoline, therefore such a combination is contraindicated.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is available without a prescription.

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.