Otrivin^® Express (Spray) Instructions for Use

Marketing Authorization Holder

Cheleon Rus, JSC (Russia)

Manufactured By

Haleon CH, SARL (Switzerland)

Contact Information

CHELEON RUS JSC (Russia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Form

Otrivin® Express

Metered-dose nasal spray with menthol aroma 35 mcg/1 dose: 10 ml bottle (not less than 120 doses) with dosing device, tip and protective cap

Dosage Form, Packaging, and Composition

Metered-dose nasal spray with menthol aroma in the form of a transparent to opalescent, colorless to white solution with the odor of menthol and eucalyptus.

Excipients: sorbitol, sodium chloride, macrogol glyceryl hydroxystearate, sodium dihydrogen phosphate dihydrate, levomenthol (menthol), cineole (eucalyptol), disodium edetate dihydrate, benzalkonium chloride 50% solution, disodium phosphate dodecahydrate, purified water.

10 ml (not less than 120 doses) – HDPE bottles (1) with a vertical pump dosing device with a tip and a protective cap – cardboard packs.
10 ml (not less than 120 doses) – HDPE bottles (1) with a pump dosing device with a side activation button with a tip and a protective cap – cardboard packs.

The secondary packaging may have a first-opening control.

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

Otrivin^® Express is a sympathomimetic that acts on α-adrenergic receptors of the nasal mucosa.

It has a vasoconstrictive effect, reducing the swelling of the nasopharyngeal mucosa. When applied topically to the inflamed nasal mucosa, it reduces its swelling and nasal discharge.

It restores nasal breathing, eliminates swelling of the nasal mucosa, and helps restore the aeration of the paranasal sinuses and the middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media).

When used intranasally in therapeutic concentrations, Oxymetazoline does not have a systemic effect, does not irritate, and does not cause hyperemia of the nasal mucosa.

The drug begins to act within 25 seconds, and the duration of action lasts up to 12 hours.

Results of a double-blind, placebo-controlled study in patients with acute viral rhinitis aged 12-70 years showed that the use of oxymetazoline in the dosage form of a metered-dose nasal spray, containing 0.5 mg of the active substance per 1 ml of spray, reduces the median duration of a runny nose from 6 to 4 days.

Pharmacokinetics

Absorption

When used as recommended, significant absorption of pharmacodynamically effective doses of oxymetazoline is considered infrequent but cannot be ruled out. In human studies, the absorption rate was 3.5%.

Elimination

The T_1/2 of oxymetazoline after its intranasal administration is 35 hours. 2.1% of oxymetazoline is excreted by the kidneys and about 1.1% through the intestines.

Indications

For adults and children aged 12 years and older

• Acute respiratory diseases with symptoms of rhinitis (runny nose);
• Acute allergic rhinitis;
• Exacerbation of vasomotor rhinitis;
• To restore drainage in inflammation of the paranasal sinuses (sinusitis);
• Eustachitis;
• Otitis media;
• To eliminate edema before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Adults

1 spray into each nostril 1-2 times/day. The minimum dosing interval is 8 hours.

The drug is used for 3 to 5 days. At the recommended dose, do not use the drug for more than 7 days without consulting a doctor.

A repeated course of the drug is possible only after several days during which the drug was not used.

With frequent and prolonged use of the drug, the feeling of nasal congestion may reappear or worsen.

Children

The dosage regimen for children aged 12 to 18 years does not differ from the dosage regimen for adults.

Children under 12 years of age the use of the drug Otrivin^® Express is contraindicated.

Method of Administration

Intranasally.

Bottle with vertical pump dosing device

The bottle with a vertical pump dosing device ensures precise distribution of the drug over the surface of the nasal mucosa.

Before first use, spray the spray into the air with several presses until the drug is evenly distributed. If the spray has not been used for several days or there is no even distribution, the procedure should be repeated. If the spray dose is not administered completely, do not repeat the administration.

Do not cut the tip of the dosing device.

Avoid contact with eyes.

1. Thoroughly clean your nose.
2. Hold the bottle vertically, supporting the bottom with your thumb, with the nozzle between your middle and index fingers.
3. Point the nozzle into the nostril, tilting the bottle slightly forward.
4. Press the spray device, spraying the drug, and simultaneously inhale through your nose.
5. After use, the nozzle should be cleaned and dried before closing it with the protective cap.

To avoid possible spread of infection, the drug should be used by only one person.

Bottle with pump dosing device with side activation button

The bottle with a pump dosing device with a side activation button ensures precise distribution of the spray over the surface of the nasal mucosa, creating a cloud of fine spray.

Before first use of the spray, press the pump dosing device 7 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 use of the drug was more than 7 days, it is necessary to activate the dosing device by pressing it 2 times.

Avoid contact with eyes.

1. Thoroughly clean your nose.
2. Hold the bottle vertically, placing your thumb on the activation button.
3. To avoid droplet formation, stand upright and insert the nozzle into the nostril.
4. Press the button with one finger, spraying the drug, and simultaneously inhale gently through your nose.
5. After use, the nozzle should be cleaned and dried before closing it with the protective cap until an audible click is heard.

To avoid possible spread of infection, the drug should be used by only one person.

Adverse Reactions

The frequency of adverse reactions was determined in accordance with the WHO classification: very common (≥ 1/10); common (≥ 1/100 but < 1/10); uncommon (≥ 1/1,000 but < 1/100); rare (≥ 1/10,000 but < 1/1,000); very rare (<1/10000).

Immune system disorders rare – systemic allergic reactions (angioedema of the tongue, throat, lips, and face).

Nervous system disorders rare – headache, insomnia, sedation, anxiety, irritability; very rare – restlessness, drowsiness.

Eye disorders rare – visual impairment (if it gets into the eyes).

Cardiac disorders rare – increased blood pressure, palpitations, tachycardia.

Respiratory, thoracic and mediastinal disorders common – epistaxis, dryness of the nasal mucosa, discomfort of the nasal mucosa, sneezing; uncommon – dry mouth, stomatitis, dry throat, throat irritation; very rare – respiratory arrest (in children).

Gastrointestinal disorders rare – nausea.

Skin and subcutaneous tissue disorders rare – exanthema, itching.

General disorders and administration site conditions very rare – fatigue.

Contraindications

• Hypersensitivity to oxymetazoline or any of the excipients included in the drug;
• Atrophic rhinitis;
• Closed-angle glaucoma;
• Surgical interventions on the dura mater (in history);
• Condition after transsphenoidal hypophysectomy;
• Inflammation of the skin and mucous membrane of the nasal vestibule;
• Children under 12 years of age;
• Pregnancy.

With caution

• Increased intraocular pressure;
• Arterial hypertension;
• Hyperthyroidism;
• Diabetes mellitus;
• Pheochromocytoma;
• Porphyria;
• Prostatic hyperplasia;
• Cardiovascular diseases;
• Breastfeeding period;
• In patients receiving MAO inhibitors at the present time or having received them within the previous 2 weeks, tri- and tetracyclic antidepressants, as well as other drugs that increase blood pressure;
• In patients with strong reactions to adrenergic agents: insomnia, dizziness, tremor, cardiac arrhythmia, increased blood pressure.

Use in Pregnancy and Lactation

Pregnancy

The drug is contraindicated during pregnancy due to the potential systemic vasoconstrictive effect.

Breastfeeding period

During breastfeeding, the drug can be used only in cases where the potential benefit to the mother outweighs the potential risk to the child. The use of the minimum effective dose and the shortest course should be considered.

Pediatric Use

Contraindicated for use under 12 years of age.

Special Precautions

The drug should not be used continuously for more than 7 days without consulting a doctor. Long-term or excessive use of the drug may cause tachyphylaxis, a rebound effect, and atrophy of the nasal mucosa.

Avoid getting the drug into the mouth, eyes, or on the skin around the eyes. If it gets into the eyes, visual impairment may occur.

To avoid the spread of infection, the drug must be used individually.

Rare cases of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) have been described during therapy with sympathomimetic drugs. 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, cerebral vasoconstriction develop, Oxymetazoline should be discontinued immediately and medical attention should be sought.

Excipients

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

Effect on the ability to drive vehicles and mechanisms

The use of the drug Otrivin^® Express in therapeutic doses does not affect the ability to drive vehicles and mechanisms. If systemic side effects develop (headache, palpitations, increased blood pressure, visual impairment), it is recommended to exercise caution when performing activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms in case of an overdose of oxymetazoline, the clinical picture is characterized by mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmia, cardiac arrest, arterial hypertension, pulmonary edema, shortness of breath, mental disorders, hallucinations, convulsions. Symptoms associated with depression of CNS functions may also appear, including drowsiness, decreased body temperature, bradycardia, shock-like hypotension, apnea, and loss of consciousness.

Treatment non-selective alpha-adrenergic blockers, in particular phentolamine, can be used to reduce blood pressure. In severe cases, intubation and mechanical ventilation may be required. In case of moderate or severe overdose as a result of accidental oral ingestion, activated charcoal and sodium sulfate (a laxative) are prescribed; after a significant overdose, gastric lavage is prescribed. Symptomatic therapy is indicated. The use of vasopressors is contraindicated.

Drug Interactions

Oxymetazoline is not recommended to be prescribed to patients receiving MAO inhibitors at the present time or having received them within the previous 2 weeks.

Concomitant use with tri- and tetracyclic antidepressants and sympathomimetics may enhance the sympathomimetic effect of oxymetazoline.

Storage Conditions

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

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

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.