Oxybris

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OXYBRYZ (OXYBRYZ)

Composition:

Active substance: oxymetazoline;

1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride;

Excipients: benzalkonium chloride; levomenthol; racemic camphor; eucalyptol; sodium dihydrogen phosphate monohydrate; disodium edetate; propylene glycol; purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: colorless or slightly yellowish clear liquid with a specific odor.

Pharmacotherapeutic group. Anti-edematous and other drugs for local use in nasal cavity diseases. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Oxybriz belongs to the group of local vasoconstrictors. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing nasal mucosal edema. It constricts blood vessels at the site of application, decreases swelling of the nasal and upper respiratory tract mucosa, and reduces nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of aeration in the paranasal sinuses and middle ear cavity, thus preventing the development of bacterial complications.

Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, clinical studies have demonstrated faster and more effective relief of symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise).

When applied topically as a nasal spray at therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The elimination half-life is approximately 35 hours after administration. About 2.1% of the drug is excreted by the kidneys, and approximately 1.1% is excreted in feces.

Treatment with 0.05% oxymetazoline as a nasal spray, compared to placebo saline spray, significantly shortened the duration of the common cold: from an average of 6 days down to 4 days (P < 0.001). In a double-blind, parallel-group comparative study involving 247 adult patients, faster and more effective reduction of typical symptoms of acute rhinitis [nasal congestion, rhinorrhea, sneezing, malaise (P < 0.05)] was demonstrated, attributable to the combined vasoconstrictive, antiviral, anti-inflammatory, and antioxidant effects of oxymetazoline.

Pharmacokinetics.

Duration of action of the drug – up to 12 hours.

Following intranasal administration, the absorbed amount may sometimes be sufficient to produce systemic effects, for example, in the central nervous and cardiovascular systems.

Additional human pharmacokinetic data are not available.

Non-clinical safety data.

In toxicity studies in dogs, repeated nasal administration of oxymetazoline did not reveal any risks to human safety. Results of the in vitro bacterial mutagenicity test were negative. Currently, there are no data on the carcinogenic potential of this medicinal product. No teratogenic effects were observed in rats and rabbits. Doses higher than the therapeutic level were embryolethal or caused delayed fetal growth. In rats, suppression of maternal milk production was observed. There were no signs of impaired fertility.

Clinical characteristics.

Indications.

• Acute rhinitis.
• Allergic rhinitis.
• Episodes of non-infectious vasomotor rhinitis.
• To restore drainage and nasal breathing in diseases of the nasal sinus cavities, eustachitis associated with rhinitis.
• To eliminate swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenomimetics, or to any component of the medicinal product; atrophic rhinitis; increased intraocular pressure, especially in closed-angle glaucoma; pheochromocytoma; severe forms of cardiovascular diseases (arterial hypertension, ischemic heart disease), pronounced atherosclerosis, acute cardiovascular disorders or cardiac asthma, tachysystolic cardiac rhythm disturbances, angina pectoris; metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria); renal insufficiency. Do not use after transsphenoidal hypophysectomy or other surgical interventions involving opening of the dura mater. Skin inflammation or damage around the nasal passages or nasal mucosa. Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as within 2 weeks after discontinuation of MAOI therapy. Also contraindicated is concomitant use with other medicinal products that increase blood pressure. Prostate hyperplasia.

Interaction with other medicinal products and other types of interactions.

Prior to starting treatment with this medicinal product, consultation with a physician is recommended if other medicinal products are being used. Oxibryz should not be used concomitantly with other local vasoconstrictors (regardless of route of administration), with other nasal decongestants, or with tricyclic antidepressants and mianserin, due to the possible increase in blood pressure. Such combined use is permissible only after consultation with a physician. Concomitant use with monoamine oxidase inhibitors (MAOIs) may lead to increased blood pressure. Oxibryz should not be used concomitantly with MAOIs or within 2 weeks after discontinuation of MAOI therapy (see section "Contraindications"). When oxymetazoline is used concomitantly with tricyclic antidepressants, the risk of developing arterial hypertension and arrhythmia increases. Oxymetazoline may reduce the effectiveness of β-adrenergic blockers, methyldopa, or other antihypertensive medicinal products. Concomitant use of sympathomimetics and antiparkinsonian agents may increase toxic effects on the cardiovascular system.

Special precautions for use.

Prolonged use and overdosing of the medicinal product should be avoided. Prolonged use or overdose of a nasal decongestant may lead to diminished effectiveness (tachyphylaxis). If used for an extended period or overdosed, treatment with this medicinal product should be discontinued immediately. Abuse of this product may cause atrophy of the mucous membrane, reactive hyperemia with drug-induced rhinitis, as well as epithelial damage and inhibition of its activity. Special monitoring is required for patients with chronic rhinitis after application of the medicinal product, and when using the spray to relieve swelling prior to diagnostic procedures. Doses higher than recommended should only be administered under medical supervision. Continuous use of the medicinal product should not exceed 7 days.

Persistent nasal congestion after the third day of using the medicinal product may indicate the presence of nasal septum deviation, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other undiagnosed conditions requiring medical consultation and specialized comprehensive therapy.

Patients should consult a physician before starting use of this medicinal product if they have high arterial pressure, cardiovascular disorders, or liver or kidney impairment.

Use during pregnancy or breastfeeding.

Oxymetazoline has not been associated with adverse pregnancy outcomes. The medicinal product should be used with caution in patients with arterial hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may lead to decreased placental blood flow. During pregnancy, the medicinal product may be used with particular caution only if, in the physician’s opinion, the expected benefit to the woman outweighs the potential risk to the fetus/child. In such cases, special caution is required; exceeding the recommended dosage must not be allowed.

It is unknown whether oxymetazoline is excreted in breast milk. Due to the lack of data, oxymetazoline should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

With prolonged use of the medicinal product in doses exceeding the recommended levels, a systemic effect on the cardiovascular system cannot be ruled out. In such cases, the ability to drive or operate machinery may be impaired.

Administration and Dosage

Adults and children aged 6 years and older

One spray of Oxibryz medicinal product into each nostril 2–3 times daily. The single dose should not be used more than 3 times daily or for longer than 7 consecutive days. Doses higher than recommended should not be used.

Administration method

The spray mechanism operates by pressing the container. Before first use, remove the protective cap, hold the nasal spray in hand, and press the container several times until a consistent aerosol mist is produced. Insert the tip of the container’s nozzle into each nostril and press the container sharply once. During spraying, inhale the mist through the nose. Do not tilt the head back or turn the container upside down when administering into the nasal cavity. To avoid spreading infection, it is not recommended that multiple individuals use the same container. After use, clean the spray nozzle and cover the container with the protective cap.

Children

Oxibryz can be used in children aged 6 years and older.

Overdose

In cases of significant overdose of oxymetazoline or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, arrhythmia, palpitations, cardiovascular insufficiency, arterial hypertension, dyspnea, respiratory disorders, pulmonary edema, cardiac arrest, excessive sweating, agitation, fear, seizures, pallor, miosis, hyposmia, hallucinations, psychiatric disorders, and physical discomfort. Very rarely, central nervous system (CNS) depression may occur, manifesting as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disorders, apnea, loss of consciousness, and potentially coma.

Clinical manifestations of overdose in children include CNS-related symptoms: seizures and coma, hallucinations, bradycardia, apnea, arterial hypertension changing to hypotension.

Emergency measures: in case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Immediate administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of overdose with a large amount of the medicinal product) is recommended, as oxymetazoline may be rapidly absorbed. If arterial hypertension develops, vasodilators (phentolamine, sodium nitroprusside) should be administered. Vasopressor agents should not be used. Non-selective α-blockers may be used as antidotes. If necessary, measures to reduce body temperature should be taken; benzodiazepines may be administered for agitation, and anticonvulsant therapy may be performed with benzodiazepines and/or barbiturates. In severe cases, tracheal intubation and artificial ventilation of the lungs may be required.

Side effects

With frequent and prolonged use, sensations of burning, tingling in the nose, facial flushing, sneezing, and dryness of the mucous membrane may occur. Prolonged continuous use of vasoconstrictive medicinal products may lead to tachyphylaxis or development of medicamentosa rhinitis. Generally, severe adverse effects are not expected.

The frequency of adverse reactions is classified as follows: 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), and not known (cannot be estimated from available data).

Cardiovascular system.

Rare: palpitations (awareness of heartbeat), tachycardia, increased blood pressure, chest pain.

Very rare: arrhythmias.

Eye disorders.

Rare: eye irritation, discomfort or redness of the eyes, blurred vision.

Gastrointestinal disorders.

Rare: nausea.

Immune system disorders.

Uncommon: hypersensitivity reactions (angioedema, rash, itching).

Nervous system disorders.

Very rare: headache, nausea, dizziness, sedation, somnolence or insomnia, restlessness, nervousness, anxiety, tremor, increased fatigue, hallucinations (especially in children).

Musculoskeletal and connective tissue disorders.

Very rare: seizures (especially in children).

Respiratory, thoracic and mediastinal disorders.

Rare: discomfort or irritation in the nose, mouth, and throat, burning or dryness of the nasal mucosa, sneezing, epistaxis. After the effect of the medicinal product ends, a sensation of severe nasal congestion may occur (rebound hyperemia).

General disorders.

Very rare: weakness.

Frequency not known: tachyphylaxis (with prolonged use or overdose).

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at temperatures not exceeding 30 °C. Keep out of reach of children.

Packaging.

10 ml in a polyethylene container with a spray pump and a cap with a tamper-evident seal, packed in a cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint enterprise "Sperko Ukraine".

Manufacturer's address and location of business operations.

25, 600-Richchia St., Vinnytsia, 21027, Ukraine.