Oxyfresh

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

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. Decongestants and other agents for local use in nasal cavity disorders. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Oxyfresh belongs to the group of local vasoconstrictive agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing edema of the nasal mucosa. It constricts blood vessels at the site of application, decreases swelling of the nasal mucosa and upper respiratory tract, reduces nasal discharge, and restores nasal breathing. Relief of nasal mucosal edema promotes restoration of aeration in the paranasal sinuses and the 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, and malaise).

When applied locally as a nasal formulation 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 in the form of a nasal spray, compared to placebo saline solution, significantly reduced 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, and 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.

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

Additional pharmacokinetic data from human studies are lacking.

Safety preclinical findings.

In repeated-dose toxicity studies in dogs following intranasal administration of oxymetazoline, no risks to human safety were identified. Results of the in vitro bacterial mutagenicity test were negative. Carcinogenicity data for this medicinal product are currently unavailable. No teratogenic effects were observed in rats and rabbits. However, 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 any component of the medicinal product; atrophic rhinitis; increased intraocular pressure, especially in angle-closure 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. Inflammation or damage to the skin around the nasal passages or to the nasal mucosa. Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as within 2 weeks after discontinuation of MAOI therapy. Also contraindicated with other medicinal products that increase blood pressure. Prostate hyperplasia.

Interaction with other medicinal products and other types of interactions.

If the patient is taking other medicinal products, consultation with a physician is recommended before starting treatment with Oxifresh. Oxifresh should not be used concomitantly with other local vasoconstrictors (regardless of administration route), 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. Oxifresh 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-adrenoblockers, methyldopa, or other antihypertensive medicinal products. Concomitant use of sympathomimetics and anti-Parkinson 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. Misuse of this product may cause atrophy of the mucous membrane and reactive hyperemia, resulting in medicamentosa rhinitis, as well as epithelial damage and inhibition of its activity. Special monitoring is required in patients with chronic rhinitis after administration of the medicinal product, and when the spray is used to relieve nasal congestion prior to diagnostic procedures. Doses higher than recommended should be administered only under medical supervision. The duration of 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 initiating use of this medicinal product if they have hypertension, cardiovascular disorders, or hepatic or renal 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 only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus/child. In such cases, special caution is required; exceeding the recommended dosage is not permitted.

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 at 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.

Method of administration and dosage.

Adults and children aged 6 years and older

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

Method of administration

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 formed. Insert the nozzle tip into each nostril and press the container once sharply. During spraying, inhale air 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 more than one person use the same container. After use, clean the spray nozzle and cover the container with the protective cap.

Children.

Oxifresh may be used in children aged 6 years and older.

Overdose.

In case 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, increased sweating, agitation, fear sensations, convulsions, pallor, miosis, hyposmia, hallucinations, psychiatric disorders, physical discomfort. Very rarely, central nervous system (CNS) depression may be observed, manifesting as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disorders, apnea, loss of consciousness with possible progression to coma.

Clinical manifestations of overdose in children include CNS-related symptoms: seizures and coma, hallucinations, bradycardia, apnea, arterial hypertension, which may shift 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 an antidote. If necessary, measures to reduce body temperature should be taken; benzodiazepines are indicated for agitation, and anticonvulsant therapy should be conducted with benzodiazepines and/or barbiturates. In severe cases, tracheal intubation and artificial ventilation of the lungs may be required.

Adverse reactions.

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 drug-induced 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), 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, blurred vision.

Gastrointestinal disorders.

Rare: nausea.

Immune system disorders.

Uncommon: hypersensitivity reactions (angioneurotic edema, rash, pruritus).

Nervous system disorders.

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

Musculoskeletal and connective tissue disorders.

Very rare: convulsions (especially in children).

Respiratory, thoracic and mediastinal disorders.

Rare: nasal, oral or throat discomfort or irritation, burning or dryness of the nasal mucosa, sneezing, epistaxis. After the effect of the medicinal product wears off, 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 enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System 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 a temperature not exceeding 30 °C. Keep out of reach of children.

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

Supply category. Over-the-counter.

Manufacturer. Ukrainian-Spanish joint venture "Sperko Ukraine".

Manufacturer's address and place of business.
21027, Ukraine, Vinnytsia, vul. 600-richchia, 25.