Nazo-spray with aloe extract

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NARO-SPRAY WITH ALOE EXTRACT

Composition:

Active substance: oxymetazoline;

1 ml of the preparation contains 0.5 mg of oxymetazoline hydrochloride;

Excipients: sorbitol (E 420), sodium citrate, tyloxapol, chlorhexidine gluconate, anhydrous citric acid, benzalkonium chloride, potassium acesulfame, menthol, eucalyptol, disodium edetate, dry aloe extract, L-carvone, sodium hydroxide, purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: clear colorless or yellowish solution with a specific odor. Slight opalescence may occur during storage.

Pharmacotherapeutic group. Anti-edematous and other preparations for local use in nasal cavity disorders. Sympathomimetics, simple preparations. ATC code R01A A05.

Pharmacological Properties

Pharmacodynamics

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

Oxymetazoline exhibits 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 general malaise).

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

Pharmacokinetics

When applied locally via the nasal route at therapeutic doses, the drug 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 via the kidneys, and approximately 1.1% is excreted in feces.

Clinical characteristics.

Indications.

• Acute respiratory diseases accompanied by nasal congestion.
• Allergic rhinitis.
• Vasomotor rhinitis.
• For restoration of drainage and nasal breathing in diseases of the nasal sinus cavities, eustachitis.
• For relief of swelling prior to diagnostic procedures in the nasal passages.

Contraindications. Hypersensitivity to the components of the drug.

Atrophic rhinitis.

Inflammation or damage of the nasal mucosa or skin around the nostrils.

Use of monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of MAOI therapy, as well as other drugs that may increase blood pressure.

Elevated intraocular pressure, especially in closed-angle glaucoma.

Severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension).

Cardiac asthma.

Pheochromocytoma.

Metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria).

Prostate hypertrophy.

After transsphenoidal hypophysectomy or other surgical interventions involving exposure of the dura mater.

Interaction with other medicinal products and other types of interactions. Do not use MAO inhibitors and other drugs that increase blood pressure due to the risk of elevated blood pressure. Concomitant use of other vasoconstrictive medicinal products increases the risk of adverse effects.

It is known that this medicinal product interacts with tricyclic antidepressants, which may manifest as an increased risk of arterial hypertension and arrhythmia.

The drug should be used with caution in patients receiving bromocriptine, as cardiovascular disorders may occur.

It may reduce the effect of β-blockers or other antihypertensive drugs, such as methyldopa, betanidine, debrisoquin, and guanethidine.

Special precautions for use

Prolonged use and overdosing of the medication should be avoided. Long-term use of a nasal decongestant may lead to reduced effectiveness of the drug. Misuse of this product may cause atrophic rhinitis, mucosal atrophy, and reactive hyperemia resulting in medication-induced rhinitis.

Special monitoring is required for patients with chronic rhinitis after administration of the drug. Doses exceeding the recommended amounts should be used only under medical supervision.

If symptoms worsen or no improvement occurs within 3 days, medical advice should be sought.

Benzalkonium chloride contained in the formulation may cause nasal mucosal swelling, particularly with prolonged use. If such a reaction is suspected (persistent nasal congestion), a preservative-free medicinal product should be used. If it is not possible to use a preservative-free formulation, consideration should be given to using another dosage form.

Use during pregnancy or breastfeeding. The medication should be used with particular caution during pregnancy or breastfeeding. Exceeding the recommended dosage is not permitted.

Ability to affect reaction speed when driving or operating machinery. After prolonged use of the drug in doses exceeding the recommended amounts, a systemic effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive or operate machinery may be impaired.

Method of Administration and Dosage.

For adults and children aged 6 years and older: 1 spray into each nostril 2–3 times per day. Doses higher than recommended should be used only under medical supervision.

The product should not be used for longer than 5–7 days. Repeated use should be performed only after several days.

Children. The product should not be used in children under 6 years of age.

Overdose. After significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, palpitations, arrhythmia, cardiovascular insufficiency, cardiac arrest, increased sweating, agitation, convulsions, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, and psychiatric disturbances.

In addition, central nervous system depression may occur, manifesting as drowsiness, decreased body temperature, bradycardia, arterial hypotension, apnea, and potential development of coma.

Treatment measures in case of overdose: gastric lavage, administration of activated charcoal, lung ventilation. In case of decreased arterial pressure, phentolamine should be administered. Vasopressor agents should not be used. Anticonvulsant therapy may be indicated if necessary.

Adverse reactions.

Respiratory system: nasal discomfort, burning or dryness of the nasal mucosa, sneezing; after the effect of oxymetazoline ends, a sensation of severe nasal congestion may occur (rebound hyperemia); epistaxis; apnea in young children (especially in case of overdose).

Nervous system: headache, insomnia, anxiety, drowsiness, restlessness, tremor, fatigue, sedative effect, irritability, seizures, hallucinations (especially in children).

Cardiovascular system: local nasal administration may cause systemic effects such as palpitations, tachycardia, arterial hypertension.

Immune system: allergic reactions are possible, including rash, itching, angioneurotic edema.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 15 ml or 20 ml in a bottle equipped with a pump valve, nasal spray nozzle, and protective cap, in a carton.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.