Nazo-spray

INSTRUCTIONS for medical use of the medicinal product NAZO-SPRAY

Composition:

Active substance: oxymetazoline;

1 ml of solution contains oxymetazoline hydrochloride 0.5 mg;

Excipients: benzalkonium chloride, racemic camphor, racemic menthol, eucalyptol, disodium edetate (Trilon B), propylene glycol, sodium dihydrogen phosphate dihydrate, sodium hydroxide or concentrated hydrochloric acid, purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: colorless or slightly yellowish, transparent liquid with a specific odor. Slight opalescence may occur.

Pharmacotherapeutic group. Decongestants and other agents for local use in nasal cavity disorders. Simple sympathomimetics. 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 and upper respiratory tract mucosa, and reduces nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of ventilation of 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, a faster and more effective relief of symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise) has been demonstrated.

When applied locally in therapeutic concentrations, it does not irritate the nasal mucosa and does not cause hyperemia.

Pharmacokinetics. The effect of the drug begins very rapidly (within 20 seconds). The elimination half-life is approximately 35 hours after administration. 2.1% of the drug is excreted by the kidneys, and about 1.1% is excreted in feces. The duration of action of the drug is up to 12 hours.

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 paranasal sinuses, eustachitis.

• For reduction of swelling prior to diagnostic procedures in nasal passages.

Contraindications. Hypersensitivity to the components of the drug. Dry rhinitis.

After transsphenoidal hypophysectomy or other surgical interventions involving the dura mater. Children under 6 years of age.

Interaction with other medicinal products and other forms of interactions. Concurrent use of oxymetazoline and tricyclic antidepressants, monoamine oxidase inhibitors (MAO) such as tranylcypromine, or hypertensive agents may lead to increased blood pressure. These drugs should not be combined if possible.

In cases of oxymetazoline overdose, ingestion, or when used simultaneously or immediately after tricyclic antidepressants and/or MAO inhibitors, an increase in blood pressure may occur.

Special precautions for use

The drug should be used only after careful benefit-risk assessment in the following conditions: increased intraocular pressure, especially in closed-angle glaucoma, severe cardiovascular disorders (e.g., ischemic heart disease) and arterial hypertension, pheochromocytoma, metabolic disorders (e.g., hyperthyroidism, diabetes mellitus), benign prostatic hyperplasia, porphyria, and when using monoamine oxidase inhibitors (MAOIs) or other medicinal products that potentially increase blood pressure.

Prolonged use or overdose of the nasal decongestant may lead to reduced drug efficacy. Misuse of this product may cause drug-induced rhinitis, mucosal atrophy, and reactive hyperemia of the nasal mucosa (rebound effect).

Benzalkonium chloride contained in the drug may cause irritation and may provoke skin reactions.

Use during pregnancy or breastfeeding. Pregnancy. The drug should be used with particular caution, based on a careful benefit-risk assessment. Exceeding the recommended dosage is not recommended.

Breastfeeding period. It is unknown whether oxymetazoline passes into breast milk. Therefore, the use of the drug is possible only after a careful benefit-risk assessment. Exceeding the recommended dosage is not recommended, as it may reduce breast milk production.

Ability to influence reaction speed while driving or operating machinery. When used at recommended doses, no effect on reaction speed during driving or operating machinery is expected. However, after prolonged use 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

For adults and children aged 6 years and older: 1 spray into each nostril 2–3 times daily. Do not use the indicated single dose more than 3 times per day. Do not exceed the recommended doses. The medication should not be used for longer than 7 days.

Children. The medication must not be used in children under 6 years of age.

Overdose. Overdose may occur following nasal or accidental oral administration. The clinical picture caused by intoxication with imidazole derivatives may be diverse, as hyperreactive phases may alternate with phases of depression of the central nervous system (CNS), cardiovascular system, and respiratory system.

CNS stimulation may manifest as anxiety, excitement, hallucinations, and seizures.

CNS depression may manifest as decreased body temperature, lethargy, drowsiness, and coma.

Other possible symptoms include miosis, mydriasis, elevated body temperature, excessive sweating, pallor, cyanosis, palpitations, tachycardia, bradycardia, arrhythmia, cardiac arrest, arterial hypertension, shock hypotension, nausea and vomiting, respiratory depression, and apnea, as well as psychogenic disorders.

In children, overdose often leads to predominant CNS effects, including seizures and coma, bradycardia, apnea, and arterial hypertension, which may follow an initial phase of arterial hypotension.

Therapeutic measures: indicated in cases of severe overdose. Administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of ingestion of a large amount of the drug) should be performed immediately, as oxymetazoline can be rapidly absorbed. Vasopressor agents are contraindicated. Non-selective α-blockers may be used as antidotes. If necessary, measures for anticonvulsant therapy, lung ventilation, and antipyretic interventions should be initiated.

Side effects.

Respiratory system, thorax and mediastinum: heartburn or dryness of nasal mucosa, sneezing, increased swelling of mucous membrane, nasal bleeding after discontinuation of use, apnea in newborns and infants.

Musculoskeletal system: cramps (mainly in children).

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

Cardiovascular system: palpitations, tachycardia, arterial hypertension, arrhythmia.

Immune system: hypersensitivity reactions (rash, itching, angioneurotic edema).

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 15 ml in a container with nasal spray pump and protective cap in a carton.

Prescription status. Over-the-counter (without prescription).

Manufacturer.

Limited Liability Company "Experimental Plant "GNCLS".

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Address of manufacturer and location of its business activity.

Ukraine, 61057, Kharkiv region, Kharkiv city, Vorobiova street, building 8.

(Limited Liability Company "Experimental Plant "GNCLS")

Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenka street, building 22.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA")