Naso-spray baby

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAZO-SPRAY BABY

Composition:

Active substance: oxymetazoline;

1 ml of the preparation contains 0.25 mg of oxymetazoline hydrochloride;

Excipients: benzalkonium chloride, propylene glycol, eucalyptol, anhydrous sodium dihydrogen phosphate, disodium edetate, sodium hydroxide, purified water.

Pharmaceutical form. Nasal spray, solution.

Main physico-chemical properties: clear, colorless or slightly yellowish solution with a characteristic odor.

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

Pharmacological properties.

Pharmacodynamics. Oxymetazoline is an α-adrenomimetic agent, an imidazoline derivative, belonging to the group of local vasoconstrictors. It constricts blood vessels at the site of application, reduces swelling of the mucous membrane of the nose and upper respiratory tract, and decreases nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of ventilation to 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 acute rhinitis symptoms (nasal congestion, rhinorrhea, sneezing, malaise) has been observed. When applied locally in nasal form at therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The essential oils contained in the formulation help relieve the sensation of nasal mucosa irritation and protect it from excessive drying.

Pharmacokinetics. 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. The duration of action of oxymetazoline 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 accessory sinuses, eustachitis.
• For elimination of edema prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to the components of the drug; atrophic rhinitis; use of monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of MAOI therapy, as well as other drugs that increase blood pressure; elevated intraocular pressure, especially closed-angle glaucoma; severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension); pheochromocytoma; metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria); prostate hypertrophy.

Interaction with other medicinal products and other types of interactions.

The drug should not be used simultaneously with other local vasoconstrictors and intranasally administered agents (increased frequency of adverse reactions), with MAO inhibitors and other drugs that increase blood pressure due to the risk of arterial hypertension.

Instructions for Use

Insert the tip of the bottle's nozzle into each nostril and press the nozzle sharply once. During spraying, inhale the air through the nose. Do not tilt the head backward or turn the bottle upside down while administering (the bottle must be held strictly vertically). To prevent the spread of infection, do not use the same bottle for multiple individuals.

Avoid prolonged use and overdosing of the medication. Long-term use of a nasal decongestant may lead to reduced effectiveness of the drug. Misuse of this product may cause atrophic rhinitis, atrophy of the mucous membrane, and reactive hyperemia resulting in medicamentosa rhinitis. Special monitoring is required after administration in patients with chronic rhinitis and when nasal swelling has been relieved prior to diagnostic procedures. Doses higher than recommended should be used only under medical supervision.

Use during pregnancy or breastfeeding

The medication may be used with particular caution only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus/infant. Exceeding the recommended dose is not permitted.

Ability to affect reaction speed when driving or operating machinery

After prolonged use of doses exceeding the recommended amount, 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.

Children aged 1 to 6 years: 1 spray into each nostril 2–3 times daily. Doses higher than recommended should be used only under medical supervision. The drug should not be used for longer than 5–7 days. The drug may be re-administered only after several days.

Children.

The drug is indicated for children aged 1 to 6 years.

Overdose.

In case of significant overdose or accidental ingestion, the following symptoms may occur: mydriasis or miosis, nausea, vomiting, cyanosis, pallor, increased sweating, hyperthermia, spasms, tachycardia, palpitations, arrhythmia, cardiovascular insufficiency, arterial hypertension, respiratory disorders, pulmonary edema, cardiac arrest, hyposmia, agitation, seizures, and psychiatric disturbances. Additionally, central nervous system depression may occur, characterized by drowsiness, decreased body temperature, bradycardia, arterial hypotension, apnea, and possible progression to coma.

Treatment measures in case of overdose: gastric lavage, administration of activated charcoal, artificial ventilation of the lungs if necessary. In case of arterial hypertension, vasodilators (phentolamine, sodium nitroprusside) should be used. Vasopressor agents should not be used. If necessary, in cases of agitation, benzodiazepines should be administered; anticonvulsant therapy should be performed with benzodiazepines and/or barbiturates.

Adverse reactions.

Respiratory system: nasal discomfort, burning or dryness of the nasal mucosa, sensation of pronounced nasal congestion (reactive hyperemia), sneezing, epistaxis, apnea in newborns and young children, especially in cases of overdose.

Gastrointestinal system: nausea, vomiting.

Nervous system: headache, drowsiness, fatigue, lethargy, insomnia, restlessness, seizures, hallucinations, dizziness.

Cardiovascular system: local nasal application of the drug may cause systemic effects (sensation of irregular heartbeat, tachycardia, arterial hypertension).

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

Shelf life. 3 years.

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

Keep out of reach of children.

Packaging. 15 ml in a glass bottle with a pump valve, nasal spray nozzle, and protective cap in a box.

20 ml in a polymer bottle with a pump valve, nasal spray nozzle, and protective cap in a box.

Dispensing category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVOYA".

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