Nokspray pediatric

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOXPREY DYTIACHYI (NOXPREY DYTIACHYI)

Composition:

Active substance: oxymetazoline;

1 ml of the preparation contains oxymetazoline hydrochloride 0.25 mg;

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

Pharmaceutical form. Nasal spray.

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

Pharmacotherapeutic group. Decongestants and other preparations for local use in nasal cavity disorders. Sympathomimetics, simple preparations.

ATC code R01A A05.

Pharmacological Properties.

Pharmacodynamics.

Nok Spray Junior is an α-adrenergic agonist, an imidazoline derivative, belonging to the group of local vasoconstrictive agents. It constricts blood vessels at the site of application, reduces swelling of the nasal and upper respiratory tract mucosa, and decreases nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of sinus and middle ear cavity aeration, thus preventing the development of bacterial complications. Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, faster and more effective symptom relief has been observed in acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise). When applied locally in therapeutic concentrations, it does not irritate the nasal mucosa and does not cause hyperemia. The essential oils contained in the formulation help relieve the sensation of nasal mucosal irritation and protect it from excessive drying.

Pharmacokinetics.

The elimination half-life is approximately 35 hours after administration. 2.1% of the drug is excreted by the kidneys, about 1.1% – in feces. The duration of action of oxymetazoline is up to 12 hours.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug, atrophic rhinitis, during use of monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of MAOI therapy, as well as other drugs that increase blood pressure, in elevated intraocular pressure, especially in closed-angle glaucoma, severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension), pheochromocytoma, metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria), prostate hypertrophy. Should not be used after transsphenoidal hypophysectomy or other surgical procedures exposing the meninges.

Interaction with other medicinal products and other forms of interaction.

The drug should not be used concurrently with other local vasoconstrictors or intranasally administered agents (increased frequency of adverse reactions), MAO inhibitors of the tranylcypromine type, tricyclic antidepressants, and other agents causing increased blood pressure due to the risk of arterial hypertension.

Instructions for Use.

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

Avoid prolonged use and overdosing of the medication. Long-term use of nasal decongestants may lead to diminished drug efficacy. 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 and after reduction of swelling prior to diagnostic procedures. Doses higher than recommended should be used only under medical supervision.

Use during pregnancy or breastfeeding.

Data regarding the effects of original oxymetazoline in a limited number of women during the first trimester of pregnancy do not indicate the development of adverse reactions affecting the course of pregnancy or the health of the fetus/newborn. Other epidemiological data are still lacking. Animal studies have shown reproductive toxicity when doses exceeding therapeutic levels were administered. The drug should be used during pregnancy only after a careful assessment of the risk-benefit ratio to the fetus and mother. During pregnancy, the recommended dosage should not be exceeded, as overdosing may impair fetal blood supply.

Data on the passage of oxymetazoline into breast milk are unknown. The drug should be used during breastfeeding only after a careful benefit-risk assessment. During breastfeeding, the recommended dosage should not be exceeded, as overdosing may reduce the amount of breast milk in women.

Ability to affect reaction speed when driving or operating machinery.

After prolonged use of the medication at doses exceeding the recommended levels, a general effect on the cardiovascular and nervous systems cannot be excluded. In such cases, the ability to drive or operate machinery may be reduced.

Method of Administration and Dosage.

For children aged 1 to 6 years – 1 spray 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.

Children.

Nokspray for children should be administered to children aged 1 to 6 years.

Overdose.

Overdose may occur after nasal or accidental oral administration. The clinical picture of intoxication with imidazole derivatives may be unclear, as periods of stimulation may alternate with periods of depression of the central nervous, cardiovascular, and respiratory systems.

Stimulation of the central nervous system may manifest as anxiety, agitation, hallucinations, and seizures.

Depression of the central nervous system may manifest as decreased body temperature, lethargy, drowsiness, and possible development of coma.

Other possible symptoms include: miosis, mydriasis, elevated body temperature, excessive sweating, pallor, cyanosis, rapid heartbeat, tachycardia, bradycardia, arrhythmia, cardiac arrest, arterial hypertension, arterial hypotension up to shock, nausea, vomiting, respiratory insufficiency, and apnea, as well as psychiatric disorders.

In particular, in children, overdose may predominantly cause effects on the central nervous system: seizures and coma, bradycardia, apnea, and arterial hypertension possibly progressing to arterial hypotension.

Treatment. In cases of severe overdose, intensive therapy is indicated. Immediate administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of overdose with a large amount of the drug) is recommended, as oxymetazoline may be rapidly absorbed. Vasopressor agents are contraindicated. As an antidote, non-selective alpha-adrenoblockers may be used. If necessary, measures to reduce body temperature, anticonvulsant therapy, and lung ventilation should be implemented.

Side effects.

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.

Nervous system: headache, drowsiness, fatigue, lethargy, insomnia, restlessness, seizures (especially in children), hallucinations (especially in children), dizziness, nausea, vomiting.

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

Immune system: possible development of allergic reactions, including skin rash, itching, angioneurotic edema.

Shelf life.

3 years.

Do not use the drug 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.

15 ml in polymer containers with spray pumps and caps with a tamper-evident seal, in a cardboard box.

Availability.

Over-the-counter.

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

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

Tel.: + 38(0432)52-30-36. E-mail: [email protected]

www.sperco.ua