Nokspray

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

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 transparent liquid with a specific odor.

Pharmacotherapeutic group. Anti-edematous and other locally acting drugs for nasal cavity disorders. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Nokspray is an α-adrenergic agonist, an imidazole derivative, belonging to the group of local vasoconstrictors. When administered into the nasal cavity, the drug constricts arterioles of the nasal mucosa, thereby reducing edema, hyperemia, and exudation, restoring nasal breathing, and decreasing nasal discharge. Nokspray reduces swelling of the mucous membrane around the opening of the Eustachian tube, improving drainage in cases of eustachitis and otitis media. The essential oils contained in the formulation help relieve the sensation of nasal mucosa irritation and protect it from excessive drying. Local vasoconstriction of the nasal mucosa and paranasal sinuses occurs within 5–10 minutes after spraying the drug into the nasal cavity and lasts for 10–12 hours.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Acute respiratory diseases accompanied by nasal congestion, allergic rhinitis, vasomotor rhinitis, to restore drainage and nasal breathing in diseases of the nasal sinuses and eustachitis, to eliminate swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenomimetics, or to any component of the drug; atrophic rhinitis; increased intraocular pressure, especially in closed-angle glaucoma; pheochromocytoma; severe forms of cardiovascular diseases (arterial hypertension, ischemic heart disease), pronounced atherosclerosis, acute cardiovascular disorders or cardiac asthma, tachysystolic cardiac rhythm disorders, angina pectoris; metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria); renal insufficiency; 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 of monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as within 2 weeks after discontinuation of MAOIs, and also with other drugs that may increase blood pressure. Prostatic hyperplasia.

Interaction with other medicinal products and other types of interactions.

When using other medicinal products prior to starting treatment with this drug, it is recommended to consult a physician. The drug should not be used simultaneously with other local vasoconstrictive agents (regardless of the route of administration), with other nasal decongestants, or with tricyclic antidepressants and maprotiline, as this may lead to increased blood pressure. Such combined use is possible only after consultation with a physician. Concomitant use with monoamine oxidase inhibitors (MAOIs) may lead to increased blood pressure. Nokspray should not be used simultaneously or within 2 weeks after discontinuation of MAOI therapy (see section "Contraindications"). Concomitant use of oxymetazoline with tricyclic antidepressants may increase the risk of developing arterial hypertension and arrhythmia. Oxymetazoline may reduce the effectiveness of β-adrenoblockers, methyldopa, or other antihypertensive drugs. Concomitant use of sympathomimetics and antiparkinsonian agents may increase toxic effects on the cardiovascular system.

Instructions for use.

Insert the tip of the bottle into each nostril and press the bottle sharply once. Inhale the sprayed air through the nose. Do not tilt the head backward or turn the bottle upside down when spraying. To prevent the spread of infection, do not use the same bottle for more than one person.

Avoid prolonged use and overdosing of the medication. Prolonged use of nasal decongestants may lead to reduced effectiveness. Misuse of these agents may cause atrophy of the mucous membrane, reactive hyperemia with drug-induced rhinitis, as well as damage to the epithelium and inhibition of its activity. Special monitoring is required after application in patients with chronic rhinitis and when reducing swelling prior to diagnostic procedures. Doses higher than recommended should be used only under medical supervision. Continuous use of the medication should not exceed 7 days.

Persistent nasal congestion after the third day of use may indicate the presence of a deviated nasal septum, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other undiagnosed conditions requiring medical consultation and specialized comprehensive treatment.

Consult a doctor before starting use of this medication in the following cases: high blood pressure, cardiovascular diseases, liver or kidney disorders.

Use during pregnancy or breastfeeding.

Oxymetazoline has not been associated with adverse pregnancy outcomes. The medication should be used with caution in patients with arterial hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may reduce placental blood flow. During pregnancy or breastfeeding, the medication may be used with particular caution only when, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus/infant. 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.

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 reduced.

Method of Administration and Dosage

For adults and children aged 6 years and older: administer 1 spray into each nostril 2–3 times daily. Doses higher than recommended should be used only under medical supervision. The medication should not be used for longer than 5–7 days. Repeated use is allowed only after several days.

Children

This medication is intended for children aged 6 years and older.

Overdose

In cases of significant overdose 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, excessive sweating, agitation, fear, seizures, pallor, miosis, hyposmia, hallucinations, psychiatric disturbances, and physical discomfort. Very rarely, central nervous system (CNS) depression may occur, manifesting as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disorders, apnea, loss of consciousness, and potential progression to coma.

Clinical manifestations of overdose in children include CNS-related symptoms: seizures and coma, hallucinations, bradycardia, apnea, arterial hypertension followed by hypotension.

Emergency measures: in case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Gastric lavage, activated charcoal administration, and artificial ventilation of the lungs if necessary are indicated. In case of arterial hypertension, vasodilators (phentolamine, sodium nitroprusside) should be administered. Vasopressor agents must not be used. In case of agitation, benzodiazepines should be administered; anticonvulsant therapy should be carried out with benzodiazepines and/or barbiturates. In severe cases, tracheal intubation and artificial ventilation of the lungs may become necessary.

Adverse reactions.

Respiratory, thoracic and mediastinal disorders: discomfort or irritation in the nose, mouth and throat, burning sensation or dryness of the nasal mucosa, sneezing, nasal bleeding, apnea in newborns and young children (especially in cases of overdose). After the effect of the drug wears off, a strong sensation of nasal congestion may occur (rebound hyperemia).

Nervous system disorders: headache, nausea, dizziness, drowsiness or insomnia, restlessness, nervousness, anxiety, tremor, increased fatigue, seizures (especially in children), hallucinations (especially in children).

Eye disorders: eye irritation, discomfort or redness, blurred vision.

Cardiovascular system disorders: local nasal application may cause systemic effects (tachycardia, increased blood pressure, palpitations, sensation of pounding heartbeat, chest pain), facial flushing.

Immune system disorders: allergic reactions, including rash, itching, angioedema.

General disorders: weakness.

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.

10 ml in a polymer container with a spray pump and a cap with a tamper-evident seal, in a cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and location of business activity.

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

Marketing authorization holder.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Address of the marketing authorization holder.

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

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

www.sperco.ua