Nazalong®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NACOLONG®

Composition:

Active substance: oxymetazoline hydrochloride; 100 g of the preparation contains 0.05 g of oxymetazoline hydrochloride calculated as 100 % substance;

Excipients: benzalkonium chloride, polyethylene glycol, disodium edetate, propylene glycol, povidone, sodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical properties: the preparation is sprayed as an aerosol jet consisting of liquid particles dispersed in air.

Pharmacotherapeutic group.

Anti-edematous and other preparations for local use in nasal cavity diseases. Simple sympathomimetics. Oxymetazoline.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Nazalong® belongs to the group of local vasoconstrictive agents (decongestants). Oxymetazoline hydrochloride is a synthetic adrenomimetic agent exerting alpha-adrenomimetic action.

The product provides rapid relief of nasal congestion symptoms of any origin. Oxymetazoline hydrochloride, an ingredient of the preparation, exerts a local vasoconstrictive effect: it rapidly reduces swelling of the nasal mucosa, restores nasal breathing, and eliminates olfactory function disturbances. It does not impair mucociliary clearance and promotes rapid recovery of the protective functions of the nasal and nasal cavity mucous membranes.

Pharmacokinetics.

The effect of the preparation begins rapidly (within a few minutes after application). Duration of action – up to 12 hours.

Clinical characteristics.

Indications.

Treatment of acute rhinitis (nasal congestion) of any origin: infectious, viral, vasomotor, or allergic (pollinosis). As part of complex therapy for sinusitis, eustachitis, and otitis media.

For facilitating rhinoscopy and surgical procedures within the nasal cavity.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenergic agents, or any component of the drug.

Atrophic rhinitis.

During use of monoamine oxidase inhibitors (MAOIs) or within 2 weeks after discontinuation of MAOIs, as well as with other drugs that may increase blood pressure.

Elevated intraocular pressure, especially in closed-angle glaucoma.

Severe cardiovascular disorders (e.g., ischemic heart disease, arterial hypertension).

Marked atherosclerosis, cardiac arrhythmias (e.g., tachycardia).

Renal insufficiency.

Pheochromocytoma.

Metabolic disorders (hyperthyroidism, thyrotoxicosis, diabetes mellitus).

Prostatic hyperplasia.

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

Inflammation or damage to the skin of the nasal passages or nasal mucosa.

Interaction with other medicinal products and other forms of interaction.

Prior to using other medicinal products, patients should consult a physician.

Concomitant use of this drug with other vasoconstrictors (regardless of route of administration) or with other nasal decongestants, as well as with tricyclic antidepressants or maprotiline, should only be performed after consultation with a physician due to the potential for increased blood pressure. The drug slows the absorption of local anesthetics and prolongs their effect. It enhances the central nervous system effects of MAO inhibitors. Due to the risk of elevated blood pressure, MAO inhibitors, tricyclic antidepressants, and other drugs that increase blood pressure and cause arrhythmias should not be used concomitantly with Nazalong®.

Oxymetazoline may reduce the effectiveness of β-blockers, methyldopa, or other antihypertensive agents.

Concomitant use of sympathomimetics and anti-Parkinson agents may result in additive toxic effects on the cardiovascular system.

Special precautions for use

When spraying into the nasal cavity, do not tilt the head back or invert the bottle. It is not recommended that several individuals use the same bottle to avoid the spread of infection.

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

Medical advice should be sought before starting use of this medication in the following cases: high blood pressure, cardiovascular diseases, liver or kidney disorders, porphyria.

Prolonged use and overdosage of the medication should be avoided. Prolonged use of nasal decongestants may lead to diminished effectiveness. Misuse of this product may cause atrophy of the nasal mucosa and reactive hyperemia, resulting in drug-induced rhinitis, as well as damage to the mucosal epithelium and inhibition of epithelial activity.

Concomitant use of this medication with other intranasally administered medicinal products is not recommended.

Special monitoring is required after administration in patients with chronic rhinitis and when relieving nasal congestion prior to diagnostic procedures. Doses higher than recommended should be used only under medical supervision.

The recommended dosage should not be exceeded.

The preservative (benzalkonium chloride) contained in the medicinal product may cause swelling of the nasal mucosa, especially with prolonged use. If such a reaction is suspected (chronically blocked nose), another intranasal medicinal product without preservatives should be used. If a preservative-free nasal preparation is unavailable, another pharmaceutical form should be considered.

Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding

Oxymetazoline has not been associated with adverse pregnancy outcomes. Caution should be exercised in patients with hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may reduce placental blood flow. Use during pregnancy is possible only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus/child.

It is not known 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

Oxymetazoline does not affect or has negligible effects on the ability to drive or operate machinery. However, after prolonged use at doses exceeding the recommended levels, a general 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

1. Remove the protective cap. Before the first use of the medication, press the spray pump several times until a fine mist appears.
2. Insert the spray nozzle into the nostril and administer a spray by firmly pressing the pump with the index and middle fingers.
3. Administer the required number of sprays (see below) into each nostril; there is no need to tilt the head backward.
4. During administration, it is recommended to gently inhale through the nose, which facilitates optimal distribution of the aerosol in the nasal cavity.
5. After use, cover the spray nozzle with the protective cap.

For adults, administer 1–2 sprays; for children aged 6 years and older – 1 spray into each nostril. The interval between administrations should be at least 10–12 hours. The treatment course should not exceed 3–5 days. Do not use doses exceeding the recommended ones.

Children.

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

Overdose.

With topical application, systemic adverse reactions usually do not occur. Overdose may occur after nasal or accidental oral ingestion.

Symptoms of oxymetazoline overdose vary. Stages of hyperexcitability and depression of the central nervous, cardiovascular, and respiratory systems may develop. Central nervous system stimulation manifests as anxiety, agitation, hallucinations, and seizures.

Depression of central nervous system function manifests as decreased body temperature, lethargy, drowsiness, bradycardia, arterial hypotension, collapse, shock, respiratory disturbances, respiratory arrest, loss of consciousness, and coma.

Other possible symptoms include miosis, mydriasis, fever, increased sweating, pallor, cyanosis, palpitations, tachycardia, bradycardia, cardiac arrhythmias, cardiac arrest, arterial hypertension, shock hypotension, nausea, vomiting, respiratory depression, apnea, and psychogenic disorders.

In children, overdose often results in predominant central nervous system effects, including seizures and coma, hallucinations, bradycardia, apnea, and arterial hypertension followed by hypotension.

Emergency Treatment. In case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Activated charcoal and laxatives should be administered. Gastric lavage is necessary. To reduce elevated blood pressure, α-adrenoreceptor blockers (phentolamine) should be prescribed. Vasopressor agents should not be used. Anticonvulsant therapy may be indicated if necessary. In severe cases, endotracheal intubation and artificial ventilation of the lungs may be required.

Side effects.

With frequent and prolonged use, sensations of burning, tingling in the nose, facial flushing, sneezing, and dryness of the nasal mucosa may occur. Rarely, after the effect of the medication ends, a feeling of severe nasal congestion may occur (rebound hyperemia). Prolonged continuous use of vasoconstrictive agents may lead to tachyphylaxis or development of medication-induced rhinitis. Apnea in newborns and young children (especially in cases of overdose). Generally, serious adverse effects are not expected.

Cardiovascular system. Very rarely possible tachycardia, palpitations (sensation of rapid heartbeat), increased blood pressure, chest pain, arrhythmias.

Eye disorders. Rarely, eye irritation, discomfort, or redness, blurred vision may occur.

Gastrointestinal tract. Nausea may rarely occur.

Immune system. In isolated cases, hypersensitivity reactions may occur, including rash, itching, angioedema (Quincke's edema).

Respiratory, thoracic and mediastinal disorders. Rarely, discomfort or irritation in the nose, mouth, and throat, nasal bleeding, a feeling of exhaustion, increased swelling of the mucous membrane may occur.

Nervous system. Restlessness, nervousness, anxiety, insomnia, drowsiness, tremor, hallucinations (especially in children), increased fatigue, sedative effect, headache, dizziness.

Skin and subcutaneous tissue disorders. Rash.

Musculoskeletal and connective tissue disorders. Cramps (especially in children).

General disorders. Weakness.

Shelf life.

3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 g in bottles with a nasal spray pump. 1 bottle per carton.

Classification of release.

Over-the-counter.

Manufacturer.

LLC "Micropharm".

Manufacturer's address and location of business activity.

20 Shevchenka Street, Kharkiv, Ukraine, 61013.

Marketing authorization holder.

LLC "VALARTIN PHARMA".

Address and location of business activity of the marketing authorization holder.

60 Hrushevskoho Street, Chayky, Kyiv-Sviatoshyn District, Kyiv Oblast, Ukraine, 08135.