Instructions for use Nazalong nasal spray 0.05% bottle 10 g
Composition
active ingredient: oxymetazoline hydrochloride; 100 g of the drug contain oxymetazoline hydrochloride in terms of 100% substance 0.05 g;
other ingredients: benzalkonium chloride, polyethylene glycol, disodium edetate, propylene glycol, povidone, sodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, purified water.
Dosage form
Nasal spray, metered.
Main physicochemical properties: the drug is sprayed in the form of an aerosol jet, which is liquid particles dispersed in the air.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. Oxymetazoline.
ATX code R01A A05.
Pharmacological properties
Pharmacodynamics
Nazalong belongs to the group of local vasoconstrictors (decongestants). Oxymetazoline hydrochloride is a synthetic adrenomimetic and has an alpha-adrenomimetic effect.
A remedy for quickly eliminating the symptoms of rhinitis of any origin. Oxymetazoline hydrochloride, which is part of the drug, has a local vasoconstrictor effect: quickly eliminates swelling of the nasal mucosa, restores nasal breathing and eliminates impaired olfactory function. Does not cause impaired mucociliary clearance, promotes rapid restoration of the protective properties of the nasal mucosa and nasal passages.
Pharmacokinetics
The drug begins to act quickly (a few minutes after application). The duration of action is up to 12 hours.
Indication
Treatment of acute rhinitis of any origin: infectious, viral, vasomotor or allergic (pollinosis). In the complex treatment of sinusitis, eustachitis, otitis media.
To facilitate rhinoscopy and surgical manipulations in the nasal cavity.
Contraindication
Increased individual sensitivity to oxymetazoline, other adrenomimetics or any components of the drug. Atrophic rhinitis. When using monoamine oxidase inhibitors (MAO) and within 2 weeks after stopping treatment with MAO inhibitors, as well as other drugs that contribute to an increase in blood pressure. With increased intraocular pressure, especially with angle-closure glaucoma. With severe forms of cardiovascular diseases (e.g. ischemic heart disease, arterial hypertension). Severe atherosclerosis, heart rhythm disturbances (e.g. tachycardia). Renal failure. Pheochromocytoma. Metabolic disorders (hyperthyroidism, thyrotoxicosis, diabetes mellitus). Prostatic hypertrophy. After transsphenoidal hypophysectomy or other surgical intervention with opening the dura mater. Inflammation or damage to the skin of the paranasal passages or nasal mucosa.
Interaction with other medicinal products and other types of interactions
When using other medications, it is recommended to consult a doctor before starting treatment.
The drug should be used together with other vasoconstrictors (regardless of the route of administration) or other nasal decongestants, as well as tricyclic antidepressants, maprotiline, after consulting a doctor, since an increase in blood pressure is possible. Slows down the absorption of local anesthetics and prolongs their effect. Enhances the effect of MAO inhibitors on the CNS. Due to the risk of increasing blood pressure, monoamine oxidase inhibitors, tricyclic antidepressants and other drugs that cause an increase in blood pressure and arrhythmia should not be used together with the drug Nazalong.
Oxymetazoline may reduce the effectiveness of β-blockers, methyldopa, or other antihypertensive drugs.
With the simultaneous use of sympathomimetics and antiparkinsonian agents, an additive toxic effect on the cardiovascular system is possible.
Application features
Do not tilt your head or invert the bottle when spraying into the nasal cavity. It is not recommended to use one bottle for multiple people to avoid spreading the infection.
Persistent swelling of the nasal passages 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 unrecognized diseases that require a doctor's consultation and specialized complex therapy.
You should consult a doctor before using the drug in the following cases: high blood pressure, cardiovascular disease, liver or kidney disorders, porphyria.
Prolonged use and overdose of the drug should be avoided. Prolonged use of a nasal decongestant may lead to a weakening of its effect. Abuse of this drug may cause mucosal atrophy and reactive hyperemia with rhinitis medicamentosa, as well as damage to the mucosal epithelium and inhibition of epithelial activity.
After using the drug, special supervision is required for patients with chronic rhinitis and for the elimination of edema before diagnostic procedures. Doses higher than recommended should be used only under the supervision of a physician.
Do not exceed the recommended dosage.
The preservative (benzalkonium chloride) contained in the drug may cause swelling of the nasal mucosa, especially with prolonged use. If such a reaction is suspected (chronic nasal congestion), another drug for intranasal administration that does not contain preservatives should be used. If a nasal drug without preservatives is not available, another dosage form should be used.
Propylene glycol may cause skin irritation.
Ability to influence reaction speed when driving vehicles or other mechanisms
Oxymetazoline has no or negligible influence on the ability to drive and use machines. After prolonged use of the drug in doses exceeding the recommended ones, a general effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive may be impaired.
Use during pregnancy or breastfeeding
Oxymetazoline has not been associated with adverse pregnancy outcomes. It should be used with caution in patients with hypertension or signs of reduced placental blood flow. Frequent or prolonged use of high doses may lead to reduced placental blood flow. The drug should be used in pregnant women 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 passes into breast milk. Due to the lack of data, oxymetazoline should not be used during breastfeeding.
Method of administration and doses
Remove the protective cap. Before using the drug for the first time, press the spray several times until a dispersed jet appears. Insert the spray into the nasal passage and inject by pressing the spray with your index and middle fingers until it stops. Inject the required number of times (see below) into each nasal passage, without tilting your head back. During the injection, it is recommended to inhale easily through the nose, which will lead to optimal distribution of the aerosol in the nasal cavity. After use, close the spray with the protective cap.
Adults should be prescribed 1-2 injections, children over 6 years old - 1 injection into each nasal passage. The interval between applications of the drug should be at least 10-12 hours. The course of treatment should not exceed 3-5 days. Do not use doses that exceed the recommended ones.
Children
The drug should not be used in children under 6 years of age.
Overdose
With topical application, systemic adverse reactions usually do not occur. Overdose is possible after nasal or accidental oral administration.
Symptoms of oxymetazoline overdose are varied. Stages of hyperreactivity and depression of the central nervous system, cardiovascular and pulmonary systems are distinguished. Central nervous system stimulation manifests itself in the form of anxiety, agitation, hallucinations, and seizures.
Central nervous system depression is manifested by decreased body temperature, lethargy, drowsiness, bradycardia, hypotension, collapse, shock, respiratory distress and respiratory arrest, loss of consciousness, and coma.
Other symptoms may include miosis, mydriasis, fever, increased sweating, pallor, cyanosis, palpitations, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, hypertension, shock-like hypotension, nausea and vomiting, respiratory depression, and respiratory arrest.
In children, overdose often leads to a predominance of the central nervous effect with convulsions and coma, hallucinations, bradycardia, apnea, and arterial hypertension alternating with hypotension.
Emergency care. In case of suspected overdose with oxymetazoline, urgent hospitalization in the intensive care unit is necessary. Activated charcoal and laxatives are prescribed. Gastric lavage is necessary. In order to reduce high blood pressure, β-blockers (phentolamine) should be prescribed. Vasopressors should not be taken. If necessary, anticonvulsant therapy is indicated. In severe cases, intubation and artificial ventilation of the lungs may be necessary.
Adverse reactions
With frequent and prolonged use, a burning sensation, tingling in the nose, flushing, sneezing, and dryness of the nasal mucosa may occur. Rarely, after the effect of the drug wears off, a feeling of severe nasal congestion (reactive hyperemia). Long-term continuous use of vasoconstrictor drugs can lead to tachyphylaxis or the development of rhinitis medicamentosa. Apnea in newborns and young children (especially in case of overdose). In general, no serious side effects are expected.
Cardiovascular system: Very rarely, tachycardia, palpitations (feeling of heartbeat), increased blood pressure, heart pain, arrhythmias are possible.
Gastrointestinal: Nausea may occur rarely.
Immune system disorders: In rare cases, hypersensitivity reactions, including rash, itching, angioedema (Quincke's edema), are possible.
Respiratory, thoracic and mediastinal disorders: Rarely, discomfort or irritation of the nose, mouth and throat, epistaxis, depletion effect, increased mucosal edema 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: Convulsions (especially in children).
General disorders: Weakness.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 g in bottles with a nasal spray. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
LLC "Micropharm".
Location of the manufacturer and its business address
Ukraine, 61013, Kharkiv, Shevchenko St., 20.
