Instructions Noxspray Active nasal spray 0.5 mg/ml container 10 ml
Composition
active ingredient: 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.
Dosage form
Nasal spray.
Main physicochemical properties: colorless or slightly yellowish transparent liquid with a specific odor.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics. ATX code R01A A05.
Pharmacological properties
Pharmacodynamics
Noxspray active is an α-adrenomimetic, an imidazole derivative, belonging to the group of local vasoconstrictors. When injected into the nasal cavity, the drug constricts the arterioles of the nasal mucosa, resulting in reduced edema, hyperemia, exudation, restored nasal breathing, and reduced nasal discharge. Noxspray reduces swelling of the mucous membrane around the opening of the Eustachian tube, improving drainage in eustachitis and otitis media. The essential oils included in the drug help eliminate the feeling of irritation of the nasal mucosa, protect it from excessive drying. Local vasoconstriction of the nasal mucosa and paranasal sinuses occurs 5-10 minutes after injection of the drug into the nasal cavity and lasts for 10-12 hours.
Pharmacokinetics
Didn't study.
Indication
Acute respiratory diseases accompanied by nasal congestion, allergic rhinitis, vasomotor rhinitis, to restore drainage and nasal breathing in diseases of the paranasal sinuses of the nasal cavity and eustachitis, to eliminate edema before diagnostic manipulations in the nasal passages.
Contraindication
Hypersensitivity to oxymetazoline, other adrenomimetics or to any of the components of the drug; atrophic rhinitis; increased intraocular pressure, especially in angle-closure glaucoma; pheochromocytoma; severe forms of cardiovascular diseases (arterial hypertension, ischemic heart disease), severe atherosclerosis, acute cardiovascular diseases or cardiac asthma, tachysystolic heart rhythm disorders, angina pectoris; metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria); renal failure; after transsphenoidal hypophysectomy or other surgical intervention with opening of the dura mater; inflammation or damage to the skin around the nasal passages or nasal mucosa. Concomitant use of monoamine oxidase inhibitors (MAO) and within 2 weeks after discontinuation of treatment with MAO inhibitors, as well as other drugs that cause an increase in blood pressure, is contraindicated. Prostatic hypertrophy.
Interaction with other medicinal products and other types of interactions
When using other medications, it is recommended to consult a doctor before starting treatment with this drug. The drug should not be used simultaneously with other vasoconstrictors (by any route of administration), with other nasal decongestants, as well as with tricyclic antidepressants, maprotiline, as an increase in blood pressure is possible. Such combined use is possible only after consulting a doctor. With simultaneous use with MAO inhibitors, an increase in blood pressure is possible.
Noxspray Active should not be used simultaneously with or within 2 weeks after discontinuation of treatment with MAO inhibitors (see section "Contraindications"). With simultaneous use of oxymetazoline with tricyclic antidepressants, the risk of developing arterial hypertension and arrhythmia may increase. Oxymetazoline may reduce the effectiveness of β-blockers, methyldopa or other antihypertensive drugs. With simultaneous use of sympathomimetics and antiparkinsonian drugs, an increase in the toxic effect on the cardiovascular system is possible.
Application features
To properly use the spray, you must:
Remove the protective cap from the sprayer. Before using the drug for the first time, press the sprayer several times until an aerosol appears.
Insert the tip of the spray into the nasal passage and inject by pressing the spray all the way down with your index and middle fingers. Inject the required number of times into each nasal passage (see section "Method of administration and dosage"), without tilting your head back. During the injection, you should take a light breath through your nose.
After use, close the sprayer with the protective cap.
Long-term use and overdose of the drug should be avoided. Long-term use of nasal decongestants may lead to a weakening of their effect. Abuse of these agents may cause atrophy of the mucous membrane and reactive hyperemia with rhinitis medicamentosa, as well as damage to the epithelium and inhibition of its activity. After using the drug, special supervision is required for patients with chronic rhinitis and in cases of edema removal before diagnostic procedures. Doses higher than recommended should be used only under the supervision of a physician. The duration of continuous use of the drug should not exceed 7 days.
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 this drug in the following cases: high blood pressure, cardiovascular disease, liver or kidney disorders.
Ability to influence reaction speed when driving vehicles or other mechanisms
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. The drug should be used with caution in patients with arterial hypertension or signs of reduced placental blood supply. Frequent or prolonged use of high doses may lead to reduced placental blood flow. During pregnancy or breastfeeding, the drug should be used only with extreme caution if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus/child. The recommended dosage should not be exceeded.
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
Adults and children over 6 years of age should use 1 spray in each nasal passage 2-3 times a day. Doses higher than recommended should be used only under the supervision of a physician. The drug should not be used for longer than 5-7 days. The drug can be used again only after a few days.
Children
The drug should be used in children over 6 years of age.
Overdose
In case of significant overdose or accidental internal use, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, cramps, tachycardia, arrhythmia, palpitations, cardiovascular failure, hypertension, shortness of breath, respiratory disorders, pulmonary edema, cardiac arrest, increased sweating, agitation, fear, convulsions, pallor, miosis, hyposmia, hallucinations, mental disorders, physical discomfort; very rarely - depression of the functions of the central nervous system (CNS), manifested by drowsiness, decreased body temperature, bradycardia, hypotension, collapse, shock, respiratory disorders, apnea, loss of consciousness with possible development of coma.
Clinical manifestations of overdose in children include CNS symptoms: convulsions and coma, hallucinations, bradycardia, apnea, arterial hypertension alternating with hypotension.
Emergency measures: in case of suspected overdose with oxymetazoline, urgent hospitalization in the intensive care unit is necessary. Gastric lavage, administration of activated charcoal, artificial ventilation of the lungs if necessary are necessary. In case of arterial hypertension, the use of vasodilators (phentolamine, sodium nitroprusside) is necessary. Vasopressors should not be used. If necessary, benzodiazepines should be prescribed for agitation, anticonvulsant therapy should be carried out with benzodiazepines and/or barbiturates. In severe cases, tracheal intubation and artificial ventilation of the lungs may be necessary.
Adverse reactions
Respiratory, thoracic and mediastinal disorders: discomfort or irritation in the nose, mouth and throat, burning or dryness of the nasal mucosa, sneezing, epistaxis, apnea in newborns and young children (especially in case of overdose). After the effect of the drug wears off, a feeling of severe nasal congestion (reactive hyperemia) may occur.
Nervous system: headache, nausea, dizziness, drowsiness or insomnia, restlessness, nervousness, anxiety, tremor, increased fatigue, convulsions (especially in children), hallucinations (especially in children).
On the part of the organs of vision: irritation, discomfort or redness of the eyes, blurred vision.
Cardiovascular system: topical nasal application may cause systemic effects (tachycardia, increased blood pressure, palpitations, palpitations, heart pain), flushing.
Immune system disorders: allergic reactions, including rash, itching, angioedema.
General disorders: weakness.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
10 ml in a polymer container with a pump and sprayer in a cardboard pack.
Vacation category
Without a prescription.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the manufacturer and its business address
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
