Instructions for use Naso-spray nasal spray 0.5 mg/ml container 15 ml
Composition
active ingredient: oxymetazoline;
1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride;
other ingredients: benzalkonium chloride, racemic camphor, racemic menthol, eucalyptol, disodium edetate (Trilon B), propylene glycol, sodium dihydrogen phosphate dihydrate, sodium hydroxide or concentrated hydrochloric acid, purified water.
Dosage form
Nasal spray.
Main physicochemical properties: colorless or yellowish, transparent liquid with a specific odor. Opalescence is allowed.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A05.
Pharmacological properties
Pharmacodynamics
The drug belongs to the group of local vasoconstrictors. Oxymetazoline has a sympathomimetic and vasoconstrictor effect, eliminating swelling of the nasal mucosa. Narrows the vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, reduces nasal discharge. Restores nasal breathing. Elimination of swelling of the nasal mucosa contributes to the restoration of aeration of the paranasal sinuses, the middle ear cavity, which prevents the development of bacterial complications.
Oxymetazoline has antiviral, anti-inflammatory, immunomodulatory and antioxidant effects. Thanks to this combined mechanism of action, faster and more effective elimination of acute rhinitis symptoms (nasal congestion, rhinorrhea, sneezing, worsening of well-being) has been proven.
When applied topically to the nose in therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia.
Pharmacokinetics
The drug begins to act very quickly (up to 20 seconds). The half-life is about 35 hours after administration. 2.1% of the drug is excreted by the kidneys, about 1.1% - with feces. The duration of action of the drug is up to 12 hours.
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, Eustachian tube. To eliminate edema before diagnostic manipulations in the nasal passages.
Contraindication
Hypersensitivity to the components of the drug. Dry rhinitis.
After transsphenoidal hypophysectomy or other surgical interventions involving the dura mater. Children under 6 years of age.
Interaction with other medicinal products and other types of interactions
Concomitant use of oxymetazoline and tricyclic antidepressants, monoamine oxidase (MAO) inhibitors such as tranylcypromine, and antihypertensive drugs may lead to an increase in blood pressure. These drugs should not be combined if possible.
In case of overdose of oxymetazoline or if it is swallowed or if used simultaneously with or immediately after tricyclic antidepressants and/or MAO inhibitors, an increase in blood pressure is possible.
Application features
In the following cases, the drug should be used only after a careful benefit-risk assessment: increased intraocular pressure, especially in angle-closure glaucoma, severe cardiovascular diseases (e.g. ischemic heart disease) and arterial hypertension, pheochromocytoma, metabolic disorders (e.g. hyperthyroidism, diabetes mellitus, diabetes mellitus), prostatic hyperplasia, porphyria, when using MAO inhibitors and other drugs that potentially increase blood pressure.
Prolonged use and overdose of nasal decongestants may lead to a decrease in the effectiveness of the drug. Abuse of this drug may cause rhinitis medicamentosa, atrophy of the mucous membranes, reactive hyperemia of the nasal mucosa (reverse effect).
Benzalkonium chloride contained in the preparation causes irritation and may cause skin reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in recommended doses, no effect on the speed of reaction when driving or using other mechanisms is expected. After prolonged use of the drug in doses exceeding the recommended, a general effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive may be reduced.
Use during pregnancy or breastfeeding
Pregnancy. The drug should be used with extreme caution, taking into account a balanced assessment of the benefit-risk ratio. It is not recommended to exceed the recommended dosage.
Breastfeeding. It is not known whether oxymetazoline passes into breast milk. Therefore, the use of the drug is possible only after a balanced assessment of the benefit-risk ratio. It is not recommended to exceed the recommended dosage, as a decrease in breast milk production is possible.
Method of administration and doses
Adults and children over 6 years old - 1 spray in each nasal passage 2-3 times a day. Do not use the indicated single dose more than 3 times a day. Do not use doses higher than recommended. Do not use the drug for more than 7 days.
Children
The drug should not be used in children under 6 years of age.
Overdose
Overdose is possible after nasal or accidental ingestion. The clinical picture caused by intoxication with imidazole derivatives can be diffuse, as hyperreactive phases can alternate with phases of inhibition of the central nervous system (CNS), cardiovascular system and pulmonary system.
CNS stimulation is manifested by anxiety, agitation, hallucinations, and seizures.
CNS depression is manifested by decreased body temperature, lethargy, drowsiness, and coma.
Miosis, mydriasis, fever, increased sweating, pallor, cyanosis, palpitations, tachycardia, bradycardia, arrhythmia, cardiac arrest, hypertension, shock-like hypotension, nausea and vomiting, respiratory depression, and apnea may also occur.
In children, overdose often results in dominant CNS effects with convulsions and coma, bradycardia, apnea, and hypertension, possibly following hypotension.
Therapeutic measures: indicated in severe overdose. The use of activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (if a large amount of the drug is used) should be carried out immediately, since oxymetazoline can be rapidly absorbed. Vasopressor drugs are contraindicated. Non-selective α-blockers can be used as an antidote. If necessary, anticonvulsant therapy, pulmonary ventilation and measures that reduce fever should be initiated.
Adverse reactions
Respiratory, thoracic and mediastinal: burning or dryness of the nasal mucosa, sneezing, increased mucosal edema, nosebleeds after discontinuation of use, apnea in newborns and young children.
Musculoskeletal system: convulsions (mainly in children).
Nervous system: anxiety, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (especially in children).
From the cardiovascular system: palpitations, tachycardia, arterial hypertension, arrhythmia.
Immune system disorders: hypersensitivity reactions (rash, itching, angioedema).
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 C in the original packaging.
Keep out of reach of children.
Packaging
15 ml in a container with a nasal sprayer and a protective cap in a pack.
Vacation category
Without a prescription.
Producer
Limited Liability Company "Research Plant "GNTSLS".
Limited Liability Company "Pharmaceutical Company Zdorovya".
Location of the manufacturer and its business address
Ukraine, 61057, Kharkiv region, Kharkiv city, Vorobyovy street, building 8.
(Limited Liability Company "Research Plant "GNTSLS")
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
(Limited Liability Company "Pharmaceutical Company "Zdorovya")
