Evkazolin Aqua nasal spray 1mg/g 10g No.1
Name
Evkazolin Aqua spray name 1 mg/g in bottle with dosage 10 g in pack No. 1
Description
When the drug leaves the bottle through a dispenser pump with a nasal spray, it is sprayed in the form of an aerosol stream that has a specific odor and consists of liquid particles dispersed in the air.
Main active ingredient
1 g of spray contains xylometazoline hydrochloride in terms of 100% substance 1 mg
Release form
Spray
Dosage
10g
Pharmacological properties
Pharmacodynamics
Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors. Xylometazoline, when administered nasally, causes a constriction of the blood vessels of the nasal mucosa and adjacent areas of the nasopharynx, thus eliminating swelling and hyperemia of the nasal mucosa and nasopharynx, and also reduces the associated increased secretion of mucus and facilitates the removal of blocked nasal secretions, which leads to clearing of nasal passages passages and easier nasal breathing. The effect of the drug begins within 2 minutes after use and lasts up to 10 hours (for example, throughout the night). The drug is well tolerated by patients with sensitive mucous membranes and does not reduce mucociliary function. Research results have shown that xylometazoline reduces the infectivity of human rhinovirus, which is associated with the common cold.
Pharmacokinetics
When applied topically, xylometazoline is practically not absorbed; the concentration of xylometazoline in the blood plasma is so low that it is practically undetectable (the concentration in the blood plasma is close to the detection limit). Xylometazoline does not have mutagenic properties. Also, animal studies did not reveal the teratogenic effect of xylometazoline.
Indications for use
For symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.
Directions for use and doses
Evkazolin Aqua, nasal spray, for use in adults and children over 12 years of age. Adults and children over 12 years of age: 1 spray into each nasal passage up to 3 times a day as needed. Use no more than 3 times in each nasal passage per day. The duration of treatment depends on the course of the disease and should not exceed 7 days in a row. The metered spray ensures accurate dosing and proper distribution of the solution over the surface of the nasal mucosa. Before use, it is necessary to prepare the dispensing device by making several injection movements until the spray begins to be released into the air. With further use, the dosing device will be ready for immediate use. The spray must be used as follows: - thoroughly clean the nose before using the drug; - hold the bottle vertically, supporting the bottom with your thumb and placing the tip between two fingers; - tilt the bottle slightly and insert the tip into the nostril; - inject and at the same time take a light breath through the nose; — after use, before closing the tip with a cap, you should clean and dry the tip; — in order to prevent infection, each bottle of the drug can only be used by one person. The last use is recommended immediately before bedtime.
Precautionary measures
The drug should not be used for more than 7 days in a row. If symptoms persist, consult your doctor. Excessive or prolonged use may result in renewed nasal congestion and/or atrophy of the nasal mucosa. The drug, like other sympathomimetics, should be prescribed with caution to patients who have severe reactions to adrenergic drugs, which manifest themselves as insomnia, dizziness, tremors, cardiac arrhythmias, or increased blood pressure. The recommended dose of the drug should not be exceeded, especially when treating children and the elderly. The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, patients with diabetes mellitus, pheochromocytoma, prostatic hypertrophy, and should not be used in patients receiving treatment with MAO inhibitors and within 2 weeks after stopping their use. The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa. Use during pregnancy or breastfeeding. The drug should not be used during pregnancy due to potential vasoconstrictive effects. There is no evidence of any adverse effects on the infant. It is not known whether xylometazoline is excreted into breast milk, so caution is necessary and the drug should only be used during breastfeeding as directed by a doctor. Fertility. There are no adequate data on the effect of the drug on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of affecting fertility is extremely low. Children. The drug should not be used in children under 12 years of age. The ability to influence reaction speed when driving a vehicle or operating other mechanisms. Usually the drug has no or negligible effect on the ability to drive vehicles or operate other machines.
Interaction with other drugs
Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline can potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAO inhibitors in the past two weeks. Tri- and tetracyclic antidepressants: with the simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs, the sympathomimetic effect of xylometazoline may be enhanced, so the simultaneous use of such drugs is not recommended. When used together with beta-blockers, it may cause bronchial spasm or a decrease in blood pressure.
Contraindications
Hypersensitivity to xylometazoline or to any other component of the drug, hyperthyroidism, angle-closure glaucoma, transsphenoidal hypophysectomy and previous surgery with exposure of the meninges, dry rhinitis (rhinitis sicca) or atrophic rhinitis.
Compound
active ingredient: xylometazoline; 1 g of spray contains xylometazoline hydrochloride in terms of 100% substance 1 mg; excipients: benzalkonium chloride; eucalyptus oil; disodium edetate; propylene glycol; polyethylene glycol 1500; povidone K-15; hypromellose (substitution type 2910); polysorbate 20; sodium hydrogen phosphate, dodecahydrate; potassium dihydrogen phosphate; purified water.
Overdose
Excessive topical use of xylometazoline hydrochloride or its accidental ingestion can lead to severe dizziness, sweating, a significant decrease in body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. High blood pressure may change to low. Young children are more sensitive to toxicity than adults. All patients with suspected overdose should be given appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include monitoring the patient for several hours. In case of severe overdose, which is accompanied by cardiac arrest, resuscitation measures should continue for at least 1 hour.
Side effect
When Evkazolin Aqua was prescribed to people with cardiovascular diseases, systemic cardiovascular disorders were observed. From the immune system: rare (
Storage conditions
Store in a place protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children. Best before date. 2 years. Do not use the drug after the expiration date indicated on the package.
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Eucazoline Aqua
Evkazoline Aqua (xylometazoline) is a vasoconstrictor drug for topical use in otorhinolaryngology. Belongs to the group of alpha-adrenergic agonists-decongestants. Upon contact with the mucous membranes of the nasal cavity, it has a rapid and persistent vasoconstrictor effect, reducing the lumen of blood vessels, which prevents intense blood flow to the affected areas and helps reduce swelling. Restores breathing through the nose during a runny nose. The vasoconstrictor effect appears within a few minutes after administration into the nasal passages. The clinically significant effect of the drug lasts for 3-4 hours. When used in accordance with the instructions for use, the likelihood of the active substance of the drug entering the systemic circulation is practically excluded: its level in the blood plasma is so insignificant that it is not detected by modern methods used in analytical chemistry. The drug is indicated for acute runny nose of various nature, inflammation of the mucous membrane of the paranasal sinuses, as an adjuvant therapy for acute inflammation of the middle ear (to relieve swelling of the inner lining of the nasal cavity). Another area of application for Evkazolin Aqua is diagnostics (the drug is used during preparatory measures before rhinoscopy). The drug is not used for individual intolerance to the active or any auxiliary component, hypertension, rapid heartbeat, serious atherosclerotic changes in blood vessels, glaucoma, ozena, and also during pregnancy. In pediatric practice, the drug is used after the patient reaches the age of six. In certain categories of people, the drug is used, observing precautions: these are patients with cardiovascular pathology, diabetes mellitus, hyperfunction of the thyroid gland, increased sensitivity to adrenergic agonists, manifested by sleep disorders, vertigo, trembling of the fingertips, cardiac arrhythmias, hypertension, as well as persons with prostate adenoma and women during breastfeeding (the drug may pass into breast milk).
Evkazolin Aqua is injected into the nasal passages. Single dose – 1 spray into each nostril. Frequency of use – 3-4 times a day. The duration of the drug course in most cases is limited to 5-7 days, depending on the nature of the disease and the severity of the therapeutic response. After completing one course of pharmacotherapy, the next course can be started no earlier than a few days later. Possible undesirable side reactions when using Evkazolin Aqua (in most cases develop with frequent or prolonged use of the drug): dehydration of the mucous membrane of the nasal cavity and pharynx, sensation of crawling, burning of the nasal mucosa, increased secretory activity of the nasal mucosa, severe and frequent sneezing palpitations, cardiac arrhythmias, arterial hypertension, cephalalgia, vomiting, sleep disturbance, visual disturbances, depressive symptoms. Other co-administered alpha-adrenergic agonists may enhance the effect of Evkazolin Aqua. Medicines that block adrenergic receptors and calcium antagonists weaken the effect of the drug. Evkazolin Aqua potentiates the hypertensive effect of amitriptyline and other drugs of the tricyclic antidepressant group, as well as drugs that suppress the activity of the monoamine oxidase enzyme. Evkazolin Aqua is not recommended for use continuously over an extended period of time. The drug should not be used in submaximal and maximum doses in children and the elderly. Persons working with dangerous mechanisms and performing various types of work that require concentration and reaction speed should exercise special caution while taking the drug.