Instructions for Eucasprey turbo nasal spray 1mg/ml 10ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains 1.0 mg of xylometazoline hydrochloride;
Excipients: benzalkonium chloride; polyethoxylated hydrogenated castor oil; sodium hydrogen phosphate dodecahydrate; sodium dihydrogen phosphate monohydrate; eucalyptus oil; disodium edetate; sodium chloride; sorbitol (E 420); purified water.
Dosage form
Nasal spray, metered.
Main physicochemical properties: opalescent solution from colorless to whitish with a specific odor of eucalyptus.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A07.
Pharmacological properties
Pharmacodynamics.
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Xylometazoline, when applied nasally, causes constriction of the blood vessels of the nasal mucosa and adjacent areas of the nasopharynx, thus eliminating edema and hyperemia of the nasal and nasopharynx mucosa, and also reduces the associated increased mucus secretion and facilitates the removal of blocked secretions from the nose, which leads to cleansing of the nasal passages and facilitating nasal breathing.
The drug's effect begins within 2 minutes after application and lasts up to 12 hours.
The drug is well tolerated, including by patients with sensitive mucous membranes, and does not reduce mucociliary function. Laboratory tests have shown that xylometazoline reduces the infectious activity of human rhinovirus, which is associated with the common cold.
The product contains a cooling, evaporating aromatic substance, eucalyptol.
Pharmacokinetics.
When applied topically, the drug 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, in animal studies, no teratogenic effects of xylometazoline were detected.
Indication
Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.
To facilitate the outflow of secretions in diseases of the paranasal sinuses.
Adjunctive therapy in cases of otitis media (to eliminate swelling of the mucous membrane).
To facilitate rhinoscopy.
Contraindication
Hypersensitivity to xylometazoline or any other component of the drug, angle-closure glaucoma, transsphenoidal hypophysectomy and transnasal or transoral surgical interventions with exposure of the meninges or their presence in history, dry rhinitis (rhinitis sicca) or atrophic rhinitis.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAO inhibitors): Xylometazoline may potentiate the effects of MAO inhibitors and cause hypertensive crisis. Xylometazoline should not be used in patients who are taking or have taken MAO inhibitors within the last two weeks.
Tricyclic and tetracyclic antidepressants: with simultaneous use of tricyclic or tetracyclic antidepressants and sympathomimetic drugs, the sympathomimetic effect of xylometazoline may be enhanced, therefore the simultaneous use of such drugs is not recommended.
When used with beta-blockers, it may cause bronchospasm or a decrease in blood pressure.
Application features
The drug should not be used for longer than 7 consecutive days, as prolonged or excessive use may lead to the development of rhinitis medicamentosa, which consists in the recurrence of nasal congestion, i.e. symptoms similar to a runny nose, and/or atrophy of the nasal mucosa.
The drug, like other sympathomimetics, should be prescribed with caution to patients who have strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia 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, diabetes mellitus, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, and should not be used in patients receiving concomitant treatment with MAO inhibitors and within 2 weeks after discontinuing their use.
Patients with long QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias.
The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa.
Use during pregnancy or breastfeeding
Pregnancy and breastfeeding
There is no evidence of any adverse effects on the infant. It is not known whether xylometazoline is excreted in breast milk, therefore caution is required and the drug should be used during breastfeeding only as directed by a physician.
Fertility
There are no adequate data on the effect of Eucasprey Turbo on fertility. Since the systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is very low.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually has no or negligible influence on the ability to drive or use machines. With prolonged use of the drug or in high doses, its effect on the cardiovascular system cannot be ruled out.
Method of administration and doses
The drug should be used by adults and children over 12 years of age, 1 injection into each nasal passage up to 3 times a day. Apply 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 consecutive days.
Do not cut off the tip of the spray. The nasal spray is metered and ready to use.
The metered spray ensures accurate dosing and proper distribution of the solution over the surface of the nasal mucosa. Each injection delivers 0.14 ml of solution, which corresponds to 0.14 mg of xylometazoline.
Before first use, prime the spray by pressing the spray 4 times. The spray will then be ready for use throughout the treatment period. If the spray does not spray when the spray is pressed or the product has not been used for more than 7 days, the spray should be primed again by pressing 4 times into the air.
The spray should be applied as follows:
- thoroughly clean the nose before using the drug;
- the bottle should be held 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 simultaneously take a light breath through the nose;
- after use, clean and dry the tip before replacing the cap;
- to prevent infection, each vial of the drug can be used by only one person.
The last application is recommended immediately before bedtime.
Children
Eucasprey Turbo should be used in children over 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in severe dizziness, increased sweating, a significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma and convulsions. Elevated blood pressure may change to low blood pressure. Young children are more sensitive to toxic effects than adults.
All patients with suspected overdose should receive appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include observation of the patient for several hours. In the case of severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour.
Adverse reactions
On the part of the immune system:
very rare (<1/10,000): hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system:
common (≥1/100, <1/10): headache.
On the part of the organs of vision:
very rare (<1/10,000): temporary visual impairment.
From the cardiovascular system:
very rare (<1/10,000): irregular or rapid heartbeat, hypertension, arrhythmia.
Respiratory, thoracic and mediastinal disorders:
common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa, burning sensation; rhinitis medicamentosa;
uncommon (≥1/1000, <1/100): epistaxis.
From the digestive system:
common (≥1/100, <1/10): nausea.
General disorders and administration site conditions:
common (≥1/100, <1/10): burning sensation at the application site.
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 25 ° C. Keep out of the reach of children.
Packaging
10 ml in a polyethylene container with a pump and sprayer in a pack.
Vacation category
Without a prescription.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the manufacturer and address of its place of business.
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
Phone: + 38(0432)52-30-36. E-mail: trade@sperco.com.ua
www.sperco.ua
