Instructions for Eucasprey nasal spray 1 mg/ml 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains 1 mg of xylometazoline hydrochloride;
Excipients: benzalkonium chloride; disodium edetate; sodium dihydrogen phosphate, monohydrate; sodium hydrogen phosphate, dodecahydrate; sodium chloride; polyethoxylated hydrogenated castor oil; sorbitol (E 420); eucalyptus oil; purified water
Dosage form
Nasal spray.
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. Decongestants and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. Xylometazoline.
ATX code R01A A07.
Pharmacological properties
Pharmacodynamics
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Xylometazoline, when applied nasally, causes a narrowing of the blood vessels of the nasal mucosa and adjacent areas of the nasopharynx, thus eliminating swelling 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 helps to cleanse the nasal passages and facilitate nasal breathing. The action of the drug 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. There are studies showing that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold. The drug has a balanced pH value within the limits inherent in the nasal cavity.
Pharmacokinetics
When applied topically, the drug is practically not absorbed, the concentrations of xylometazoline in blood plasma are so low that they are practically undetectable (the concentration in 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 case of otitis media (to eliminate swelling of the mucous membrane).
To facilitate rhinoscopy.
Contraindication
Hypersensitivity to xylometazoline, any other component of the drug or to other sympathomimetic amines; angle-closure glaucoma, transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges in history, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Simultaneous use of monoamine oxidase inhibitors (MAO) or their use within 2 weeks before treatment with Eucasprey.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAOIs): Xylometazoline may potentiate the effects of monoamine oxidase inhibitors and cause hypertensive crisis. Xylometazoline should not be used in patients who are taking or have taken MAOIs within the last two weeks (see Contraindications).
Tricyclic and tetracyclic antidepressants: with simultaneous use of tricyclic or tetracyclic antidepressants and sympathomimetic drugs, in particular xylometazoline, an increase in the sympathomimetic effect is possible, therefore the simultaneous use of such drugs is not recommended.
Use with beta-blockers may cause bronchospasm or a decrease in blood pressure.
Application features
The drug should not be used for more than 5 consecutive days. Prolonged or excessive treatment with xylometazoline may cause secondary edema of the nasal mucosa with the risk of chronic rhinitis and/or atrophy of the nasal mucosa.
Due to the risk of developing atrophy of the nasal mucosa, this drug should be used in patients with chronic inflammation of the nasal mucosa only under the supervision of a physician.
Repeated or chronic use of this medicinal product may lead to a congestive withdrawal syndrome and narrowing of the upper airways. This may manifest as chronic hyperemia of the nasal mucosa (which may eventually lead to atrophic rhinitis). In moderate cases, the use of the drug in one of the nasal passages or, alternatively, in both nasal passages may be discontinued until the symptoms subside in order to maintain nasal patency.
Xylometazoline, like other sympathomimetics, should be administered with caution to patients who have severe reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, porphyria, prostatic hypertrophy. Xylometazoline should not be used in patients receiving concomitant treatment with MAO inhibitors and within 2 weeks after their discontinuation.
Patients with long QT syndrome who use xylometazoline are at increased risk of serious ventricular arrhythmias.
Isolated cases of posterior reversible encephalopathy syndrome/reverse cerebral vasoconstriction syndrome have been reported with the use of sympathomimetic drugs. The symptoms reported included sudden severe headache, nausea, vomiting and visual disturbances. In most cases, symptoms improved or disappeared within a few days after appropriate treatment. The drug should be discontinued immediately and a doctor should be consulted if signs/symptoms of posterior reversible encephalopathy syndrome/reverse cerebral vasoconstriction syndrome develop. The drug contains benzalkonium chloride, which may cause nasal irritation and skin reactions.
The product contains polyethoxylated hydrogenated castor oil, which may cause allergic reactions.
There is also data indicating that the moisturizing component sorbitol, which is part of Eucasprey, helps with dryness and irritation of the mucous membrane of the nasal passages.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy due to its potential vasoconstrictor effect.
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. If used during breastfeeding, prolonged use should be avoided due to the risk of adverse effects in the infant (tachycardia, agitation, increased blood pressure).
Fertility: There are no adequate data on the effect of the drug on fertility. Since the systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely 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. However, prolonged use in high doses may cause undesirable effects on the cardiovascular system, which may adversely affect the ability to drive or use machines.
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 interval between applications should be at least 8-10 hours. The duration of treatment depends on the course of the disease and should not exceed 5 consecutive days.
Apply the spray as follows: insert the tip of the bottle into the nasal passage and press the bottle sharply once. Inhale through the nose during injection. Do not tilt your head back or turn the bottle over when injecting the spray. To prevent the spread of infection, do not use the same bottle for several people. The last application is recommended immediately before bedtime.
Children
Eucasprey should be used in children over 12 years of age.
Overdose
Symptoms: With nasal administration, systemic effects are unlikely due to local vasoconstriction, which inhibits absorption. In the case of systemic absorption, xylometazoline, as an α2-adrenergic agonist, can be expected to have effects similar to clonidine: a short-term increase in blood pressure followed by more prolonged hypotension and sedation.
Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of depression of the central nervous and cardiovascular systems.
Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and seizures.
Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.
Additional symptoms may include miosis, mydriasis, sweating, nausea, cyanosis, fever, pallor, central nervous system paralysis, sedation, dry mouth, arrhythmia, tachycardia, ataxia, bradycardia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory distress, and apnea. Gastrointestinal symptoms such as nausea and vomiting may also occur.
Impaired consciousness may be a sign of severe overt intoxication. Young children are more sensitive to toxic effects than adults.
No severe symptoms have been observed after accidental use, however, in newborns (2 weeks of age), the use of 1 drop of a 0.1% solution in each nostril may lead to coma.
Treatment. Severe overdose will require hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (when using higher doses) should be administered immediately. Lowering blood pressure can be achieved with non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants, as well as artificial oxygen respiration, are used. There are no antidotes, atropine can be used for bradycardia.
Side effects
On the part of the immune system:
uncommon (≥ 1/1000, < 1/100): hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system:
rarely (≥ 1/10,000, < 1/1000) headache, insomnia, fatigue, seizures (usually in children);
very rare (< 1/10,000): nervousness, drowsiness/inhibition (usually in children).
On the part of the organs of vision:
uncommon (≥ 1/1000, < 1/100): temporary visual impairment.
From the cardiovascular system:
uncommon (≥ 1/1000, < 1/100): palpitations, tachycardia;
very rare (< 1/10,000): arrhythmia, arterial hypertension.
Respiratory, thoracic and mediastinal disorders:
common (≥ 1/100, < 1/10): dryness or discomfort of the nasal mucosa;
uncommon (≥ 1/1000, < 1/100): nosebleeds (epistaxis).
From the gastrointestinal system:
often (≥ 1/100, < 1/10): nausea;
uncommon (≥ 1/1000, < 1/100): vomiting.
General disorders and administration site conditions:
Common (≥ 1/100, < 1/10): burning sensation at the application site, rhinitis medicamentosa.
Prolonged or frequent use of high doses of xylometazoline may cause a burning sensation or dryness of the mucous membrane and increased swelling of the mucous membrane, which worsen with continued use of the drug (rhinitis medicamentosa). This effect may be observed after as little as 5 days of treatment and, if treatment is continued, may lead to long-term damage to the mucous membrane with the formation of crusts (rhinitis sicca).
Reporting of suspected adverse reactions. Reporting of adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
3 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 ml in a container with a spray stopper and a lid 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
