Instructions for Eucabal drops 0.1% bottle 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains xylometazoline hydrochloride 1 mg;
Excipients: benzalkonium chloride, citric acid monohydrate, sodium citrate 2H2O, glycerin 85%, purified water.
Dosage form
Drops.
Main physicochemical properties: transparent colorless solution with a faint odor.
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.
The drug begins to act within a few minutes after application and lasts up to 12 hours. The drug causes a narrowing of the nasal blood vessels, reducing swelling of the nasal mucosa and paranasal sinuses, thereby improving nasal breathing in case of nasal and paranasal sinus congestion.
Pharmacokinetics
When applied topically, the drug is almost not absorbed, the concentration of xylometazoline in blood plasma is so low that it cannot be determined by modern analytical methods.
Indication
Symptomatic treatment of nasal congestion in colds, hay fever, other allergic rhinitis, sinusitis. To facilitate the outflow of secretions in diseases of the paranasal sinuses. As an adjunct therapy in cases of otitis media (to eliminate swelling of the mucous membrane). To facilitate rhinoscopy.
Contraindication
Hypersensitivity to any component of the drug; dry inflammation of the nasal mucosa (rhinitis sicca), acute coronary disease, hyperthyroidism, angle-closure glaucoma, transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges in history. Concomitant treatment with monoamine oxidase inhibitors (MAO) and within 2 weeks after their discontinuation.
Interaction with other medicinal products and other types of interactions
MAO inhibitors: Xylometazoline may potentiate the effects of MAO inhibitors and induce hypertensive crisis. Do not use Xylometazoline in patients who are taking or have taken MAO inhibitors within the last two weeks.
Tri- and tetracyclic antidepressants: with simultaneous use of tri- 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 together with β-blockers, the drug may cause bronchial spasm or a decrease in blood pressure.
Application features
The drug is not used in children under 12 years of age.
The drug should not be used for more than 10 consecutive days. Prolonged or excessive use may lead to the recurrence of nasal congestion and/or atrophy of the nasal mucosa.
The drug should be prescribed with caution to patients who have severe reactions to adrenergic drugs, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, and increased blood pressure.
Patients with long QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias.
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, thyroid diseases, pheochromocytoma, prostatic hypertrophy, and should not be used in patients receiving concomitant treatment with MAO inhibitors and within 2 weeks after discontinuation of their use.
One bottle of drops should be used by only one person to avoid infection.
The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually has no or minimal effect on the ability to drive or operate machinery.
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.
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 very low.
Method of administration and doses
Before administering the drug, the nasal cavity should be thoroughly cleaned.
The duration of treatment depends on the course of the disease and should not exceed 10 consecutive days.
Children
The drug should not be used to treat children under 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in severe dizziness, excessive 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 toxicity than adults.
All patients suspected of overdose should be given 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
Immune system disorders: hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system: headache.
On the part of the organs of vision: transient visual impairment.
Cardiac: irregular or rapid heartbeat.
Respiratory, thoracic and mediastinal disorders: dryness or discomfort of the nasal mucosa, burning sensation.
On the part of the digestive system: nausea.
General disorders and administration site conditions: burning sensation at the application site.
If any adverse reactions occur, treatment should be discontinued and a doctor should be consulted.
Expiration date
3 years.
After opening the bottle, the drug is suitable for use for 6 months.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 ml drops in a bottle with a screw-on pipette cap, 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Pharma Wernigerode GmbH, Germany.
Location of the manufacturer and its business address
Dornbergsweg 35, 38855 Wernigerode, Germany.
