Instructions Farmazolin with mint and eucalyptus spray nasal solution 1 mg/ml bottle 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of the drug contains xylometazoline hydrochloride, calculated as 100% anhydrous substance, 1 mg;
Excipients: eucalyptus oil; peppermint oil; benzalkonium chloride; disodium edetate; propylene glycol; polyethylene glycol 1500; povidone; hypromellose; polysorbate 20; sodium hydrogen phosphate dodecahydrate; potassium dihydrogen phosphate; sorbitol (E 420); water for injections
Dosage form
Nasal spray, solution.
Main physicochemical properties: transparent liquid from slightly yellowish to yellowish with a greenish tint.
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 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.
Thanks to moisturizing components (sorbitol, hypromellose), Farmazolin® with mint and eucalyptus, nasal spray, helps with dryness and irritation of the nasal mucosa. The drug has a balanced pH value within the limits characteristic of the nasal cavity.
Pharmacokinetics
When applied topically, the drug is almost not absorbed, and the concentrations of xylometazoline in blood plasma are so low that they are almost 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 in colds, hay fever, other allergic rhinitis, 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, acute coronary disease, coronary asthma, hyperthyroidism, angle-closure glaucoma, transsphenoidal hypophysectomy and surgical interventions with meningeal exposure in history, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Concomitant treatment with MAO inhibitors and within 2 weeks after their discontinuation.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAOIs): Xylometazoline may potentiate the effects of monoamine oxidase inhibitors and induce hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAOIs 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, it may cause bronchial spasm or a decrease in blood pressure.
Application features
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, 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 case of concomitant treatment with MAO inhibitors and within 2 weeks after discontinuation of their use.
The drug contains benzalkonium chloride, which may cause bronchospasm.
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 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 Farmazolin® with mint and eucalyptus on fertility. Since the systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
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 10 consecutive days.
The metered spray ensures accurate dosing and proper distribution of the solution over the surface of the nasal mucosa. Each injection delivers 0.14 g of solution, which corresponds to 0.14 mg of xylometazoline.
Before use, prime the dosing device by pumping it several times until the spray starts to come out into the air. The dosing device will be ready for immediate use the next time it is used.
The spray should be applied 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 simultaneously inhale lightly through the nose; after use, clean and dry the tip before closing the tip with the cap; to prevent infection, each bottle with the drug should be used by only one person.
The last application is recommended immediately before bedtime.
Children
The drug should not be used in children under 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in severe dizziness, 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 with suspected 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
On the part of the immune system:
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:
rare (<1/10,000): temporary visual impairment.
From the cardiovascular system:
rare (<1/10,000): irregular or rapid heartbeat.
Respiratory, thoracic and mediastinal disorders:
Common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa.
From the gastrointestinal 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
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 ml in a bottle. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
