Kuchiku® nasal
Ukraine|
KUCHIKOO®NASAL INSTRUCTION for medical use KUCHIKOO®NASAL Composition: Active substance: xylometazoline hydrochloride; 1 mL of solution contains xylometazoline hydrochloride 0.5 mg; Excipients: benzalkonium chloride; potassium dihydrogen phosphate; sodium hydrogen phosphate dodecahydrate; sorbitol (E 420); disodium edetate; sodium chloride; purified water. Pharmaceutical form. Nasal drops, solution. Main physicochemical properties: clear, colorless, odorless liquid. Pharmacotherapeutic group. Decongestants and other drugs for local use in nasal disorders. Simple sympathomimetics. ATC code R01A A07. Pharmacological properties. Pharmacodynamics. Xylometazoline is a sympathomimetic agent (an imidazole derivative) acting on α-adrenergic receptors of the nasal mucosa. After nasal administration, xylometazoline causes vasoconstriction, thereby reducing swelling of the nasal and nasopharyngeal mucosa. The effect begins within 2 minutes after application and lasts up to 12 hours. The product is well tolerated, including by patients with sensitive mucosa. The drug does not impair mucociliary function. Laboratory test results indicate that xylometazoline reduces the infective activity of human rhinovirus associated with the common cold. Pharmacokinetics. After nasal administration, the amount of absorbed substance may sometimes be sufficient to produce systemic effects, for example, on the central nervous and cardiovascular systems. No metabolites or excretion pathways have been identified. Clinical characteristics. Indications.
Contraindications.
Interaction with other medicinal products and other forms of interaction. Monoamine oxidase inhibitors (MAOIs): xylometazoline may potentiate the action of monoamine oxidase inhibitors or tricyclic antidepressants and may 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: concomitant use of xylometazoline with antidepressants that are monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, or with tri- or tetracyclic antidepressants and sympathomimetic drugs may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use is not recommended. When used together with β-blockers, it may cause bronchospasm or decreased blood pressure. Special precautions. Like other sympathomimetics, xylometazoline should be used with caution in patients who experience strong reactions to adrenergic drugs, such as insomnia, dizziness, tremor, cardiac arrhythmias, or high blood pressure. Patients with long QT syndrome receiving xylometazoline may be at increased risk of serious ventricular arrhythmias. Xylometazoline should be used with caution and only if the therapeutic benefit outweighs the potential risk in patients who have taken monoamine oxidase inhibitors (MAOIs) or antidepressants, or other drugs that may increase blood pressure. In patients with severe cardiovascular diseases (e.g., severe coronary artery disease, high blood pressure), pheochromocytoma, or metabolic disorders (e.g., hyperthyroidism, diabetes mellitus). Decongestant sympathomimetics may lead to reactive hyperemia of the nasal mucosa, especially after prolonged treatment or use of high doses. Repeated or chronic use of this drug may result in rebound congestion syndrome and narrowing of the upper airways. This may manifest as chronic hyperemia of the nasal mucosa (which may subsequently lead to atrophic rhinitis). In moderate cases, administration of the drug into one nostril may be discontinued, or alternatively, the drug may not be administered into both nostrils until symptom intensity decreases, to partially maintain nasal airway patency. The medicinal product contains benzalkonium chloride, which is an irritant and may cause skin adverse reactions. The medicinal product contains sorbitol. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product. Patients with rare hereditary fructose intolerance should not use this product. For hygienic reasons and to avoid infection, each bottle should be used by only one person. Use during pregnancy or breastfeeding. The product is intended for use in children. The product should not be used during pregnancy or breastfeeding due to its potential vasoconstrictive effect. Fertility. Adequate data on the effect of xylometazoline on fertility are lacking. Since systemic exposure to xylometazoline is very low, the likelihood of an effect on fertility is extremely low. Ability to affect reaction rate when driving or operating machinery. The product is intended for use in children. Prolonged treatment or high-dose use of xylometazoline may pose a risk of adverse reactions affecting the central nervous and cardiovascular systems. If such effects occur, they may negatively affect the ability to drive vehicles or operate machinery. Method of administration and dosage. Nasal drops 0.05% : For use in children aged 2 to 6 years (under adult supervision). Recommended dose: 1–2 drops, 1–2 times daily (with an 8–10 hour interval), into each nostril. Do not exceed 3 doses per nostril per day. Duration of use The product should not be used for more than 5 consecutive days unless otherwise recommended by a physician. A break of several days between treatments is required before further use of xylometazoline. The bottle should be used for only one child to prevent the spread of pathogenic microorganisms via the dropper. Children. KUCHIKOO ® Nasal, 0.05% nasal drops, should not be used in children under 2 years of age. Use in children aged 2 to 6 years is recommended only under adult supervision. Overdose. Excessive local use of xylometazoline or accidental ingestion may lead to pronounced dizziness, sweating, significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and convulsions. After an initial rise in blood pressure, a subsequent drop may occur. Younger children are more sensitive to toxicity than adults. Treatment. All patients suspected of overdose should receive appropriate supportive measures and, if necessary, urgent symptomatic treatment under medical supervision. Medical care should include monitoring of the patient for several hours. In cases of severe overdose with cardiac arrest, resuscitation efforts should continue for at least 1 hour. Adverse reactions. Immune system disorders: rare (<1/10,000): hypersensitivity reactions, including angioedema, rash, itching. Nervous system disorders: common (≥1/100, <1/10): headache, insomnia, fatigue, visual disturbances; rare (<1/10,000): hallucinations, mainly in children. Eye disorders: rare (<1/10,000): transient visual disturbances. Cardiac and vascular disorders: rare (<1/10,000): local intranasal use may lead to systemic sympathomimetic effects such as palpitations, tachycardia, or increased blood pressure. Respiratory, thoracic and mediastinal disorders: common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa. In patients with increased sensitivity, xylometazoline may cause local, mild, and transient irritation (burning or dryness of the nasal mucosa). In some cases, rebound congestion syndrome (reactive hyperemia) may occur after discontinuation of the drug. Prolonged, frequent use and/or high doses of xylometazoline may lead to irritation (burning or dryness of the nasal mucosa) and medication-induced reactive hyperemia. This effect may occur only after 5 days of treatment, and if continued, may result in epistaxis, sneezing, chronic nasal mucosal disorders with crust formation. Musculoskeletal and connective tissue disorders: rare (<1/10,000): convulsions, especially in children. Gastrointestinal disorders: common (≥1/100, <1/10): nausea. General disorders and administration site conditions: common (≥1/100, <1/10): burning sensation at site of application, dryness in the nose; prolonged use may lead to rebound effect. Within each frequency group, adverse reactions are listed in order of decreasing severity. Shelf life. 3 years. Use within 30 days after first opening the bottle. Storage conditions. Store at temperatures not exceeding 25 °C in the original packaging. Keep out of reach of children. Packaging. 10 mL in a bottle with nasal applicator; 1 bottle per cardboard box. Prescription status. Over-the-counter. Manufacturer. Biofarm SA Manufacturer's address and place of business . Str. Logofetului Teutu No. 99, Sector 3, Code 031212, Bucharest, Romania. Marketing Authorization Holder. Delta Medical Promotions AG. Address of the Marketing Authorization Holder. 26 Oetenbachgasse, Zurich CH-8001, Switzerland. |