Otrivin Nasal Drops 0.05% 10ml

OTRIVIN Active Ingredient (INN): Xylometazoline Dosage Form: Nasal drops 0.05% Composition: 1 ml of solution contains: Active substance: Xylometazoline hydrochloride - 0.5 mg. Excipients: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, benzalkonium chloride, methylhydroxypropylcellulose 4000 mPa · S, sorbitol 70%, purified water. Description: Clear solution from colorless to pale yellow, practically odorless. Pharmacotherapeutic group: Nasal preparations. Decongestant and other preparations for local use. Xylometazoline. ATC code: R01AA07. Pharmacological properties Mechanism of action. Xylometazoline is a sympathomimetic agent that acts on alpha-adrenergic receptors of the nasal mucosa. When sprayed into the nose, it causes vasoconstriction of the nasal mucosa, which relieves swelling of the nasal and nasopharyngeal mucosa. It facilitates nasal breathing. The preparation contains excipients - sorbitol and methylhydroxypropylcellulose, which help reduce the symptoms of nasal dryness. The effect begins within a few minutes of application and lasts for 12 hours. OTRIVIN does not impair the function of the ciliated epithelium. Pharmacokinetics With local use, the concentration of xylometazoline in plasma is low and approaches the limit of detection. Indications for use Rhinitis of various origins. To facilitate the release of accumulated secretions in inflammation of the paranasal sinuses. As adjunctive therapy in otitis media (to reduce swelling of the nasopharyngeal mucosa). To facilitate rhinoscopy. Method of administration and dosage Children aged 2 to 11 years: The medicinal product should be used only under adult supervision. Usually, 1-2 drops are instilled into each nostril 1-2 times a day. The preparation should not be used more than 3 times a day. Children aged 1 to 2 years: The medicinal product should be used as prescribed by a doctor. Children under 1 year of age: The use of the medicinal product is contraindicated. Before use, the nasal cavity should be thoroughly cleaned. Tilt your head back slightly. Instill the drops into each nostril and maintain the head in this position for a few more minutes to allow the nasal drops to spread throughout the nose. After use, clean and dry the dropper. Close the bottle with the cap. Special patient populations No data on the need for dose adjustment in elderly patients (over 65 years of age). Side effects Information on adverse reactions is provided according to system-organ classes and frequency categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000). Within each group, adverse reactions are listed in order of decreasing severity. Immune system: very rare - hypersensitivity reactions (rash, itching, angioedema). Nervous system: common - headache. Eye disorders: very rare - temporary visual impairment. Cardiovascular system: very rare - irregular or increased heart rate, hypertension, arrhythmia. Respiratory system: common: dryness, discomfort, burning sensation of the nasal mucosa, medicamentous rhinitis. Gastrointestinal tract: common - nausea. General disorders: common - burning sensation at the application site. If any of the listed side effects or a reaction not indicated in these instructions for medical use occurs, consult a doctor. Contraindications Hypersensitivity to the components of the preparation, angle-closure glaucoma, atrophic rhinitis, dry rhinitis, hypophyseal transsphenoidal removal (or transnasal or transoral surgery with exposure of the dura mater). Contraindicated in children under 1 year of age. Interactions with other medicinal products Monoamine oxidase inhibitors. Xylometazoline can enhance the effect of monoamine oxidase inhibitors and cause hypertensive crisis. The use of xylometazoline is not recommended in patients taking monoamine oxidase inhibitors or who have taken these drugs within the last 14 days (see "Special Instructions"). Tri- or tetracyclic antidepressants. Concomitant use of tri- or tetracyclic antidepressants and sympathomimetic agents is not recommended, as this may enhance the sympathomimetic effect of xylometazoline. Special instructions OTRIVIN should be used with caution in patients with the following conditions: · QT interval prolongation syndrome. In patients with this syndrome, the use of xylometazoline may increase the risk of developing serious ventricular arrhythmias; · Arterial hypertension, cardiovascular diseases; · Hyperthyroidism, diabetes mellitus, pheochromocytoma; · Benign prostatic hyperplasia; · In patients treated or who have been treated with monoamine oxidase inhibitors within the last 14 days (see "Interactions with other medicinal products") · Increased sensitivity to sympathomimetic agents, manifested by symptoms such as insomnia, dizziness, etc. Rare cases of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) have been reported with sympathomimetic agents, including xylometazoline. Symptoms included sudden onset of severe headache, nausea, vomiting, and visual disturbances. In most cases, the condition improved or resolved within a few days with appropriate treatment. If symptoms of posterior reversible encephalopathy syndrome or reversible cerebral vasoconstriction syndrome develop, OTRIVIN should be discontinued immediately and medical attention sought. Like other topical vasoconstrictors, OTRIVIN is not recommended for continuous use for more than 1 week, as medicamentous rhinitis with nasal mucosal swelling, the symptoms of which are similar to cold symptoms, may develop. Do not exceed the recommended dose, especially in children and elderly patients. OTRIVIN, nasal drops for children 0.05%, should not be used in children under 1 year of age. In children aged 1 to 2 years, the use of the preparation is recommended only as prescribed by a doctor. In children aged 2 to 11 years, the use of the preparation is recommended under adult supervision. Benzalkonium chloride, which is part of the preparation, can cause irritation and swelling of the nasal mucosa, especially with prolonged use. Use during pregnancy and breastfeeding Pregnancy. Due to its vasoconstrictive properties, OTRIVIN should not be used during pregnancy. Breastfeeding. It is not known whether xylometazoline is excreted in breast milk. The use of OTRIVIN during breastfeeding is possible only as prescribed by a doctor. Fertility. There is no relevant data on the effect of OTRIVIN on fertility. There are no controlled animal studies. Since the systemic exposure to xylometazoline is very low, the probability of affecting fertility is extremely small. Effect on ability to drive and use machinery With prolonged and high-dose use of xylometazoline, possible systemic effects with cardiovascular effects cannot be excluded. Overdose Local overdose of xylometazoline or accidental ingestion can cause sympatholytic effects, including central nervous system depression (e.g., drowsiness, coma), hypertension or hypotension, tachycardia and bradycardia. Gastrointestinal symptoms such as nausea and vomiting may also develop. Other symptoms include pallor, excessive sweating, hypothermia, pupillary constriction, respiratory depression, ataxia, and anxiety. No severe symptoms were observed in cases of accidental overdose. In one newborn (2 weeks old), the use of 1 drop of 0.1% solution in each nostril led to coma. In young children, the use of the preparation at a dose of 0.5 mg/kg body weight did not cause clinically relevant symptoms. Due to the lack of data on doses above 0.5 mg/kg body weight, the development of severe symptoms cannot be ruled out. In such cases, medical observation is recommended after consultation with an experienced clinician or a poison control center, and a single dose of activated charcoal. There is no specific antidote. Bradycardia can be treated with atropine. Dosage form 10 ml plastic bottle with a dropper cap. The bottle is placed in a cardboard box with instructions for use. Storage conditions Store at a temperature not exceeding 30°C, out of reach of children. Shelf life 3 years. Do not use after the expiry date. Dispensing category: Pharmaceutical product group - III, available without a prescription. See also: Xylomarin - Xylomarin 0.05% 10ml spray Gmp