Otrivin Nasal Spray 0.1% 10ml Bottle #1

Otrivin Nasal Spray 0.1% 10ml bottle Composition: 1 ml solution contains: Active substance: Xylometazoline hydrochloride - 1 mg. Excipients: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, benzalkonium chloride, methylhydroxypropylcellulose 4000 mPa · S, sorbitol 70%, purified water. 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 use and lasts for 12 hours. Otrivin does not impair the functions of the ciliated epithelium. Pharmacokinetics With topical application, the concentration of xylometazoline in plasma is low and approaches the limit of detection. Indications for use: Rhinitis of various origins. To facilitate the discharge 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: Adults and children over 12 years of age: One spray in each nostril 3 times a day. Repeat if necessary. It is not recommended to use more than 3 times a day. Children under 12 years of age Otrivin nasal spray 0.1% is not recommended for use in children under 12 years of age. Proper cleansing of the nasal cavity is required before use. Remove the protective cap. Before first use, press the applicator several times until you get a spray stream. The spray will be ready for subsequent use. If spraying is not complete after multiple presses on the applicator, e.g., when the spray has not been used for more than 7 days, it is necessary to press the applicator 4 times again. Place the nozzle in the nostril, press the applicator quickly once, inhaling slightly at the same time - this will help optimal distribution of the spray in the nasal cavity. After use, replace the protective cap. Special patient populations There is no data to confirm that dose adjustment is required in elderly patients (over 65 years of age). Side effects: Within each group, adverse events are listed in order of decreasing seriousness. Immune system disorders: very rare - hypersensitivity reactions (rash, itching, angioedema). Nervous system disorders: frequent - headache. Eye disorders: very rare - temporary visual impairment. Cardiovascular disorders: very rare - irregular or increased heart rate, hypertension, arrhythmia. Respiratory system disorders: frequent - dryness, discomfort, burning sensation of the nasal mucosa, medicamentous rhinitis. Gastrointestinal disorders: frequent - nausea. General disorders: frequent: burning sensation at the site of application. If you experience any of the listed side effects or any side effects not described in this leaflet, consult your doctor. Contraindications: Children under 12 years of age. Hypersensitivity to the components of the preparation, angle-closure glaucoma, atrophic rhinitis, dry rhinitis, transsphenoidal hypophysectomy (or transnasal or transoral surgery with exposure of the dura mater). Interactions with other medicines: Monoamine oxidase inhibitors. Xylometazoline can enhance the effect of monoamine oxidase inhibitors and cause a 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 "Precautions"). 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: What you need to know before using Otrivin. If you have heart disease (e.g., prolonged QT interval syndrome), talk to your doctor before using xylometazoline. Otrivin should be used with caution in: Patients with arterial hypertension, cardiovascular diseases. In patients with prolonged QT interval syndrome, the use of xylometazoline may increase the risk of developing serious ventricular arrhythmias. Hyperthyroidism, diabetes mellitus, pheochromocytoma; Benign prostatic hyperplasia; Patients who are being treated or have been treated with monoamine oxidase inhibitors within the last 14 days (see "Interactions with other medicines"). Patients being treated with tri- and tetracyclic antidepressants (see "Interactions with other medicines"). Increased sensitivity to sympathomimetic agents, manifested by symptoms such as insomnia, dizziness, etc. Rare cases of posterior reversible encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS) have been reported during therapy with sympathomimetic agents, including xylometazoline. Symptoms included sudden onset of severe headache, nausea, vomiting, and visual disturbances. In most cases, the condition improved or symptoms resolved within a few days of appropriate treatment. If symptoms of RPES or RCVS develop, you should immediately stop using Otrivin and seek medical attention. Like other topical vasoconstrictors, continuous use of Otrivin for more than 1 week is not recommended, 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 spray 0.1% is not used in children under 12 years of age. 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. Lactation. It is not known whether xylometazoline is excreted in breast milk. Otrivin can be used during breastfeeding only as prescribed by a doctor. Fertility. There is no adequate 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 of the preparation on the ability to drive and operate machinery: With prolonged and high-dose use of xylometazoline, possible systemic effects with cardiovascular effects cannot be ruled out. Overdose: Local overuse of xylometazoline or accidental ingestion can lead to 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 the use of doses greater than 0.5 mg/kg body weight, the development of severe symptoms cannot be ruled out. In such cases, medical supervision 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. Treatment is symptomatic; bradycardia can be treated with atropine. Storage conditions: Store at a temperature not exceeding 30 °C. Keep out of reach of children. Shelf life: 3 years.