Otrivin Nasal Spray 0.1% 10ml

Otrivin Trade name: Otrivin International Nonproprietary Name: Xylometazoline Dosage form: Nasal metered spray 0.1% Composition 1 ml of 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. Description Clear solution from colorless to pale yellow, practically odorless. Pharmacotherapeutic group Decongestants and other local use preparations. Sympathomimetic agents. ATC code: R01AA07. See blog: Otrivin - a nasal preparation for healthy breathing 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. The preparation Otrivin does not impair the functions of the ciliated epithelium. Pharmacokinetics With local 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 release of accumulated secretions in inflammation of the paranasal sinuses. As an adjunct therapy for 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 The use of Otrivin nasal metered spray 0.1% is not recommended 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 a spray stream is obtained. 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, press the applicator 4 times again. Insert the nozzle into the nostril, press the applicator quickly once, inhaling slightly at the same time - this will help to optimally distribute 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 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 <1/1,000), very rare (<1/10,000). Within each group, adverse events 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 mentioned side effects develop, or if you experience 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 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 "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. · In hyperthyroidism, diabetes mellitus, pheochromocytoma; · In prostatic hypertrophy; · In patients who are being treated or have been treated with monoamine oxidase inhibitors within the last 14 days (see "Interactions with other medicinal products"). · In patients being treated with tri- and tetracyclic antidepressants (see "Interactions with other medicinal products"). · In case of 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 stop using Otrivin immediately 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 metered 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 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 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 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 small 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. Packaging 10 ml of the preparation in a bottle with a pump dispenser and a polyethylene protective cap. The bottle is placed in a cardboard box with instructions for use. Storage conditions Store at a temperature not exceeding 30 °C. Keep out of reach of children. Shelf life 3 years. Dispensing conditions from pharmacies Pharmaceutical product group III, available without a prescription.