Otrivin Express nasal spray with menthol fragrance 0.05%, 10ml

Composition

Per 1 ml: Active ingredient: Oxymetazoline hydrochloride 0.5 mg; Excipients: Sorbitol 14.0 mg, sodium chloride 5.5 mg, castor oil hydrogenated 2.5 mg, sodium dihydrogen phosphate dihydrate 2.0 mg, levomenthol (menthol) 2.0 mg, cineol (the evkaliptola) 1.5 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride 50% solution of 0.2 mg (in terms of benzalkonium chloride 0.1 mg), sodium hydrogen phosphate, dodecahydrate 0.1 mg, purified water to 1.0 ml.

Pharmacological action

Otrivin Express (oxymetazoline) is a sympathomimetic agent that acts on alpha-adrenergic receptors of the nasal mucosa. It has a vasoconstrictive effect, reducing swelling of the nasopharyngeal mucosa. When applied topically to the inflamed nasal mucosa, it reduces its puffiness and nasal discharge. Restores nasal breathing, eliminates swelling of the nasal mucosa, helps restore aeration of the paranasal sinuses of the nasal cavity, the middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media). When applied locally intranasally at therapeutic concentrations, oxymetazoline has no systemic effect, does not irritate or cause hyperemia of the nasal mucosa. The drug begins to act in 25 seconds, the duration of action is maintained for up to 12 hours.

Indications

Symptomatic treatment of nasal congestion in acute respiratory diseases with rhinitis (runny nose), acute allergic rhinitis, pollinosis, sinusitis, eustachiitis, otitis (to reduce swelling of the nasopharyngeal mucosa). To facilitate the outflow of secretions in diseases of the paranasal sinuses. Preparation of the patient for diagnostic manipulations in the nasal passages.

Contraindications

Hypersensitivity to the components of the drug, transfenoidal pituitary and surgical interventions on the meninges (in the anamnesis), angle-closure glaucoma, pregnancy, atrophic rhinitis, age up to 12 years. With caution:  Increased intraocular pressure, arterial hypertension, hyperthyroidism, diabetes mellitus, pheochromocytoma, porphyria, prostatic hyperplasia, diseases of the cardiovascular system. Caution is recommended when treating patients who are currently receiving MAO inhibitors or who have received them for the previous 2 weeks, tri-and tetracyclic antidepressants, as well as other drugs that increase blood pressure. If you have one of these diseases, be sure to consult your doctor before taking the drug. Pregnancy and lactation:  Otrivin Express is contraindicated during pregnancy due to its potential systemic vasoconstrictor effect. During breastfeeding, the drug should be used only after a thorough assessment of the benefit-risk ratio for the mother and fetus, and it is not allowed to exceed the recommended dosage.

Side effects

Classification of the frequency of adverse reactions: very often — more than 1/10 appointments (> 10%); often — more than 1/100, but less than 1/10 appointments (>> 1%, but >>< 10%); infrequently — more than 1/1000, but less than 1/100 appointments (> 0.1%, but < 10%); infrequently — more than 1/1000, but less than 1/100 appointments (>< 1%); rarely — more than 1/10000, but less than 1/1000 appointments (> 0.01%, but < 1%); rarely — more than 1/10000, but less than 1/1000 appointments (>< 0.1%); very rarely — less than 1/10000 appointments (Nervous system disorders: rarely-headache, insomnia, sedation, anxiety, irritability; very rarely-restlessness, drowsiness. Gastrointestinal disorders: rarely-nausea. Respiratory, thoracic, and mediastinal disorders: common: nasal bleeding, dryness of the nasal mucosa, discomfort from the nasal mucosa, sneezing. Infrequently: dry mouth, stomatitis, dry throat, sore throat. Cardiac disorders: rarely-increased blood pressure, palpitation, tachycardia. Skin and subcutaneous tissue disorders: rarely-exanthema, pruritus. General disorders and disorders at the injection site: very rarely – fatigue. Allergic reactions: rarely-systemic allergic reactions (angioedema of the tongue, throat, lips and face). If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Otrivin Express is not recommended for patients who are currently receiving monoamine oxidase inhibitors or who have received them during the previous 2 weeks. Concomitant use with tri-and tetracyclic antidepressants and sympathomimetic drugs may enhance the sympathomimetic effect of oxymetazoline.

How to take, course of use and dosage

Intranasally. Adults and children over 12 years of age: 1 injection in each nasal passage 1-2 times a day. Do not use more than twice a day. Before first use, spray the nasal spray with a few taps until the drug is evenly distributed.

Overdose

In the case of an overdose of oxymetazoline, the clinical picture is characterized by: mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmia, cardiac arrest, arterial hypertension, pulmonary edema, shortness of breath, mental disorders, hallucinations, convulsions. Symptoms associated with central nervous system depression may also occur, including drowsiness, decreased body temperature, bradycardia, shock-like hypotension, apnea, and loss of consciousness. Non-selective a-adrenergic antagonists, in particular phentolamine, can be used to lower blood pressure. In severe cases, intubation and mechanical ventilation may be required. In the case of moderate or severe overdose as a result of accidental oral use, activated charcoal and sodium sulfate (a laxative) are prescribed, and after a significant overdose, gastric lavage is prescribed. Symptomatic therapy is indicated. The use of vasopressors is contraindicated.

Special instructions

With caution: increased intraocular pressure, arterial hypertension, hyperthyroidism, diabetes mellitus, pheochromocytoma, porphyria, prostatic hyperplasia, diseases of the cardiovascular system. Caution is recommended when treating patients who are currently receiving MAO inhibitors or who have received them for the previous 2 weeks, tri-and tetracyclic antidepressants, as well as other drugs that increase blood pressure. If you have one of these diseases, be sure to consult your doctor before taking the drug. It is contraindicated during pregnancy due to the potential systemic vasoconstrictor effect. During breastfeeding, the drug should be used after careful assessment of the benefit-risk ratio for the mother and fetus, and it is not allowed to exceed the recommended dosage. Do not use continuously for more than 7 days without consulting your doctor. Prolonged or excessive use of the drug can cause tachyphylaxis, a “rebound” effect, and atrophy of the nasal mucosa. Avoid contact with the mouth, eyes, or around the eyes. In case of contact with the eyes, there may be a visual impairment. To avoid the spread of infection, it is necessary to use the drug individually. The use of Otrivin Express in therapeutic doses does not affect the ability to drive vehicles and mechanisms. With the development of undesirable reactions, it is recommended to use caution when performing actions that require increased concentration of attention and speed of psychomotor reactions.

Active ingredient

Oxymetazoline

Dosage Form

Spray nasal