Otrivin Oxy - instructions for use, dose, side effects, contraindications

Sorbitol liquid non-crystallizing (70%) 20.0 mg, sodium dihydrogenphosphate dihydrate 5.0 mg, hypromellose 5.0 mg, sodium chloride 4.5 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride 50 % solution 0.2 mg (in terms of benzalkonium chloride 0.1 mg), sodium hydrogen phosphate dodecahydrate 0.17 mg, water purified to 1.0 ml.

Spray nasal with a scent of menthol:

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, cineole (eucalyptol) 1.5 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride 50% solution 0.2 mg (in terms of benzalkonium chloride 0.1 mg), sodium hydrogen phosphate dodecahydrate 0.1 mg, water purified to 1.0 ml.

Description:

Spray nasal:

Transparent solution from colorless to light yellow color.

Spray nasal with a scent of menthol:

Transparent or opalescent solution from colorless to white with the smell of menthol and eucalyptus.

Pharmacotherapeutic group:Anti-cocongifiable agent α-adrenomimetic

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

Otrivin® Oxy (oxymetazoline) is a sympathomimetic agent acting on α-adrenergic receptors of the nasal mucosa. Has vasoconstrictive effect, reducing edema of the mucous membrane of the nasopharynx. When applied locally to the inflamed mucous membrane of the nasal cavity reduces its swelling and discharge from the nose. It restores nasal breathing, eliminates the swelling of the mucous membrane of the nasal cavity, helps restore the aeration of the paranasal sinuses of the nasal cavity, the middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media). With topical intranasal application in therapeutic concentrations oxymetazoline has no systemic effect, does not irritate and does not cause hyperemia of the mucous membrane of the nasal cavity.

The drug begins to act after 25 seconds, the duration of the action is kept up to 12 hours.

Pharmacokinetics:

With topical intranasal application oxymetazoline does not have a systemic effect. Absorption of oxymetazoline is regarded as not having clinical significance.

Indications:

Symptomatic treatment of nasal congestion in acute diseases with the phenomena of rhinitis (rhinitis), acute allergic rhinitis, pollinosis, sinusitis, eustachitis, otitis (to reduce edema mucous membrane of the nasopharynx). To facilitate the outflow of secret at diseases of the paranasal sinuses. Preparation of the patient for diagnostic manipulations in the nasal passages.

Contraindications:

Hypersensitivity to the drug components, transphenoidal hypophysectomy and surgical interventions on the brain membranes (in the anamnesis), angle-closure glaucoma, pregnancy, atrophic rhinitis, age of 12 years.

Carefully:

Increased intraocular pressure, arterial hypertension, hyperthyroidism, diabetes mellitus, pheochromocytoma, porphyria, prostatic hyperplasia, diseases of the cardiovascular system. It is advisable to use caution in the therapy of patients who are receiving MAO inhibitors at this time or who received them during the previous 2 weeks, tri- and tetracyclic antidepressants, as well as other drugs that increase blood pressure.

If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:

Otrivin® Oxy is contraindicated during pregnancy in connection with a potential systemic vasoconstrictor effect.

During breastfeeding, the drug should only be used after a thorough assessment of the benefit-risk ratio for the mother and fetus, and it is not allowed to exceed the recommended dosage.

Dosing and Administration:

Intranasally.

Adults and children over 12 years: 1 injection in each nasal passage 1-2 times a day. Do not use more than twice a day.

Before the first use, spray a nasal spray with several by pressing until the drug is evenly distributed.

1. Do not cut the spray tip.

2. Thoroughly clean the nose.

3. Remove the protective cap. Take the bottle vertically, supporting the bottom with your thumb, the nozzle is between the middle and index fingers.

4. Aim the nozzle in the nasal passage, slightly tilting the bottle forward.

5. Click on the spray device, spraying the drug, and simultaneously inhale through the nose.

6. Repeat for the other nasal passage.

7. After use, clean and dry the nozzle before closing it with a protective cap.

In the recommended dose without consulting a doctor apply no more than 7 days. Do not exceed the recommended dosage.

Side effects:

Classification of incidence of adverse reactions: very often - more than 1/10 of prescriptions (≥ 10%); often more than 1/100, but less than 1/10 of prescriptions (≥ 1%, but <10%); infrequently - more than 1/1000, but less than 1/100 of prescriptions (≥ 0.1%, but <1%); rarely more than 1/10000, but less than 1/1000 appointments (≥ 0.01%, but <0.1%); very rarely - less than 1/10000 prescriptions (<0.01%).

Impaired nervous system:

Rarely: headache, insomnia, sedation, anxiety, irritability. Very rarely: anxiety, drowsiness.

Disorders from the gastrointestinal tract:

Rarely: nausea.

Disturbances from the respiratory system, chest and mediastinal organs:

Often: nosebleeds, dry nasal mucosa, discomfort from the mucous membrane of the nose, sneezing.

Infrequent: dry mouth, stomatitis, dryness in the throat, irritation in the throat.

Heart Disease:

Rarely: increased blood pressure, palpitations, tachycardia.

Disturbances from the skin and subcutaneous tissues:

Rarely: exanthema, itching.

General disorders and disorders at the site of administration:

Very rarely: fatigue.

Allergic reactions:

Rarely: systemic allergic reactions (angioedema, swelling of the tongue, throat, lips and face).

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

In the case of an overdose of oxymetazoline, the clinical picture is characterized by: mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, pulmonary edema, dyspnea, mental disorders, hallucinations, seizures. Symptoms associated with central nervous system depression, including drowsiness, decreased body temperature, bradycardia, shock-like hypotension, apnea, and loss of consciousness may also appear.

To reduce blood pressure, non-selective α-adrenergic antagonists, in particular phentolamine, can be used. In severe cases, intubation and artificial ventilation may be required. In the case of a moderate or severe overdose, as a result of accidental oral administration, Activated carbon and sodium sulfate (laxative), after a significant overdose, gastric lavage is prescribed.Symptomatic therapy is indicated. The use of vasopressors is contraindicated.

Interaction:

Otrivin® Oxide is not recommended for patients who are receiving monoamine oxidase inhibitors at this time or who received them within the previous 2 weeks. Simultaneous use with tri- and tetracyclic antidepressants and sympathomimetic drugs can enhance the sympathomimetic effect of oxymetazoline.

Special instructions:

Otrivine® Oxy should not be used continuously for more than 7 days without consulting a physician. Prolonged or excessive use of the drug may cause tachyphylaxis, a "ricochet" effect and atrophy the nasal mucosa.

Avoid getting into the mouth, eyes, or around the eyes. Eye contact may result in visual impairment. To avoid the spread of infection, it is necessary to apply the drug individually.

Effect on the ability to drive transp. cf. and fur:The use of Otrivin® Oxy in therapeutic doses does not affect the ability to drive vehicles and mechanisms. When developing unwanted reactions, it is advisable to use caution when performing actions,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Spray nasal, 0.05%; Spray nasal with the aroma of menthol, 0.05%.

Packaging:

For 10 ml of the drug in a vial of PVP, equipped with a spray device with a tip made of polypropylene and a protective cap made of polyethylene. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004409

Date of registration:14.08.2017

Expiration Date:14.08.2022

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

NOVARTIS CONSUMER HEALTH, S.A. Switzerland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp06.09.2017

Illustrated instructions

Instructions

Otrivin® Oxy (Otrivin® Oxy)