Universal reference book for medicines
Product name: OTRIVIN ® (OTRIVIN ® )

Active substance: xylometazoline

Type: Vasoconstrictive drug for topical application in ENT practice

Manufacturer: GlaxoSmithKline Helsker (Russia) manufactured by NOVARTIS CONSUMER HEALTH (Switzerland)
Composition, form of production and packaging

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Spray nasal dosed (for children) 0.05% in the form of a clear, colorless solution, practically odorless.
1 ml

xylometazoline hydrochloride 0.5 mg

Auxiliary substances: sodium dihydrogen phosphate dihydrate - 5 mg, sodium hydrophosphate dodecahydrate - 1.7 mg, disodium edetate - 0.5 mg, benzalkonium chloride 50% solution 0.1 mg (in terms of benzalkonium chloride - 0.5 mg), sorbitol 70% - 20 mg, hypromellose 4 thousand - 5 mg, sodium chloride - 4 mg, water - up to 1 ml.

10 ml - bottles of high-density polyethylene (1) with a pump dispensing device - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Vasoconstrictive drug for topical application in ENT practice (decongestant).
Xylometazoline has an alpha-adrenomimetic effect. Causes constriction of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the nasopharyngeal mucosa. Relieves nasal breathing in rhinitis.
Otrivin ® is well tolerated by patients with sensitive mucous membranes, its effect does not prevent the separation of mucus.
The drug has a balanced pH value, characteristic of the nasal cavity.
The composition of the drug includes inactive components - sorbitol and hypromellose, which are moisturizers, which can reduce the symptoms of irritation and dryness of the nasal mucosa arising with prolonged use of xylometazoline.

In therapeutic concentrations, the drug does not irritate the mucosa, does not cause hyperemia.

The action occurs after 2 minutes after application and lasts for 12 hours.

In vitro studies have shown that in humans, xylometazoline inhibits the infectious activity of rhinovirus causing a "cold".

PHARMACOKINETICS

When topical application in recommended doses is practically not absorbed, the plasma concentrations are below the detection limit.

INDICATIONS

- acute respiratory diseases with phenomena of rhinitis;

acute allergic rhinitis;

- Pollinosis;

- sinusitis;

- Eustachyte;

- otitis media (to reduce edema of the nasopharynx mucosa);

- Preparation of the patient for diagnostic manipulation in the nasal passages.

DOSING MODE

Children from 2 to 5 years: 1 injection in each nasal passage 1-3 times / day.

To children from 6 to 11 years: 1-2 injections in each nasal passage 2-3 times / day.

Do not use more than 3 times / day.
It is recommended to apply the last time just before bedtime.
The drug should be administered under the supervision of adults.

SIDE EFFECT

Determination of the frequency of adverse reactions: very often? 10);
often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely ( ? 1/10 000, <1/1000); very rarely (<1/10 000).
From the immune system: very rarely - hypersensitivity reactions (angioedema, rash, itching).

From the nervous system: often - headache;
rarely - insomnia, depression (with prolonged use in high doses).
From the senses: very rarely - a violation of the clarity of visual perception.

On the part of the cardiovascular system: rarely - a feeling of palpitations, increased blood pressure;
very rarely - tachycardia, arrhythmia.
On the part of the respiratory system: often - irritation and / or dryness of the mucous membrane of the nasopharynx, burning, tingling, sneezing, hypersecretion of the mucous membrane of the nasopharynx.

From the digestive system: often - nausea;
rarely vomiting.
Local reactions: often - burning in the place of application.

If any of the above side effects are aggravated, or the patient has noticed any other side effects, he should inform the doctor about it.

CONTRAINDICATIONS

- Hypersensitivity to xylometazoline and other components of the drug;

- arterial hypertension;

- tachycardia;

- severe atherosclerosis;

- glaucoma;

- dry rhinitis or atrophic rhinitis;

- hyperthyroidism;

- condition after transsphenoidal hypophysectomy;

- surgical interventions on the meninges (in the anamnesis);

- Children under 2 years.

With caution: diabetes mellitus;
pheochromocytoma; cardiovascular diseases (including IHD, angina pectoris); hyperplasia of the prostate; with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.
PREGNANCY AND LACTATION

The drug should not be used during pregnancy.

During lactation, the application is only possible under the supervision of a doctor and after a thorough assessment of the risk-benefit relationship for the mother and fetus.
Do not exceed the recommended dose.
APPLICATION FOR CHILDREN

Do not exceed the recommended dose and duration of the drug, especially in children.

When using the drug in children under 1 year, a doctor's consultation is necessary.

In children under the age of 6, the drug should be administered under adult supervision.

APPLICATION IN ELDERLY PATIENTS

Do not exceed the recommended dose and duration of use, especially in elderly patients.

SPECIAL INSTRUCTIONS

It is not recommended to apply continuously for more than 10 days.

Do not exceed recommended doses, especially in children and elderly patients.

Long (more than 10 days) or excessive use of the drug can cause the effect of "ricochet" (drug rhinitis) and / or atrophy of the nasal mucosa.

Impact on the ability to drive vehicles and manage mechanisms

Xylometazoline does not affect the ability to drive vehicles and control mechanisms.

OVERDOSE

Symptoms: xylometazoline with topical application in excessive dose or with occasional ingestion can cause severe dizziness, increased sweating, a sharp decrease in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions.
Following a rise in blood pressure, there may be a sharp decrease.
Treatment: appropriate supportive measures should be taken for any suspected overdose, in some cases immediate symptomatic treatment is indicated under the supervision of a physician.
These measures should include monitoring the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation should last at least 1 hour.
DRUG INTERACTION

Xylometazoline is contraindicated in patients receiving MAO inhibitors at this time or receiving them within the previous 2 weeks.

Simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs may lead to an increase in the sympathomimetic effect of xylometazoline, so this combination is recommended to be avoided.

TERMS OF RELEASE FROM PHARMACY

The drug is dispensed without a prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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