Otrivin spray 0.1% 10ml for adults

Release form, composition and packaging

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Dosed nasal spray 0.1% in the form of a clear, colorless solution, practically odorless.

1 ml

xylometazoline hydrochloride 1 mg

sodium dihydrogen phosphate dihydrate - 5 mg, sodium hydrogen phosphate dodecahydrate - 1.7 mg, disodium edetate - 0.5 mg, benzalkonium chloride 50% solution - 0.1 mg (in terms of benzalkonium chloride - 0.05 mg), sorbitol 70% - 20 mg, hypromellose 4 thous. - 5 mg, sodium chloride - 4 mg, purified water - up to 1 ml.

10 ml - bottles made of high density polyethylene (1) with a pump dispensing device, a tip and a protective cap made of polyethylene - cardboard packs.

pharmachologic effect

A vasoconstrictor drug for topical use in ENT practice (decongestant). Xylometazoline has an alpha-adrenomimetic effect: it causes narrowing of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the nasopharyngeal mucosa. Xylometazoline also reduces concomitant mucus hypersecretion and facilitates drainage of blocked nasal passages and thus improves nasal breathing in case of nasal congestion. Otrivin® is well tolerated by patients with sensitive mucous membranes its effect does not prevent mucus separation. Otrivin® has a balanced pH value characteristic of the nasal cavity. The menthol and eucalyptol contained in the preparation have a cooling effect on the nasal mucosa, giving a feeling of freshness. In therapeutic concentrations, the drug does not irritate the mucous membrane,does not cause flushing. The effect occurs 2 minutes after application and lasts for 12 hours. In vitro studies have shown that xylometazoline in humans suppresses the infectious activity of the rhinovirus that causes the cold".

Pharmacokinetics

When applied topically in recommended doses, it is practically not absorbed, plasma concentrations are below the detection limit.

Indications for use

- acute respiratory diseases with symptoms of rhinitis

- acute allergic rhinitis

- hay fever

- sinusitis

- eustachitis

- otitis media (to reduce swelling of the nasopharyngeal mucosa)

- preparation of the patient for diagnostic manipulations in the nasal passages.

Contraindications for use

- 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 history)

- children under 12 years of age (nasal spray dosed 0.1%).

With care: diabetes mellitus

pheochromocytoma

cardiovascular diseases (including ischemic heart disease, angina pectoris)

hyperplasia of the prostate

with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Dosage regimen

Intranasally.

Adults and children over 12 years old: 1 injection in each nasal passage 3 times / day.

Should not be used more than 3 times / day.

It is recommended to apply one last time just before bedtime.

Overdose

Symptoms: Xylometazoline, when applied topically in an excessive dose or when taken accidentally, can cause severe dizziness, increased sweating, a sharp drop in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions.

Following an increase in blood pressure, a sharp decrease can be observed.

Treatment: Appropriate supportive measures should be taken in case of any suspicion of an overdose, in some cases, immediate symptomatic treatment is indicated under medical supervision.

These measures should include monitoring the patient for several hours.

In case of severe poisoning with cardiac arrest, resuscitation measures

Name ENG

OTRIVIN

Clinical and pharmacological group

A vasoconstrictor drug for local use in ENT practice

ATX code

Xylometazoline

Dosage

0.1% x 10ml

Structure

1 ml contains: Active ingredient: xylometazoline hydrochloride 1 mg Excipients: sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, sodium chloride, benzalkonium chloride (in the form of a 50% solution), sorbitol 70%, disodium edetate, levomenthol (menthol), cyneole eucalyptol), macrogol glyceryl hydroxystearate, purified water

Indications

acute respiratory diseases with symptoms of rhinitis

acute allergic rhinitis

hay fever

sinusitis

eustachitis

otitis media (to reduce swelling of the nasopharyngeal mucosa)

preparation of the patient for diagnostic manipulations in the nasal passages.

INN / Active ingredient

Xylometazoline

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

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 history)

children under 12 years of age (nasal spray dosed 0.1%).

With care: diabetes mellitus

pheochromocytoma

cardiovascular diseases (including ischemic heart disease, angina pectoris)

hyperplasia of the prostate

with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Specifications

Category

Runny nose

Scope of the drug

Ear, Throat, Nose

Release form

Spray

Manufacturer country

Switzerland

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

6 years

Way of introduction

Through the respiratory tract

Vacation conditions

Without recipe

Volume, ml.

10 ml

Brand name

Otrivin

Components

protective cap, pump metering device

The amount of the dosage form in the primary package

10 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Decongestant - alpha adrenergic agonist

Anatomical and therapeutic characteristics

R01AA07 Xylometazoline

Dosage form

Dosed nasal spray

Dosage (volume) of the substance in the preparation

xylometazoline hydrochloride 1000 mcg

Expiration date in days

1095

The target audience

Children

Package weight, g

fifty

Mode of application

:

Intranasally.

Adults and children over 12 years old - 1 injection into each nasal passage 3 times a day.

Should not be used more than 3 times a day.

Information on technical characteristics, delivery set, country of manufacture "