Otrivin Children’s Spray 0.05% 10 ml

A vasoconstrictor for local use in ENT practice (decongestant). Xylometazoline has an alpha-adrenomimetic effect. Causes narrowing of blood vessels of nasal mucosa, eliminating edema and hyperemia of nasopharyngeal mucosa. It relieves nasal breathing in rhinitis.

Otrivin® is well tolerated by patients with sensitive mucous membranes, its effect does not prevent mucus secretion. The drug has a balanced pH-value typical for nasal cavity.

The composition of the drug includes inactive components – sorbitol and hypromellose that are humectants, reducing symptoms of irritation and dry nasal mucosa which occur after long-term use of xylometazoline.

In therapeutic concentrations the drug does not irritate the mucous membrane and does not cause hyperemia.

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

In vitro studies have shown that in humans xylometazoline suppresses the infectious activity of rhinovirus that causes “colds”.

Indications

Acute respiratory diseases with symptoms of rhinitis; acute allergic rhinitis; hay fever; sinusitis; eustachitis; otitis media (to reduce swelling of the nasopharyngeal mucosa); preparing the patient for diagnostic manipulations in the nasal passages.

Pharmacological effect

Vasoconstrictor drug for topical use in ENT practice (decongestant). Xylometazoline has an alpha-adrenomimetic effect. Causes a narrowing of the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the nasopharynx mucosa. Facilitates nasal breathing during rhinitis.

Otrivin® is well tolerated by patients with sensitive mucous membranes; its effect does not interfere with mucus secretion. The drug has a balanced pH value characteristic of the nasal cavity.

The drug contains inactive components – sorbitol and hypromellose, which are humectants, which can reduce the symptoms of irritation and dryness of the nasal mucosa that occur with prolonged use of xylometazoline.

In therapeutic concentrations, the drug does not irritate the mucous membrane and does not cause hyperemia.

The effect begins 2 minutes after application and lasts for 12 hours.

In vitro studies have shown that in humans, xylometazoline inhibits the infectious activity of rhinovirus, which causes the common cold.

Special instructions

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

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

Long-term (more than 10 days) or excessive use of the drug may cause a rebound effect (rhinitis medicamentosa) and/or atrophy of the nasal mucosa.

Impact on the ability to drive vehicles and operate machinery

Xylometazoline does not affect the ability to drive vehicles or operate machinery.

Active ingredient

Xylometazoline

Composition

1 ml:

– xylometazoline hydrochloride 500 mcg

Excipients:

sodium dihydrogen phosphate dihydrate – 5 mg,

sodium hydrogen phosphate dodecahydrate – 1.7 mg,

disodium edetate – 500 mcg,

benzalkonium chloride (in the form of a 50% solution) – 100 mcg,

sorbitol 70% – 20 mg,

hypromellose-4 thousand – 5 mg

sodium chloride – 4 mg,

purified water – up to 1 ml.

Pregnancy

The drug should not be used during pregnancy.

During lactation, use is only possible under the supervision of a physician and after a careful assessment of the risk-benefit ratio for the mother and fetus.

Do not exceed the recommended dose.

Contraindications

Hypersensitivity to the components of the drug; arterial hypertension; tachycardia; severe atherosclerosis; glaucoma; atrophic rhinitis; hyperthyroidism; surgical interventions on the meninges (history); children under 6 years of age (for spray 0.1%).

Use with caution in patients with diabetes mellitus, cardiovascular diseases, with increased sensitivity to adrenergic drugs, accompanied by symptoms of insomnia, dizziness, cardiac arrhythmia, tremor, high blood pressure.

Side Effects

Determination of the frequency of adverse reactions: very often ≥10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (< 1/10,000).From the immune system: very rarely – hypersensitivity reactions (angioedema, rash, itching).From the nervous system: often – headache; rarely – insomnia, depression (with long-term use in high doses).From the senses: very rarely – impaired clarity of visual perception.From the cardiovascular system: rarely – palpitations, increased blood pressure; very rarely – tachycardia, arrhythmia.From the respiratory system: often – irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa.From the digestive system: often – nausea; rarely – vomiting.Local reactions: often – burning at the site of application.If any of the above side effects worsen, or the patient notices any other side effects, he should inform the doctor.

Interaction

Incompatible with MAO inhibitors and tricyclic antidepressants.

Overdose

Symptoms: xylometazoline, when applied topically in excessive doses or when accidentally ingested, can cause severe dizziness, increased sweating, a sharp decrease in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions. Following an increase in blood pressure, a sharp decrease may be observed.

Treatment: Appropriate supportive measures should be taken if overdose is suspected, and in some cases immediate symptomatic treatment under medical supervision is indicated. These measures should include monitoring the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation measures should last at least 1 hour.

Clinical pharmacology

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

Short product description

Otrivin nasal spray dosed for children 0.05%.

The moisturizing formula helps reduce symptoms of irritation and dryness of the nasal mucosa. Can be used in children over 2 years of age.

Relieves congestion in 2 minutes, maintaining the effect for up to 12 hours*.

*Instructions for medical use, RU No. P N011649/03 dated 12/28/09

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf life

3 years

Manufacturer

GSK Consumer Healthcare S.A., Switzerland