Otrivin Children’s nasal spray 0.05%, 10ml

Product description

Otrivin nasal spray dosed for children 0,05%. The moisturizing formula helps to reduce the symptoms of irritation and dryness of the nasal mucosa. It 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 of 28.12.09

Composition

1 ml:

– xylometazoline hydrochloride 500 mcg

Auxiliary substances:  

sodium dihydrogen phosphate dihydrate 5 mg,

sodium hydrogen phosphate, dodecahydrate – 1.7 mg,

disodium edetate – 500 mg,

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

sorbitol 70%,20 mg,

hypromellose-4 thousand 5 mg

sodium chloride 4 mg,

purified water – up to 1 ml.

Pharmacological action

Vasoconstrictor drug for topical use in ENT practice (decongestant). Xylometazoline has an alpha-adrenomimetic effect. Causes narrowing of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the nasopharyngeal mucosa. Facilitates nasal breathing in rhinitis. Otrivin® is well tolerated in patients with sensitive mucosa, its effect does not interfere with 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 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, does not cause hyperemia. The action occurs 2 minutes after application and lasts for 12 hours. In vitro studies have shown that in humans, xylometazoline suppresses the infectious activity of the rhinovirus that causes the “common cold”.

Clinical pharmacology

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

Indications

Acute respiratory diseases with rhinitis phenomena; acute allergic rhinitis; pollinosis; sinusitis; eustachiitis; otitis media (to reduce the swelling of the nasopharyngeal mucosa); preparation of the patient for diagnostic manipulations in the nasal passages.

Use during pregnancy and lactation

The drug should not be used during pregnancy. During lactation, use is possible only under the supervision of a doctor and after 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 (in the anamnesis); children under 6 years of age (for a spray of 0.1%).

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

Side effects

Determination of the frequency of adverse reactions: very common ≥10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10 000, <1/1000); very rare (Immune system disorders: very rarely – hypersensitivity reactions (angioedema, rash, pruritus). From the nervous system: often-headache; rarely-insomnia, depression (with prolonged use in high doses). From the side of the senses: very rarely – violation of the clarity of visual perception. From the cardiovascular system: rarely-palpitation, 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 sensation at the site of application. If any of the above side effects get worse, or the patient notices any other side effects, they should inform their doctor.

Interaction

Incompatible with MAO inhibitors and tricyclic antidepressants.

How to take, course of use and dosage

Children from 2 to 5 years: 1 injection in each nasal passage 1-3 times / day. Children from 6 to 11 years: 1-2 injections in each nasal passage 2-3 times / day. Do not apply more than 3 times a day. It is recommended to apply the last time just before bedtime. The drug should be used under adult supervision.

Overdose

Symptoms: xylometazoline, when applied topically in an excessive dose or 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, there may be a sharp decrease in it. Treatment: Appropriate supportive measures should be taken in case of any suspected overdose, in some cases immediate symptomatic treatment is indicated under the supervision of a doctor. 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.

Description

Nasal spray dosed (for children) 0.05% in the form of a clear colorless solution, almost odorless.

Special instructions

It is not recommended to use continuously for more than 10 days. Do not exceed the recommended dose, especially in children and elderly patients. Prolonged (more than 10 days) or excessive use of the drug can cause a “rebound” effect (drug-induced rhinitis) and/or atrophy of the nasal mucosa. Effect on the ability to drive motor vehicles and manage mechanicsmi Xilometazoline does not affect the ability to drive motor vehicles and manage mechanisms.

Product form

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

Storage conditions

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

Shelf life

3 years

Active ingredient

Xylometazoline

Dosage form

nasal spray

Description

Children over 2 years old

Indications

Sinusitis, Pollinosis, Allergies, Colds, Allergic Rhinitis, Sinusitis, Runny nose, Otitis Media, Flu