SOLOXYLOMETHAZOLINE - instructions for use, dose, side effects, contraindications

Active substance:	35 mcg / dose	140 mcg / dose
Xylometazoline hydrochloride	35 μg	140 μg
Excipients:
Benzalkonium chloride	7.0 μg	14.0 μg
Disodium edetate (Trilon B)	35.0 μg	70.0 μg
Sodium hydrogen phosphate dihydrate	140.0 μg	280.0 μg
Sodium dihydrogen phosphate dihydrate	140.0 μg	280.0 μg
Sodium chloride	518.0 μg	1020.0 μg
Water for injections	69.4 mg	138.75 mg

Description:

Transparent, colorless or light yellow liquid.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with α₂-adrenomimetic action. Has a rapid, pronounced and prolonged vasoconstrictive action against the vessels of the mucous membrane of the nasal cavity, thus eliminating its swelling and flushing. Restores the patency of the nasal passages, facilitates nasal breathing in rhinitis.

In therapeutic concentrations, it does not irritate the mucous membrane of the nasal cavity, does not cause hyperemia. The action comes in a few minutes and lasts for 10-12 hours.

Pharmacokinetics:

With topical application is practically not absorbed, plasma concentrations are so small that they can not be determined by modern analytical methods.

Indications:

Acute respiratory diseases with phenomena of rhinitis (rhinitis), acute allergic rhinitis, pollinosis, sinusitis, eustachitis, otitis media (to reduce edema of the nasopharyngeal mucosa).

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

Contraindications:

- Hypersensitivity to the components of the drug;

- arterial hypertension;

- tachycardia;

- severe atherosclerosis;

- glaucoma;

- Atrophic rhinitis;

- thyrotoxicosis;

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

- states after transphenoidal hypophysectomy;

- Children under 2 years old - for SOLOXYLOMETHAZOLINE, nasal spray dosage of 35 μg / dose;

- Children under 6 years old - for SOLOXYLOMETHAZOLINE, nasal spray 140 mg / dose;

- Pregnancy.

Do not use with monoamine oxidase inhibitors and tricyclic antidepressants (including the period of 14 days after their withdrawal).

Carefully:

Diabetes mellitus, prostatic hyperplasia, ischemic heart disease (angina pectoris), pheochromocytoma, hyperthyroidism, lactation period; with increased sensitivity to adrenergic drugs, accompanied by insomnia,dizziness, arrhythmia, tremor, increased blood pressure.

Pregnancy and lactation:

Contraindicated use of the drug during pregnancy.

It is possible to use the drug during breastfeeding as prescribed by the doctor if the expected therapeutic effect of the mother exceeds the risk of developing possible side effects in the child.

Dosing and Administration:

Intranasally (in each nasal passage).

Children aged 2 to 6 years: 1 injection of SOLOXYLOMETHAZOLINE, a nasal spray dosed with 35 μg / dose in each nasal passage; Do not use more than 3 times a day.

Adults and children over 6 years of age: 1 injection of SOLOXYLOMETHAZOLINE, nasal spray 140 mg / dose in each nasal passage (if necessary, repeat); Do not use more than 3 times a day.

If the symptoms increase or the improvement does not occur within 3 days, you should consult your doctor. In the recommended dose without consulting a doctor apply no more than 7 days.

Doses above recommended can be used only under the supervision of a doctor.

With frequent and prolonged use of the drug, the sensation of "congestion" of the nose may appear again or worsen.

If these symptoms appear, discontinue treatment and consult a doctor.One 70 μl injection contains 35 μg xylometazoline hydrochloride - for SOLOXYLOMETHAZOLINE, a nasal spray dosed with 35 μg / dose.

One 140 μl injection contains 140 μg xylometazoline hydrochloride - for SOLOXYLOMETHAZOLINE, a nasal spray dispensed with 140 μg / dose.

Side effects:

With frequent and / or prolonged use - irritation and / or dryness of the mucosa of the nasopharynx, burning, tingling, sneezing, hypersecretion mucosa nasopharynx, hypersensitivity, swelling of nasal mucosa, palpitations, tachycardia, arrhythmia, hypertension, headache , nausea, vomiting, insomnia, impaired vision, depression (with prolonged use of high doses).

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

Overdose:

Symptoms: increased side effects (dose-dependent), lower body temperature, confusion. In case of accidental ingestion of the drug can cause: severe dizziness, sweating, headache, bradycardia, hypertension, respiratory depression, coma and convulsions.After increasing blood pressure, there may be a sharp decrease in blood pressure.

Treatment: symptomatic.

Interaction:

Xylometazoline should not be used in patients receiving monoamine oxidase inhibitors and tricyclic antidepressants (including the period of 14 days after their withdrawal) due to the possibility of increasing blood pressure.

Special instructions:

Avoid contact with eyes.

To avoid the spread of infection, it is necessary to apply the drug individually.

Do not exceed the recommended dose and apply the drug for a long (more than 7 days) time. Prolonged use of the drug may cause a ricochet effect (drug rhinitis), the risk of reactive hyperemia and atrophy of the nasal mucosa increases.

Since the drug contains benzalkonium chloride, as a preservative, especially with prolonged use (more than 7 days), the edema of the mucous membrane of the nasal cavity may develop. If there is a suspicion of such a reaction (nasal congestion), it is necessary, if possible, to use a drug that does not contain preservatives.If such medicines are not available, it is necessary to use another dosage form.

Effect on the ability to drive transp. cf. and fur:

Xylometazoline can affect the ability to drive vehicles or equipment.

In drug treatment, caution should be exercised when driving and busy with other potentially hazardous activities that require high concentration and speed of psychomotor actions.

Form release / dosage:

Spray nasal dosed, 35 mcg / dose and 140 mcg / dose.

Packaging:

For a dosage of 35 mcg / dose:

For 120 doses (10 ml) or 180 doses (15 ml) in a bottle of polyethylene, completed with a metering nozzle.

For a dosage of 140 mcg / dose:

For 60 doses (10 ml) or 90 doses (15 ml) in a bottle of polyethylene, completed with a metering nozzle.

1 bottle with instructions for use in a pack of cardboard.

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.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003420

Date of registration:20.01.2016 / 21.12.2016

Expiration Date:20.01.2021

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Representation: & nbspGROTEKS, LLCGROTEKS, LLC

Information update date: & nbsp06.02.2018

Illustrated instructions

Instructions

SOLOXYLOMETHAZOLINE (SOLOxylometazoline)