Xyloct-Solofarm, spray 35 µg/dose 15 ml

Acute respiratory diseases with rhinitis (runny nose) acute allergic rhinitis pollinosis sinusitis eustachianitis otitis media (to reduce nasopharyngeal mucosal edema).

Patient preparation for diagnostic manipulations in the nasal passages.

Active ingredient

Xylometazoline

Composition

Composition of the drug per 1 dose

1 dose of the drug contains:

The active ingredient:

Xylometazoline hydrochloride – 35 µg,

Excipients:

Benzalkonium chloride – 7.0 µg,

Dinatrium edetate (trilon B) – 35.0 µg,

Sodium hydrophosphate dihydrate – 140.0 µg,

Sodium dihydrophosphate dihydrate – 140.0 µg,

Sodium chloride – 518.0 µg,

Injection water – 69.4 mg.

How to take, the dosage

Intranasally (in each nasal passage).

In children aged 2 to 6 years: 1 injection of SOLOXYlometazoline nasal dosage spray 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 Soloxylomethasoline nasal spray dosed 140 µg/dose in each nasal passage (may be repeated if necessary); do not use more than 3 times daily.

If symptoms worsen or do not improve within 3 days, consult a physician. At the recommended dose without consulting a physician, use for no more than 7 days.

Higher doses than the recommended doses should only be used under a physician’s supervision.

The feeling of a stuffy nose may reoccur or get worse with frequent and prolonged use.

If these symptoms occur, discontinue treatment and see a physician. One 70 µl injection contains 35 µg xylometazoline hydrochloride – for SOLOxylometazoline nasal spray dispensed 35 µg/dose.

One injection of 140 µL contains 140 µg xylometazoline hydrochloride – for SOLOxylometazoline nasal spray dosed with 140 µg/dose.

Interaction

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

Special Instructions

Avoid getting the drug in the eyes.

The drug should be used individually to avoid spreading infection.

The recommended doses should not be exceeded and the drug should not be used for prolonged periods (more than 7 days). Prolonged use of the drug may cause a “ricochet” effect (drug-induced rhinitis) increasing the risk of reactive hyperemia and atrophy of the nasal mucosa.

Because the drug contains benzalkonium chloride as a preservative, especially with prolonged use (more than 7 days), nasal mucosal edema may develop. If there is suspicion of this reaction (nasal congestion) it is necessary to use a drug that does not contain preservatives. If these drugs are not available, you need to use another form of medication.

Effects on ability to operate vehicles and machinery:

Xylometazoline may affect the ability to operate vehicles or equipment.

When treating with the drug, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and quick psychomotor actions.

Synopsis

Pharmacotherapeutic group: Antinoconstrictive agent – alpha-adrenomimetic

ATC code: R01AA07

Pharmacodynamics:

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with α2-adrenomimetic action. It has quickly expressed and prolonged vasoconstrictor effect in respect to mucous membrane vessels of the nasal cavity eliminating thereby its edema and hyperemia. It restores nasal passageways patency which eases nasal breathing in rhinitis.

In therapeutic concentrations it does not irritate the nasal cavity mucosa and does not cause hyperemia. The effect occurs within a few minutes and lasts for 10-12 hours.

Pharmacokinetics:

When applied topically, concentrations in the plasma are practically not absorbed so low that they cannot be determined by modern analytical methods.

Contraindications

– Hypersensitivity to the components of the drug;

– arterial hypertension;

– tachycardia;

– pronounced atherosclerosis;

– glaucoma;

– atrophic rhinitis;

– thyrotoxicosis;

– brain surgery (history);

– conditions after transsphenoidal pituitaryectomy;

– children under 2 years of age – for Soloxylomethasoline nasal spray dosed 35 mcg/dose;

– children under 6 years of age – for SOLOXYLOMETAZOLIN nasal spray dosed 140 mcg/dose;

– pregnancy.

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

Cautions:

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

Side effects

In frequent and/or prolonged use – irritation and/or dry nasopharyngeal mucosa burning tingling sneezing hypersecretion of nasopharyngeal mucosa hypersensitivity reactions nasal mucosa edema palpitation palpitations tachycardia arrhythmia increased blood pressure headache vomiting insomnia visual disturbance depression (in prolonged use of high doses).

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: increased side effects (dose-dependent) decrease in body temperature confusion. If ingested accidentally, the drug may cause: severe dizziness increased sweating headache bradycardia increased blood pressure respiratory depression coma and seizures. After an increase in blood pressure there may be a sharp decrease in blood pressure.

Treatment: symptomatic.

Pregnancy use

The drug is contraindicated in pregnancy.

The drug can be used during breastfeeding by prescription of the attending physician if the expected therapeutic effect in the mother exceeds the risk of possible side effects in the child.

Similarities

Atrivin, Galazolin, Xylen, Snoop, Rinonorm, Xymelin Eco, Rinorus, Rinostop, Rinomaris, Xylometazolin, Tisin Classic, Xymelin Eco Menthol, Asterisk, Cold and Flu, Asterisk for Colds, Quatran xylo