Xyloct-Solofarm, spray 140 mcg/dose 15 ml

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with α₂ adrenomimetic action. It has a fast, pronounced and prolonged vasoconstrictor effect on the vessels of nasal mucosa, thus eliminating its edema and hyperemia. It restores nasal passageway patency and eases nasal breathing in rhinitis.

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

Pharmacokinetics

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

Indications

Acute respiratory diseases with symptoms of rhinitis (runny nose), 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

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with an α2-adrenomimetic effect. It has a rapid, pronounced and long-lasting vasoconstrictor effect on the vessels of the nasal mucosa, thus eliminating its swelling and hyperemia. Restores the patency of the nasal passages, facilitates nasal breathing during rhinitis.

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

Pharmacokinetics

When applied topically, it is practically not absorbed; plasma concentrations are so small that they cannot be determined by modern analytical methods.

Special instructions

Avoid getting the drug into your eyes.

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

Do not exceed the recommended doses and use the drug for a long time (more than 7 days). Long-term use of the drug can cause a “ricochet” effect (medicinal rhinitis), increasing the risk of reactive hyperemia and atrophy of the nasal mucosa.

Since the drug contains benzalkonium chloride as a preservative, especially with long-term use (more than 7 days), swelling of the nasal mucosa may develop. If you suspect such a reaction (nasal congestion), it is necessary, if possible, to use a medicine that does not contain preservatives. If such drugs are not available, a different dosage form must be used.

Impact on the ability to drive vehicles and machinery

Xylometazoline may affect the ability to operate vehicles or operate equipment.

When treating with the drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor actions.

Active ingredient

Xylometazoline

Composition

1 dose of the drug contains:

Active ingredient:

xylometazoline hydrochloride – 140 mcg,

Excipients:

benzalkonium chloride – 14.0 mcg,

disodium edetate (trilon B) – 70.0 mcg,

sodium hydrogen phosphate dihydrate – 280 mcg,

sodium dihydrogen phosphate dihydrate – 280 mcg,

sodium chloride – 1020.0 mcg,

water for injection – 138.75 mcg.

Pregnancy

The use of the drug during pregnancy is contraindicated.

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

Contraindications

– Hypersensitivity to the components of the drug;

– Arterial hypertension;

– Tachycardia;

– Severe atherosclerosis;

– Glaucoma;

– Atrophic rhinitis;

– Thyrotoxicosis;

– Surgical interventions on the meninges (history);

– Conditions after transsphenoidal hypophysectomy;

– Children under 2 years of age – for SOLOXYLOMETAZOLINE, nasal spray dosed 35 mcg/dose;

– Children under 6 years of age – for SOLOXYLOMETAZOLINE, 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 discontinuation).

With caution

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

Side Effects

With frequent and/or prolonged use – irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa, hypersensitivity reactions, swelling of the nasal mucosa, palpitations, tachycardia, arrhythmia, increased blood pressure, headache, nausea, vomiting, insomnia, blurred vision, depression (with long-term use of high doses).

If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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

Overdose

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

Treatment: symptomatic.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Grotex LLC, Russia