Xyloct-Solopharm nasal drops 0.1% in vial, 10ml

Composition

1 dose of the drug contains: Active ingredient: xylometazoline hydrochloride-1.0 mg, Excipients: benzalkonium chloride-0.15 mg, disodium edetate (trilon B) – 0.5 mg, sodium hydrophosphate dihydrate-3.54 mg, sodium dihydrogen phosphate dihydrate-3.63 mg, sodium chloride-9.0 mcg, water for injection-up to 1 ml

Pharmacological action

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with_α2-adrenomimetic action. It has a rapid, pronounced and long-lasting vasoconstrictive effect on the vessels of the nasal mucosa, thus eliminating its swelling and hyperemia. Restores the patency of the nasal passages, facilitates nasal breathing in rhinitis.

In therapeutic concentrations, it does not irritate the nasal mucosa, does not cause hyperemia. The effect occurs in 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.

Indications

Acute respiratory diseases with rhinitis (runny nose), acute allergic rhinitis, pollinosis, sinusitis, eustachiitis, otitis media (to reduce swelling of the nasopharyngeal mucosa).

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

Contraindications

-Hypersensitivity to the components of the drug;

– Arterial hypertension;

– Tachycardia;

–  Marked atherosclerosis;

– Glaucoma;

– Atrophic rhinitis;

– Thyrotoxicosis;

Surgical interventions on the meninges (in the anamnesis);

– Condition after transsphenoidal hypophysectomy;

– Children’s age up to 2 years for Coaxiality, spray nasal dosed 35 mcg/dose;

– Children’s age up to 6 years for Coaxiality, spray nasal dosed 140 mcg/dose;

– Pregnancy.

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

With caution

Diabetes mellitus, prostatic hyperplasia, coronary heart disease (angina pectoris), pheochromocytoma, hyperthyroidism, lactation; with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, 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, palpitation, tachycardia, arrhythmia, increased blood pressure, headache, nausea, vomiting, insomnia, visual impairment, depression (with prolonged use of high doses).

If any of the side effects listed 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 monoamine oxidase inhibitors and tricyclic antidepressants (including a period of 14 days after their withdrawal) due to the possibility of increased blood pressure.

How to take, course of use and dosage

Intranasally (in each nasal passage). Solution of the drug with a concentration of 0.05%: children – from 2 to 6 years-1-2 drops in each nasal passage 1-2 times a day; do not use more than 3 times a day. Solution of the drug with a concentration of 0.1%: adults and children over 6 years-2-3 drops in each nasal passage 2-3 times a day (if necessary, you can repeat); do not use more than 3 times a day. The drug is used for no more than 7 days.

Overdose

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

Treatment:  symptomatic.

Special instructions

Avoid contact with eyes.

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

Do not exceed the recommended dose and use the drug for a long time (more than 7 days). Prolonged use of the drug can cause a “rebound” effect (drug-induced 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), edema of the nasal mucosa may develop. If you suspect a similar reaction (nasal congestion), you should, if possible, use a drug that does not contain preservatives. If such medicines are not available, a different dosage form should be used.

Influence on the ability to drive vehicles and mechanisms

Xylometazoline may affect the ability to drive vehicles or equipment.

During treatment with the drug, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor actions.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. After opening the bottle – 1 month. Do not use after the expiration date!

Active ingredient

Xylometazoline

Dosage form

nasal drops