Xyloct-SOLOfarm nasal spray dispensed with 35mcg/dose, 15ml

Composition

Composition of the drug for 1 dose

1 dose of the drug contains:

Active ingredient:

Xylometazoline hydrochloride-35 mcg,

Auxiliary substances:

Benzalkonium chloride – 7.0 mcg,

Disodium edetate (trilon B) – 35.0 mcg,

Sodium hydrophosphate dihydrate – 140.0 mcg,

Sodium dihydrogen phosphate dihydrate – 140.0 mcg,

Sodium chloride – 518.0 mcg,

Water for injection – 69.4 mg.

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.

Use during pregnancy and lactation

It is contraindicated to use the drug during pregnancy.

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 (in the anamnesis);

– condition after transphenoidal of 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 ischemic heart disease (angina pectoris) pheochromocytoma hyperthyroidism lactation period; 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).

Children aged 2 to 6 years: 1 injection of SOLOxylometazoline nasal spray dosed 35 mcg / 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 SOLOxylometazoline nasal spray dosed 140 mcg / dose in each nasal passage (if necessary, you can repeat); do not use more than 3 times a day.

If symptoms worsen or no improvement occurs within 3 days, you should consult your doctor. At the recommended dose, do not use for more than 7 days without consulting a doctor.

Doses higher than recommended should only be administered under medical supervision.

With frequent and prolonged use of the drug, the feeling of “stuffy” nose may reappear or worsen.

If these symptoms occur, you should stop treatment and consult a doctor. One injection with a volume of 70 µl contains 35 µg of xylometazoline hydrochloride – for SOLOxylometazoline nasal spray dosed 35 µg/dose.

One injection with a volume of 140 microliters contains 140 micrograms of xylometazoline hydrochloride – for SOLOxylometazoline nasal spray dosed 140 micrograms/dose.

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, there may be a sharp decrease in it.

Treatment:  symptomatic.

Description

Pharmacotherapy group: Anticongestive agent-alpha-adrenomimetic ATX code: R01AA07 Pharmacodynamics :

Composition

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with an α2-adrenomimetic effect. 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 and does not cause hyperemia. The action occurs in 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.

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), which increases the risk of reactive hyperemia and atrophy of the nasal mucosa.

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, another 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.

Do not use after the expiration date.

Active ingredient

Xylometazoline

Dosage Form

Spray nasal