Xylokt-Solopharm 0.1% Nasal Drops

Indications

Acute respiratory diseases with symptoms of rhinitis (runny nose), acute allergic rhinitis, hay fever, sinusitis, eustachitis, otitis media (to reduce swelling of the mucous membrane of the nasopharynx).
Preparation of the patient for diagnostic procedures in the nasal passages.

Method of application and doses

Intranasally (in each nasal passage).

Solution of the drug with a concentration of 0.05%: for children aged 2 to 6 years - 1-2 drops in each nasal passage 1-2 times a day; should not be used more than 3 times a day.

Solution of the drug with a concentration of 0.1%: for adults and children over 6 years - 2-3 drops in each nasal passage 2-3 times a day (can be repeated if necessary); should not be used more than 3 times a day.

The drug is used for no more than 7 days.

Section: Composition

1 ml of the preparation contains:
Active ingredient:
Xylometazoline hydrochloride 1.0 mg
Excipients:
Benzalkonium chloride 0.15 mg
Disodium edetate dihydrate (Trilon B) 0.5 mg
Sodium dihydrogen phosphate dihydrate 3.54 mg
Dihydrogen potassium phosphate 3.63 mg
Sodium chloride 9.0 mg
Water for injections up to 1 ml

Description of the dosage form

Transparent colorless or light yellow liquid.

• increased sensitivity to the components of the drug,

• arterial hypertension,

• tachycardia,

• severe atherosclerosis,

• glaucoma,

• atrophic rhinitis,

• hyperthyroidism,

• surgical interventions on the meninges (in history),

• condition after transsphenoidal hypophysectomy,

• age under 2 years - for the solution with a concentration of 0.05 %,

• age under 6 years - for the solution with a concentration of 0.1 %,

• pregnancy.
Do not use in therapy with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, as well as with other drugs that increase blood pressure.
With caution
Diabetes mellitus; prostatic hyperplasia; ischemic heart disease (angina); pheochromocytoma; lactation period; in case of increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.
Use during pregnancy and lactation
The use of the drug is contraindicated during pregnancy.
The use for treating nursing mothers may be considered at the discretion of the attending physician if the expected therapeutic effect for the mother outweighs the risk of possible side effects for the child.

Special instructions

Before use, the nasal passages should be cleared.
Do not exceed the recommended doses and do not use the medication for an extended period (more than 7 days). Using the medication for more than 7 days may cause a "rebound" effect (medication-induced rhinitis).
With prolonged use of the medication, the risk of reactive hyperemia and atrophy of the nasal mucosa increases.
Since the medication contains benzalkonium chloride as a preservative, especially with prolonged use (more than 7 days), swelling of the nasal mucosa may develop. If there are suspicions of such a reaction (nasal congestion), it is necessary, if possible, to use a medication that does not contain preservatives. If such medications are not available, another dosage form should be used.
In cases of "cold" diseases where crusts form in the nose, it is preferable to prescribe it in the form of a gel.
Effect on the ability to drive vehicles and operate machinery
Xylometazoline may affect the ability to drive vehicles or operate equipment.
When treating with the medication, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased attention and quick psychomotor responses.

Section: Side Effects

With frequent and/or prolonged use - irritation and/or dryness of the mucous membrane of the nasopharynx, burning, tingling, sneezing, hypersecretion of the mucous membrane of the nasopharynx, hypersensitivity reactions, swelling of the mucous membrane of the nasal cavity, sensation of heartbeat, tachycardia, arrhythmia, increased blood pressure, headache, nausea, vomiting, insomnia, vision disturbances, depression (with prolonged use of high doses).
If any of the side effects listed in the instructions worsen or you notice any other side effects not mentioned in the instructions, inform your doctor.

Overdose

Enhancement of side effects (dose-dependent), decrease in body temperature, confusion. In case of accidental ingestion, the drug may cause: severe dizziness, increased sweating, headache, bradycardia, elevated blood pressure, respiratory depression, coma, and seizures; after an increase in blood pressure, a sharp decrease may be observed.
Treatment: symptomatic.

Interaction

The simultaneous use of xylometazoline with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants may lead to increased blood pressure; therefore, the simultaneous use of these medications is not recommended.

Section: Pharmacodynamics

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha2-adrenergic mimetic action. It provides a rapid, pronounced, and prolonged vasoconstrictive effect on the blood vessels of the nasal mucosa, thereby eliminating its swelling and hyperemia. It restores the patency of the nasal passages and facilitates nasal breathing in cases of rhinitis. At therapeutic concentrations, it does not irritate the nasal mucosa and does not cause hyperemia. The effect begins within a few minutes and lasts for 10-12 hours.

Section: Pharmacokinetics

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

Description

Xylokt Solopharm 0.1% dropper bottle 10 ml - a medicinal product, nasal drops for the treatment of colds, runny nose, and nasal congestion in adults and children over 6 years old. The active ingredient xylometazoline hydrochloride has a rapid, pronounced, and prolonged vasoconstrictive effect on the blood vessels of the nasal mucosa, thereby eliminating its swelling and hyperemia; it restores the patency of the nasal passages and facilitates nasal breathing in cases of rhinitis.
Intranasally (in each nasal passage) for adults and children over 6 years old - 2-3 drops in each nasal passage 2-3 times a day (can be repeated if necessary); do not use more than 3 times a day. The medication should not be used for more than 7 days.
It is recommended to consult a doctor before use.

Storage conditions

After opening the vial - 1 month.