Xylazol-kids

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KSYLAZOL-KIDS (XYLAZOL-KIDS)

Composition:

Active substances: xylometazoline, dexpanthenol;

1 ml of solution contains xylometazoline hydrochloride 0.5 mg and dexpanthenol 50 mg;

Excipients: sodium hydrogen phosphate heptahydrate; sodium dihydrogen phosphate monohydrate; benzalkonium chloride; purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical characteristics: clear, colorless solution.

Pharmacotherapeutic group

Anti-edematous and other rhinological preparations for local use. Sympathomimetics, combinations, excluding corticosteroids. ATC code R01A B06.

Pharmacological Properties

Pharmacodynamics

The rhinological medicinal product is a combination of an alpha-sympathomimetic agent with a vitamin B5 analogue for local application to the nasal mucosa. Xylometazoline has vasoconstrictive activity, thereby reducing swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5) that promotes wound healing and protects mucous membranes.

Xylometazoline

Xylometazoline, an imidazole derivative, is an alpha-adrenergic sympathomimetic agent. The onset of action usually occurs within 5–10 minutes, manifested by improved nasal breathing due to reduction of swelling and enhanced drainage of secretions.

Dexpanthenol

Dexpanthenol (D-(+)-pantothenyl alcohol) is an alcohol analogue of pantothenic acid and, through intermediate conversion, exhibits the same biological activity as pantothenic acid. However, only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins that, as coenzyme A, participate in numerous metabolic processes, including supporting the synthesis of proteins and corticosteroids, as well as antibody production. Coenzyme A also participates in the formation of lipids, including sebum secreted by sebaceous glands, which plays an important protective role. Furthermore, coenzyme A is involved in the acetylation of aminosugars, which are key building blocks for various mucopolysaccharides.

Dexpanthenol protects epithelial layers and promotes wound healing.

Pharmacokinetics

Xylometazoline

In some cases, intranasal administration of xylometazoline leads to significant absorption, resulting in systemic effects, for example on the central nervous system (CNS) and cardiovascular system.

Pharmacokinetic data in humans are lacking.

Dexpanthenol

Dexpanthenol is absorbed through the skin and undergoes enzyme-catalyzed oxidation to pantothenic acid in the body and skin cells. The vitamin is transported in the blood plasma in a protein-bound form. As an essential structural component, pantothenic acid combines with coenzyme A and is distributed throughout the body. Detailed studies on metabolism in the skin and mucous membranes are lacking. 60–70% of an orally administered dose is excreted in urine and 30–40% in feces.

Clinical Characteristics

Indications

• Nasal congestion during acute rhinitis;
• promoting healing of the skin around the nasal passages and injuries of the mucous membrane in the nasal cavity;
• vasomotor rhinitis;
• impaired nasal breathing after surgical interventions in the nasal cavity.

Contraindications

• Hypersensitivity to the active substance and/or to any of the excipients of the medicinal product;
• dry inflammation of the nasal mucosa;
• acute coronary diseases, including cardiac asthma;
• hyperthyroidism;
• closed-angle glaucoma;
• transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges in medical history;
• concomitant use with MAO inhibitors and within 2 weeks after discontinuation of their use;
• children under 2 years of age.

The medicinal product contains benzalkonium chloride; therefore, it should not be used in patients with known hypersensitivity to this substance.

Interaction with other medicinal products and other forms of interaction

Xylometazoline

Concomitant use of the drug with tranylcypromine, monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, or β-adrenergic blockers may lead, due to the effect of these drugs on the cardiovascular system, to an increase in blood pressure.

Dexpanthenol

No data available.

Special precautions for use

The medicinal product should be used only after careful assessment of the risk-benefit ratio:

• in patients taking monoamine oxidase inhibitors or other medicinal products capable of increasing blood pressure;
• in patients with elevated intraocular pressure, especially with closed-angle glaucoma;
• in patients with phaeochromocytoma;
• in patients with benign prostatic hyperplasia;
• in patients with porphyria.

The medicinal product should be used with caution in patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, and in patients with prostatic hyperplasia.

Patients with prolonged QT interval syndrome who are receiving xylometazoline may be at increased risk of serious ventricular arrhythmias.

Use of the medicinal product during chronic rhinitis should only be performed under medical supervision due to the risk of nasal mucosal atrophy.

Decongestant sympathomimetics (including xylometazoline) may, especially with prolonged use or in cases of overdose, lead to reactive hyperemia of the nasal mucosa. This reversible effect leads to narrowing of the airways, forcing the patient to reapply the sympathomimetic. This may result in chronic edema (medication-induced rhinitis), up to atrophy of the nasal mucosa (atrophic rhinitis).

In mild cases, it may be sufficient to discontinue the sympathomimetic in one nostril initially, and then, once symptoms have resolved, repeat this with the other nostril to maintain at least partial nasal breathing.

As with other drugs in this class, the medicinal product should be used with caution in patients who experience strong reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The recommended dose of the medicinal product should not be exceeded, especially when treating children and elderly patients.

The medicinal product contains benzalkonium chloride, which may cause irritation of the nasal mucosa.

Each package should be used by only one person to avoid infection.

Use during pregnancy or breastfeeding

Pregnancy

The medicinal product should not be used during pregnancy, as there are insufficient data on the use of xylometazoline for treatment in pregnant women.

Breastfeeding period

The medicinal product should not be used during breastfeeding, as it is unknown whether xylometazoline passes into breast milk.

Fertility

No adverse effects on fertility have been observed during treatment with xylometazoline hydrochloride.

Ability to affect reaction speed when driving or operating machinery

When used according to instructions, no effect on the ability to drive or operate machinery is expected.

Method of Administration and Dosage

Dosing

Children aged 2 to 6 years

The nasal spray should be administered once into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response.

The medicinal product should not be used for longer than 7 days, except when otherwise recommended by a physician.

Duration of use should always be discussed with a doctor.

Method of Administration

The medicinal product is intended for nasal administration.

During use, the bottle should be held vertically. The patient should gently inhale through the nose during spraying.

Before first use, remove the plastic protective semi-ring from the spray bottle. Remove the protective cap from the spray nozzle. Before the first application, prime the nasal spray by pressing the pump several times until a fine, uniform mist appears. Insert the nozzle into one nostril and press once; repeat for the other nostril. After use, replace the protective cap on the spray nozzle.

Children

The medicinal product is indicated for use in children aged 2 to 6 years.

Overdose

Xylometazoline

Symptoms

Symptoms of intoxication with imidazole derivatives (including xylometazoline) may be clinically unclear, as periods of stimulation may alternate with periods of central nervous system (CNS) and cardiovascular depression.

Overdose, particularly in children, may lead to significant CNS effects, including seizures, coma, bradycardia, apnea, and arterial hypertension, which may later shift to arterial hypotension.

Symptoms of CNS excitation include anxiety, agitation, hallucinations, and convulsions.

Symptoms of CNS depression include decreased body temperature, lethargy, somnolence, and coma.

Additional possible symptoms include miosis, mydriasis, sweating, nausea, cyanosis, fever, pallor, tachycardia, bradycardia, cardiac arrest, cardiac arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression, apnea, and occasionally impaired consciousness.

Treatment

Severe overdose requires hospitalization. Since xylometazoline is rapidly absorbed, absorbents (activated charcoal) should be administered immediately, along with laxatives (sodium sulfate), or gastric lavage should be performed (in cases of high doses). Decreased arterial pressure may be managed with non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants should be administered, as well as artificial oxygen respiration.

Dexpanthenol

Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no specific therapeutic measures are required.

Adverse Reactions

Adverse reactions are classified by system organ class and frequency according to MedDRA: very common (≥ 1/10); common (≥ 1/100 – <1/10); uncommon (≥ 1/1000 – <1/100); rare (≥ 1/10,000 – <1/1000); very rare (<1/10,000); unknown (frequency cannot be estimated from available data).

Immune system disorders:

Uncommon – hypersensitivity reactions (angioedema, rash, pruritus).

Psychiatric disorders:

Very rare – anxiety, insomnia, hallucinations (mainly in children).

Nervous system disorders:

Very rare – fatigue (drowsiness, sedative effect), headache.

Cardiac disorders:

Rare – palpitations, tachycardia, arterial hypertension; very rare – arrhythmia.

Respiratory, thoracic and mediastinal disorders:

Very rare – after the effect subsides, increased mucosal swelling; epistaxis; unknown – nasal mucosa burning and dryness, sneezing.

Musculoskeletal and connective tissue disorders:

Very rare – convulsions (especially in children).

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life

3 years.

After opening the bottle, the product can be used for up to 12 weeks.

Storage conditions

Store at temperatures not exceeding 25 °C in a place inaccessible to children.

Packaging

10 ml in a bottle with a spray pump and protective cap; 1 bottle per cardboard box.

Supply category

Over-the-counter (without prescription).

Manufacturer

UORLД MEDICINE ILAC SAN. VE TIC. A.S.
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and location of operations

15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.