Decatilen rino kids

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Decatylen Rino KIDS

Composition:

Active substances: xylometazoline hydrochloride, dexpanthenol;

1 ml of nasal spray solution contains xylometazoline hydrochloride 0.5 mg, dexpanthenol 50 mg;

Excipients: sodium hydrogen phosphate heptahydrate, potassium dihydrogen phosphate, water for injections.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical characteristics: clear, almost colorless solution without visible particles.

Pharmacotherapeutic group. Decongestants and other nasal preparations for local use. Sympathomimetics, combinations, excluding corticosteroids.

ATC code R01A B06.

Pharmacological properties.

Pharmacodynamics.

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

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

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. These include supporting the synthesis of proteins and corticosteroids, as well as antibody production. Coenzyme A also participates in the formation of lipids, including those that constitute sebaceous gland secretions, which have an important protective function. It also plays a role in acetylation of amino sugars, which are key building blocks for various mucopolysaccharides.

Dexpanthenol protects epithelial layers and promotes wound healing.

Pharmacokinetics.

Xylometazoline hydrochloride. In some cases, following intranasal administration, the amount absorbed is sufficient to cause systemic effects, for example, on the central nervous system (CNS) and cardiovascular system. There are no available data from pharmacokinetic studies in humans.

Dexpanthenol. Dexpanthenol is absorbed through the skin and undergoes enzyme-catalyzed oxidation to pantothenic acid in the body and skin. The vitamin is transported in the blood plasma in protein-bound form. Pantothenic acid, as an essential component, combines with coenzyme A and is distributed throughout the body. More detailed studies on the metabolism of the active substance 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 in acute rhinitis;
• promoting healing of the skin around the nasal passages and injuries of the nasal mucosa;
• vasomotor rhinitis;
• impaired nasal breathing after surgical interventions in the nasal cavity.

Contraindications.

Hypersensitivity to the active substances or to any excipient of the medicinal product, dry inflammation of the nasal mucosa, transsphenoidal hypophysectomy or surgical interventions with exposure of the dura mater in medical history, acute coronary diseases including cardiac asthma, hyperthyroidism, closed-angle glaucoma. Concomitant treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use.

The medicinal product Decatilen Rhinocid should not be used in children under 2 years of age.

Interaction with other medicinal products and other types of interactions.

Xylometazoline hydrochloride

When used concomitantly with tranylcypromine, MAO inhibitors, tricyclic or tetracyclic antidepressants, or β-adrenergic blockers, an increase in blood pressure may occur due to the effects of these drugs on the cardiovascular system.

Special precautions for use

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

• in patients taking medicinal products that may potentially increase blood pressure;
• in patients with elevated intraocular pressure;
• in patients with phaeochromocytoma;
• in patients with porphyria;
• in patients with benign prostatic hyperplasia.

Patients with long QT syndrome who use xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

Particularly with prolonged use and overdose of decongestant sympathomimetics, reactive hyperaemia of the nasal mucosa may occur. This reversible effect leads to narrowing of the airways, prompting the patient to reapply the medicinal product repeatedly. This may result in chronic oedema and even atrophy of the nasal mucosa. In mild cases, it may be sufficient to discontinue the sympathomimetic agent first in one nostril, and then, after symptoms resolve, in the other nostril, to maintain at least partial nasal breathing.

The product, like other products in this class, should be used with caution in patients who exhibit marked reactions to sympathomimetics, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

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

The product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, or prostatic hyperplasia.

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 hydrochloride in pregnant women.

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

Ability to affect reaction speed when driving or operating machinery.

When the medicinal product is used according to instructions, no effect on reaction speed is expected.

Method of Administration and Dosage

Decatilen Rhino KIDS medication is intended for use in children aged 2 to 6 years.

It is intended for nasal administration.

The dosage of Decatilen Rhino KIDS is 1 spray into each nostril, not more than 3 times daily. Dosage depends on individual sensitivity and clinical response.

Decatilen Rhino KIDS should not be used for longer than 7 days, except when otherwise directed by a physician. The duration of treatment should always be discussed with a doctor.

Method of Administration

Before use, remove the protective cap. Before the first use or after an interruption in treatment lasting more than 7 days, press the pump several times until a uniform spray is produced. For subsequent uses, the spray is immediately ready for administration. Insert the nozzle into the nostril and press once on the pump. During spraying, the patient should breathe calmly through the nose. After use, wipe the nozzle thoroughly with a clean paper towel and replace the protective cap.

Children. For use in children aged 2 to 6 years.

Overdose.

Symptoms of intoxication with imidazole derivatives may be clinically unclear, as phases of hyperactivity may alternate with phases of central nervous system (CNS) and cardiovascular system depression.

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

CNS stimulation may manifest as anxiety, agitation, hallucinations, and seizures. Symptoms of CNS depression may include decreased body temperature, lethargy, drowsiness, and coma. Additional symptoms may include miosis, mydriasis, increased sweating, nausea, cyanosis, fever, pallor, tachycardia, bradycardia, cardiac arrest, cardiac arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression, apnea, and sometimes impaired consciousness.

Treatment. Severe overdose requires hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent) or sodium sulfate (laxative) should be administered immediately; in cases of high doses, immediate gastric lavage should be performed. Reduction of blood pressure can be achieved using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants should be administered, along with artificial oxygen ventilation.

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

Adverse Reactions

The frequency of adverse reactions is defined as follows: 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), frequency not known (cannot be estimated from the available data).

Immune system disorders. Uncommon: hypersensitivity reactions (angioedema, skin rash, pruritus).

Nervous system disorders. Very rare: anxiety, insomnia, hallucinations (especially in children), 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 swelling of the mucous membrane, epistaxis. Frequency not known: burning and dryness of the nasal mucosa, sneezing.

Musculoskeletal and connective tissue disorders. Very rare: muscle spasms (especially in children).

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

Shelf life. 3 years. After first opening – 6 months.

Storage conditions.

The medicinal product does not require special storage conditions. Keep out of reach and sight of children.

Packaging.

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

Classification. Over-the-counter (without prescription).

Manufacturer. Merckle GmbH.

Manufacturer's address and place of business.

Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany.