Decatilen rhin duo

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DECATYLEN RHINO DUO (Decatylen Rino DUO)

Composition:

Active substances: xylometazoline hydrochloride, dexpanthenol;

1 ml of nasal spray solution contains xylometazoline hydrochloride 1 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 rhinological preparations for topical 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 on the nasal mucosa. Xylometazoline has vasoconstrictive properties that reduce 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. The onset of action usually occurs within 5–10 minutes and is characterized by relief of nasal congestion and improved drainage of secretions, resulting in easier nasal breathing.

Dexpanthenol (D-(+)-pantothenyl alcohol) is an alcohol analogue of pantothenic acid. Through intermediate conversion, it exhibits the same biological activity as pantothenic acid, although 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 sebum secreted by sebaceous glands, which plays an important protective role. 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. With intranasal administration, the amount absorbed in some cases is sufficient to produce systemic effects, for example, on the central nervous system (CNS) and cardiovascular system. Data from pharmacokinetic studies in humans are lacking.

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 a key structural 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 during 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 of the excipients 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 conditions including cardiac asthma, hyperthyroidism, angle-closure glaucoma. Concomitant treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use.

The medicinal product Decatilen Rhinо DUO must not be used in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Xylometazoline hydrochloride

When used concomitantly with tranylcypromine, monoamine oxidase inhibitors (MAOIs), tricyclic or tetracyclic antidepressants, or β-adrenoblockers, 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 only be used after careful assessment of the benefit-risk ratio in the following patients:

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

Patients with QT prolongation syndrome who use xylometazoline may have an increased risk of developing serious ventricular arrhythmias.

Particularly with prolonged use or 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 re-administer the medicinal product. 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, repeat this procedure with the other nostril to maintain at least partial nasal breathing.

As with other drugs in this class, caution is advised in patients who exhibit strong reactions to sympathomimetics, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The recommended dosage should not be exceeded, especially when treating children and elderly patients.

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

Do not use Decatilen RhinO DUO in children under 6 years of age. For children under 6 years of age, use Decatilen RhinO KIDS.

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

Use during pregnancy or breastfeeding

Pregnancy. This medicinal product should not be used during pregnancy, as there are insufficient data on the use of xylometazoline hydrochloride in pregnant women.

Breastfeeding. This medicinal product should not be used during breastfeeding, as it is unknown whether xylometazoline hydrochloride is excreted in breast milk.

Ability to affect reaction speed when driving or operating machinery

When used according to the instructions, no effect is expected.

Method of Administration and Dosage

The medicinal product Decatinel Rino DUO is intended for use in adults and children aged 6 years and older.

It is designated for nasal administration.

The medicinal product Decatinen Rino DUO should be administered as 1 spray into each nostril no more than 3 times daily.

Dosage depends on individual sensitivity and clinical response.

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

Regarding duration of use in children, consultation with a physician is always required.

Repeated use of the medicinal product should only begin after an interval of several days and following consultation with a physician. The duration of treatment in children is determined individually by a physician.

In cases of chronic rhinitis, the medicinal product should be used only under medical supervision due to the risk of developing atrophy of the nasal mucosa.

Method of Administration

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

Children. Do not use in children under 6 years of age. For children aged 2 to 6 years, the medicinal product Decatinel Rino KIDS should be used.

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 progress to arterial hypotension.

CNS stimulation may manifest as anxiety, excitement, hallucinations, and seizures. Symptoms of CNS depression 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 occasionally 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 arterial pressure can be achieved using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants should be administered, along with artificial oxygen respiration.

Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no therapeutic 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, fatigue (drowsiness, sedative effect), headache, hallucinations (especially in children).

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. Frequency not known: burning sensation and dryness of the nasal mucosa, sneezing.

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

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after the medicinal product has been authorized is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical 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 first opening – 6 months.

Storage conditions.

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

Packaging.

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

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer. Merckle GmbH.

Manufacturer's address and place of business.

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