Tizin® panthenol pediatric

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TYZINE® PANTHENOL FOR KIDS (TYZINE® PANTHENOL FOR KIDS)

Composition:

Active substances: xylometazoline hydrochloride and dexpanthenol;

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

1 spray of 0.1 ml of solution contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol;

Excipients: potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, water for injections.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical characteristics: solution ranging from clear to slightly opalescent, colorless to slightly yellowish.

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

ATC Code: R01A B06.

Pharmacological Properties

Pharmacodynamics

A nasal medication, a combination of an alpha-sympathomimetic agent with a vitamin 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 Hydrochloride

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

Dexpanthenol

Dexpanthenol (D-(+)-pantothenyl alcohol) is a synthetic 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 amino sugars, which serve as essential building blocks for various mucopolysaccharides.

Dexpanthenol protects epithelial layers and promotes wound healing.

Pharmacokinetics

Xylometazoline Hydrochloride

In some cases, intranasal administration results in significant systemic absorption, potentially causing systemic effects on the central nervous and cardiovascular systems.

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 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 in acute rhinitis.
• To promote healing of the skin around the nasal passages and mucosal damage in the nasal cavity.
• Vasomotor rhinitis.
• Impaired nasal breathing following surgical procedures in the nasal cavity.

Contraindications.

Hypersensitivity to any component of the medicinal product, dry inflammation of the nasal mucosa, acute coronary conditions including cardiac asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical procedures with exposure of the meninges in medical history. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of such treatment.

Do not use in children under 2 years of age.

Interaction with other medicinal products and other forms of interaction.

Xylometazoline hydrochloride

Concomitant use of the drug with tranylcypromine, monoamine oxidase inhibitors (MAOIs), tricyclic or tetracyclic antidepressants, or β-adrenoblockers may lead to increased arterial blood pressure 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 risk/benefit ratio:

• in patients taking medicinal products capable of increasing blood pressure;
• in patients with elevated intraocular pressure;
• in patients with phaeochromocytoma;
• in patients with benign prostatic hyperplasia;
• in patients with porphyria.

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

Sympathomimetic decongestants may, especially with prolonged use or in cases of overdose, cause reactive hyperaemia of the nasal mucosa.

This rebound effect causes airway constriction, forcing the patient to reapply the medicinal product.

This leads to chronic swelling and eventually to atrophy of the nasal mucosa.

In mild cases, discontinuation of the sympathomimetic agent may be sufficient—initially in one nostril, and then, once symptoms have resolved, in the other, to maintain at least partial nasal breathing.

Tyzine® Pantothenol Children, like other drugs in this group, should be used with caution in patients who experience strong reactions to sympathomimetics, such 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 individuals.

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

The medicinal product container should be used by only one person to avoid infection.

Use during pregnancy or breastfeeding.

The medicinal product is intended for use in children.

Tyzine® Pantothenol Children should not be used during pregnancy, as there are insufficient data on the use of xylometazoline hydrochloride for the treatment of pregnant women.

The medicinal product should not be used during lactation, as it is unknown whether the active ingredient, xylometazoline hydrochloride, passes into breast milk.

Ability to influence reaction rate when driving or operating machinery.

No effect is expected when the product is used according to instructions.

Method of Administration and Dosage

For nasal use.

Tyzine® Pantothenol Children should be administered as 1 spray into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response.

Tyzine® Pantothenol Children should not be used for longer than 7 days, except when recommended by a physician.

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

Repeated use should only be initiated after a several-day break and following consultation with a physician. The treatment duration for children is determined individually by a physician.

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

Method of Administration

Remove the protective cap from the spray nozzle. Before the first use, prime the nasal spray by pressing the nozzle five times until a fine, even mist appears. Holding the bottle vertically, insert the nozzle into one nostril and press once; repeat the procedure for the other nostril if necessary. The patient should gently inhale through the nose during spraying. After each use, wipe the nozzle with a paper tissue 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 periods of stimulation may alternate with periods of depression of the central nervous and cardiovascular systems.

Overdose, especially in children, may cause disturbances of the central nervous system, including seizures, coma, bradycardia, apnea, and arterial hypertension, which may progress to arterial hypotension.

Symptoms of central nervous system excitation include anxiety, agitation, hallucinations, and convulsions.

Symptoms of central nervous system depression manifest as decreased body temperature, lethargy, drowsiness, 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 and apnea, and occasionally impaired consciousness.

Treatment in case of overdose

Severe overdose requires hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in cases of high doses) should be administered immediately. 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 following frequency categories are used to assess adverse effects:

Very common (≥ 1/10);
Common (≥ 1/100 to <1/10);
Uncommon (≥ 1/1,000 to <1/100);
Rare (≥ 1/10,000 to <1/1,000);
Very rare (<1/10,000);
Frequency not known (cannot be estimated from available data).

Nervous system:
Very rare: anxiety, insomnia, fatigue (drowsiness, sedative effect), headache, hallucinations (mainly in children).

Cardiovascular system:
Rare: palpitations, tachycardia, hypertension.
Very rare: arrhythmia.

Respiratory system:
Very rare: increased nasal mucosal swelling after waning of effect, epistaxis (nasal bleeding).
Frequency not known: burning sensation and dryness of nasal mucosa, sneezing.

Musculoskeletal system:
Very rare: muscle cramps (especially in children).

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

Shelf life: 3 years.

Shelf life after first opening of the container: 6 months.

Storage conditions:
Store at temperatures not exceeding 25 °C. Keep in a place inaccessible to children.

Packaging:
10 ml in a bottle, 1 bottle with instructions for medical use in a cardboard package.

Prescription status:
Over-the-counter (without prescription).

Manufacturer:
Famar Health Care Services Madrid, S.A.U. / Famar Health Care Services Madrid, S.A.U.

Manufacturer's address:
Avda. Leganes, 62, Alcorcon, Madrid, 28923, Spain / Avda. Leganes, 62, Alcorcon, Madrid, 28923, Spain

Marketing Authorization Holder:
McNeil Products Limited / McNeil Products Limited.

Address of Marketing Authorization Holder:
50–100 Holmers Farm Way, High Wycombe, HP12 4EG, England / 50–100 Holmers Farm Way, High Wycombe, HP12 4EG, England.

Representative of the Marketing Authorization Holder:
LLC "Johnson & Johnson Ukraine" / TOV "Dzhonson i Dzhonson Ukraina".

Address of the Representative:
32/2 Moskovska St., Kyiv, 01010, Ukraine.
+38 (044) 498 0888
+38 (044) 498 7392