Septanazal® for children
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SeptaNazal® for children
Composition:
Active substances: xylometazoline hydrochloride, dexpanthenol;
1 ml of solution contains 0.5 mg xylometazoline hydrochloride and 50 mg dexpanthenol;
one spray of 0.1 ml solution contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol;
Excipients: potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, purified water.
Pharmaceutical form. Nasal spray, solution.
Main physicochemical characteristics: clear, colorless liquid.
Pharmacotherapeutic group.
Anti-edematous and other rhinological preparations for topical use. Sympathomimetics, combinations, excluding corticosteroids. ATC code R01A B06.
Pharmacological properties.
Pharmacodynamics.
A nasal preparation, a combination of an alpha-sympathomimetic agent with a vitamin analogue for local application to the nasal mucosa. Xylometazoline exerts a vasoconstrictor effect, 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. It exerts a vasoconstrictive effect, thereby reducing swelling and hyperemia of the nasal mucosa (decongesting the nasal passages). 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 analog of pantothenic acid and, due to intermediate conversion (transformation), exhibits the same biological activity as pantothenic acid. Only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins that, like coenzyme A, participate in numerous metabolic processes, including supporting the synthesis of proteins and corticosteroids, as well as antibody production. Coenzyme A also plays a role in the formation of lipids, including those that constitute sebum secreted by sebaceous glands, which has an important protective function. Furthermore, coenzyme A is involved in the acetylation of amino sugars, which serve as the primary building blocks for various mucopolysaccharides. Pantothenic acid is essential for the regeneration (recovery) of damaged nasal mucosa and skin around the nasal passages.
Dexpanthenol protects epithelial layers and promotes wound healing and tissue repair.
When applied topically, dexpanthenol/pantenol can compensate for increased requirements for pantothenic acid during skin or mucous membrane damage.
Pharmacokinetics.
Xylometazoline hydrochloride
In some cases, intranasal administration results in significant absorption, leading to systemic effects, for example 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 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 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;
- vasomotor rhinitis (rhinitis vasomotorica);
- impaired nasal breathing following surgical interventions in the nasal cavity.
The drug promotes healing and regeneration (recovery) of damaged nasal mucosa and skin around the nasal passages.
Contraindications.
Hypersensitivity to any of the components of the drug; dry inflammation of the nasal mucosa (rhinitis sicca); acute coronary conditions, including cardiac asthma; hyperthyroidism; closed-angle glaucoma; transsphenoidal hypophysectomy and surgical interventions involving exposure of the meninges in medical history; concomitant treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use. Children under 2 years of age.
Interaction with other medicinal products and other types of interactions.
Xylometazoline hydrochloride
Concomitant use of SeptaNazal® for children with tranylcypromine, MAO inhibitors of tricyclic or tetracyclic antidepressants, or with drugs capable of increasing blood pressure, may lead to increased arterial pressure due to the effects of these drugs on the cardiovascular system.
Concomitant use of SeptaNazal® for children with drugs for local or systemic treatment of colds and with sympathomimetics contained in cold remedies (such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, tramazoline, naphazoline, thiaminogheptan) may result in additional effects on the cardiovascular and nervous systems.
Dexpanthenol
Unknown.
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 porphyria;
- in patients with benign prostatic hyperplasia.
In patients with long QT syndrome who are using xylometazoline, there is an increased risk of serious ventricular arrhythmias.
Use during chronic rhinitis should only be under medical supervision due to the risk of nasal mucosal atrophy.
Decongestant sympathomimetics may, especially with prolonged use or in cases of overdose, lead to reactive hyperemia of the nasal mucosa.
This rebound effect leads to nasal passage constriction, forcing the patient to reapply the medicinal product repeatedly, potentially leading to chronic use. This may result in chronic edema (rhinitis medicamentosa) and even atrophy of the nasal mucosa.
In mild cases, discontinuation of the sympathomimetic agent may be sufficient—initially in one nostril, and then, once symptoms resolve, repeating this in the other nostril, to maintain at least partial nasal breathing.
The product, like other drugs in this class, should be used with caution in patients who experience strong reactions to sympathomimetics, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure. Direct contact of the product with the eyes should be avoided.
The recommended dose should not be exceeded, especially when treating children and elderly patients.
The product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, or urinary retention.
The spray bottle should be used by only one person to avoid infection.
The product does not contain preservatives.
Use during pregnancy or breastfeeding.
The product is intended for use in children.
Ability to affect reaction speed when driving or operating machinery.
The product is intended for use in children.
Method of Administration and Dosage
For nasal use in children aged 2 to 6 years.
Typically, one spray of SeptaNazal® for children should be administered into each nostril no more than three times daily. Dosage depends on individual sensitivity and clinical response.
The product should not be used for longer than 7 days, except when recommended by a physician. The duration of treatment in children is determined individually by the doctor.
Children should use the product under adult supervision.
If there is no improvement or if symptoms worsen after 3 days of treatment, the clinical condition should be re-evaluated.
Method of Administration
Remove the protective cap from the spray pump. Before the first use, press the nozzle several times until a fine, even mist appears (Fig. 1).
Fig. 1
Insert the nozzle into the nostril and press once (Fig. 2). The patient should gently inhale through the nose during spraying. Repeat for the other nostril if necessary.
Fig. 2
After use, wipe the nozzle with a paper tissue and replace the protective cap.
Children
SeptaNazal® for children is indicated for use in children aged 2 to 6 years.
Overdose
Xylometazoline hydrochloride
The clinical picture of intoxication with imidazole derivatives may be unclear, as periods of stimulation may alternate with periods of depression of the central nervous system and cardiovascular system.
Overdose, especially in children, may lead to significant effects on the central nervous system, including seizures, coma, bradycardia, apnea, and arterial hypertension, which may later shift to arterial hypotension.
Symptoms of central nervous system stimulation include anxiety, excitement, 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, apnea, and occasionally impaired consciousness.
Treatment in case of overdose
In cases of severe overdose, treatment should be conducted in a hospital setting. Since xylometazoline hydrochloride is rapidly absorbed when administered orally, activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of high doses) should be administered immediately. Decreased blood pressure can be managed using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics, anticonvulsants, and artificial ventilation may be used.
Dexpanthenol
Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no therapeutic measures are required.
Adverse reactions.
Immune system disorders: hypersensitivity reactions, including angioneurotic edema, rash, itching.
Nervous system disorders: excitement, insomnia, increased fatigue (drowsiness, sedative effect), headache, hallucinations (especially in children).
Cardiac disorders: palpitations, accelerated pulse, increased blood pressure, arrhythmia.
Respiratory, thoracic and mediastinal disorders: reactive hyperemia, nosebleeds, dryness and burning sensation of nasal mucosa, sneezing, discomfort of nasal mucosa, increased swelling of mucosa.
Musculoskeletal and connective tissue disorders: convulsions (especially in children).
Eye disorders: transient visual disturbances.
Gastrointestinal disorders: nausea, burning sensation in the throat.
Shelf life.
3 years.
After first opening of the bottle, the product should be used within 12 months.
Storage conditions.
This medicinal product does not require special storage conditions.
After opening, store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 ml of solution in a white high-density polyethylene plastic bottle with a white metered spray pump and a blue plastic cap, placed in a cardboard box.
Pharmaceutical category. Over-the-counter (without prescription).
Manufacturer.
KRKA, d.d., Novo mesto, Slovenia.
Manufacturer's address and place of business.
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.