Instructions for use Septanazal nasal spray bottle 10 ml
Composition
active ingredients: xylometazoline hydrochloride, dexpanthenol;
1 ml of solution contains 1 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol;
one spray of 0.1 ml of solution contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol;
Excipients: potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, purified water.
Dosage form
Nasal spray, solution.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Anti-edematous and other rhinological preparations for topical use. Sympathomimetics, combinations, excluding corticosteroids. ATX code R01A B06.
Pharmacological properties
Pharmacodynamics
Rhinological preparation, a combination of an alpha-sympathomimetic drug with a vitamin analogue for topical application to the nasal mucosa. Xylometazoline has a vasoconstrictor effect, as a result of which it eliminates swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5), which promotes healing and treatment of wounds and protects the mucous membranes.
Xylometazoline hydrochloride
Xylometazoline hydrochloride, an imidazole derivative, is an alpha-adrenergic sympathomimetic. It has a vasoconstrictor effect and thereby eliminates edema and hyperemia of the nasopharyngeal mucosa (unblocks the nose). The onset of action usually occurs after 5-10 minutes, which is manifested by relief of nasal breathing due to the elimination of edema and improved discharge.
Dexpanthenol
Dexpanthenol (D-(+)-pantothenic alcohol) is an alcohol analogue of pantothenic acid and, due to an intermediate conversion (transformation), has 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, are involved in many metabolic processes, including promoting the synthesis of proteins and corticoids, as well as the production of antibodies. Coenzyme A also participates in the formation of lipids, which, in particular, constitute the secretion of the sebaceous glands, which has an important protective function. In addition, coenzyme A plays a role in the acetylation of amino sugars, which are the main building material for various mucopolysaccharides. Pantothenic acid is necessary for the regeneration (restoration) of damaged nasal mucosa and skin around the nasal passages.
Dexpanthenol protects the epithelial layers and promotes wound healing and healing.
When applied externally, dexpanthenol/panthenol can compensate for the increased need for pantothenic acid in case of skin or mucous membrane damage.
Pharmacokinetics
Xylometazoline hydrochloride
In some cases, intranasal administration results in significant amounts being absorbed, causing systemic effects, such as on the central nervous and cardiovascular systems. Pharmacokinetic data in humans are not available.
Dexpanthenol
Dexpanthenol is absorbed through the skin and undergoes enzyme-catalyzed oxidation to pantothenic acid in the body and in skin cells. The vitamin is transported into the plasma in a protein-bound form. As an important structural element, pantothenic acid combines with coenzyme A and is distributed throughout the body. Detailed studies of metabolism in the skin and mucous membranes are lacking. 60-70% of an orally administered dose is excreted in the urine and 30-40% in the feces.
Indication
Nasal congestion during acute rhinitis; vasomotor rhinitis (rhinitis vasomotorica); impaired nasal breathing after surgical interventions in the nasal cavity. The drug promotes healing and regeneration (restoration) of damaged nasal mucosa and skin around the nasal passages.
Contraindication
Hypersensitivity to any of the ingredients of the drug; dry inflammation of the nasal mucosa (rhinitis sicca); acute coronary diseases, including cardiac asthma; hyperthyroidism; angle-closure glaucoma; transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges in history; concomitant treatment with monoamine oxidase inhibitors (MAO) and within 2 weeks after their discontinuation. Children under 6 years of age.
Interaction with other medicinal products and other types of interactions
Xylometazoline hydrochloride
Concomitant use of SeptaNazal® with tranylcypromine, MAO inhibitors such as tricyclic or tetracyclic antidepressants, or with drugs that can increase blood pressure may lead to an increase in blood pressure due to the effects of these drugs on the cardiovascular system.
Concomitant use of SeptaNazal® with drugs for local or systemic treatment of colds and with sympathomimetics contained in anti-cold drugs (such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, tramazoline, naphazoline, thiaminoheptane) may lead to additional effects on the cardiovascular and nervous systems.
Dexpanthenol
Unknown.
Application features
patients taking medications that have the ability to increase blood pressure; patients with increased intraocular pressure; patients with pheochromocytoma; patients with porphyria; patients with prostatic hyperplasia.
Patients with long QT syndrome who use xylometazoline are at increased risk of serious ventricular arrhythmias.
Use during chronic rhinitis is possible only under the supervision of a physician due to the risk of atrophy of the nasal mucosa.
Decongestant sympathomimetics may, especially with prolonged use or in case of overdose, lead to reactive hyperemia of the nasal mucosa.
This reversible effect leads to a narrowing of the nasal passages, which forces the patient to repeatedly use the drug, leading to chronic use. This leads to chronic swelling (rhinitis medicamentosa) and even atrophy of the nasal mucosa.
In mild cases, it may be sufficient to discontinue the sympathomimetic agent first for one nostril and then, once symptoms have resolved, repeat this with the other to maintain at least partial nasal breathing.
The drug, like other drugs of this group, should be used with caution in patients who have strong reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremor, cardiac arrhythmia, increased blood pressure. Direct contact of the drug with the eyes should be avoided.
The recommended dose of the drug should not be exceeded, especially when treating children and elderly patients.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, thyroid diseases, and difficulty urinating.
In case of improper use or use of excessive amounts of aerosol, absorption of xylometazoline may cause systemic side effects, especially in children (cardiovascular and neurological side effects, see sections "Adverse reactions" and "Overdose").
The spray bottle should only be used by one person to avoid infection.
The drug does not contain preservatives.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used correctly, SeptaNazal® does not affect the ability to drive or use other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy
SeptaNazal® should not be used during pregnancy due to the lack of data on the use of xylometazoline hydrochloride in pregnant women.
Breastfeeding period.
SeptaNazal® should not be used during breastfeeding due to the lack of data on the penetration of xylometazoline hydrochloride into breast milk.
Fertility.
It is not known whether the use of SeptaNasal® affects fertility.
Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
Method of administration and doses
For nasal use in adults and children aged 6 years and over.
Apply one spray of SeptaNasal® into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response.
The drug should not be used for more than 7 days, unless recommended by a doctor. Repeated use should be started only after a break of several days and after consultation with a doctor. The duration of use in children is determined individually by the doctor.
In case of chronic rhinitis, the drug can only be used under the supervision of a doctor due to the risk of atrophy of the nasal mucosa.
Use in children aged 6 years and over.
Children under 12 years of age should use the drug under adult supervision.
If after 3 days of treatment there is no improvement or worsening of symptoms, the clinical situation should be re-evaluated.
Method of application
Remove the protective cap from the sprayer. Before using the nasal spray for the first time, press the nozzle several times until a fine, even spray appears.
Insert the nozzle into the nostril and press once. The patient should breathe in gently through the nose during the spray. Repeat for the other nostril if necessary.
After use, wipe the nozzle with a paper towel and close the sprayer with the protective cap.
Children
SeptaNazal® is used in children aged 6 years and older. SeptaNazal® for children is used in children aged 2 to 6 years.
Overdose
Xylometazoline hydrochloride
The clinical picture of intoxication with imidazole derivatives can be unclear, since periods of stimulation can alternate with periods of depression of the central nervous system and cardiovascular system.
Overdose, especially in children, may result in significant central nervous system effects, including convulsions, coma, bradycardia, apnea, and hypertension, which may progress to hypotension.
Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and seizures.
The following additional symptoms are possible: miosis, mydriasis, sweating, nausea, cyanosis, fever, pale skin, tachycardia, bradycardia, cardiac arrest, cardiac arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea, sometimes impaired consciousness.
Overdose treatment
In case of severe overdose, treatment should be carried out in a hospital. Since xylometazoline hydrochloride is rapidly absorbed when administered orally, activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (at high doses) should be administered immediately. Blood pressure can be reduced with non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants, as well as artificial respiration, are 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 angioedema, rash, itching.
From the nervous system: agitation, insomnia, increased fatigue (drowsiness, sedative effect), headache, hallucinations (especially in children).
On the part of the heart: palpitations, rapid pulse, increased blood pressure, arrhythmia.
Respiratory, thoracic and mediastinal disorders: reactive hyperemia, nosebleeds, dryness and burning of the nasal mucosa, sneezing, nasal mucosa discomfort, increased mucosal edema.
Musculoskeletal and connective tissue disorders: convulsions (especially in children).
On the part of the organs of vision: transient visual impairment.
On the part of the digestive system: nausea, burning sensation in the throat.
Expiration date
3 years.
After first opening the bottle, the drug should be used within 12 months.
Storage conditions
This medicine does not require any special storage conditions.
After opening the bottle, 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 dosing spray and a transparent plastic cap, which is placed in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto, Slovenia.
Location of the manufacturer and its business address
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
