Pharmacological properties
Pharmacodynamics. Rhinological drug, a combination of α-sympathomimetics 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 wound healing and protects the mucous membranes.
Xylometazoline hydrochloride. Xylometazoline hydrochloride, an imidazole derivative, is an α-adrenergic sympathomimetic. The onset of action usually occurs after 5-10 minutes, its manifestation is the 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, has 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, like coenzymes, are involved in many metabolic processes, including promoting the synthesis of proteins and corticoids, as well as the production of antibodies. Coenzyme A is also involved in the formation of lipids, of which, in particular, the secret of the sebaceous glands consists, which has an important protective function. In addition, coenzyme A plays a role in the acetylation of amino sugars, which are the main building blocks for various mucopolysaccharides.
Dexpanthenol protects the layers of the epithelium and promotes wound healing.
Pharmacokinetics. Xylometazoline hydrochloride. In some cases, intranasal administration results in a significant amount being absorbed, causing systemic effects, for example on the CNS and cardiovascular system.
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 blood 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 the administered dose is excreted in the urine and 30-40% in the feces.
Indication
Nasal congestion during acute rhinitis; promoting healing of the skin around the nasal passages and damage to the mucous membrane in the nasal cavity; vasomotor rhinitis (rhinitis vasomotorica); impaired nasal breathing after surgical interventions in the nasal cavity.
Application
Nasik is used in adults and children over 6 years of age. for nasal use.
Nasik should be used as one spray in each nostril no more than 3 times a day. The dosage depends on individual sensitivity and clinical response.
When using Nasik, the bottle should be held vertically. During spraying, the patient should inhale easily through the nose.
Nasik should not be used for more than 7 days unless recommended by a doctor.
Regarding the duration of use in children, consultation with a doctor is always required.
Repeated use should be started only after a break of several days and after consultation with a doctor. The duration of treatment in children is determined individually by the doctor.
In case of chronic rhinitis, the drug can be used only under the supervision of a doctor due to the risk of atrophy of the nasal mucosa.
Before use, remove the long protective cap from the bottle with the removable spray, unscrew the bottle cap and screw the spray nozzle onto the bottle. Remove the protective cap from the spray nozzle. 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, then repeat for the other nasal passage. After use, close the nozzle with the protective cap.
Nasik for children is used in children aged 2 to 6 years. For nasal use in children.
Nasik for children should be administered as one spray in each nostril no more than 3 times daily. The dosage depends on individual sensitivity and clinical response.
When using Nasik for children, the bottle should be held vertically. During spraying, the patient should inhale easily through the nose.
Nasik for children should not be used for more than 7 days, unless recommended by a doctor.
You should always consult a doctor regarding the duration of use.
Before use, remove the long protective cap from the bottle with the removable spray, unscrew the bottle cap and screw the spray nozzle onto the bottle. Remove the protective cap from the spray nozzle. 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 1 time, then repeat for the other nasal passage. After use, close the nozzle with the protective cap.
Contraindication
Hypersensitivity to any component of the drug Nasik or Nasik for children, 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 MAO inhibitors and within 2 weeks after discontinuation of their use.
Nasik and Nasik for children contain benzalkonium chloride, and therefore should not be used in patients with hypersensitivity to this substance.
Side effects
The following categories are used to estimate the frequency of side effects: very common (≥1/10), common (≥1/100 to 1/10); uncommon (≥1/1000 to 1/100); rare (≥1/10,000 to 1/1000); very rare (<1/10,000); not known (cannot be estimated from available data).
From the nervous system: very rarely - anxiety, insomnia, increased fatigue (drowsiness, sedative effect), hallucinations (mainly in children), headache.
From the cardiovascular system: rarely - palpitations, tachycardia, increased blood pressure; very rarely - arrhythmia.
On the part of the respiratory system: very rarely - after the effect decreases, increased swelling of the mucous membrane, nasal bleeding; frequency unknown - burning and dryness of the nasal mucosa, sneezing.
Musculoskeletal and connective tissue disorders: very rarely - convulsions (especially in children).
On the part of the immune system: occasionally - hypersensitivity reactions (angioedema, rash, itching).
Special instructions
This medicinal product should only be used after careful benefit/risk assessment in patients:
taking medications that have the ability to increase blood pressure; with increased intraocular pressure; with pheochromocytoma; with prostatic hyperplasia; with porphyria.
The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa.
Anti-edematous sympathomimetics can, especially with prolonged use or in case of overdose, lead to reactive hyperemia of the nasal mucosa.
This reversible effect leads to narrowing of the nasal passages, forcing the patient to re-apply the drug for chronic use. This leads to chronic swelling (rhinitis medicamentosa) and atrophy of the nasal mucosa (ozaena).
In mild cases, it may be sufficient to discontinue the sympathomimetic first for one nasal passage and then, once symptoms have resolved, repeat this with the other to maintain at least partial nasal breathing.
The drug, like other drugs in this group, should be used with caution in patients who have severe reactions to sympathomimetics, which manifest as insomnia, dizziness, tremor, arrhythmias, and increased blood pressure.
The recommended dose of the drug should not be exceeded, especially when used in children and the elderly.
The drug should be prescribed with caution to patients with cardiovascular diseases, hypertension, diabetes mellitus, thyroid diseases, and prostatic hyperplasia.
Nasik is not prescribed for children under 6 years of age. Children under 6 years of age should use Nasik for children.
Each package should be used by only one person to avoid infection.
Use during pregnancy and breastfeeding. Nasik should not be used during pregnancy and breastfeeding due to the lack of studies in these categories of patients.
Children. Nasik for children is used in children aged 2 to 6 years. Nasik is used in children over 6 years of age.
Ability to influence the reaction rate when driving vehicles or operating other mechanisms. When used according to the instructions, no effect on the reaction rate is expected.
Interactions
Xylometazoline hydrochloride. Simultaneous use of the drug with tranylcypromine, MAO inhibitors, tricyclic or tetracyclic antidepressants or β-adrenergic blockers as a result of their effect on the cardiovascular system may lead to an increase in blood pressure.
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 system and cardiovascular system.
Overdose, especially in children, can lead to significant CNS effects, including spasms, coma, bradycardia, apnea, and hypertension, which may progress to hypotension.
Symptoms of CNS impairment include anxiety, agitation, hallucinations, and seizures.
Symptoms of CNS depression include decreased body temperature, lethargy, drowsiness, and coma.
Additional symptoms are also possible: miosis, mydriasis, increased sweating, nausea, cyanosis, fever, pale skin, tachycardia, bradycardia, cardiac arrest, arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea, sometimes with impaired consciousness.
Treatment. In case of severe overdose, inpatient treatment is required. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (at high doses) should be taken immediately. Lowering blood pressure can be achieved with non-selective α-adrenoceptor blockers. Vasoconstrictor drugs are contraindicated. If necessary, antipyretic and anticonvulsant drugs, as well as mechanical ventilation, are used.
Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no therapeutic measures are required.
Storage conditions
Does not require special storage conditions.
