Pharmacological properties

Pharmacodynamics. rhinologic medicine, a combination of α-sympathomimetics with a vitamin analog for topical administration on a mucous membrane of a nose. xylomethazolinum has vasoconstrictive effect owing to what eliminates hypostasis of a mucous membrane. dekspantenol is derivative pantothenic acid (b5 vitamin) which promotes healing of wounds and protects mucous membranes.

hydrochloride. Xylomethazolinum the hydrochloride, derivative an imidazole, is a α-adrenergic sympathomimetic. The beginning of action usually comes in 5–10 min., its manifestation is simplification of nasal breath owing to elimination of hypostasis and improvement of removal of discharges.

Dekspantenol. Dekspantenol (D-(+) - pantothenyl alcohol) is an alcohol analog of pantothenic acid and thanks to intermediate conversion has the same biological activity, as well as pantothenic acid, however biologically active is only a dextrorotatory D-configuration. Pantothenic acid and its salts are water-soluble vitamins which, as well as coenzyme, participate in many metabolic processes, including assistance to synthesis of protein and kortikoid and also products of antibodies. Coenzyme And also participates in formation of lipids of which, in particular, secretion of sebaceous glands which has important protective function consists. Besides, coenzyme A plays a role in acetylation of aminosugars which are the main construction material for various mucopolysaccharides.

Dekspantenol protects layers of an epithelium and promotes healing of wounds.

Pharmacokinetics. Xylomethazolinum hydrochloride. In certain cases intranasal application leads to the fact that a significant amount is absorbed, causing system influence, for example on central nervous system and a cardiovascular system.

Pharmacokinetic data concerning people are absent.

Dekspantenol. Dekspantenol is absorbed through skin and is exposed to the oxidation catalyzed by enzyme to pantothenic acid in a body and in skin cells. Vitamin is transferred to blood plasma in the form connected with proteins. As the important structural element pantothenic acid connects to coenzyme A and extends on an organism. Detailed researches of metabolism on skin and a mucous membrane are absent. 60–70% of the dose accepted inside are removed with urine and 30–40% — with a stake.

Indication

• Congestion of a nose during sharp rhinitis; assistance to healing of skin around the nasal courses and injuries of a mucous membrane to a nasal cavity; vasomotorial rhinitis (rhinitis vasomotorica); violation of nasal breath after surgical interventions in a nasal cavity.

Use

Nazik is applied at adults and children aged from 6 years. for nasal application.

Nazik should be applied on one injection of medicine in each nasal course no more than 3 times a day. The dosage depends on individual sensitivity and clinical reaction.

At use of the medicine Nazik a bottle should be held vertically. During dispersion the patient needs to inhale easily a nose.

more than 7 days, except cases when it is recommended the doctor.

Concerning duration of application for children always needs consultation with the doctor.

only after a break in several days and after consultation with the doctor. The doctor determines treatment duration at children individually.

in case of chronic rhinitis can use medicine only under control of the doctor because of danger of developing of a mucosal atrophy of a nose.

with a removable nozzle for dispersion before application should remove a long protective cap From a bottle, to turn off a cover of a bottle and to wind a nozzle for dispersion on a bottle. To remove a protective cap from a nozzle for dispersion. Before the first use of spray nasal to press several times a nozzle before emergence of small uniform dispersion. To enter a nozzle into the nasal course and to press 1 time, then to repeat for other nasal course. After use to close a nozzle a protective cap.

Nazik to children is applied at children aged from 2 up to 6 years. For nasal application for children.

Nazik should be applied to children on one spraying of medicine in each nasal course no more than 3 times a day. The dosage depends on individual sensitivity and clinical reaction.

At use of the medicine Nazik for children a bottle should be held vertically. During dispersion the patient needs to inhale easily a nose.

to children more than 7 days, except cases when it is recommended the doctor.

On duration of application should consult with the doctor always.

with a removable nozzle for dispersion before application should remove a long protective cap From a bottle, to turn off a cover of a bottle and to wind a nozzle for dispersion on a bottle. To remove a protective cap from a nozzle for dispersion. Before the first use of spray nasal to press several times a nozzle before emergence of small, uniform dispersion. To enter a nozzle into the nasal course and to press 1 time, then to repeat for other nasal course. After use to close a nozzle a protective cap.

Contraindication

Hypersensitivity to any component of medicine nazik or nazik for children, dry inflammation of a mucous membrane of a nose (rhinitis sicca), sharp coronary diseases, including cardiac asthma, a hyperthyroidism, closed-angle glaucoma, transfenoidalny hypophysectomy and surgical interventions with exposure of a meninx in the anamnesis. the accompanying treatment by Mao's inhibitors and during 2 weeks after the termination of their application.

Drug Nazik is not used at children under 6 years, the medicine Nazik for children — at children under 2 years.

Nazik and Nazik for children contain a benzalkoniya chloride, and therefore it should not be applied at patients with hypersensitivity to this substance.

Side effects

For assessment of frequency of side effects use the following categories: very often (≥1/10), it is frequent (from ≥1/100 to 1/10); sometimes (from ≥1/1000 to 1/100); seldom (from ≥1/10 000 to 1/1000); very seldom (1/10,000); it is unknown (it is impossible to estimate on the available data).

from nervous system: very seldom — uneasiness, insomnia, increased fatigue (drowsiness, sedative action), hallucinations (mainly at children), a headache.

from a cardiovascular system: seldom — strong heartbeat, tachycardia, increase in the ABP; very seldom — arrhythmia.

from a respiratory system: very seldom — after action reduction increase in puffiness of a mucous membrane, nasal bleeding; frequency is unknown — burning and xeromycteria, sneezing.

from a musculoskeletal system and connective tissue: very seldom — spasms (especially at children).

from the immune system: periodically — reactions of hypersensitivity (Quincke's disease, rash, an itch).

Special instructions

It is medicine it is necessary to apply only after careful assessment of a ratio advantage/risk at patients:

• accepting medicines having ability to raise the ABP;
• with the increased intraocular pressure;
• with a pheochromocytoma;
• with a prostate hyperplasia;
• with a porphyria.

Drug the benzalkoniya contains chloride which can cause irritation of a mucous membrane of a nose.

Antiedematous sympathomimetics can, especially at prolonged use or in case of overdose, to lead to a reactive hyperemia of a mucous membrane of a nose.

to narrowing of the nasal courses, forcing the patient to use repeatedly medicament before chronic use. It leads to chronic hypostasis (rhinitis medicamentosa) and a mucosal atrophy of a nasal cavity (ozaena).

In mild cases sufficient to stop application of a sympathomimetic at first for one nasal course, and then as soon as symptoms disappear, to repeat it with another to support at least partial nasal breath.

Drug, as well as other medicines of this group, it is necessary to apply with care at patients at whom note strong reactions to the sympathomimetics which are shown in the form of insomnia, dizziness, a shiver, arrhythmia, increase in the ABP.

should not exceed the recommended medicine dose, especially at application for children and elderly people.

with care medicine to patients with cardiovascular diseases, AG, sick diabetes, with diseases of a thyroid gland, with a prostate hyperplasia.

Drug Nazik is not appointed to children under 6 years. At children under 6 years it is necessary to use the medicament Nazik for children.

to avoid infection.

Use during pregnancy and feeding by a breast. Nazik it is not necessary to apply during pregnancy and feeding by a breast due to the lack of researches at these categories of patients.

Children. Nazik apply to children at children aged from 2 up to 6 years. Nazik apply at children aged 6 years are more senior.

Ability to influence speed of response at control of vehicles or work with other mechanisms. At application according to the instruction of any influence on speed of response it is not expected.

Interaction

hydrochloride. simultaneous use of medicine with Tranylcyprominum, Mao's inhibitors, three - either tetracyclic antidepressants or blockers of β-adrenoceptors as a result of their impact on a cardiovascular system can lead hell to increase.

Overdose

intoxication Symptoms derivatives of an imidazole can be clinically not clear as the periods of stimulation can alternate with the periods of a depression of central nervous system and a cardiovascular system.

Overdose, especially at children, can lead to considerable influence on central nervous system, including spasms, a coma, bradycardia, apnoea and AG which can pass into arterial hypotension.

uneasiness, excitement, hallucinations and spasms belong To symptoms of excitement of central nervous system.

in the form of decrease in body temperature, slackness, drowsiness and a coma.

: a miosis, a mydriasis, the increased sweating, nausea, cyanosis, fever, pallor of integuments, tachycardia, bradycardia, cardiac arrest, arrhythmia, AG, shocklike hypotension, a fluid lungs, respiratory depression and an apnoea, sometimes with consciousness violation.

Treatment. At heavy overdose the hospital treatment is required. As xylomethazolinum the hydrochloride is quickly soaked up, it is necessary to accept immediately activated carbon (absorbent), sodium sulfate (laxative) or to resort to gastric lavage (at high doses). Decrease in the ABP can be reached by means of non-selective blockers of α-adrenoceptors. Vasoconstrictive medicines are contraindicated. If necessary use febrifugal and anticonvulsant medicaments and also IVL.

Pantothenic acid and its derivatives, such as dekspantenol, have very much hypotoxicity. In case of overdose no treatment is required.

Storage conditions

does not demand special storage conditions.