Pharmacological properties

Pharmacodynamics. rhinologic medicine, a combination of α-sympathomimetics with b5 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 and treatment of wounds and protects mucous membranes.

Ksilometazolin's

hydrochloride — derivative an imidazole, is a α-adrenergic sympathomimetic. It has vasoconstrictive effect and by that eliminates hypostasis and hyperaemia of a mucous membrane of a nasopharynx (will unblock a nose). The beginning of action usually comes in 5–10 min., manifestation of what is simplification of nasal breath owing to elimination of hypostasis and improvement of removal of discharges.

Dekspantenol (D-(+) — pantothenyl alcohol) is an alcohol analog of pantothenic acid and thanks to intermediate conversion (transformation) pantothenic acid has the same biological activity, as well as. Only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins which, as well as coenzyme A, participate in many metabolic processes, including assistance to protein synthesis and GKS and also development of antibodies. Coenzyme And also takes part in formation of lipids of which, in particular, secretion of sebaceous glands consists that imeet important protective function. Besides, coenzyme A plays a role in acetylation of aminosugars which are the main construction material for various mucopolysaccharides. Pantothenic acid is necessary for regeneration (restoration) of the injured mucous membrane of a nose and skin around the nasal courses.

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

dekspantenol / panthenol can compensate to

At external use the increased needs for pantothenic acid at injury of skin or mucous membrane.

Pharmacokinetics

Ksilometazolin's

hydrochloride. In certain cases intranasal application leads to the fact that a significant amount is absorbed, causing system impact, for example, on central nervous system and a cardiovascular system. Pharmacokinetic these applications for people are absent.

Dekspantenol is absorbed by

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

Indication

Congestion of a nose during sharp rhinitis; vasomotorial rhinitis (rhinitis vasomotorica); violation of nasal breath after surgical interventions in a nasal cavity.

Drug promotes healing and regeneration (restoration) of the injured mucous membrane of a nose and skin around the nasal courses.

Use

Septanazal for nasal application by the adult and to children is aged more senior than 6 years.

to Apply

on 1 spraying of the medicine SeptaNazal in each nasal course no more than 3 times a day. The dosage depends on individual sensitivity and clinical reaction.

should not use Drug more than 7 days, except cases when it is recommended the doctor. Repeated application should be begun only after a break in several days and after consultation with the doctor.

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.

SeptaNazal for children for nasal application for children at the age of 2–6 years.

are Usually applied on one spraying of the medicine SeptaNazal to children in each nasal course by no more than 3 times a day. The dose depends on individual sensitivity and clinical reaction.

should not use Drug longer than 7 days, except cases when it is recommended the doctor.

On duration of application should consult with the doctor always.

Route of administration. To remove a protective cap from the spray. 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 once. The patient has to inhale carefully through a nose during dispersion. If necessary it is necessary to repeat for the second nasal course.

After use to wipe a nozzle with a tissue and to close the spray a protective cap.

Contraindication

Hypersensitivity to any of medicine ingredients, dry inflammation of a mucous membrane of a nose (rhinitis sicca), sharp coronary diseases, including cardiac asthma; hyperthyroidism, 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.

Side effects

from the immune system: reactions of hypersensitivity, including a Quincke's disease, rash, the naggers.

from nervous system: excitement, insomnia, increased fatigue (drowsiness, sedative action), a headache, hallucinations (especially at children).

from heart: strong heartbeat, tachycardia, increase in the ABP, arrhythmia.

from respiratory organs, a chest cavity and mediastinum: a reactive hyperemia, bleeding from a nose, dryness and burning of a mucous membrane of a nose, sneezing, discomfort from a mucous membrane of a nose, strengthening of hypostasis of a mucous membrane.

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

from an organ of sight: passing deterioration in sight.

from digestive system: nausea, burning in a throat.

Special instructions

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

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

Use in the period of chronic rhinitis is possible

only under observation of the doctor in connection with danger of a mucosal atrophy 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.

This converse effect leads

to narrowing of the air courses, forces the patient to use repeatedly medicament with transition to chronic application. It leads to chronic hypostasis (rhinitis medicamentosa) up to a nasal cavity mucosal atrophy.

can be

In mild cases enough to stop application of a sympathomimetic at first for one nasal course, and then as soon as symptoms disappear — for 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 with strong reactions to sympathomimetics which are shown in the form of insomnia, dizziness, a shiver, arrhythmia, increase in the ABP. It is necessary to avoid direct contact of medicine with eyes.

should not exceed the recommended medicine dose, especially at treatment of children and patients of advanced age.

Should appoint

with care to patients with cardiovascular diseases, AG, diabetes, diseases of a thyroid gland complicated by urination.

in case of the wrong use or use of excess amount of aerosol the absorption of xylomethazolinum can cause system side effects, especially in children (cardiovascular and neurologic side effects, cm. Side EFFECTS and OVERDOSE).

Bottle with spray only one person in order to avoid infection can use

.

Drug does not contain preservatives.

Use during pregnancy and feeding by a breast. Pregnancy. SeptaNazal it is not necessary to apply during pregnancy due to the lack of data on use of xylomethazolinum of a hydrochloride for pregnant women.

Feeding by a breast. SeptaNazal it is not necessary to apply during feeding by a breast due to the lack of data on hydrochloride xylomethazolinum penetration into breast milk.

Fertility. It is unknown whether use of the medicine SeptaNazal affects fertility. As system exposure of xylomethazolinum of a hydrochloride very low, the probability of influence on fertility is extremely small.

Children. SeptaNazal apply at children aged from 6 years. To children aged from 2 up to 6 years appoint SeptaNazal for children.

Ability to influence speed of response at control of vehicles or work with other mechanisms. At the correct application SeptaNazal does not affect ability to drive the car or to work with other mechanisms.

Interaction

Ksilometazolin's

hydrochloride. septanazat simultaneous use of medicine with Tranylcyprominum, Mao's inhibitors of type three - or tetracyclic antidepressants or with the medicines capable to raise hell, can lead to increase hell owing to influence of these medicines on a cardiovascular system.

Simultaneous use of the medicine SeptaNazal with medicines for topical or system treatment of cold and with the sympathomimetics which are contained in anti-cold medicines (such as pseudoephedrine, ephedrine, Phenylephrinum, oxymetazoline, tramazolin, naphazoline, tuaminogeptan), can lead to emergence of additional effects from cardiovascular and nervous system.

Dekspantenol. It is unknown.

Overdose

Ksilometazolin's

hydrochloride. the clinical picture of intoxication derivatives of an imidazole can be not clear as the periods of stimulation can alternate with the periods of oppression of central nervous system and a cardiovascular system.

Overdose, especially at children, can lead to considerable impact 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 stimulation of central nervous system.

Symptoms of oppression of central nervous system are shown by

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

also such additional symptoms Are possible

: 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 — consciousness violations.

Treatment at overdose. In case of heavy overdose the treatment should be carried out in the conditions of a hospital. As xylomethazolinum the hydrochloride is quickly soaked up at application inside, 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 artificial respiration.

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

Storage conditions

This medicine does not demand special storage conditions. after opening of a bottle to store at a temperature not above 25 °C.