Ksilometazol-Zdorovye, gel of nasal 0,1% on 10 g

General characteristics. Structure:

Active ingredient: xylometazoline; 1 g of gel contains xylomethazolinum of a hydrochloride 1 mg; excipients: carbomer, glycerin, propylene glycol, ammonia solution of 15%, ethanol of 96%, methylparaben (Е 218), propylparaben (Е 216), the water purified.

Pharmacological properties:

Xylomethazolinum is derivative imidazoline, the having sympathomimetic effect. It is a direct agonist of alpha receptors.

Drug causes narrowing of blood vessels of a mucous membrane, eliminates hypostasis, reduces a hyperemia of mucous membranes of a nasopharynx and amount of exudate.

Prolonged use of drug (more than 2 weeks) can expand for the second time blood vessels that can become the reason of medicamentous rhinitis (rhinitis medicamentosa).

Drug begins to work in 5 - 10 minutes; its action lasts for 5 - 6 h, but the spasm of blood vessels keeps to 8 - 12 h. The drug which is correctly applied on a mucous membrane becomes the reason of local narrowing of blood vessels.

It is not soaked up in clinically significant quantity, has no systemic action.

Indications to use:

• Acute cold of a virus or bacterial origin;
• acute sinusitis or exacerbation of chronic sinusitis;
• allergic cold;
• acute otitis of a middle ear – for the purpose of recovery of passability of an Eustachian tube.

Route of administration and doses:

Drug is applied on a mucous membrane of a nasal cavity in a dose of 100 - 200 mg (that corresponds to 1 - 2 peas of gel) 1 - 3 time a day. A course of treatment – 3 - 5 days, it is not necessary to apply longer than 2 weeks at all.

The dose depends on individual sensitivity of each patient and on clinical effect of drug.

Treatment can be repeated only after a break in its use for several days.

In case of chronic rhinitis, in connection with danger of emergence of an atrophy of a mucous nasal cavity, long use of drug is possible only under observation of the doctor.

Features of use:

It is not necessary to use drug to patients with chronic or vasculomotor rhinitis as such patients usually use drug more than 2 weeks. To avoid an accidental proglatyvaniye of gel, it is necessary to apply with care it to patients to whom use of sympathomimetics is contraindicated: the patient with arterial hypertension, stenocardia, a diabetes mellitus, with a prostatauxe, a hyperthyroidism, a pheochromocytoma.

Prolonged use and overdose of sympathomimetic anticongestive (antiedematous) means can lead to a reactive hyperemia of a mucous membrane of a nasal cavity.

This side effect can lead to obstruction of respiratory tracts that, in turn, forces the patient repeatedly or even constantly to use drug.

It can serve as the reason of chronic hypostasis (medicamentous rhinitis) and, eventually, even to a mucosal atrophy of a nasal cavity and an ozena. In not acute cases it is possible to stop administration of sympathomimetic drug in one nostril and when the complication decreases, to continue treatment by introduction to other nostril to keep, at least, partially nasal breath.

Use during pregnancy or feeding by a breast. Do not apply.

Способностьвлиять on speed of response at control of motor transport or work with other mechanisms. During treatment by drug it is necessary to be careful at control of motor transport or work with other mechanisms as emergence of side reactions from the central nervous system is possible.

Children. Do not apply to children aged up to 12 years.

Side effects:

Respiratory path: drug can cause the passing, poorly expressed signs of irritation (burning sensation) in a nasal cavity, sneezing.

In certain cases, at reduction of effect of drug, increase in a swelling of a mucous nasal cavity can be observed (reactive hyperemia).

Too long or frequent intranasal introduction of xylomethazolinum, and also use in high doses can lead it to a reactive hyperemia or dryness of a mucous nasal cavity, and also to reactive stagnation (to a hyperemia, a kongestiya) with symptoms of medicamentous rhinitis. This effect can be observed even after 5 - 7 days of treatment and after long-term introduction to lead to constant injury of a mucous nasal cavity with crusting (a scab – rhinitis sicca).

Nervous system: seldom or never the headache, sleeplessness, drowsiness, fatigue can be observed.

Cardiovascular system: in certain cases at topical intranasal administration system sympathomimetic effects, such as the accelerated heartbeat and pulse, and also increase in arterial pressure can be observed.

Others: passing rash, asthma, Quincke's disease.

System allergic reactions, temporary vision disorder were seldom observed. Nausea was sometimes noted. Very seldom – the general weakness, tachycardia, excessively sedative state after overdose.

In case of use of too high dose or wrong use gel can be swallowed accidentally that causes absorption of active ingredient from a digestive tract. Such cases are observed, mainly, at children. In these cases the main undesirable action is development of a serious sedative state.

Interaction with other medicines:

Because drug in the minimum quantity gets to general circulation, its interaction with other applied means is very improbable.

Simultaneous use of monoamine oxidase inhibitors like Tranylcyprominum or tricyclic antidepressants can lead to increase in arterial pressure owing to influence of these drugs on cardiovascular system.

Contraindications:

Hypersensitivity to drug components. Dry inflammation of a mucous membrane of a nasal cavity (rhinitis sicca), zakrytouglovy glaucoma, simultaneous treatment by monoamine oxidase inhibitors (MAO) and tricyclic antidepressants. Pregnancy and period of feeding by a breast. Children's age up to 12 years.

It is not necessary to use drug the patient after a hypophysectomy or other surgeries which are carried out with a section of a firm cover of a brain.

Overdose:

Symptoms: The overdose of drug or accidental oral administration can lead to such symptoms: mydriasis, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, circulator collapse (vascular insufficiency), cardiac standstill, arterial hypertension, fluid lungs, dysfunction of breath, disorder of mental activity.

Besides, such symptoms as the inhibition of function of the central nervous system which is followed by drowsiness, decrease in body temperature, bradycardia, shocklike hypotension, an apnoea and a coma can be also observed.

Treatment: reception of absorbent carbon, gastric lavage, oxygen artificial respiration. For a lowering of arterial pressure (adults) need to enter slowly intravenously 5 mg of phentolamine in normal saline solution or to accept 100 mg (adult) orally. Reception of vasoconstrictors is contraindicated. If there is a requirement – to appoint treatment antipyretics or anticonvulsant drugs.

Storage conditions:

To store in original packaging at a temperature not above 25 °C.

To store in unavailable to children of places.

Period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Gel of nasal 0,1% on 5 g or 10 g, or 15 g in tubas in a box.