Noksivin (spray)
Producer: LLC Pharmtekhnologiya Republic of Belarus
Code of automatic telephone exchange: R01AA05
Release form: Liquid dosage forms. Spray nasal.
General characteristics. Structure:
Active ingredient: 0,25 mg or 0,5 mg of oxymetazoline in the form of hydrochloride oxymetazoline in 1 ml of solution.
Excipients: a macrogoal 400, propylene glycol, sodium dihydrophosphate a dihydrate, povidone (# polyvinylpirrolidone), dinatrium эдетат, a benzalkoniya chloride, dinatrium phosphate 12-water, Acidum hydrochloricum concentrated or sodium hydroxide, the water purified.
Drug with the expressed vasoconstrictive action.
Pharmacological properties:
Pharmacodynamics. Oxymetazoline has vasoconstrictive effect. At local drawing reduces its puffiness and allocations from a nose by the inflamed mucous membrane of a nasal cavity. Nasal breath recovers. Elimination of hypostasis of a mucous membrane of a nasal cavity promotes recovery of aeration of adnexal bosoms of a nasal cavity, tympanic cavity that prevents development of bacterial complications (antritis, sinusitis, average otitis). At topical intranasal administration in therapeutic concentration does not irritate and does not cause a hyperemia of a mucous membrane of a nasal cavity.
Pharmacokinetics. Oxymetazoline begins to work quickly, within several minutes. Duration of effect of medicine till 12 o'clock.
Indications to use:
- treatment of the acute respiratory diseases which are followed by cold;
- allergic rhinitis;
- vasculomotor rhinitis;
- for recovery of a drainage at an inflammation of adnexal bosoms of a nasal cavity at an eustachitis, average otitis;
- for elimination of hypostasis before diagnostic manipulations in the nasal courses.
Route of administration and doses:
Medicine with the content of oxymetazoline of 0,25 mg / 1 ml, 0,5 mg / 1 ml apply intranazalno. Before use of medicine and in 5 minutes after its use it is necessary to clear the nasal courses. To remove a protective cap from a bottle. Before the first use it is necessary to press several times a raspylitelny nozzle before emergence of a stream with "a fog cloudlet". The bottle is ready to use.
Implementation of the procedure: at injection it is necessary to squeeze sharply 1 time a bottle and to make spray injection serially in each nasal pass. It is necessary to hold a bottle sprayer vertically, at injection not to throw back the head up. Not to spray spray horizontally or down. After use to clear a bottle sprayer nozzle tip, to close a protective cap. The bottle has to be used only by one person because of risk of transmission of infection.
To children from 1 year to 6 years: to apply spray with a dosage of 0,25 mg / 1 ml on 1 injection in each nasal course 2-3 times a day.
To adults and children 6 years are more senior: to apply spray with a dosage of 0,5 mg / 1 ml on 1 injection in each nasal course 2-3 times a day.
Medicine is contraindicated to newborns and children aged till 1 year.
Doses are higher recommended it is possible to apply only under observation of the doctor.
It is not necessary to apply medicine more than 3 times a day. Duration of reception of medicine has to make no more than 7 days.
Features of use:
Use of medicine is possible only after real assessment advantage/risk at:
- the increased intraocular pressure, especially at closed-angle glaucoma;
- severe forms of cardiovascular diseases (for example, coronary heart disease, arterial hypertension);
- to a pheochromocytoma;
- disbolism (for example, hyperthyroidism, diabetes mellitus);
- porphyrias;
- prostate hyperplasia;
- treatment by inhibitors of a monoaminooxidase (MAO) and other medicines which influence increase in arterial pressure.
Prolonged use and overdose of medicine can lead to easing of its effect. Abuse of this medicine can cause:
- reactive hyperemia of a mucous membrane of a nose (converse effect);
- chronic rhinedema (medicamentous rhinitis);
- mucosal atrophy.
Due to the existence in composition of medicine the benzalkoniya of chloride and propylene glycol exists risk of development of a bronchospasm, irritation of a mucous membrane of a nasal cavity and skin of wings of a nose; at prolonged use hypostasis of a mucous nasal cavity develops. At manifestation of above-mentioned symptoms it is necessary to stop use of medicine or to replace with the medicine which is not containing these components.
Use at pregnancy and feeding by a breast. At use during pregnancy or breastfeeding it is not necessary to exceed the recommended dosage. Medicine has to be applied only after careful assessment of a ratio of risk and advantage to mother and a fruit.
Influence on ability to drive the car and to work with mechanisms. After prolonged use of medicine in the dosages exceeding recommended it is impossible to exclude the general influence on cardiovascular system and the central nervous system. In these cases ability to manage the vehicle or mechanisms can decrease.
Side effects:
From respiratory system. Often (≥ 1% - <10%): burning or xeromycteria, sneezing. Infrequently (≥ 0,1% - <1%) after the effect of use of medicine ends - feeling of a strong congestion of a nose (reactive hyperemia), nasal bleeding. Very seldom (<0,01%): an apnoea at babies.
From a nervous system. Very seldom (<0,01%): sleeplessness, fatigue (drowsiness, sedation), a headache, concern, hallucinations (it is preferential at children).
From cardiovascular system. Seldom (≥ 0,01% - <0,1%): local nasal uses can cause system effects, such as palpitation, increase of pulse and increase in arterial pressure.
Very seldom (<0,01%): arrhythmia.
From a musculoskeletal system. Very seldom (<0,01%): spasms (especially at children).
From immune system. Infrequently (≥ 0,1% - <1%): allergic reactions (Quincke's edema, urticaria, itch).
Interaction with other medicines:
At co-administration of blockers of MAO, tricyclic antidepressants – increase in arterial pressure is possible. Joint purpose of other vasoconstrictive medicines increases risk of development of side effects.
Contraindications:
- atrophic rhinitis;
- closed-angle form of glaucoma;
- hypersensitivity to oxymetazoline and other components of medicine;
- children aged till 1 year;
- children under 6 years (spray with a dosage of 0,5 mg / 1 ml);
- after a transfenoidalny hypophysectomy or after other surgical intervention which mentions a firm meninx.
Overdose:
After considerable overdose or accidental intake there can be symptoms connected both with hyperactive phases, and with inhibitory phases of the central nervous system (CNS). Stimulation of TsNS is shown in concern, excitement, hallucinations and spasms. Oppression of TsNS is shown in decrease in body temperature, slackness, drowsiness, a coma.
Following additional symptoms: miosis, mydriasis, nausea, vomiting, cyanosis, temperature increase, perspiration, pallor, spasms, palpitation, tachycardia, bradycardia, arrhythmia, cardiovascular insufficiency, cardiac standstill, arterial hypertension, respiratory depression, apnoea, fluid lungs, respiratory frustration, mental disorders.
At overdose children often have disturbances from TsNS which are followed by spasms, bradycardia, an apnoea, arterial hypotension, a hypertension and possible development of a coma.
Therapeutic actions at overdose: reception of absorbent carbon (absorbent), sodium sulfate (laxative), gastric lavage, ventilation of the lungs. It is not necessary to accept angiotonic means. If necessary decrease in temperature, anticonvulsant therapy.
Storage conditions:
To store in the place protected from light at a temperature not higher than + 25 ˚С. To store in the place, unavailable to children. Period of validity.
Issue conditions:
Without recipe
Packaging:
On 10,0 ml or 25,0 ml in bottles polyethylene, corked by the nozzle spraying, placed together with a leaf insert for the consumer in packs from a cardboard.