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1 dose includes 50 mkg of a flutikazon.
In addition: polysorbate-80, dextrose, disperse cellulose, benzalkoniya chloride, water, feniletanol.
Nazarel is made in the form of the nasal dosed spray on 60, 120 or 150 doses in the glass bottle placed in a cardboard pack.
Local antiedematous, antiinflammatory, antiallergic.
Pharmacodynamics and pharmacokinetics
Spray Nazarel is a local remedy from group of glucocorticoids (GKS). At use of spray in the recommended doses its expressed antiedematous, antiinflammatory and antiallergenic efficiency is shown.
Anti-inflammatory activity of a flutikazon is caused by its influence on glucocorticoid receptors. During development of allergic reaction, including its early and late stage, thanks to effect of drug oppression of proliferation of mast cells, neutrophils, eosinophils, macrophages, lymphocytes, decrease in products and an exit of inflammatory mediators and other biological highly active substances is observed (including a histamine, leukotrienes, prostaglandins, cytokines).
Antiallergic effects of a flutikazon are shown after 2-4 hours after its first use and characterized by reduction of a congestion of a nose, sneezing, a nasal itch, decrease in the phenomena of rhinitis, unpleasant feelings around adnexal bosoms, pressure sense in eyes and a nose, and also simplification of the eye negative symptomatology connected with allergic rhinitis.
Use in therapeutic dosages is not followed by systemic action of drug and practically does not lead to its influence on gipotalamo - pituitary and adrenal system.
Efficiency of once accepted dose of a flutikazon remains on an extent till 24 o'clock.
At most of patients intranasal daily introduction of 200 mkg of a flutikazon gave to an indicator of its plasma Cmax below definition marks (less than 0,01 ng/ml). Because of low solubility of a flutikazon in water its absorption with nasal mucous extremely low owing to what the most part of the entered dose of drug is swallowed. Orally accepted thus flutikazon, thanks to small absorption and a presistemny metabolism, comes to a blood plasma in quantity smaller 1% of a full dose. These features of drug define its extremely low total absorption with nasal mucous and from bodies of a gastrointestinal tract.
In a stable state flutikazon differs in considerable Vd, averaging 318 liters. Linkng with plasma proteins equals about 91%. Flutikazon is subject to effect of the so-called "first passing" through a liver. Metabolic transformations happen to participation of an isoenzyme of CYP3A4 and allocation of a carboxyl product a metabolism (an inactive metabolite).
T1/2 of a flutikazon is equal to about 3 hours. Excretion is carried out generally thanks to intestines. Indicators of renal clearance make: 0,2% for the flutikazon and less than 5% for its carboxyl metabolite.
Indications to use
Spray Nazarel is shown to use for the purpose of prevention (before emergence) and treatments (during manifestation) year-round, and also seasonal rhinitis of an allergic origin.
Nazarel's use is absolutely contraindicated:
- to children till 4 years;
- to patients with personal hypersensitivity to a flutikazon or minor ingredients of spray.
Nazarel's use with respect for extra care is possible at:
- the accompanying herpes;
- infections of ways of breath of a bacterial etiology (such therapy demands additional connection of antiviral means and/or antibiotics);
- cankers of nasal mucous;
- feeding by a breast;
- nasal injuries;
- operative measures concerning nasal cavities, and also in the post-operational period;
- parallel to the carried-out therapy with use of other glucocorticoids (including the tableted forms, ointments, sprays, creams, drops in a nose and antiasthmatic inhalers).
In the course of Nazarel's use rather often observed:
- taste disturbance;
- disorders of sense of smell;
- nasal bleedings;
- irritation and/or dryness mucous nasopharynxes.
During Nazarel's use in rare instances noted:
- delay of children's growth;
- anaphylactic reactions;
- increase of intraocular pressure;
- phenomena of skin hypersensitivity;
- decrease in functionality of adrenal bark;
- development of glaucoma, cataract;
- Quincke's disease;
- perforation of a nasal partition;
- forming of osteoporosis;
- ulcerations of a hypodermic and mucous nasal layer.
Spray Nazarel, application instruction (Way and dosage)
The remedy Nazarel is intended only for intranasal (through a nasal cavity) introductions. For achievement of a full-fledged therapeutic effectiveness spray should be used regularly.
To patients is more senior than 12 years usually appoint single introduction of 100 mkg (2 doses) of spray to each nasal pass in days, it is desirable in the morning. In certain cases there is a need of two times use of the recommended dose (100 mkg) of drug at 24 o'clock (in the morning and in the evening). At achievement of a therapeutic effectiveness it is possible to transfer the patient to use of the supporting daily dosage making 50 mkg entered into each nasal pass. As much as possible at 24 o'clock introduction of 400 mkg of a flutikazon is allowed (4 doses of spray in each nasal pass).
In a children's age group of 4-12 years the recommended daily mode of use of drug is single introduction of 50 mkg (1 dose) of spray to each nasal pass, it is desirable in the morning. As much as possible at 24 o'clock children can enter 200 mkg of a flutikazon into each nasal pass.
In pediatrics it is necessary to use the minimum dosages of nasal glucocorticoids providing effective disposal of negative symptomatology.
Elderly patients do not demand correction of the dosing regime of Nazarel.
Application instruction of Nazarel
The correct use of drug demands observance of following rules of use of a bottle with spray.
- To remove the protective cap protecting the portioning device from hit of dirt and dust from a bottle doser tip.
- At the first use of Nazarel, as well as in case of lack of operation of drug for 7 days, it is necessary to prepare the bottle doser for further use having pressed it 6 times, thereby having unblocked the spraying mechanism.
- To make cleaning of a nasal cavity (both nasal courses).
- Pressing a finger one of the nasal courses before its full closing to enter a doser tip into the opposite nasal course.
- Continuing to hold vertical position of a bottle slightly to incline the head forward.
- To carry out a breath through the open nasal course, having at the same time once pressed fingers the bottle doser.
- To exhale through a mouth.
- To repeat all manipulations concerning other nasal pass.
- After use of spray to blot a doser tip with a pure handkerchief or a one-time napkin and to close it a protective cap.
The spraying mechanism is subject cleanings with frequency not less than 1 time a week, by removal of a tip of the doser and its washing in warm water. After drying of a tip it is carefully established into place and closed a protective cap. In case of a contamination of an opening of a tip it is necessary to leave it in warm water for some time, with the subsequent drying and installation on a bottle. To clean a tip opening by means of a pin, a needle or other thin sharp objects it is forbidden.
After a bottle unblocking spray can be used before the termination of its period of validity.
The negative symptomatology of chronic and acute overdose flutikazony is not recorded. When carrying out researches on volunteers and intranasal two times daily introduction it on 2 mg of a flutikazon for 7 days, did not reveal any influence of drug on gipotalamo - pituitary and adrenal system.
Because of insignificant plasma concentration of a flutikazon its interaction with other remedies is improbable.
Parallel use of a flutikazon with the drugs which are strong CYP3A4 inhibitors of an isoenzyme (for example, ritonaviry) can lead to strengthening of its systemic action and, as a result, to development of negative side effects (including oppression of function of adrenal bark and a syndrome of Kushinga).
The combined purpose of a flutikazon with other inhibitors of P450 cytochrome (for example, ketokonazol, erythromycin) can become the reason of slight increase of its serumal contents that practically does not affect cortisol level.
Terms of sale
For Nazarel's acquisition it is necessary to show the recipe.
It is necessary to store bottles with spray at a surrounding temperature to 25 °C.
Period of validity
The term of use of spray makes 36 months.
At joint appointment of Nazarel with isoenzyme CYP3A4 inhibitors (for example, ketokonazol, ritonavir) attentive supervision over the patients accepting them as this combination of drugs can lead to increase of plasma concentration of a flutikazon is necessary.
In case of prolonged use of high doses of intranasal glucocorticoids increase of risk of emergence of their systemic action is observed that demands a constant control over function of bark of adrenal glands.
Because of delay of the children's growth observed at long use even of therapeutic dosages of intranasal glucocorticoids, use of these drugs has to take place in pediatrics under regular control of parameters of growth of the child and timely correction of dosages of glucocorticoids.
Therapy of seasonal allergic rhinitis with use Nazarela is rather effective, nevertheless, in case of especially high content of allergens noted in summertime in air purpose of additional treatment can be necessary.
In need of Nazarel's use by patients with a herpetic keratitis, infectious process, tuberculosis, and also the patients who transferred a recent operative measure on an oral or nasal cavity it is necessary to estimate adequately a ratio risk/advantage of such therapy.
Coincidence on the ATH code of the 4th level:
Nazarel's analogs are provided by other medical drugs for intranasal use:
- Polideksa with Fenilefrin;
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