Nazarel spray 50mcg/dose 120doses

Nazarel instruction

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Composition

1 dose includes 50 μg of fluticasone.
In addition: polysorbate-80, dextrose, dispersed cellulose, benzalkonium chloride, water, phenylethanol.

Form of issue

Nazarel is produced in the form of a nasal dispensed spray of 60, 120 or 150 doses in a glass vial, placed in a cardboard box.

pharmachologic effect

Local anti-edematous, anti-inflammatory, anti-allergic.

Pharmacodynamics and pharmacokinetics

Spray Nazarel is a local remedy from the group of glucocorticoids (GCS). When applying the spray at recommended doses, its pronounced anti-edematous, anti-inflammatory and antiallergic efficacy is manifested.
The anti-inflammatory activity of fluticasone is due to its effect on glucocorticoid receptors. During the development of the allergic reaction, including its early and late stage, the oppression of proliferation of mast cells, neutrophils, eosinophils, macrophages, and lymphocytes, the production and release of inflammatory mediators and other biological highly active substances (including histamine, leukotrienes, prostaglandins, cytokines ).
Antiallergic effects fluticasone manifested after 2-4 hours after its first use and are characterized by a decrease in nasal congestion, sneezing, nasal itching, reduction phenomena rhinitis, discomfort in the area of ​​the paranasal sinuses, feeling of pressure in the eye and nose, and eye relief negative symptoms associated with allergic rhinitis.
Use in therapeutic dosages is not accompanied by systemic action of the drug and practically does not lead to its effects on the hypothalamic-pituitary-adrenal system.
The efficacy of a single-dose dose of fluticasone persists for up to 24 hours.
In most patients, the daily intranasal administration of 200 micrograms fluticasone indicator led to its plasma Cmax definitions below (less than 0.01 ng / ml). Due to the low solubility of fluticasone in water, its absorption with nasal mucosa is extremely low, as a result of which most of the administered dose of the drug is swallowed. Orally taken in this way fluticasone, due to low absorption and presystemic metabolism, enters the blood plasma in an amount less than 1% of the total dose. These features of the drug determine its extremely low total absorption with nasal mucosa and from the intestine.
In a stable state, fluticasone has a significant Vd, averaging 318 liters. The binding with plasma proteins is approximately 91%. Fluticasone is prone to the so-called "first pass" effect through the liver. Metabolic transformations occur with the participation of the CYP3A4 isoenzyme and the release of the carboxyl product metabolism (inactive metabolite).
T1 / 2 fluticasone is approximately 3 hours. Excretion is mainly due to the intestine. The parameters of renal clearance are: 0.2% for most fluticasone and less than 5% for its carboxyl metabolite.

Indications for use

Spray Nazarel is indicated for use in the prevention (before occurrence) and treatment (during development) of the year-round, as well as seasonal rhinitis of allergic origin.

Contraindications

The use of Nazarel is absolutely contraindicated:
    children up to 4 years;
    patients with a personal hypersensitivity to fluticasone or secondary ingredients of the spray.
Application of Nazarel with special care is possible with:
    concomitant herpes;
    pregnancy;
    infections of the respiratory tract of bacterial etiology (such therapy requires additional connection of antiviral agents and / or antibiotics);
    ulcerative lesions of the nasal mucosa;
    breastfeeding;
    nasal injuries;
    surgical interventions for the nasal cavity, as well as in the post-operation period;
    parallel to the therapy with other glucocorticoids (including tablet forms, ointments, sprays, creams, nose drops and antiasthmatic inhalers).

Side effects

In the process of using Nazarel relatively often observed:
    a taste disorder;
    headache;
    smell disorders;
    nasal bleeding;
    irritation and / or dryness of nasopharyngeal mucosa.
In the course of applying Nazarel in rare cases noted:
    bronchospasm;
    delay in child growth;
    anaphylactic reactions;
    increased intraocular pressure;
    skin hypersensitivity phenomena;
    decreased functionality of the adrenal cortex;
    the development of glaucoma, cataracts;
    angioedema;
    perforation of the nasal septum;
    formation of osteoporosis;
    ulceration of subcutaneous mucous nasal layer.

Spray Nazarel, instructions for use (Method and dosage)

The medicine Nazarel is intended exclusively for intranasal (through the nasal cavity) introduction. To achieve full therapeutic effectiveness, the spray should be used regularly.
Patients over the age of 12 is usually administered in a single administration per day of 100 mg (2 doses) spray into each nasal passage, preferably in the morning. In some cases, there is a need for a two-time use of the recommended dose (100 μg) of the drug at 24 hours (morning and evening). When therapeutic effectiveness is achieved, the patient can be transferred to use a maintenance daily dosage of 50 μg injected into each nasal passageway. Maximum of 24 hours allowed the introduction of 400 mcg fluticasone (4 doses of spray in each nasal passage).
In the pediatric age group 4-12 years recommended daily regime of the drug is a single injection of 50 ug (1 dose) spray into each nasal passage, preferably in the morning. Maximum of 24 hours children can enter 200 mcg fluticasone in each nasal passage.
In pediatrics it is necessary to use the minimum dosages of nasal glucocorticoids, which provide effective relief from negative symptoms.
Elderly patients do not need to adjust the dosage regimen of Nazarel.

Instructions for use

Proper use of the drug requires compliance with the following rules for the use of a spray bottle.
    Remove the protective cap from the tip of the bottle dispenser, which protects the dispenser from dirt and dust.
    When using Nazarela for the first time, as in the case of a lack of drug use for 7 days, it is necessary to prepare the dispenser of the vial for further use by pressing it 6 times, thereby unlocking the spraying mechanism.
    Purge the nasal cavity (both nasal passages).
    Pressing one of the nasal passages with your finger until it is fully closed, insert the tip of the dispenser into the opposite nasal passage.
    Continuing to hold the vertical position of the bottle slightly tilt the head forward.
    Take a breath through the open nasal passage, while simultaneously pressing your fingers on the dispenser of the vial.
    Exhale through the mouth.
    Repeat all manipulations against the other nasal passage.
    After using the spray, wipe the tip of the dispenser with a clean handkerchief or disposable napkin and cover it with a protective cap.
The spraying mechanism is to be cleaned at a frequency of at least 1 time per week, by removing the tip of the dispenser and washing it in warm water. After the tip is dried, carefully place it and cover it with a protective cap. In case of clogging of the tip of the tip it is necessary to leave it in warm water for a while, followed by drying and installation on a vial. Clean the tip of the tip with a pin, needle or other thin sharp objects.
Once the vial is unlocked, the spray may be used before the end of its shelf life.

Overdose

Negative symptoms of chronic and acute overdose with fluticasone are not fixed. When conducting studies on volunteers and intranasal two-day daily administration of 2 mg of fluticasone for 7 days, no effect of the drug on the hypothalamic-pituitary-adrenal system was detected.

Interaction

Due to the insignificant plasma concentrations of fluticasone, its interaction with other therapeutic agents is unlikely.
The concurrent use of fluticasone with drugs that are potent inhibitors of the CYP3A4 isoenzyme (eg, ritonavir) can lead to an increase in its systemic effect and, as a consequence, to the development of negative side effects (including suppression of adrenal cortex and Cushing's syndrome).
The concomitant use of fluticasone with other cytochrome P450 inhibitors (eg, ketoconazole, erythromycin) may cause a slight increase in its serum content, which has little effect on cortisol levels.

Terms of sale

To buy Nazarel the prescription is not required.

Storage conditions

Spray bottles should be stored at ambient temperatures up to 25 ° C.
Shelf life - 36 months.

special instructions

When co-prescribing Nazarel with inhibitors of the CYP3A4 isoenzyme (eg, ketoconazole, ritonavir), careful monitoring of the patients taking them is necessary, since this combination of drugs can lead to an increase in the plasma concentration of fluticasone.
In the case of prolonged use of high doses of intranasal glucocorticoids, there is an increased risk of their systemic action, which requires constant control over the function of the adrenal cortex.
Due to the slowing of child growth observed with prolonged use of even therapeutic doses of intranasal glucocorticoids, the use of these drugs in pediatrics should be under regular control of the child's growth parameters and timely adjustment of glucocorticoid dosages.
Therapy of seasonal allergic rhinitis using Nazarel is quite effective, however, in the case of an especially high allergen content noted in the summer in the ambient air, additional treatment may be necessary.
If Nazarel is necessary for patients with herpetic keratitis, infection, tuberculosis, and patients who have undergone recent surgery on the oral cavity or nasal cavity, the risk / benefit ratio of such therapy should be adequately assessed.

Children

Spray Nazarel is contraindicated in prescribing to children under 4 years old. Older children may use the drug in the above dosages, consistent with the principle of using the lowest effective therapeutic doses.

In pregnancy and lactation

The appointment of Nazarel to pregnant and lactating women is not recommended.

Reviews of Nazarel

Reviews of people who use this spray to remove the negative symptoms of allergic rhinitis, are mostly positive and coincide with the opinion of specialists about the effectiveness and safety of the drug Nazarel. The doctors' comments about this remedy come down to a high evaluation of its effect on the use of the spray according to the indications, but only if the patient responds positively to the active ingredient of the drug. Also note the effectiveness of the influence of Nazarella when it is used to eliminate dependence on vasoconstrictive nasal drugs. Among the negative side effects of the spray is often mentioned the rapidly passing feeling of burning and dryness of the nasal mucous membranes.