Nazarel
Nazarel: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Prices in pharmacies
Latin name: Nazarel
ATX code: R01AD08
Active ingredient: fluticasone (fluticasone)
Producer: Teva Czech Industries sro, IVAX Pharmaceuticals sro (Czech Republic)
Description and photo update: 2018-22-10
Prices in pharmacies: from 226 rubles.
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Nazarel is a topical glucocorticosteroid.
Release form and composition
Nazarel is available in the form of a metered-dose nasal spray, which is an opaque white or almost white homogeneous suspension placed in a dark glass bottle with a dispenser. A bottle for 60, 120 or 150 doses (1 dose contains 50 mcg of active ingredient) is packed in a cardboard box.
1 dose of the drug contains:
- active substance: fluticasone propionate - 50 mcg;
- excipients: microcrystalline cellulose + sodium carmellose (dispersive cellulose), polysorbate 80, benzalkonium chloride, dextrose, water, phenylethanol.
Pharmacological properties
Pharmacodynamics
Nazarel is a topical glucocorticosteroid (GCS). In the recommended doses, it has a pronounced anti-edematous, anti-allergic and anti-inflammatory effect.
The anti-inflammatory effect is the result of the interaction of the active substance with glucocorticosteroid receptors. The drug inhibits the proliferation of eosinophils, mast cells, neutrophils, macrophages, lymphocytes, reduces the release and production of inflammatory mediators and other biologically active substances (including histamine, leukotrienes, cytokines, prostaglandins) during the late and early phases of an allergic reaction.
The manifestation of antiallergic effect as a result of the use of the drug begins after 2-4 hours. Nazarel reduces sneezing, itching in the nose, nasal congestion, runny nose, unpleasant sensations in the paranasal sinuses, a feeling of pressure in the eyes and nose, and also relieves eye symptoms caused by allergic rhinitis …
The drug works for 1 day after a single use. In the case of using therapeutic doses, fluticasone practically does not affect the function of the hypothalamic-pituitary-adrenal system and does not show a systemic effect.
Pharmacokinetics
In most patients, C max in blood plasma after intranasal administration of the drug at a dose of 200 μg per day is lower than the detection level (less than 0.01 ng / ml). Due to the low solubility of Nazarel in water, direct absorption from the nasal mucosa is small, so most of the dose is swallowed. Due to presystemic metabolism and low absorption, up to 1% of the dose enters the blood from the gastrointestinal tract. These reasons are due to the low total absorption from the gastrointestinal tract mucosa and nasal cavity.
In a stable state, fluticasone has a significant Vd (approximately 318 L). The amount of binding to plasma proteins is 91%.
The drug has the effect of first passing through the liver. Metabolism in the liver occurs with the participation of the CYP3A4 isoenzyme of the cytochrome P450 system, resulting in the formation of an inactive carboxylic metabolite.
The excretion of the drug is carried out mainly through the intestines. The half-life of fluticasone is 3 hours. The maximum renal clearance of fluticasone does not exceed 0.2%. The renal clearance of a metabolite with a carboxyl group is up to 5%.
Indications for use
Nazarel is prescribed for the prevention and treatment of perennial and seasonal allergic rhinitis.
Contraindications
Absolute
- hypersensitivity to the components of the drug;
- age up to 4 years.
Relative
- bacterial infections of the upper respiratory tract and concomitant herpes simplex [in such cases, additional therapy with antiviral agents and / or antibiotics is recommended];
- nasal injuries, surgical interventions in the nasal cavity;
- ulcerative lesions of the nasal mucosa;
- a history of allergic diseases;
- the joint use of other dosage forms of corticosteroids (including tablets, ointments, creams, agents for the treatment of bronchial asthma, similar eye, nasal sprays and nasal drops).
Instructions for the use of Nazarel: method and dosage
Spray Nazarel is administered intranasally.
When treating adults and children over 12 years old: 1 time per day, preferably in the morning, 100 mcg (2 doses) of the drug in each nasal passage. In some cases, an increase in the frequency of administration is required up to 2 times a day (no more than 400 mcg per day).
The maintenance dose after achieving a therapeutic effect is 50 μg 1 time per day for each nasal passage. The maximum daily dose is 400 mcg (4 doses for each nasal passage).
The full therapeutic effect is achieved with regular use of the drug.
Directions for use
Nazarel is packaged in bottles with a protective cap to protect the tip from dirt and dust.
When using for the first time, you need to prepare the bottle: press the dispenser 6 times to unlock the spray mechanism. If the drug has not been used for 1 week or more, you must repeat the procedure for unlocking the spray mechanism again.
Next, you need to do the following manipulations:
- clear your nose;
- insert the tip of the bottle into the nasal passage, while closing the other nasal passage;
- tilt your head forward slightly, while continuing to hold the aerosol bottle vertically;
- starting to inhale through the nose, press once on the spray mechanism;
- exhale through your mouth.
In the other nasal passage, the drug is administered in the same way.
After use, you need to blot the tip with a clean handkerchief or tissue and close it with a cap. The sprayer must be flushed at least once every 7 days. To do this, remove the tip; rinse in warm water, dry it and carefully place it on the top of the bottle, then put on the protective cap. If the hole is clogged, the tip must be removed, immersed in warm water and left for a certain time. After that, the tip must be rinsed with running water, dried and re-put on the bottle. The hole cannot be cleaned with a pin or other sharp object.
After opening the package, Nazarel should be used until the expiration date.
Side effects
- immune system: rarely - anaphylactic reaction, bronchospasm; very rarely - angioedema, skin hypersensitivity reaction;
- central nervous system: often - impaired sense of smell, impaired taste, headache;
- organs of vision: very rarely - glaucoma, cataracts, increased intraocular pressure;
- skin and subcutaneous tissues: very rarely - the appearance of ulcers of the subcutaneous mucous layer;
- respiratory system: very often - the appearance of nosebleeds; often - irritation and dryness of the nasopharyngeal mucosa; very rarely - the development of perforation of the nasal septum;
- other: very rarely - a decrease in the function of the adrenal cortex, growth retardation in childhood, osteoporosis.
Overdose
Symptoms of chronic and acute overdose have not been registered. In the case of a study involving volunteers, the intranasal administration of the drug (2 times a day, 2 mg of fluticasone for 7 days) did not show any effect on the functioning of the hypothalamic-pituitary-adrenal system.
special instructions
The combined use of Nazarel and inhibitors of the CYP3A4 isoenzyme (ketoconazole, ritonavir) requires careful monitoring of the patient's condition, since these drugs can increase the plasma concentration of fluticasone.
With the appointment of high doses of nasal glucocorticosteroids over a long period of time, the likelihood of systemic effects of glucocorticosteroids increases. With prolonged use of the drug, regular monitoring of the function of the adrenal cortex is required.
Nasal glucocorticosteroids, even when used in recommended doses, in the case of long-term treatment, can cause growth retardation in children, therefore, regular monitoring of the child's growth and timely dose adjustment of Nazarel are necessary.
The therapy of seasonal allergic rhinitis with Nazarel is quite effective, but if the concentration of allergens increases in summer, additional treatment may be required.
When treating patients with tuberculosis, herpetic keratitis, an infectious process or persons who have recently undergone surgery on the nasal and oral cavity, the drug should be prescribed after a careful assessment of the ratio of potential risk and possible benefit.
Application during pregnancy and lactation
According to the instructions, Nazarel is not recommended for use during pregnancy and lactation. If fluticasone therapy is necessary, the drug should be prescribed after a careful assessment of the ratio of the potential risk to the fetus and the possible benefit to the mother.
The release of the active substance into breast milk is unlikely, however, it is recommended to stop breastfeeding during treatment with Nazarel.
Pediatric use
No dose adjustment of Nazarel spray is required for the treatment of patients aged 12 years and older.
When treating children aged 4–12 years: 1 time per day, preferably in the morning, 1 dose (50 mcg) in each nasal passage. The maximum daily dose is 200 mcg for each nasal passage. It is recommended to use the lowest dosage that provides effective symptom relief.
Nazarel is prohibited to use for the treatment of patients under the age of 4 years.
Use in the elderly
When treating elderly patients, dose adjustment is not required.
Drug interactions
The interaction of Nazarel with other drugs is unlikely, since with the intranasal route of administration, the plasma concentration of fluticasone is low. In the case of the simultaneous use of Nazarel and strong inhibitors of the isoenzyme ICYP3A4 of the cytochrome P450 system (ritonavir), there is a possibility of an increase in the systemic action of fluticasone with the development of side effects (suppression of the function of the adrenal cortex, Cushing's syndrome).
With the simultaneous use of other inhibitors of the cytochrome P450 system (ketoconazole, erythromycin) with the drug, a slight increase in the concentration of fluticasone in the blood is observed, which practically does not change the concentration of cortisol.
Analogs
The analogues of Nazarel are Kutiveit, Sinoflurin, Fliksonase, Flixotide.
Terms and conditions of storage
Keep out of reach of children at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Nazarel
Reviews of Nazarel from patients indicate that this drug is effective in eliminating the negative symptoms of allergic rhinitis and dependence on nasal vasoconstrictor drugs. Experts confirm this information, however, note that the effectiveness of the spray directly depends on the patient's positive response to the active substance.
According to reviews, the most common side effects of Nazarel are dryness and a rapidly passing burning sensation in the nasal mucosa.
Price for Nazarel in pharmacies
The price for Nazarel is approximately 390 rubles per bottle of 120 doses of 50 mcg each.
Nazarel: prices in online pharmacies
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Drug name Price Pharmacy |
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Nazarel 50 mcg / dose 120 doses nasal spray dosed 1 pc. 226 r Buy |
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Nazarel nasal spray. 50mcg / dose 120 doses 351 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
