NAZAREL - instructions for use, analogs, testimonials and release forms (spray or nasal drops) of a hormonal drug for the treatment of allergic rhinitis or rhinitis in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Nazarel. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of NAZAREL in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Nazarela with existing structural analogues. Use for the treatment of an allergic rhinitis or rhinitis,including pollen-induced plants in adults, children, as well as during pregnancy and lactation. Composition of the hormonal drug.

Nazarel - Glucocorticosteroid agent (SCS) for topical application. In recommended doses, it has a pronounced anti-inflammatory, anti-edematous and anti-allergic effect.

The anti-inflammatory effect is due to the interaction of the drug with the GCS receptors. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances (including histamine, prostaglandins, leukotrienes, cytokines) during the early and late phases of an allergic reaction.

Antiallergic effect manifests itself 2-4 hours after the first application. It reduces itching in the nose, sneezing, rhinitis, nasal congestion, discomfort in the sinuses and a feeling of pressure around the nose and eyes. It alleviates eye symptoms associated with allergic rhinitis.

When used in therapeutic doses of fluticasone, propionate shows no systemic effect and has virtually no effect on the hypothalamic-pituitary-adrenalsystem.

The effect of the drug is maintained for 24 hours after a single application.

Composition

Fluticasone propionate + auxiliary substances.

Pharmacokinetics

After intranasal administration of fluticasone propionate at a dose of 200 μg per day, Cmax in blood plasma in most patients is below the detection level (less than 0.01 ng / ml). Absorption from the mucous membrane of the nasal cavity is extremely small due to the low solubility of the drug in the water (as a result, most of the dose is swallowed). With oral administration of fluticasone propionate, less than 1% of the dose is delivered to the blood due to low absorption and presystemic metabolism. These reasons cause an extremely low total absorption of the drug from the nasal mucosa and gastrointestinal tract. Fluticasone propionate in a stable state has a significant Vd of about 318 liters. Binding to plasma proteins is 91%. Exposed to the effect of "first passage" through the liver. Metabolised in the liver with the participation of the isoenzyme CYP3A4 with the formation of an inactive carboxyl metabolite. It is excreted mainly through the intestine. Renal clearance of fluticasone propionate is less than 0.2%, the renal clearance of a metabolite containing a carboxyl group is less than 5%.

Indications

• prevention and treatment of seasonal and all-year-round allergic rhinitis (including pollinosis or hay fever).

Forms of release

Spray nasal dosed 50 mcg (sometimes mistakenly called drops in the nose).

Instructions for use and how to use them

The drug is used intranasally (in the nose).

Adults and children 12 years of age and older are prescribed 2 doses (100 mcg) in each nasal passage 1 time per day, preferably in the morning. In some cases it is necessary to administer 2 doses in each nasal passage 2 times a day (the maximum daily dose is 400 mcg). After achieving the therapeutic effect, a maintenance dose of 50 μg per day can be administered to each nasal passage (100 μg). The maximum daily dose should not exceed 400 mcg (4 doses per each nasal passage).

Older patients do not need a dose adjustment.

Children aged 4 to 12 years are prescribed 1 dose (50 μg) 1 time per day in each nasal passage, preferably in the morning. The maximum daily dose should not exceed 200 mcg in each nasal passage. It is necessary to apply the minimum dosage, which ensures effective elimination of symptoms.

To achieve full therapeutic effect the drug should be used regularly.

Terms of use

The bottle with nasal spray is equipped with a protective cap, which protects the tip from getting dust and pollution.

At the first application it is necessary to prepare the bottle by pressing the dispenser 6 times. The spraying mechanism is unlocked. If the drug has not been used for more than one week, you should again prepare the vial and unlock the spraying mechanism.

Then you need:

• clean the nasal cavity;
• close one nasal passage and insert the tip into the other nasal passage;
• Tilt his head slightly forward, continuing to hold the bottle vertically;
• start breathing in through your nose and, continuing to inhale, make a single tap with your fingers;
• exhale through the mouth.

Then, in the same way, inject the drug into the other nasal passage.

After use, the tip should be soaked with a clean cloth or a handkerchief and cover it with a cap. The sprayer should be washed at least once a week. To do this, remove the tip, rinse it in warm water, dry it and then gently place it on the top of the bottle. Put the protective cap on. If the tip of the tip is clogged, the tip should be removed and left for a while in warm water.Then rinse under the stream, dry and re-put on the bottle. Do not clean the hole with a pin or other sharp objects.

After opening the package, the drug can be used until the expiration date.

Side effect

• bronchospasm;
• anaphylactic reaction;
• skin hypersensitivity reaction;
• angioedema;
• headache;
• a violation of taste sensations;
• impairment of smell
• increased intraocular pressure;
• glaucoma;
• cataract;
• nose bleed;
• dryness and irritation of the mucous membrane of the nasopharynx;
• perforation of the nasal septum;
• ulceration of the subcutaneous mucous layer;
• growth retardation in children;
• decreased function of the adrenal cortex;
• osteoporosis.

Contraindications

• children under 4 years;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

It is not recommended to prescribe the drug Nazarel during pregnancy. If necessary, consider the expected benefit of therapy for the mother and the potential risk to the fetus.

It is unlikely that fluticasone propionate excreted in breast milk. Nevertheless, it is recommended to stop breastfeeding while the drug is being used.

Use in children

Contraindicated in childhood up to 4 years. Children aged 4 to 12 years are prescribed 1 dose (50 μg) 1 time per day in each nasal passage, preferably in the morning. The maximum daily dose should not exceed 200 mcg in each nasal passage. It is necessary to apply the minimum dosage, which ensures effective elimination of symptoms.

Because glucocorticosteroids for intranasal use even when used in therapeutic doses can cause growth retardation of children in long-term treatment, it is necessary to regularly monitor the growth of the child and in a timely manner to adjust the dose of the drug Nazarel.

Application in elderly patients

Older patients do not need a dose adjustment.

special instructions

The simultaneous use of inhibitors isoenzyme CYP3A4 (ritonavir, ketoconazole) requires careful monitoring of the patient, since these drugs can cause increased concentration of fluticasone propionate in plasma.

In the appointment of GCS for intranasal use in high doses for a long time increases the risk of systemic effects of GCS.With prolonged use of the drug Nazarel, regular monitoring of the function of the adrenal cortex is necessary.

Because GCS for intranasal use even when used in therapeutic doses can cause a slowdown in the growth of children with prolonged therapy, it is necessary to regularly monitor the growth of the child and timely adjust the dose of the drug Nazarel.

In the treatment of seasonal allergic rhinitis, Nazarel is quite effective, but in the case of an especially high concentration in the air in the summer, allergens may require additional treatment.

When prescribing Nazarel to patients with tuberculosis, the infectious process, herpetic keratitis, and also recently undergone surgical intervention in the oral cavity and nose, the relationship between possible risk and the expected benefit should be carefully evaluated.

Drug Interactions

Interaction with other drugs is unlikely, because with intranasal administration of the concentration of fluticasone in the plasma is very low.

When used simultaneously with strong inhibitors of the isoenzyme CYP3A4 (ritonavir), Nazarel's systemic action may be strengthened and the development of side effects (Cushing's syndrome, suppression of adrenal cortex function).

When used simultaneously with other inhibitors of the cytochrome P450 system (erythromycin, ketoconazole), a slight increase in the concentration of fluticasone propionate in the blood is observed, which practically does not affect the cortisol content.

Analogues of the medicinal product of Nazarel

Structural analogs for the active substance:

• Kutiweit;
• Fliksonase;
• Fliksotid;
• Fluticasone;
• Fluticasone propionate.

Analogues for the pharmacological group (agents for the treatment of vasomotor and allergic rhinitis):

• Avamis;
• Aqua Maris;
• Aqualor;
• Allergodyl;
• Allergoferon;
• Aldecin;
• Astemizole;
• Berlikort;
• Vibrocil;
• Halazolin;
• Histaglobin;
• Histafen;
• Dexamethasone;
• Derinat;
• Diazoline;
• Diprospan;
• Fornos;
• Zaditen;
• Zincet;
• Zodak;
• Intal;
• IRS 19;
• Ketotifen;
• Claritin;
• Clemastine;
• Xylen;
• Xylometazoline;
• Loratadine;
• Lordestin;
• Morenezal;
• Nazivin;
• Nasol;
• Nazonex;
• Nasobek;
• Naphthysine;
• Otrivin;
• Parliamentary;
• Pinosol;
• Polyoxidonium;
• Prednisolone;
• Sanorin;
• Snoop;
• Suprastin;
• Tavegil;
• Telfast;
• Tysine;
• Fenkarol;
• Physiomer spray nasal;
• Celeston;
• Cetirizine;
• Erbisol;
• Erolin.

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