Nazarel, nasal spray 50mcg/dose 120 doses

Composition

1 dose contains fluticasone propionate 50 mcg;

excipients:

polysorbate 80,

microcrystalline cellulose + sodium carmellose (dispersed cellulose),

dextrose,

benzalkonium chloride (50% solution),

phenylethanol,

water.

Pharmacological action

Glucocorticosteroid (corticosteroid) for topical use. In recommended doses, it has a pronounced anti-inflammatory, anti-edematous and anti-allergic effect. The anti-inflammatory effect is realized as a result of the interaction of the drug with glucocorticoid receptors.

Inhibits 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.

The anti-allergic effect manifests itself within 2-4 hours after the first application. Reduces itchy nose, sneezing, runny nose, nasal congestion, sinus discomfort, and pressure around the nose and eyes. Relieves eye symptoms associated with allergic rhinitis. The effect of the drug persists for 24 hours after a single application.

When used in therapeutic doses, fluticasone does not show a systemic effect and practically does not affect the hypothalamic-pituitary-adrenal system.

Indications

Prevention and treatment of seasonal and year-round allergic rhinitis.

Use during pregnancy and lactation

It is not recommended to prescribe Nazarel during pregnancy.

If necessary, the intended benefit of therapy for the mother and the potential risk to the fetus should be taken into account.

It is unlikely that fluticasone propionate is excreted in breast milk.

However, it is recommended to stop breastfeeding for the duration of the drug’s use.

Contraindications

-children under 4 years of age;

– hypersensitivity to fluticasone propionate and other components of Nazarelle.

With caution, the drug should be used for concomitant herpes, bacterial infections of the upper respiratory tract (in such cases, antibiotics and/or antiviral agents should be additionally prescribed); after surgery in the nasal cavity or trauma to the nose, as well as in the presence of ulcerative lesions of the nasal mucosa; simultaneously with other medicinal forms of corticosteroids (including tablets, creams, ointments, agents for the treatment of bronchial asthma, similar nasal or eye sprays and nasal drops).

Side effects

Headaches, dryness and irritation of the nasopharynx, unpleasant taste and smell, burning, nasal congestion, nosebleeds are often observed; very rarely – perforation of the nasal septum (usually in patients who have previously undergone surgery in the nasal cavity).

Allergic reactions: skin rash; very rarely-anaphylactic reactions, bronchospasm, angioedema (mainly swelling of the face, mouth and pharynx).

With prolonged use in high doses, concomitant or previous use of corticosteroids for systemic action, in rare cases, there is a decrease in the function of the adrenal cortex, osteoporosis, growth retardation in children, cataracts, increased intraocular pressure.

Interaction

Interaction with other medicinal products is unlikely, since plasma concentrations of fluticasone are very low when administered intranasally.

When used concomitantly with strong inhibitors of the CYP3A4 isoenzyme (ritonavir), it is possible to increase the systemic effect of fluticasone and develop side effects (Cushing’s syndrome, suppression of the adrenal cortex).

When used concomitantly with other cytochrome p450 inhibitors (erythromycin, ketoconazole), a slight increase in the concentration of fluticasone propionate in the blood is observed, which practically does not affect the cortisol content.

How to take, course of use and dosage

Nazarelle is used intranasally.

Adults and children 12 years and older are prescribed 2 doses (100 mcg) in each nasal passage 1 time/day, preferably in the morning.

In some cases, it is necessary to administer 2 doses in each nasal passage 2 times / day. (the maximum daily dose is 400 mcg).

After the therapeutic effect is achieved, a maintenance dose of 50 mcg/day can be administered. in each nasal passage (100 mcg).

The maximum daily dose should not exceed 400 mcg (4 doses in each nasal passage).

Overdose

No symptoms of acute or chronic overdose have been reported.

With intranasal use of 2 mg of fluticasone propionate 2 times a day to volunteers. No effect on the hypothalamic-pituitary-adrenal system was detected within 7 days.

Special instructions

Concomitant use with inhibitors of the CYP3A4 isoenzyme (ritonavir, ketonazole) requires careful monitoring of the patient’s condition, since these drugs can cause an increase in the concentration of fluticasone propionate in plasma.

Systemic effects of corticosteroids for intranasal use may occur, especially if they are prescribed for a long period of time and in large doses. Therefore, with prolonged use of the drug, regular monitoring of the function of the adrenal cortex is necessary.

Since corticosteroids for intranasal use, even when used in therapeutic doses, can cause a slowdown in the growth of children with long-term therapy, it is necessary to regularly monitor the growth of the child and adjust the dose of the drug in a timely manner.

In the treatment of seasonal allergic rhinitis, Nazarel is quite effective, but in the case of a particularly high concentration of allergens in the air in the summer, additional treatment may be required.

Product form

Spray for nasal use.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

of Fluticasone furoate

Conditions of release from pharmacies

By prescription

Dosage form

nasal spray

Description

For adults as prescribed by a doctor, Children over 4 years of age, Children as prescribed by a doctor

Indications

Nasal Polyposis, Allergy, Pollinosis, Sinusitis, Allergic Rhinitis