Nazarel, spray 50 mcg/dose 120 doses

Interaction

Ritonavir (a highly active inhibitor of the CYP3A4 isoenzyme of the cytochrome P450 enzyme system) can significantly increase plasma concentrations of fluticasone propionate, resulting in a sharp decrease in serum cortisol concentrations.

The use of fluticasone propionate (inhaled or intranasally) and ritonavir leads to the development of systemic glucocorticoid effects, including Icenko-Cushing syndrome and suppression of adrenal cortical function. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided unless the possible benefits exceed the risks of systemic effects.

The concomitant use of fluticasone propionate for inhaled use and less potent CYP3A isoenzyme inhibitors such as ketoconazole and itraconazole leads to increased exposure of fluticasone propionate and increased risk of systemic side effects. Caution is recommended and long-term co-administration of these drugs should be avoided if possible.

The CYP3A4 isoenzyme inhibitors of the cytochrome P450 enzyme system cause negligible (erythromycin) or slight (ketoconazole) increase in plasma concentrations of fluticasone propionate, which do not result in any significant decrease in serum cortisol concentrations. However, caution should be exercised when using CYP3A4 isoenzyme inhibitors of cytochrome P450 enzyme system (e.g., ketoconazole) and fluticasone propionate concomitantly due to possible increase of plasma concentration of the latter.

Concomitant use of fluticasone propionate with cobicistat-containing drugs increases the risk of systemic side effects. Concomitant use should be avoided unless the potential benefit to the patient outweighs the possible risk of developing systemic side effects of glucocorticosteroids. In case of concomitant use, the development of systemic side effects in patients should be monitored.

Special Instructions

The drug is indicated for intranasal use only.

For adults and children from 12 years of age: Do not use Nazarel Nasal Spray for more than 3 months. If it is necessary to use the drug for more than 3 months, a physician’s consultation is required.

For children from 4 to 12 years of age: Do not use Nazarel nasal spray for more than 2 months.

If the drug must be used for more than 2 months, a physician’s consultation is required. Continuous use requires regular monitoring of adrenal function.

Systemic effects may occur with nasal glucocorticosteroids, particularly when high doses are used over an extended period of time. These effects are much less likely to occur than with oral glucocorticosteroids, and they can vary between patients and between different glucocorticosteroid products.

Possible systemic effects may include Icenko-Cushing’s syndrome, characteristic signs of cushingoid, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (especially in children).

In children receiving therapy with some intranasal glucocorticosteroids at approved doses, a decrease in growth rate has been observed. It is recommended that the growth rate of children receiving long-term treatment with intranasal glucocorticosteroids be monitored regularly. If growth rate decreases, treatment should be reconsidered to reduce the intranasal glucocorticosteroid dose, if possible, to the lowest dose that maintains effective symptom control and contact the pediatrician.

The concomitant use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient exceeds the possible risk of systemic side effects of the glucocorticosteroids (see section “Interaction with other drugs”).

The full effect of fluticasone propionate in nasal spray can only be seen after 3-4 days of treatment.

We recommend stopping the product and consulting a physician if there is no improvement within 4 days. Your physician should also be consulted if you have any new symptoms, such as significant facial pain or thick nasal discharge, which could indicate an infection and are not due to an allergy.

Infections of the nasal cavity or sinuses require appropriate treatment, but are not contraindications to the use of Nazarel Nasal Spray.

In most patients, fluticasone propionate nasal spray resolves symptoms of seasonal allergic rhinitis, but in some cases, additional therapy may be necessary if there are very high levels of airborne allergens.

Additional therapy may be necessary to relieve eye symptoms with successful therapy of seasonal allergic rhinitis.

To achieve maximum therapeutic benefit, it is necessary to adhere to a regular regimen of use.

Caution should be used when converting patients from systemic glucocorticosteroid therapy to treatment with fluticasone propionate nasal spray, especially if there is impaired adrenal function with regular monitoring.

Nasarel, a nasal water spray, contains benzalkonium chloride, which can cause bronchospasm.

In case of contact with patients with chickenpox, measles, and changes in vision, we recommend stopping treatment and seeing a doctor.

Influence on driving and operating ability

In clinical trials no data have been obtained on the effect of the drug on the ability to drive vehicles and other mechanisms, but side effects that may be caused by the drug should be considered.

Synopsis

A white or almost white opaque, homogeneous suspension placed in a dark glass vial (type 1) with a dosing device and protective cap for 60, 120, 150 doses containing 50 µg of fluticasone propionate in one dose.

Contraindications

– Hypersensitivity to fluticasone propionate or any other component of the drug.
– Children under 4 years of age.
– Recent nasal trauma or surgery in the nasal cavity.

With caution
Before using the drug, you should consult your doctor if you are taking:
– medications to treat HIV infection, such as ritonavir;
– glucocorticosteroids to treat bronchial asthma, allergies, skin rash;
– medications to treat fungal infections, such as ketoconazole;
– other potent CYP3A isoenzyme inhibitors, such as itraconazole.
Also consult your doctor if you have glaucoma or cataracts.

Take with caution if you have infections of the nasal cavity or sinuses. Note that nasal infections require appropriate treatment, but are not a contraindication to the use of Nazarel Nasal Spray.

Side effects

The undesired reactions presented below are listed according to organ and organ system involvement and frequency of occurrence. The frequency is defined as follows: very frequent (≥1/10), frequent (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10000 and < 1/1000), very rare (< 1/10000, including individual cases). Very common, frequent, and infrequent adverse reactions are mainly established on the basis of data from clinical trials. Rare and very rare reactions are mainly determined from spontaneous reports. In forming the incidence of adverse reactions, baseline rates in the placebo group were not taken into account because they were generally comparable to the active treatment group.

Immune system disorders: very rare – hypersensitivity reactions, including bronchospasm, rash, facial and tongue swelling, anaphylactic reactions, anaphylactoid reactions.

Nervous system disorders:often – headache, sensation of unpleasant taste and smell.

The occurrence of headache, unpleasant taste and odor have also been reported with other nasal sprays.

Visual disorders:very rarely, glaucoma, increased intraocular pressure, cataracts. A small number of spontaneous reports have been associated with long-term therapy with the drug.

Disorders of the respiratory system, thorax and mediastinum:

very often – nasal bleeding; often – dryness and irritation of the mucous membrane in the nasal cavity and pharynx.

These adverse reactions, as well as nasal bleeding, have also been observed with other intranasal medications.

Very rarely, nasal septal perforation (also reported with other intranasal glucocorticosteroids).

Some intranasal glucocorticosteroids may develop systemic effects, especially when administered in high doses over a long period of time (see also section on “Special Precautions”).

Overdose

There are no data on acute or chronic overdose of fluticasone propionate. In healthy volunteers, intranasal administration of 2 mg fluticasone propionate twice daily for 7 days had no effect on hypothalamic-pituitary-adrenal system function (doses 20 times higher than therapeutic). Administration of the drug in doses higher than recommended for a long period of time may lead to temporary suppression of adrenal function. In case of overdose, consult a physician.

Pregnancy use

Before using Nazarel during pregnancy and lactation, consult a physician. Pregnant and lactating women may be prescribed the drug only when the expected benefits to the patient exceed any possible risk to the fetus or child.

Similarities

Flixotide, Flixonase, FeniVeit