Description
Release form
Nasal spray.
Packaging
Bottle 120 doses.
Pharmacological action
Nazarel has an anti-inflammatory, anti-allergic effect.
Indications
Prevention and treatment of seasonal and perennial allergic rhinitis.
Contraindications
– children under 4 years of age
– Hypersensitivity to fluticasone propionate and other Nazarel components.
With caution, the drug should be used with 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 nasal injury, as well as in the presence of ulcerative lesions of the nasal mucosa simultaneously with other dosage forms of corticosteroids (including tablets, creams, ointments, asthma medications, similar nasal or ophthalmic sprays, and nasal ny drops).
Use during pregnancy and lactation
Nazarel is not recommended for use during pregnancy. If necessary, the anticipated benefits of therapy to the mother and the potential risk to the fetus should be considered.
Fluticasone propionate is unlikely to be excreted in breast milk. Nonetheless, at the time of use of the drug, breastfeeding is recommended to be stopped.
Special instructions
Combined use with inhibitors of the isoenzyme CYP3A4 (ritonavir, ketonazole) requires careful monitoring of the patient’s condition, since these drugs can cause an increase in the concentration of fluticasone propionate in the 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.
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.
In the treatment of seasonal allergic rhinitis, Nazarel is quite effective, but in the case of especially high concentrations of allergens in the air in the summer, additional treatment may be required.
Composition
1 dose contains fluticasone propionate 50 mcg
excipients: polysorbate 80, microcrystalline cellulose + sodium carmellose (dispersive cellulose), dextrose, benzalkonium chloride (50% solution), phenylethanol, water.
Dosage and administration of
Nazarel is administered intranasally.
Adults and children 12 years of age 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. (Maximum daily dose is 400 mcg). After the therapeutic effect is achieved, a maintenance dose of 50 μg / 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).
Side effects of
Headaches, dryness and irritation of the nasopharynx, bad taste and smell, burning, nasal congestion, nose bleeding are very rare – perforation of the nasal septum (usually in patients who have previously had surgery in the nasal cavity).
Allergic reactions: skin rash is very rare – anaphylactic reactions, bronchospasm, angioedema (mainly swelling of the face, oral cavity and pharynx).
With prolonged use at high doses, concomitant or previous use of corticosteroids for systemic action, in rare cases, there is a decrease in adrenal cortex function, osteoporosis, growth retardation in children, cataracts, increased intraocular pressure.
Drug Interactions
Interaction with other drugs is unlikely because plasma concentrations of fluticasone are very low with intranasal administration.
With simultaneous use with strong inhibitors of the CYP3A4 isoenzyme (ritonavir), it is possible to enhance the systemic effect of fluticasone and the development of side effects (Cushing’s syndrome, inhibition of adrenal cortex function).
With simultaneous use 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.
Overdose
No symptoms of acute or chronic overdose have been reported. Intranasal administration to volunteers of 2 mg of fluticasone propionate 2 times / day. no effect on the hypothalamic-pituitary-adrenal system was detected within 7 days.
Storage Conditions
In a dark place at a temperature not exceeding 25 ° C.
Active ingredient
Fluticasone furoate
Terms leave through pharmacies
In retseptu
Dosage form
spray nasal
Assignment
Antiallergic
Possible product name
NAZAREL 50MKG / DOSE 120DOZ NAZAL.SPREY
NAZAREL 50MKG / DOSE 120DOZ SPRAY Naz
Nazarel 50mkg / dose nasal spray scrapper . 120 doses Fl.t / s X1
Nazarel 50mkg120 doses
spray NAZAREL SPR. NAZ DOSE. 50MKG / DOSE FL. 120 DOZ No. 1
Teva Pharmaceutical Enterprise Co., Ltd., Israel
