Nazarel nasal spray 50mcg/dose 120dose fl
The drug is indicated for intranasal use only. For adults and children over 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, consult a doctor.
For children from 4 to 12 years old: do not use Nazarel nasal spray for more than 2 months.
If it is necessary to use the drug for more than 2 months, consult a doctor. With long-term use, regular monitoring of the function of the adrenal cortex is necessary.
When using nasal glucocorticosteroids, systemic effects may occur, especially when used in high doses for a long time. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid medications.
Possible systemic effects may include Cushing's syndrome, Cushing's signature features, adrenal suppression, 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 (in characteristics in children).
In children receiving therapy with certain intranasal corticosteroids in approved doses, a decrease in growth rate was observed. It is recommended to regularly monitor the growth of children receiving long-term treatment with intranasal glucocorticosteroids. If growth slows, treatment should be reconsidered to reduce the dose of intranasal glucocorticosteroid, if possible, to the minimum dose that ensures effective control of symptoms and contact a pediatrician.
The simultaneous use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient outweighs the possible risk of systemic side effects of glucocorticosteroids (see section "Interaction with other drugs").
The full effect of fluticasone propionate in the form of a nasal spray may appear only after 3-4 days of treatment.
It is recommended to stop taking the drug and consult a doctor if there is no improvement within 4 days. Consultation with a doctor is also necessary if you develop new symptoms, such as severe facial pain, thick nasal discharge, which may indicate an infection and are not related to allergies.
Infections of the nasal cavity or paranasal sinuses require appropriate treatment, but are not a contraindication to the use of Nazarel nasal spray.
For most patients, fluticasone propionate nasal spray relieves the symptoms of seasonal allergic rhinitis, but in some cases, when the concentration of allergens in the air is very high, additional therapy may be necessary.
Additional therapy may be required to relieve eye symptoms during successful treatment of seasonal allergic rhinitis.
To achieve maximum therapeutic effect, it is necessary to adhere to a regular regimen of use.
Caution should be exercised when transferring patients from systemic corticosteroid therapy to treatment with fluticasone propionate nasal spray, especially if adrenal dysfunction is observed during regular monitoring.
Nazarel aqueous nasal spray contains benzalkonium chloride, which may cause bronchospasm.
In case of contact with patients with chickenpox, measles, or in case of changes in vision, it is recommended to stop treatment and consult a doctor.
Effect on the ability to drive: Clinical studies have not provided data on the effect of the drug on the ability to drive vehicles and other mechanisms, however, side effects that the drug may cause should be taken into account.
Nazarel nasal spray, dosed 50 mcg/dose, 120 doses
Registration Certificate Holder
Teva Pharmaceutical Industries (Israel)
Dosage form
Medicine - Nazarel
Description
Dosed nasal spray
in the form of an opaque, homogeneous suspension of white or almost white color.
1 dose
fluticasone propionate 50 mcg
Excipients
: polysorbate 80 - 0.005 mg, microcrystalline cellulose + sodium carmellose (dispersed cellulose) - 1.55 mg, dextrose - 5 mg, benzalkonium chloride (50% solution) - 0.04 mg, phenylethanol - 0.25 mg, water - qs
120 doses - dark glass bottles (1) with a dosing device and a protective cap - cardboard packs.
Indications
- prevention and treatment of seasonal and year-round allergic rhinitis.
Contraindications for use
- children under 4 years of age;
- hypersensitivity to the components of the drug.
Carefully _
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; concomitantly with other dosage forms of corticosteroids (including tablets, creams, ointments, asthma medications, similar nasal or eye sprays and nasal drops).
pharmachologic effect
GCS for local use. 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 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 the allergic reaction.
The antiallergic effect appears 2-4 hours after the first use. Reduces nasal itching, sneezing, rhinitis, nasal congestion, discomfort in the sinuses and pressure around the nose and eyes. Relieves eye symptoms associated with allergic rhinitis.
When used in therapeutic doses, fluticasone propionate does not exhibit systemic effects and has virtually no effect on the hypothalamic-pituitary-adrenal system.
The effect of the drug lasts for 24 hours after a single use.
Drug interactions
Interaction with other drugs is unlikely, since plasma concentrations of fluticasone are very low when administered intranasally.
When used simultaneously with strong inhibitors of the CYP3A4 isoenzyme (ritonavir), the systemic effect of fluticasone may be enhanced and side effects may develop (Cushing's syndrome, suppression of adrenal 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 has virtually no effect on cortisol levels.
Dosage regimen
The drug is used intranasally.
Adults and children 12 years and older
Prescribe 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 into each nasal passage 2 times a day (maximum daily dose - 400 mcg). After achieving a therapeutic effect, a maintenance dose of 50 mcg/day can be administered into each nasal passage (100 mcg). The maximum daily dose should not exceed 400 mcg (4 doses in each nasal passage).
Elderly patients
no dose adjustment required.
Children aged 4 to 12 years
Prescribe 1 dose (50 mcg) 1 time/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 use the minimum dosage that ensures effective relief of symptoms.
To achieve the full therapeutic effect, the drug should be used regularly.
Rules for using the drug
The nasal spray bottle is equipped with a protective cap that protects the tip from dust and contamination.
When using for the first time, you need to prepare the bottle by pressing the dispenser 6 times. The spray mechanism is unlocked. If the drug has not been used for more than one week, the bottle should be prepared again and the spray mechanism should be unlocked.
Next you need:
- clean the nasal cavity;
- close one nasal passage and insert the tip into the other nasal passage;
- tilt your head slightly forward, continuing to hold the bottle vertically;
- begin to inhale through your nose and, continuing to inhale, press once with your fingers;
- exhale through the mouth.
Next, inject the drug into the other nasal passage in the same way.
After use, blot the tip with a clean napkin or handkerchief and close it with the 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 carefully install it in the upper part of the bottle. Put on the protective cap. If the tip hole becomes clogged, the tip should be removed and left in warm water for a while. Then rinse under running water, dry and put back 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.
Overdose
No symptoms of acute or chronic overdose have been recorded. When intranasally administered to volunteers 2 mg of fluticasone propionate 2 times a day for 7 days, no effect on the hypothalamic-pituitary-adrenal system was found.
Side effect
Determination of the frequency of adverse reactions (according to WHO recommendations): very often (≥10%), often (≥1%, but <10%), infrequently (≥0.1%, but <1%), rarely (≥0.01%, but < 0.1%), very rare, including isolated cases (<0.01%).
From the immune system:
rarely - bronchospasm, anaphylactic reaction; very rarely - skin hypersensitivity reaction, angioedema.
From the nervous system:
often - headache, impaired taste, impaired sense of smell.
From the side of the organ of vision:
very rarely - increased intraocular pressure, glaucoma, cataracts.
From the respiratory system:
very often - nosebleeds;
often - dryness and irritation of the nasopharynx mucosa; very rarely - perforation of the nasal septum. From the skin and subcutaneous tissues:
very rarely - ulceration of the subcutaneous mucous layer.
Other:
very rarely - growth retardation in children, decreased function of the adrenal cortex, osteoporosis.
special instructions
Concomitant use with inhibitors of the CYP3A4 isoenzyme (ritonavir, ketonazole) requires careful monitoring of the patient's condition, since these drugs may cause an increase in the concentration of fluticasone propionate in plasma.
When GCS is prescribed for intranasal use in high doses for a long time, the risk of developing systemic effects of GCS increases. With long-term 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 long-term therapy; it is necessary to regularly monitor the child’s growth and promptly adjust the dose of Nazarel.
In the treatment of seasonal allergic rhinitis, Nazarel is quite effective, however, in the case of particularly high concentrations of allergens in the air in the summer, additional treatment may be required.
When prescribing the drug Nazarel to patients with tuberculosis, an infectious process, herpetic keratitis, as well as those who have recently undergone surgery on the oral and nasal cavity, the ratio of possible risk and expected benefit should be carefully assessed.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
Shelf life: 3 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
It is not recommended to prescribe the drug during pregnancy. If necessary, the expected 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 while using the drug.
Use in elderly patients
Restrictions for elderly patients - No restrictions.
Elderly patients
no dose adjustment required.
Use in children
Restrictions for children - With caution.
Contraindicated in children under 4 years of age. Children aged 4 to 12 years
Prescribe 1 dose (50 mcg) 1 time/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 use the minimum dosage that ensures effective relief of symptoms. Because
GCS 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 child’s growth and promptly adjust the dose of Nazarel. Terms of sale
The drug is available with a prescription.
Contacts for inquiries
TEVA (Israel)
Teva LLC
115054 Moscow Valovaya st. 35 Business Tel.
Nazarel spray naz doses 50 mcg/dose 120 doses fl t/st/pack cards x1
Trade name: Nazarel International name: Fluticasone Pharmacological group: glucocorticosteroid for local use Pharmacological group according to ATC: R01AD08. Fluticasone Pharmacological action: local glucocorticosteroid, local anti-inflammatory Pharmacodynamics: GCS for local use (inhalation and intranasal), has anti-edematous, anti-inflammatory and anti-allergic effects. Restores the patient's response to bronchodilators, allowing to reduce the frequency of their use. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances (histamine, Pg, leukotrienes, cytokines).
Pharmacokinetics: When administered intranasally in doses of up to 1 mg, the plasma concentration is very low and approaches the sensitivity threshold of the method (0.05 ng/ml).
Indications for use: Allergic rhinitis (seasonal and year-round) - prevention and treatment.
Contraindications: Hypersensitivity.
Dosage regimen: Intranasal only. To achieve the full therapeutic effect, the drug should be used regularly. Adults and children 12 years of age and older are prescribed 100 mcg in each nasal passage, 1 time per day, preferably in the morning, in some cases - 2 times per day. The maximum daily dose should not exceed 200 mcg in each nasal passage. Elderly patients do not require dosage adjustment. Children aged 4-11 years are prescribed 50 mcg in each nasal passage, 1 time per day. The maximum daily dose is 100 mcg in each nasal passage. The maximum therapeutic effect appears after 3-4 days. Before use, shake the bottle carefully, take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom. When using the drug for the first time or a break in its use for more than 1 week, you should check the serviceability of the sprayer: pointing the tip away from you, make several presses until a small cloud appears from the tip. Next, you need to clear your nose (blow your nose lightly). Close one nasal passage and insert the tip into the other nasal passage. Tilt your head slightly forward while continuing to hold the aerosol bottle vertically. Then you should begin to inhale through your nose and, continuing to inhale, press once with your fingers to spray the drug. Exhale through your mouth. Repeat the procedure for the second spray in the same nasal passage. Next, repeat the described procedure completely, inserting the tip into the other nasal passage. After use, blot the tip with a clean napkin or handkerchief and close it with the cap. The sprayer should be washed at least once a week. For this purpose, you must carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully place the tip in its original place at the top of the brown bottle. Put on the protective cap. If the tip hole is clogged, the tip should be removed as described above and soaked in warm water for a while. Then rinse under running cold water, dry and put back on the bottle. Do not clean the tip hole with a pin or other sharp objects.
Side effects: Local reactions (very rare): dryness and irritation of the mucous membrane of the nasopharynx, burning, unpleasant taste and smell, nosebleeds, nasal congestion, in isolated cases - perforation of the nasal septum, especially with a history of surgical interventions in the nasal cavity. When administered intranasally to healthy individuals 2 mg 2 times a day for 7 days, no effect on the function of the hypothalamic-pituitary-adrenal system was found.
Special instructions: With long-term use, regular monitoring of the function of the adrenal cortex is necessary. To relieve ophthalmological manifestations of allergic diseases, even against the background of successful treatment of seasonal allergic rhinitis, additional therapy may be required. Upper respiratory tract infections are not a contraindication for use. It should be used with caution after systemic corticosteroids, especially in cases where suppression of adrenal function is expected.
Manufacturer: IVAX Pharmaceuticals sro, Czech Republic Registration certificate holder: IVAX Pharmaceuticals sro, Czech Republic Release form: metered nasal spray 50 mcg/dose, dark glass bottles with a dosing device Composition: fluticasone propionate 50 mcg - 1 dose Preferential release: DLO Dispensing conditions : by prescription Shelf life: 3 years Registration data: LSR-005468/08 dated July 15, 2008 Registration certificate status: valid Pharmaceutical article number: ND 42-15310-08
Manufacturer: Teva Czech Industries sro, Czech Republic Holder of the registration certificate: Teva LLC Release form: metered nasal spray 50 mcg/dose, dark glass bottle Preferential release: DLO Conditions of release: by prescription Registration data: LSR-005468/08 dated 15.07. 2008 Status of the registration certificate: valid Pharmaceutical article number: LSR-005468/08-150708
