Nazarel - instructions for use, dose, side effects, contraindications

auxiliary substances: polysorbate-80 0,005 mg; cellulose microcrystalline + carmellose, sodium (dispersive cellulose) 1.55 mg, dextrose 5.00 mg; benzalkonium chloride (50% solution) 0.04 mg; phenylethanol 0.25 mg; water is sufficient.

Description:

White or almost white An opaque, homogeneous suspension placed in a dark glass bottle (type 1) with a metering device and a protective cap for 60, 120, 150 doses containing 50 μg fluticasone propionate in a single dose.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.08 Fluticasone

Pharmacodynamics:

Glucocorticosteroid agent (SCS) for topical application. In recommended doses, it has a pronounced anti-inflammatory, anti-edematous and anti-allergic effect. Anti-inflammatory effect is realized as a result of interaction of the drug with receptors of glucocorticosteroids.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 phase of an allergic reaction. Antiallergic effect is manifested in 2-4 hours after the first application. It reduces itching in the nose, sneezing, runny nose, stuffy nose, discomfort in the sinuses and a feeling of pressure around the nose and eyes. It alleviates eye symptoms associated with allergic rhinitis. The effect of the drug is preserved for 24 hours after a single application. When used in therapeutic doses fluticasone does not show a systemic effect and has virtually no effect on the hypothalamic-pituitary-adrenal system.

Pharmacokinetics:

Absorption:

After intranasal administration of fluticasone (200 μg / day), the maximum plasma concentration in most patients is below the detection level (<0.01 cg / ml). Direct absorption from the mucous membrane of the nasal cavity is extremely small due to the low solubility of the drug in water, as a result, most of the dose is swallowed.When oral fluticasone is taken into the blood, less than 1% of the dose is delivered due to low absorption and presystemic metabolism. These reasons cause an extremely low total absorption of the drug from the mucous membrane of the nasal cavity and gastrointestinal tract.

Distribution:

Fluticasone in a stable state has a significant volume of distribution - about 318 liters. Binding to plasma proteins is 91%.

Metabolism:

Has the effect of "first pass" through the liver. Metabolised in the liver with the participation of the CYP3A4 isoenzyme of the cytochrome P450 system to form an inactive carboxyl metabolite.

Excretion:

The half-life period (T1 / 2) is 3 hours. It is excreted mainly through the intestine. Renal clearance of fluticasone 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.

Contraindications:

hypersensitivity to fluticasone and other components of the drug;

children's age up to 4 years.

Carefully:

apply with concomitant simple herpes, as well as bacterial infections of the upper respiratory tract.In such cases, antibiotics and / or antiviral drugs should be additionally prescribed;
after surgery in the nasal cavity or nose trauma, as well as in the presence of ulcerative lesions of the nasal mucosa;
simultaneously with other forms of corticosteroids, including tablets, creams, ointments, agents for the treatment of bronchial asthma, similar nasal or ophthalmic sprays and nasal drops.

Pregnancy and lactation:

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

Penetration of fluticasone in breast milk is unlikely. Nevertheless, it is recommended to stop breastfeeding while the drug is being used.

Dosing and Administration:

Intranasally.

Adults and children 12 years and older: 2 doses (100 micrograms) per 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 (maximum daily dose of 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; stroke).

Older patients do not need a dose adjustment.

Children aged 4 to 12 years: one dose (50 mcg) once a 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.

INSTRUCTIONS FOR USE

The bottle with nasal spray is supplied a protective cap thatprotects the tip from hitting dust and pollution.

At the first application it is necessary prepare the bottle: click on tocongestion 6 times. Spraying mechanism is unlocked. If you do not useThe drug was administered for more than one week, Once again, prepare the vial and Unlock spraying furlow.

Then you need:

-clean the nose;

to cover one nasal passage and enter tip in the other nasal passage;

-turn your head a little forward, continuing to keep the aerosol fl owcon vertically;

start breathing in through your nose and, aboutlong to inhaleFinger pressing for spraytion;

-expend through the mouth.

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

After use, theto soak the tip of a clean napkinkoy or a handkerchief and close his cap. The atomizer follows wash at least once a week. To do this, remove the tipnickname, rinse it in warm water, aboutdry and then carefully install at the top of the vial. Wear forshield cap. If the hole is onthe tip was clogged, the tip should be removed and left for some time in warm water. Then rinse under a stream, dry and put on again on the bottle. You can not clean the holeswith a pin or other sharp objects.

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

Side effects:

The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; not often - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.

From the immune system; rarely - bronchospasm, anaphylactic reaction; very rarely - the reaction of skin hypersensitivity, angioedema.

From the central nervous system:

often - a headache, a violation of taste, a violation of the sense of smell.

From the side of the organ of vision: very rarely - increased intraocular pressure, glaucoma, cataract.

From the respiratory system, chest and mediastinum: very often - nosebleeds; often - dryness and irritation of the mucous membrane of the nasopharynx; very rarely - perforation of the nasal septum.

From the skin and subcutaneous tissues: very rarely - ulceration of the subcutaneous-mucous layer.

Other: very rarely - stunted growth in children, decreased function of the adrenal cortex, osteoporosis.

Overdose:

Symptoms of acute and chronic overdose have not been reported. With intranasal administration of 2 mg of fluticasone to volunteers 2 times per day during; 7 days, no effect was found on the hypothalamic-pituitary-adrenal system.

Interaction:

Interaction with other drugs is unlikely, because in the intranasal route of administration, fluticasone concentrations in the plasma are very low.When applied simultaneously with strong inhibitors of the isoenzyme ICYP3A4 of the cytochrome P450 system (ritonavir), the systemic effect of fluticasone and the development of side effects (Cushing's syndrome, suppression of adrenal cortex function) are possible. When used simultaneously with other inhibitors of the cytochrome P450 system (erythromycin, ketoconazole) there is an insignificant increase in the concentration in the blood of fluticasone, which practically does not affect the content of cortisol.

Special instructions:

Simultaneous application with inhibitors of the isoenzyme CYP3A4 (ritonavir, ketoconazole) requires careful monitoring of the patients' condition, as these drugs can cause an increase in the plasma fluticasone concentration (see "Interactions with Other Drugs" section).

When prescribing nasal glucocorticosteroids in high doses for a long period of time, the risk of systemic effects of glucocorticosteroids increases. With prolonged use of the drug Nazarel, regular monitoring of the function of the adrenal cortex is necessary.

Since nasal glucocorticosteroids, even when used in approved 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, the drug Nazarel is quite effective, but with an increased concentration of allergens in summer, additional treatment may be required. When Nazarel is prescribed for patients with tuberculosis, infectious process, herpetic keratitis, and recently underwent surgical intervention on the oral cavity and nose assess the ratio of possible risk and expected benefits.

Form release / dosage:

Spray nasal dosed with 50 mcg / dose.

Packaging:

For 60, 120 or 150 doses per vial of dark glass (type 1) with a dosing device and a protective cap. Each bottle together with instructions for use is placed in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:LSR-005468/08

Date of registration:15.07.2008

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Czech Industries, s.r.o. Czech Republic

Information update date: & nbsp24.10.2015

Illustrated instructions

Instructions

Nazarel (Nazarel)