Universal reference book for medicines
Name of the drug: NAZONEX ® (NASONEX ® )

Active substance: mometasone

Type: GCS for intranasal administration

Manufacturer: SCHERING-PLOUGH LABO (Belgium) manufactured by SCHERING-PLOUGH LABO (Belgium) Packaging and quality-controling chemical-pharmaceutical factory AKRIKHIN (Russia)
Spray nasal dosed with 50 μg / 1 dose in the form of a suspension of white or almost white.
1 dose of 1 g

mometasone furoate (micronized, in the form of monohydrate) 50 μg 500 μg

Auxiliary substances: cellulose dispersed (cellulose microcrystalline, processed with carmellose sodium) - 20 mg, glycerol - 21 mg, citric acid monohydrate - 2 mg, sodium citrate dihydrate - 2.8 mg, polysorbate 80 - 0.1 mg, benzalkonium chloride (as a 50% solution ) - 0.2 mg, purified water - 950 mg.

60 doses (10 g) - polyethylene bottles (1) complete with a dosing device - packs cardboard.

120 doses (18 g) - polyethylene bottles (1) complete with a dosing device - packs cardboard.

120 doses (18 g) - polyethylene bottles (2) complete with a dispenser - packs of cardboard.

120 doses (18 g) - polyethylene bottles (3) complete with a dispenser - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

GCS for topical application.
Has anti-inflammatory and antiallergic effect when used in doses, in which no systemic effects occur.
It inhibits the release of inflammatory mediators.
Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of metabolic products of arachidonic acid-cyclic endoperoxides, prostaglandins. It prevents the accumulation of neutrophils, which reduces inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of the chemotaxis substance (effect on late allergy reactions), inhibits the development of an allergic reaction of an immediate type (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).
In studies with provocative tests with application of antigens to the mucosa of the nasal cavity, high anti-inflammatory activity of mometasone was demonstrated both at the early and late stages of the allergic reaction.

This was confirmed by a decrease (compared with placebo) of histamine concentration and eosinophil activity, as well as a decrease in the amount of eosinophils, neutrophils and adhesion proteins of epithelial cells (as compared to the baseline level).

PHARMACOKINETICS

Suction

In intranasal application, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of 0.25 pg / ml).

Mometasone is very poorly absorbed from the digestive tract.

Metabolism and excretion

A small amount of active substance, which can enter the digestive tract after intranasal administration, undergoes active metabolism during the "first passage" through the liver.
It is excreted in urine and bile.
INDICATIONS

- seasonal and year-round allergic rhinitis in adults, adolescents and children from 2 years;

- Acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents with 12 years of age - as an auxiliary therapeutic agent in the treatment of antibiotics;

- Acute rhinosinusitis with mild and moderate symptoms without signs of severe bacterial infection in patients 12 years and older;

- prevention of seasonal allergic rhinitis of moderate and severe course in adults and adolescents from the age of 12 (it is recommended to spend 2-4 weeks before the expected beginning of the dusting season);

- Polyposis of the nose, accompanied by violation of nasal breathing and smell in adults (from 18 years).

DOSING MODE

The drug is administered intranasally.

Treatment of seasonal or year-round allergic rhinitis

Adults (including elderly patients) and adolescents from age 12

The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 μg each) in each nostril 1 time / day (total daily dose - 200 μg).
When the therapeutic effect for maintenance therapy is achieved, it is possible to reduce the dose to 1 inhalation in each nostril 1 time / day (the total daily dose is 100 μg).
If the decrease in symptoms of the disease can not be achieved using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 1 time / day (total daily dose - 400 μg).
After reducing the symptoms of the disease, a dose reduction is recommended.
The onset of the drug is usually observed clinically as early as 12 hours after the first use of the drug.

Children from 2 to 11 years old

The recommended therapeutic dose is 1 inhalation (50 μg) in each nostril 1 time / day (total daily dose is 100 μg).

The use of the drug in young children requires the help of adults.

Auxiliary treatment of acute sinusitis or exacerbation of chronic sinusitis

Adults (including elderly patients) and adolescents from age 12

The recommended therapeutic dose is 2 inhalations (50 μg each) in each nostril 2 times / day (total daily dose - 400 μg).

If the decrease in symptoms of the disease can not be achieved using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 2 times / day (total daily dose of 800 μg).
After reducing the symptoms of the disease, a dose reduction is recommended.
Treatment of acute rhinosinusitis without signs of severe bacterial infection

The recommended dose for adults and adolescents is 2 inhalations of 50 μg per each nasal passage 2 times / day (total daily dose of 400 μg).
If symptoms worsen during treatment, specialist consultation is necessary.
Treatment of polyposis of the nose

For adults (including elderly patients) of 18 years, the recommended therapeutic dose is 2 inhalations (50 μg each) in each nostril 2 times / day (total daily dose - 400 μg).

After reducing the symptoms of the disease, a dose reduction of up to 2 inhalations (50 μg each) per nostril 1 time / day is recommended (the total daily dose is 200 μg).

Rules for the use of the drug Nazonex ®

Inhalation of the suspension contained in the spray bottle is carried out using a special dispensing nozzle on the vial.

Before the first application of Nazonex ® nasal spray, it is necessary to calibrate by pressing the dosing device 10 times, until splashes appear, indicating the preparation is ready for use.

You should tilt your head and inject the drug into each nostril as recommended by your doctor.

If the nasal spray is not used for 14 days or longer, you must press the dosing nozzle 2 times until splashes appear.

Before each use, vigorously shake the bottle.

Cleaning the dispensing nozzle

It is important to clean the dispensing nozzle regularly to avoid improper operation.
It is necessary to remove the cap, which protects the nozzle from dust, then carefully remove the nozzle for spraying. It is necessary to thoroughly rinse the spray tip and the dust cap in warm water and rinse under the tap.
Do not try to open the nasal applicator with a needle or other sharp object, because
this will damage the applicator, resulting in an incorrect dose of the drug.
Dry the cap and tip in a warm place.
After this, it is necessary to attach the spray tip to the bottle and screw the dustproof cap back onto the bottle again. When using the nasal spray for the first time after cleaning, it is necessary to re-calibrate by pressing the dosing nozzle 2 times.
SIDE EFFECT

Adults and teenagers

Undesirable effects associated with the use of the drug (> 1%), revealed during clinical trials in patients with allergic rhinitis or polyposis of the nose, and during the post-marketing use of the drug, regardless of the indication for use, are presented in Table 1. Undesirable reactions are listed in accordance with the classification of system-organ classes MedDRA.
Within each system-organ class, undesirable reactions are classified by frequency of occurrence.
Nasal bleeding, as a rule, was moderate and stopped on their own, the frequency of their occurrence was slightly greater than when using placebo (5%), but equal to or less than with the appointment of other intranasal GCS, which were used as active controls (some of them the incidence of nasal bleeding was up to 15%).
The incidence of all other adverse events was comparable to the incidence of their occurrence with a placebo.
Table 1.

The frequency of unwanted reactions is established as follows: very often (? 1/10);
(often (? 1/100, <1/10), rarely (? 1/1000, <1/100) .For undesired reactions during post-registration monitoring, the frequency is not established (can not be determined on the basis of available data).
System-Organ class Very often Frequently Frequency not set

Infectious and parasitic diseases Pharyngitis, upper respiratory tract infection *

Immune System Disorders Reactions of increased sensitivity, including anaphylactic reactions, angioedema, bronchospasm, dyspnoea

Disorders from the nervous system Headache

Disturbances from the organ of vision Increased intraocular pressure, glaucoma,

Disturbances from the respiratory system, chest and mediastinal organs Nasal bleeding ** Nasal bleeding (ie, obvious bleeding, as well as secretion of blood-colored mucus or blood clots), a burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa Perforation of nasal septum

Disturbances of the throat (irritation of the mucous membrane of the pharynx) ** Disorders of taste and smell

* was detected with the frequency of "rarely" with the drug 2 times / day for polyposis of the nose

** was detected with the drug 2 times / day for polyposis of the nose

Children

Disturbances from the respiratory system, chest and mediastinal organs: nasal bleeding (6%), irritation of the nasal mucosa (2%), sneezing (2%).

Disturbances from the nervous system: headache (3%).

The incidence of these adverse events in children was comparable to the incidence of their occurrence with placebo.

With the use of intranasal GCS, systemic side effects may develop, especially with prolonged use of intranasal GCS in high doses (see section "Special instructions").

CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- recent surgical intervention or trauma to the nose with damage to the nasal mucosa - until the wound is healed (due to the inhibitory effect of GCS on healing processes);

- children and adolescents (with seasonal and allergic rhinitis all year round - up to 2 years, with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, with polyposis - up to 18 years) - due to lack of relevant data;

Caution should be used in cases of tuberculosis infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, prescribing with the listed infections as directed by a doctor), the presence of an untreated local infection involving the mucous membrane of the nasal cavity.

PREGNANCY AND LACTATION

Special, well-controlled studies of the safety of the use of the drug NAZONEX ® were not carried out during pregnancy.

Like other GCS for intranasal use, Nazonex ® should be given during pregnancy and during breastfeeding only if the expected benefit from its use justifies the potential risk to the fetus or baby.

Infants whose mothers received SCS during pregnancy should be carefully examined to identify possible hypofunction of the adrenal glands.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

A small amount of active substance that can enter the digestive tract with intranasal application is absorbed to a small extent and is actively biotransformed when "first passed" through the liver.

APPLICATION FOR CHILDREN

Contraindicated in seasonal and year-round allergic rhinitis - in childhood to 2 years, with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, with polyposis - up to 18 years (due to the lack of relevant data).

In placebo-controlled clinical trials in children, when Nazonex ® was administered at a dose of 100 mcg / day during the year, there was no growth retardation.

SPECIAL INSTRUCTIONS

As with any long-term treatment, patients who use Nazonex ® nasal spray for several months and longer should periodically check with the doctor for possible changes in the nasal mucosa.
It is necessary to monitor patients receiving intranasal GCS for a long time. Possible development of growth retardation in children. In case of detection of growth retardation in children, it is necessary to reduce the intranasal SCS dose to the lowest, which allows to effectively control the symptoms. In addition, you should refer the patient to a consultation with the pediatrician.
In case of development of a local fungal infection of the nose or throat, it may be necessary to stop therapy with Nazonex nasal spray and conduct special treatment.The long-lasting irritation of the nasal and pharyngeal mucosa can also serve as a basis for discontinuing the treatment with Nazonex nasal spray.

In placebo-controlled clinical trials in children, when nasonex nasal spray was used at a daily dose of 100 mcg during the year, there was no growth retardation in children.

With prolonged treatment with Nazonex nasal spray, no signs of suppression of the function of the hypothalamic-pituitary-adrenal system were observed.
Patients who switch to Nazonex nasal spray treatment after prolonged therapy with SCS of systemic action require special attention. The abolition of SCS systemic action in such patients can lead to adrenal insufficiency, the subsequent recovery of which can take up to several months. If signs of adrenal insufficiency appear, the systemic GCS should be resumed and other necessary measures taken.
With the use of intranasal GCS, it is possible to develop systemic side effects, especially with prolonged use in high doses.
The probability of these effects is much lower than when using oral GCS. Systemic side effects can vary both in individual patients and depending on the GCS used. Potential systemic effects include Cushing's syndrome, characteristic cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma, and less often a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression or aggression (especially in children).
During the transition from treatment of SCS systemic action to treatment with Nazonex nasal spray, some patients may experience initial symptoms of systemic SCS abolition (for example, joint and / or muscle pain, fatigue and depression), despite a decrease in the severity of the symptoms associated with the lesion the nasal mucosa.
Such patients should be specifically convinced of the advisability of continuing treatment with Nazonex nasal spray. Transition from systemic to local SCS can also reveal allergic diseases, such as allergic conjunctivitis and eczema already masked by GCS therapy.
Patients undergoing SCS treatment have potentially decreased immune reactivity and should be warned about the increased risk of infection in case of contact with patients with certain infectious diseases (for example, chicken pox, measles) and the need for medical advice if such contact occurs .
If signs of severe bacterial infection (eg fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area) appear, immediate medical attention is required.
With the use of Nazonex nasal spray for 12 months, there was no evidence of atrophy of the nasal mucosa.
In addition, mometasone furoate tended to promote normalization of the histological pattern in the study of biopsies of the nasal mucosa.
The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis and polyps that completely cover the nasal cavity.

In the case of unilateral polyps of unusual or irregular shape, especially ulcerated or bleeding, an additional medical examination is necessary.

Influence on ability to drive vehicles and work with mechanisms

There is no evidence of the effect of the drug Nazonex ® on the ability to drive or move vehicles.

OVERDOSE

With prolonged use of GCS in high doses or with the simultaneous use of several GCS, oppression of the hypothalamic-pituitary-adrenal system is possible.

The drug has low systemic bioavailability (<1%, with a sensitivity of 0.25 pg / ml), so it is unlikely that any accidental or intentional overdose will require any special measures other than follow-up with a possible subsequent resumption of the drug at the recommended dose.

DRUG INTERACTION

Combination therapy with loratadine was well tolerated by patients.
At the same time, there was no evidence of any drug effect on the concentration of loratadine or its main metabolite in blood plasma. In these studies, mometasone furoate in the blood plasma was not detected (with the sensitivity of the method of determining 50 pg / ml).
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of 2 ° to 25 ° C.
Do not freeze. Shelf life - 2 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.

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