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

Excipients: cellulose, dispersed (microcrystalline cellulose, treated with carmellose sodium) 20.0 mg, glycerol 21.0 mg, citric acid monohydrate 2.0 mg, sodium citrate dihydrate 2.8 mg, polysorbate 80 mg 0.1 mg, benzalkonium chloride 50% solution) 0.2 mg, purified water 0.95 g.

Description:

The suspension is white or almost white.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:

Mometasone is a synthetic glucocorticosteroid (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 the "late" allergy reaction), inhibits the development of an allergic reaction of 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 in the early and late stages of the allergic reaction. This was confirmed by a decrease (in comparison with placebo) of the level of histamine and eosinophil activity, as well as a decrease in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells (as compared to the baseline level).

Pharmacokinetics:

In intranasal application, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of 0.25 pg / ml).The suspension of mometasone is very poorly absorbed in the gastrointestinal tract, and a small amount of mometasone suspension that can enter the gastrointestinal tract after nasal inhalation is subjected to active primary metabolism even before excretion with urine or bile.

Indications:

- Seasonal and year-round allergic rhinitis in adults, adolescents and children from 2 years of age.

- 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 aged 12 years and over.

- Prophylactic treatment of seasonal allergic rhinitis of moderate and severe course in adults and adolescents from the age of 12 (recommended two to four 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).

Contraindications:

- Hypersensitivity to any of the substances that make up the drug.

- A recent surgery or injury to the nose with damage to the mucous membrane of the nasal cavity - until the wound is healed (due to the inhibitory effect of GCS on healing processes).

- Children's age (with seasonal and year-round allergic rhinitis - up 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.

Carefully:

NAZONEX® should be used with caution in case of tuberculosis infection (active or latent) respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with the defeat of the eyes (as an exception, the administration of the drug is possible with the listed infections as directed by the doctor), the presence of an untreated local infection involving the nasal cavity in the mucosa process.

Pregnancy and lactation:

Appropriately planned and well-controlled studies of the drug in pregnant women have not been conducted.

As with other nasal SCS, NAZONEX® should be given to pregnant or breast-feeding patients only if the expected benefit of the drug justifies the potential risk to the fetus or infant.Infants whose mothers received SCS during pregnancy should be carefully screened for possible hypofunction of the adrenal glands.

Dosing and Administration:

Intranasally. Inhalation of the suspension contained in the vial is carried out by means of a special dispensing nozzle on the vial.

Before the first application of NAZONEX® nasal spray, it is necessary to carry out its "calibration". Do not pierce the nasal applicator.

To perform the "calibration", it is necessary to press the dispensing nozzle 10 times, until splashes appear, which indicates the readiness of the preparation for use.

Tilt your head and inject the drug into each nostril as recommended by your doctor.

If the medicinal product has not been used for 14 days or longer, you must press the dispensing nozzle 2 times until splashes appear.

Tilt your head and inject the drug into each nostril as recommended by your doctor.

Cleaning the dispensing nozzle.

It is important to clean the dispensing nozzle regularly to avoid improper operation.Remove the cap that protects the nozzle from dust, then gently remove the spray tip. Rinse the spray tip thoroughly and the dust cap in warm water and rinse under the tap.

Do not attempt to open the nasal applicator with a needle or other sharp object, as this will damage the applicator, as a result of which you may take the wrong dose of the drug.

Dry the cap and tip in a warm place. Then attach the spray tip to the vial 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. Before each use, vigorously shake the bottle.

Treatment of seasonal or year-round allergic rhinitis

Adults (including the elderly) and adolescents with 12 years of age:

The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 μg each) in each nostril 1 time per 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 per day (the total daily dose is 100 μg).

If the symptoms can not be reduced by applying the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril once a day (total daily dose of 400 μg). After reducing the symptoms of the disease, a dose reduction is recommended.

The onset of the drug is usually observed clinically within 12 hours after the first use of the drug.

Children 2-11 years:

The recommended therapeutic dose is 1 inhalation (50 μg) in each nostril 1 time per 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 the elderly) and adolescents with 12 years of age:

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

If the symptoms can not be reduced by applying the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 2 times a day (total daily dose 800 mcg). 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 a day (total daily dose of 400 μg). If symptoms worsen during treatment, specialist consultation is necessary.

Treatment of polyposis of the nose

Adults (including the elderly) of 18 years:

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

After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 inhalations (50 μg each) in each nostril 1 time per day (total daily dose - 200 μg).

Side effects:

In adults and adolescents: headache, nasal bleeding (ie, obvious bleeding, as well as secretion of blood-colored mucus or blood clots), pharyngitis, burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa. 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 or less,than with the appointment of other nasal SCS, which were used as an active control (in 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.

Children: nosebleeds, headache, irritation in the nose, sneezing. The incidence of these adverse events in children was comparable to the incidence of their occurrence with placebo.

Rarely there were reactions of hypersensitivity of immediate type (for example, bronchospasm, dyspnea).

Very rarely - anaphylaxis, angioedema, impaired taste and smell. Also very rarely with nasal application of GCS there were cases of perforation of the nasal septum and increased intraocular pressure.

Overdose:

With prolonged use of GCS in high doses, as well as with the simultaneous use of several GCS, oppression of the function of the hypothalamic-pituitary-adrenal system is possible. Due to the low systemic bioavailability of the drug (<1%, with sensitivity of the 0.25 pg / ml assay method), it is unlikely,that in case of accidental or intentional overdose it will be necessary to take any measures besides observation with possible subsequent resumption of taking the drug at the recommended dose.

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).

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. In case of development of a local fungal infection of the nose or throat, it may be necessary to stop NAZONEX® nasal spray discontinuation and special treatment. The long-lasting irritation of the nasal and pharyngeal mucosa can also serve as a basis for discontinuing NAZONEX® nasal spray treatment.

When conducting placebo-controlled clinical trials in children, when NAZONEX nasal spray was applied 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 hypothalamic-pituitary-adrenal system function were observed. Patients who switch to NAZONEX® nasal spray treatment after long-term therapy with systemic glucocorticosteroids require special attention. Abolition of systemic glucocorticosteroids in such patients can lead to adrenal insufficiency, the subsequent restoration of which can take up to several months. If signs of adrenal insufficiency appear, you should resume taking systemic glucocorticosteroids and take other necessary measures.

During the transition from treatment with systemic glucocorticosteroids to treatment with NAZONEX® nasal spray, some patients may experience initial symptoms of systemic glucocorticosteroid withdrawal (eg joint and / or muscle pain, fatigue and depression) despite a decrease in symptom severity,associated with damage to the nasal mucosa; such patients need to specifically convince in the advisability of continuing treatment with nasal spray NAZONEX®. Transition from systemic to local glucocorticosteroids can also reveal already existing, but masked by the therapy of glucocorticosteroids of systemic action, allergic diseases such as allergic conjunctivitis and eczema.

Patients treated with glucocorticosteroids have potentially decreased immune reactivity and should be warned of the increased risk of infection if they become infected 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.

When NAZONEX® nasal spray was used for 12 months, there was no evidence of atrophy of the nasal mucosa; Besides, mometasone furoate showed a tendency to promote the normalization of the histological pattern in the study of biopsies of the nasal mucosa.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of the effect of the drug NAZONEX® on the ability to drive a car or moving machinery.

Form release / dosage:

Spray nasal dosed with 50 mcg / dose.

Packaging:

For 10 g (60 doses) or 18 g (120 doses) of the suspension in polyethylene bottles of white color, equipped with a dosing device and closed with a cap. For 1 bottle (10 g) or 1, 2, 3 bottles (18 g), together with instructions for use in a cardboard bundle.

Storage conditions:

In a place inaccessible to children; at a temperature of 2 to 25 ° C. Do not freeze.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N014744 / 01

Date of registration:17.03.2009 / 05.07.2013

The owner of the registration certificate:Schering-Plau N. Labo.Schering-Plau N. Labo. Belgium

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp17.02.2016

Illustrated instructions

Instructions

Nazonex® (Nasonex®)