Nasonex in the nose instructions for use. Nasonex hormonal drops against the runny nose and features of their use. When the drug is contraindicated

Medicines for local application in ENT practice containing Mometasone (Mometasone, ATC code R01AD09):

Nasonex - instructions for use. The drug is a prescription, the information is intended only for healthcare professionals!

Clinical and pharmacological group

GCS for intranasal use (glucocorticosteroid for administration into the nasal cavity).

pharmachologic effect

GCS for local use. Has anti-inflammatory and anti-allergic effects. The local anti-inflammatory effect of the drug is manifested when it is used in doses at which systemic effects do not occur.

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 arachidonic acid metabolic products - cyclic endoperoxides, prostaglandins. Prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, and leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of chemotaxis substance (impact on late allergy reactions), inhibits the development allergic reaction 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 the application of antigens to the nasal mucosa, high anti-inflammatory activity of the drug was demonstrated, both in the early and late stages of the allergic reaction.

This was confirmed by a decrease (compared with placebo) in histamine levels and eosinophil activity, as well as a decrease (compared with baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.

Pharmacokinetics

Suction

When administered intranasally, the systemic bioavailability of mometasone furoate is<1% (при чувствительности метода определения 0.25 пг/мл).

Mometasone is very poorly absorbed from the gastrointestinal tract.

Metabolism and excretion

A small amount of active substance, which can enter the gastrointestinal tract after intranasal administration, undergoes active metabolism during the “first pass” through the liver. Excreted in urine and bile.

Indications for use of the drug NAZONEX®

treatment of seasonal and year-round allergic rhinitis in adults, adolescents and children over 2 years of age;
acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents over 12 years of age - as an auxiliary therapeutic agent in treatment with antibiotics;
acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years and older;
prevention of moderate and severe seasonal allergic rhinitis in adults and adolescents from 12 years of age (recommended 2-4 weeks before the expected start of the dusting season);
Nasal polyposis, accompanied by impaired nasal breathing and sense of smell in adults.

Dosage regimen

The drug is used intranasally (in the nose).

Treatment of seasonal or year-round allergic rhinitis:

The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) into each nostril once a day (total daily dose - 200 mcg). Upon achieving a therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 inhalation in each nostril 1 time per day (total daily dose - 100 mcg).

If a reduction in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations into each nostril once a day (total daily dose - 400 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.

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

To use the drug in young children, adult assistance is required.

Adjuvant treatment of acute sinusitis or exacerbation of chronic sinusitis:

Adults (including elderly patients) and adolescents from 12 years of age

If a reduction in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations into each nostril 2 times a day (total daily dose - 800 mcg). After the symptoms of the disease decrease, 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 mcg in each nostril (total daily dose 400 mcg). If symptoms worsen during treatment, consultation with a specialist is necessary.

Treatment of nasal polyposis:

For adults (including elderly patients) over 18 years of age, the recommended therapeutic dose is 2 inhalations (50 mcg each) into each nostril 2 times a day (total daily dose - 400 mcg).

Rules for using Nasonex®:

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

Before using Nasonex® nasal spray for the first time, it is necessary to calibrate it by pressing the dispensing device 6-7 times. After calibration, the stereotypical feed is established medicinal substance, in which with each press of the dosing device, approximately 100 mg of a suspension containing mometasone furoate (as monohydrate) in an amount equivalent to 50 μg of mometasone furoate anhydrous is released. If the nasal spray has not been used for 14 days or longer, recalibration is necessary before reuse.

Before each use, shake the bottle vigorously.

Side effect

Side effects observed in the treatment of seasonal and year-round allergic rhinitis: in adults - nosebleeds (i.e. obvious bleeding, as well as discharge of blood-stained mucus or blood clots), pharyngitis, burning sensation in the nose; irritation of the nasal mucosa. Nosebleeds, as a rule, stopped on their own and were not severe; they occurred with a frequency slightly higher than with placebo (5%), but equal to or less than with the administration of other intranasal corticosteroids studied, which were used as active controls (in some of them the frequency of nosebleeds was up to 15%) . Frequency of occurrence of others side effects was comparable to that with placebo. In children - nosebleeds, headache, a feeling of irritation in the nose, sneezing (the frequency of occurrence is comparable to the frequency of side effects in children when using placebo).

Side effects observed when using Nasonex as an adjuvant for chronic sinusitis in adults and adolescents: headache, pharyngitis, burning sensation in the nose, irritation of the nasal mucosa. Nosebleeds were moderate, and the incidence of nosebleeds with Nasonex was comparable to the incidence of nosebleeds with placebo (5% and 4%, respectively).

Very rarely, with intranasal use of GCS, cases of perforation of the nasal septum or increased intraocular pressure have been reported.

Contraindications to the use of the drug NAZONEX®

recent surgery or trauma to the nose with damage to the mucous membrane of the nasal cavity - before the wound heals (due to the inhibitory effect of GCS on the healing processes);
children's age (for seasonal and year-round allergic rhinitis - up to 2 years, for acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, for polyposis - up to 18 years) - due to the lack of relevant data;
hypersensitivity to the components of the drug.

The drug should be used with caution in case 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, the drug can be prescribed for these infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa.

Use of the drug NASONEX® during pregnancy and breastfeeding

There have been no special, well-controlled studies of the safety of Nasonex® during pregnancy.

Like other corticosteroids for intranasal use, Nasonex® should be prescribed during pregnancy and breastfeeding only if the expected benefit from its use justifies the potential risk to the fetus or infant.

Infants whose mothers received corticosteroids during pregnancy should be carefully examined to identify possible adrenal hypofunction.

Use for liver dysfunction

A small amount of the active substance, which can enter the gastrointestinal tract during intranasal use, is absorbed to a small extent and is actively biotransformed during the “first pass” through the liver.

special instructions

When using the drug long time(as with any long-term treatment), periodic examination of the nasal mucosa by an ENT doctor is necessary. If a local bacterial or fungal infection of the nose or pharynx develops, it is recommended to stop treatment with the drug and begin special treatment. Irritation of the mucous membrane of the nasal cavity and pharynx that persists for a long time is an indication for discontinuation of the drug.

With long-term use of the drug, no signs of suppression of the function of the hypothalamic-pituitary-adrenal system were observed.

Patients who switch to treatment with Nasonex® nasal spray after long-term therapy with systemic GCS require special attention. Withdrawal of systemic corticosteroids in such patients can lead to adrenal insufficiency, the subsequent recovery of which may take up to several months. If symptoms of adrenal insufficiency appear, you should resume taking systemic corticosteroids and take other necessary measures.

During the transition from treatment with systemic GCS to treatment with Nasonex® nasal spray, some patients may experience symptoms of GCS withdrawal for systemic use(for example, joint and/or muscle pain, fatigue, depression), despite a decrease in the severity of symptoms associated with damage to the nasal mucosa; such patients must be specifically convinced of the advisability of continuing treatment with Nasonex® nasal spray. Changing therapy may also reveal previously developed allergic diseases, such as allergic conjunctivitis and eczema, which were previously masked by systemic corticosteroid therapy.

Patients who have been treated with corticosteroids have a potentially reduced immune reactivity and should be warned about the increased risk of infection when in contact with patients infectious diseases(incl. chicken pox, measles), as well as the need to consult a doctor if such contact occurs.

If signs of a severe bacterial infection appear (for example, fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), immediate consultation with a doctor is required.

After using Nasonex® for 12 months, there were no signs of atrophy of the nasal mucosa. When studying biopsy samples of the nasal mucosa, it was revealed that mometasone furoate tended to contribute to the normalization of the histological picture.

Use in pediatrics

In placebo-controlled clinical studies in children, when Nasonex® was used at a dose of 100 mcg per day for a year, no growth retardation was observed.

Overdose

With long-term use of GCS in high doses or when simultaneous use Several GCS may inhibit the hypothalamic-pituitary-adrenal system.

The drug has low systemic bioavailability (< 1%, при чувствительности метода определения 0.25 пг/мл), поэтому маловероятно, что при случайной или намеренной передозировке потребуется принятие каких-либо специальных мер, кроме наблюдения с возможным последующим возобновлением приема препарата в рекомендованной дозе.

Drug interactions

The simultaneous use of Nasonex® with loratadine did not lead to changes in the concentration of loratadine or its main metabolite in the blood plasma. In these studies, mometasone furoate was not detected in plasma (with a sensitivity of the detection method of 50 pg/ml). Combination therapy with loratadine was well tolerated by patients.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 2° to 25°C; do not freeze. Shelf life - 2 years.

Reading time: 10 min

Allergies, manifested by seasonal or year-round rhinitis, can negatively affect the general well-being and work activity of any person.

Contraindications

After operations on the nose or in case of its injuries with violation of the integrity of the mucous layer. The contraindication is temporary - after the wound has healed, Nasonex is not prohibited for use.
For the treatment of allergic rhinitis in children under two years of age. When treating sinusitis, the restriction is valid for up to 12 years, for the treatment of polyps - up to 18 years.
In case of hypersensitivity to one or several components of the spray.

With caution and under constant monitoring of all changes in well-being, Nasonex is prescribed to patients:

With respiratory tuberculosis;
With untreated viral, fungal or bacterial infection;
With eye infection caused by Herpes simplex;
With local infection of the mucous membrane of the internal nasal cavity.

Composition of Nasonex and its release form

The main active component of the spray is mometasone furoate. This is a synthetic glucocorticosteroid with a powerful anti-inflammatory effect.

The remaining components of Nasonex are auxiliary, these are:

Dispersed cellulose;
Glycerol;
Sodium citrate dihydrate;
Benzalkonium chloride;
Monohydrate citric acid;
Purified water.

The main function of the auxiliary components is to improve the absorption of glucocorticosteroids and reduce the risk of developing possible adverse reactions.

Nasonex is available in the form of a spray in a polyethylene bottle and equipped with a dosing device.

A bottle of Nasonex, placed in a cardboard package, can contain 60, 120 or 140 doses.

Pharmacological effect on the body

Mometasone furoate is a glucocorticosteroid of synthetic origin and is used only as a component of drugs with local action.

The main effect of this GCS is antiallergic and anti-inflammatory.

In those doses that provide a therapeutic effect when applied topically, Nasonex does not have a central effect. That is, the drug does not cause side changes in the body, the likelihood of which is increased with systemic use of glucocorticosteroids.

Mometasone furoate has several effects on the body:

Blocks the release of a complex of inflammatory mediators;
Increases the production of lipomodulin, which in turn leads to a decrease in the release of arachidonic acid;
Prevents the accumulation of neutrophils;
Reduces the production of inflammatory exudate;
Reduces the processes of granulation and infiltration;
Reduces the formation of hematoxin, a substance involved in triggering “late” allergic reactions;
Prevents the development of the “immediate” type of allergy.

When conducting studies with the application of antigens to the walls of the nasal cavity and the subsequent use of Nasonex, it was found that the spray has a high anti-inflammatory effect in both the early and late stages of allergies.

This was confirmed by a decrease in the number of eosinophils and histamine levels, a decrease in the number of neutrophils and eosinophils. Comparisons were made using placebo.

Pharmacokinetics

Mometasone furoate is a substance characterized by the lowest bioavailability, it is only ≤0.1%. When Nasonex is prescribed for intranasal inhalation, mometasone is practically not detected in the blood. Therefore, there is no reliable pharmacokinetic data when using the spray.

The suspension that forms the basis of Nasonex, which enters the digestive organs during inhalation, undergoes active breakdown and is completely excreted along with bile or urine.

Rules for using the drug

Nasonex spray is used intranasally, that is, the medicine is sprayed inside the nasal passages.

Dosage.

A single dose of the drug, that is, the number of simultaneous injections, is selected depending on the disease and is also determined taking into account the age of the patient.

Therefore, you cannot select the number of Nasonex injections without consulting your doctor.

Overdose.

An overdose of Nasonex, requiring a doctor’s assessment, is possible only in two cases:

If the glucocorticosteroid was used in too high doses.
With simultaneous treatment with several types of GCS.

Since the bioavailability of mometasone furoate when used topically is one of the lowest, in case of overdose only minor adrenal dysfunction is possible.

General rules for using Nasonex

The effectiveness of treating allergies with Nasonex depends on how correctly this drug is used.

Before using the spray for the first time, you should perform several steps in stages:

After unpacking the package, shake the bottle vigorously and perform “calibration”. To do this, press the dispenser 10 times; it is necessary that splashes appear from the sprayer with the last presses. “Calibration” allows you to adjust the power of the sprayed stream of medicine.
The drug prepared in accordance with all requirements is ready for use. Before inhalation, you need to slightly tilt your head back and inject the spray into each nasal passage as many times as prescribed by the allergist or ENT doctor.
The spray bottle is shaken well before each inhalation. This is necessary so that the suspension contained inside becomes completely homogeneous.
If Nasonex has not been used for 14 days or more, then it is necessary to “calibrate” it again in accordance with point No. 1.

When using Nasonex, one should not forget about observing the storage conditions of the medicine and its expiration date.

Cleaning the Metering Sprayer

The hole in the dosing nozzle must be cleaned periodically, as it becomes clogged with suspension residues and dust.

Cleaning is done as follows:

It is necessary to carefully remove the sprayer from the bottle;
Then you should wash it in warm, possibly soapy water, and rinse with plenty of water under the tap;
The protective cap should also be washed;
After washing, the removed parts are thoroughly dried and re-attached to the bottle;
After cleaning, you need to calibrate again; just press the sprayer 2 times.

When cleaning the nozzle opening, it is strictly forbidden to use needles or other sharp objects. This will cause the diameter of the hole to increase and the amount of medicine sprayed at a time will change, which will affect the quality of treatment.

And do not forget to put a protective cap on the bottle after each use of Nasonex.

Treatment with Nasonex

Allergic rhinitis in adults and children.

Nasonex is used both for the treatment and prevention of seasonal or year-round allergic rhinitis. In both cases, the single dose is 2 injections into each nostril, which amounts to 100 mg in each nasal passage.

The drug is used once a day; if the therapeutic effect is achieved, it is recommended to reduce the previous dose to one inhalation in each nostril.

If the dosage of Nasonex suggested above is not effective in eliminating the symptoms of rhinitis, the amount of injection is increased.

Usually this is 4 inhalations once a day in each nasal passage. After the main manifestations of the disease have been eliminated, the dose of Nasonex is gradually reduced.

If there is a need to treat children from 2 to 12 years old, the therapeutic dose should be only one injection per day into each nostril.

Spraying the spray intranasally for children is carried out only with the participation of an adult.

Treatment of nasal polyposis.

When identifying polyps in the nose, Nasonex can be used from 18 years of age.

Patients with polyposis are prescribed 2 sprays of Nasonex in each nasal passage, inhalation is carried out twice a day. After the signs of polynosis decrease, the dose of Nasonex is reduced to one inhalation per day, during which two sprays are given in each nasal passage.

Treatment of acute rhinosinusitis.

Nasonex for the treatment of acute rhinosinusitis is prescribed to adolescents from 12 years of age and to adult patients, including those who have reached old age.

You just need to remember that GCS is not used if rhinosinusitis is of a bacterial nature.

Adjuvant therapy for acute sinusitis or relapse of chronic sinusitis.

Nasonex treatment of acute or chronic sinusitis is possible in patients over 12 years of age.

The therapeutic dose for these pathologies is two inhalations into each nostril, the spray is used twice a day.

If the symptoms of sinusitis do not decrease within several days, then the dose of Nasonex is increased to 4 sprays in each nostril, and the frequency of use of the drug per day is not changed, that is, the medicine should be sprayed in the morning and evening. Once the symptoms of sinusitis are reduced, the dose is gradually reduced.

Side effects

When Nasonex is used correctly in the dose prescribed by the doctor, adverse reactions develop extremely rarely.

In adults and adolescents, starting from 12 years of age, the following may appear:

Pain in the head;
Nosebleeds and bloody nasal discharge. Bleeding usually resolved spontaneously;
Symptoms of pharyngitis;
Burning sensation in the nasal cavity, ulceration of the mucous wall.

When Nasonex is used to eliminate pathologies in children under 12 years of age, headaches and nosebleeds may develop. There may also be periodic sneezing and irritation of the nasal mucosa.

In very rare cases, shortness of breath, bronchospasm, impaired sense of smell and taste, and anaphylaxis have occurred when using Nasonex.

Intranasal use of GCS can cause an increase in intraocular pressure and perforation of the nasal septum.

Drug interactions

Only a study was conducted on the combined use of Nasonex and an antihistamine -.

The use of these two drugs was well tolerated by patients, from which we can conclude that the use of others based on Loratadine is also possible.

Use of Nasonex during pregnancy and lactating women

The manufacturer of Nasonex has not conducted specific studies on the safety and use of this medication by pregnant women.

Since mometasone furoate is practically not absorbed into the blood plasma, it can be assumed that it does not have a toxic effect on the developing fetus.

But, nevertheless, Nasonex is prescribed to pregnant women and nursing mothers only if there are no other effective means and methods for treating the identified pathology or they do not work.

If a woman received glucocorticosteroids during pregnancy, it is recommended that the born children be examined to determine the function of the adrenal glands.

In case of liver dysfunction

When Nasonex spray is used intranasally, a small amount may enter the stomach.

The components of the drug are quickly biotransformed when passing through the liver and therefore do not settle in the tissues of the organ.

That is, Nasonex is not contraindicated for use in patients with impaired liver function.

Use in pediatrics

The drug is not prohibited for use starting from the age of two. Until this age, the nasal mucosa is still developing and therefore has increased sensitivity, which increases the likelihood of developing adverse reactions.

When treating children, it is extremely important to follow the dosage prescribed by the doctor. Clinical trials have not shown that Nasonex causes growth retardation.

Storage conditions and periods

The shelf life of Nasonex is three years, starting from the date of release of the drug.

The spray should be stored in places where the temperature ranges from two to 20 degrees Celsius. It is strictly forbidden to freeze the medicine.

special instructions

When using Nasonex for several months, it is necessary to periodically visit an ENT doctor to identify possible changes in the nasal mucosa.

If it is determined that a fungal infection is developing, then Nasonex is either discontinued or antifungal therapy is administered.

If irritation inside the nasal cavity persists for a long time, it is necessary to discontinue Nasonex and use other means.

When prescribing Nasonex, special attention is required for those patients who have been using systemic glucocorticosteroids for a long time before prescribing this medication.

Their withdrawal often leads to muscle and joint pain, severe fatigue and depression. Many people mistakenly associate these symptoms with Nasonex; they need to be convinced that in a few weeks everything will return to normal, and the first positive aspects of using local GCS will appear.

The use of glucocorticosteroids leads to a decrease in immune reactivity, which increases the risk of contracting infections.

Patients receiving Nasonex should avoid contact with influenza patients, those with measles or chickenpox.

Nasonex is a local drug containing the active substance mometasone, which belongs to the group of potent synthetic glucocorticosteroids and is therefore an anti-inflammatory, vasoconstrictor, antiallergic and antipruritic agent. In this regard, it provides effective treatment of allergic and inflammatory processes of the nasopharynx, nasal cavity and complex treatment of protracted inflammatory processes in the paranasal sinuses, and is also used in the treatment of nasal polyps.

Pharmacological properties of Nasonex and mechanism of action

Nasonex has a rapid, pronounced and fairly long-lasting anti-inflammatory and anti-allergic effect on the mucous membrane of the nasal cavity, as well as a vasoconstrictor (vasoconstrictor) effect on the vessels of the mucous membranes of the nasal cavity and paranasal sinuses and in this regard, also reducing swelling and inflammation in the nasal cavity and paranasal sinuses.

Its anti-inflammatory effect is based on the impact and inhibition of mediators of allergic reactions and inflammation, and as a result, swelling and hyperemia of the mucous membranes decreases.

The mechanism of action of Nasonex is associated with inhibition of cytokine synthesis and indication of the release of proteins - lipocortins, which are inhibitors of phospholipase A2 and control the synthesis of leukotrienes and prostaglandins - potent inflammatory mediators, by inhibiting the release of arachidonic acid, which is their common precursor. Mometasone furoate is ten times more active than other steroid drugs, including dexamethasone, betamethasone, hydrocortisone and beclomethasone dipropionate, in inhibiting the synthesis and release of IL-6, IL-1 and is six times more active than beclomethasone and beclomethasone dipropionate. regarding inhibition of IL-5 production.

Clinical studies of Nasonex

In accordance with clinical studies of the intranasal spray Nasonex with the application of antigens to the mucous membrane of the nasal cavity and provocative tests, the high activity of this medicinal product at any stage of the allergic process. This is confirmed by a decrease in the number of eosinophils compared to their baseline level and a decrease in their activity, a decrease in epithelial cell adhesion proteins and the number of neutrophils, as well as a decrease in histamine levels compared to placebo

The clinical effect of the drug occurs within 12 hours after using the intranasal spray in 28% of patients suffering from seasonal allergic rhinitis, and in 50% of patients improvement occurred within 35.9 hours. Nasonex also shows high activity in reducing eye symptoms in patients and eliminates lacrimation, redness of the conjunctiva and itching.

In clinical studies of the effectiveness of Nasonex in patients with nasal polyps, significant effectiveness of this drug was noted in relieving nasal congestion, restoring the sense of smell and reducing the size of polyps.

Clinical studies have also been conducted to compare the effectiveness of Nasonex, amoxicillin and placebo in groups of patients > 12 years of age for the treatment of rhinosinusitis for 15 days. The results were assessed using the Major Symptom Score for the following main symptoms: a feeling of squeezing in the paranasal sinuses, pain when pressing on the projections of the paranasal sinuses, pain in the face, rhinorrhea and mucus drainage. back wall throats. Nasonex was used at a dose of 200 mg twice a day, and amoxicillin was prescribed at a dose of 500 mg three times a day. According to these studies, the effectiveness of amoxicillin was practically no different from placebo in terms of symptomatic relief on the MSS scale, due to its pronounced antibacterial and minimal anti-inflammatory effect. And the use of Nasonex has shown the high effectiveness of this drug in eliminating the main symptoms of rhinosinusitis. And upon further observation of patients in this group, it was noted that relapses of rhinosinusitis after the use of Nasonex were observed significantly less frequently than after treatment with amoxicillin and in the placebo group.

Indications for use of the drug

Indications for the use of Nasonex are: treatment of year-round and seasonal allergic rhinitis, treatment for the prevention of exacerbations of seasonal rhinitis in its moderate and severe stages with frequent relapses, symptomatic treatment of rhinosinusitis without signs of bacterial infection in children over 12 years of age and in adults, treatment of nasal polyps in patients over 18 years of age. And also as an adjuvant in the treatment of acute sinusitis, aggravated by a bacterial infection in combination with antibacterial drugs in children over 12 years of age and in adults.

Use of Nasonex

Nasonex is available in the form of a nasal spray of 18 ml in a bottle containing 50 mcg of the active substance mometasone furoate per dose of the drug. The bottle contains 140 doses of the drug.

Before you start using the Nasonex bottle, you need to calibrate it, which is done by ten clicks on the bottle's dispensing device and at the same time a stereotypical supply of the drug substance is established and one dose of the drug is released, which corresponds to 100 mg of suspension and contains 50 mcg of mometasone. When using the intranasal spray for more than fourteen days, it is necessary to repeat the calibration of the bottle.

Before each use of the drug, shake the bottle of medication.

If the nozzle becomes clogged, you need to remove the plastic cap, avoiding pressing on the white ring, remove the nozzle from the bottle and rinse it warm water, then dry and install in its original place. Do not clean the nozzle with sharp objects, because this action will damage the dispenser.

Regular cleaning of the nozzle is also very important.

And before each use of the drug, it is necessary to clear the mucus from the nose.

Use of Nasonex for the treatment of year-round or seasonal rhinitis

The recommended therapeutic and prophylactic dose of the drug for children over 12 years of age, adolescents and adult patients is two doses (injections) of 50 mcg once a day in each nostril, with a total daily dose of no more than 200 mcg. After the onset of the therapeutic effect, it is recommended to reduce the dose to 100 mcg per day - one dose (injection) into each nostril once a day.

If a therapeutic effect is not achieved when using an average therapeutic dose of Nasonex, the daily dose of the drug can be increased to a maximum of 400 mcg per day. This amounts to four injections into each nostril once, followed by a gradual reduction in the dose after the severity of the symptoms of seasonal rhinitis decreases.

IN pediatric practice The use of the drug is possible only for children over 2 years of age and the recommended therapeutic dose is 100 mcg - one dose (injection) into each nostril once a day.

Use of Nasonex for the treatment of acute sinusitis

When treating patients with acute episodes of sinusitis, Nasonex is used as an adjuvant to reduce the severity of the main symptoms of the disease. It is used in children over 12 years of age, in adults, as well as in elderly patients and the recommended therapeutic dose is two doses (injections) into each nostril twice a day, which makes a total daily dose of 200 mcg. In the absence of a decrease in the severity of symptoms and relief of the patient's well-being, the therapeutic dose of the drug can be increased to four doses (injections) twice a day in each nostril and the total daily dose will be 400 mcg, followed by a dose reduction as the severity of symptoms of rhinosinusitis decreases.

Use of Nasonex in the treatment of acute rhinosinusitis

Nasonex for the treatment of acute rhinosinusitis, aggravated by a bacterial infection, is used as an adjuvant in combination with antibacterial drugs in children over 12 years of age and adults and consists of two doses (injections) of fifty mcg each twice a day in each nostril with a total daily dose dose - 400 mcg.

Nasonex is a medical drug, available in the form of drops and spray. The main purpose is to combat allergic reactions of varying severity, rhinitis, polyps, adenoids. Nasonex can be used by adults and children, but in different dosages. The drug is based on the potent substance mometasone furoate.

The drug is guaranteed to have a beneficial effect, helping to alleviate the condition of a person with a runny nose caused by allergies and other diseases.

Composition of the drug

Nasonex spray contains (per 1 g of product):

Mometasone furoate 0.5 mg (main active ingredient);
Dispersed cellulose;
Citric acid monohydrate;
Glycerol;
Sodium dihydrate;
Phenylethanol;
Benzalkonium chloride;
Polysorbate;
Water.

The appearance of the spray is a transparent, whitish suspension.

About the active substance

Mometasone furoate is of synthetic origin. The substance is a potent glucocorticosteroid. After entering the nasal cavity, the substance is absorbed through the walls of blood vessels, processed by the body and decomposed into mometasone. It is mometasone that has anti-inflammatory and anti-allergenic effects.

Possible side effects

After using Nasonex or analogues containing mometasone, there is a risk of developing side effects:

Burning sensation, itching in the nose.

In rare cases, allergic contact dermatitis develops.

Indications for use of Nasonex

According to the instructions for Nasonex, it is recommended to use the product for:

Rhinitis in seasonal or chronic form(can be used by adults and children over 2 years old);
Sinusitis in the chronic and acute stages (used from 12 years of age in children, therapy includes treatment with antibiotics);
Prevention of seasonal rhinitis in moderate and severe forms (can be used by adults and children over 12 years of age);
Polyps, adenoids that interfere with normal breathing (can be used by people over 18 years of age).

Contraindications

Absolute contraindications to the use of Nasonex:

Intolerance to the active substances in the drug;
Infectious diseases of the nasal mucosa, open wounds;
Postoperative period, nasal injuries until the skin is completely healed;
Age restrictions: up to 2 years for allergies, up to 12 years for sinusitis, up to 18 years for the formation of polyps.

Relative contraindications:

Tuberculosis;
Infectious diseases;
Herpes;
Fungus.

At relative contraindications The spray can only be used under the supervision of a doctor.

Instructions for use, dosage

Instructions for use of Nasonex vary depending on the goals of therapy, disease, age and physical condition of the person.

For adults

The absorption of the active substance of the drug is no more than 0.1% of the amount of the applied product. For this reason, Nasonex is widely used for various diseases and even as a remedy for snoring.

For allergies:

Adults and adolescents over 12 years old 1 time per day (maximum 2 times);
The permissible dose is 400 mcg, one-time 200 mcg;
12 hours after inhalation, all symptoms disappear completely.

Subsequently, when the symptoms of allergic rhinitis decrease, Nasonex is used in a dosage half as much as in the first inhalation - 100 mcg for a single application.

For chronic runny nose in acute form:

Used against the background of anti-cold and antibacterial drugs;
Inhalations are done twice a day;
The maximum dose is 800 mcg per day, with subsequent treatment the dosage is gradually reduced.

Along with lowering the dosage, the number of Nasonex doses per day also decreases.

For polyps:

When polyps appear, the drug is prescribed to be taken twice a day;
Inhalation dose 200 mcg;
After relief occurs, the number of applications is reduced to 1 time per day;
Stopping inhalations is recommended after complete elimination of polyps.

For children

Synthetic mometasone
Nasonex contains a hormone. The substance has minimal effect on the adult body and is practically not traced in the blood even after complete absorption. Children can use the drug continuously for a long time, but only in accordance with the instructions. Neither reviews of Nasonex nor clinical studies have confirmed the effect of the spray on the physical condition of children, development, and growth.

The drug does not have an effect immediately, but only after the breakdown of the synthetic hormone. Within 12 hours after inhalation, no effect may be observed, but after that it will occur. Children should not re-apply the product.

For babies

The spray has not been tested on infants. For this reason, Nasonex is not prescribed in pediatrics to children under 2 years of age. It is also not recommended to use the drug on your own on infants, because active substances can cause serious harm to the body of babies.

As with infants, clinical trials have not been conducted in pregnant women. However, the manufacturer claims that the amount of active substance entering the body is minimal, so use during pregnancy is acceptable.

If the drug is used, monitoring of the hormonal state of the mother’s body is necessary. Side effects are possible in the form of increased activity of the adrenal glands, which will negatively affect the development of the fetus.

You should also use the spray with caution when breastfeeding. There are no studies proving or disproving that mometasone passes into breast milk. If possible, it is better not to use Nasonex during pregnancy and breastfeeding.

Sprayer care

The drug is produced by a Belgian company in plastic bottles with a dispenser. The dispenser functions as a nebulizer and allows you to apply the recommended amount of suspension to the mucous membrane of the nasal sinuses. The product is packaged under pressure; when pressed, the dispenser sprays it.

The spray can only be used in combination with a spray dispenser. The use of Nasonex as nasal drops is strictly not recommended due to the risk of side effects and overdose.

Caring for the spray dispenser
is an important stage of therapy. Before each use, shake the bottle of suspension to mix it. Each press of the dispenser releases 100 mcg of product, half of which is active substance mometasone. For effective treatment Without side effects, you need to care for the removable dispenser:

Make a few test presses in the air to adjust the sprayer;
If the drug has not been used for more than 2 weeks, test presses should be repeated;
After use, remove the nozzle and rinse in running water under the tap and dry;
Close the cap with the cap each time to prevent dust from getting inside the bottle;
Under no circumstances should you clean the dispenser spout with sharp or cutting objects; this will cause the hole to widen and the dosage to increase.

At proper care and the use of Nasonex will not cause harm to the body.

Nasonex for snoring

According to most studies, snoring most often occurs in people with chronic rhinitis. Over time, a relationship has emerged between the use of the spray and improved quality of sleep and breathing at night. Nasonex for snoring is used quite widely, but the manufacturer did not intend such an effect from the drug.

According to reviews of Nasonex for snoring, one can judge the effective result of the drug with regular prophylactic use. Also, in 2004, a large-scale study was conducted that revealed a stable decrease in snoring in subjects who used the drug against the background of rhinitis, apnea, and allergies. The recommended dose to eliminate snoring is 200 mcg per day, you need to irrigate the nasopharynx once.

Another important aspect is eliminating snoring in children with Nasonex. The product can be used starting from 2 years of age.

Over time, the drug began to be prescribed by doctors to patients with complaints of nighttime snoring. Now Nasonex is one of the most common remedies in the fight against snoring.

The medicine can be used by people with snoring without complications. In some cases, snoring is caused by lung diseases, of cardio-vascular system etc. However, snoring is a symptom, not a problem. Before use, you should consult your doctor.

To prevent snoring, Nasonex can be used for a long period (up to 1 year) in a small dosage.

Interaction with other drugs

IN official instructions For Nasonex, there are no instructions from the manufacturer regarding the negative effects of the drug with other substances. The spray is used together with antibiotics, antihistamines and others medicines without the risk of side effects.

The only thing is
noted in the instructions - improvement of the effect of the anti-allergy drug Loratadine against the background of irrigation of the nasopharynx with a spray. For this reason, the spray is especially recommended for the formation of allergic rhinitis, if treatment is carried out with the use of Loratodine.

About overdoses

It has already been said above that the drug must be used in accordance with thoughtful dosages and medical prescriptions. Overdoses occur due to prolonged use of the spray in quantities exceeding the norm. Increased intake of mometasone causes suppression of the adrenal system.

A one-time overdose does not lead to tangible consequences. If a person taking the drug is not sure about the duration of taking increased doses, it is recommended to undergo a medical examination.

Precautionary measures

Despite the minimal number of side effects, measuring doses with a nebulizer in advance, precautions must be taken when using the nasal spray for a long time:

Treatment is more than 2-3 months. It is necessary to examine the nasopharynx for the occurrence of pathologies, changes in the condition of the mucous membrane, and the development of fungal formations. If any changes are confirmed, stop spray irrigation or use additional medications.
More than 1 month. Regular monitoring by a therapist or pediatrician. Periodic visits to the doctor are especially important for children and adolescents under 18 years of age, pregnant and lactating women.
After discontinuation of Nasonex. It is recommended to test adrenal function and prescribe treatment if pathologies are detected. In rare cases, patients experience depressive states, feeling tired, drowsy after stopping use of the spray. Any change in condition becomes a signal to see a doctor as soon as possible.
Replacing the drug. When changing the nasal spray, some people experience the development of allergic eczema, conjunctivitis, and dermatitis. Previously, such diseases were suppressed due to the antihistamine effect of Nasonex.
Before canceling the spray. The immune system of patients is in an elevated state due to regular use of the medicine. A few weeks before the planned withdrawal of the spray, it is recommended to take a vitamin course in order to strengthen the immune system. Otherwise, the risk of developing infectious and/or colds increases.

The above circumstances occur in rare cases, but they are recommended to be followed as precautions.

Storage conditions

Stored for 3 years;
Recommended storage temperature is from +2 to +25 degrees;
Keep out of contact sun rays, moisture.

Open bottle:

Apply within 1 year;
Store in a dark place, out of reach of children, sun, and humidity;
Clean the dispenser regularly.

It is also necessary to regularly recheck the functionality of the spray button.

Cost in pharmacies

The price for Nasonex in pharmacies depends on the volume of the bottle. Average cost:

10 ml – 390 rub;
15 ml – 450 rub;
40 ml – 760 rub.

Nasonex's analogs

Based on mometasone
other drugs have been developed similar action. The lists contain sprays that are analogues of Nasonex.

Cheap analogues:

Rinoklenil – 370 rub. (200 doses). The analogue is used according to a scheme similar to Nasonex. Improves performance immune system, stops the development of rhinitis against the background of allergies.
Nazarel – 400 rub. (200 doses). Reduces the feeling of itching in the nose, quickly eliminates nasal congestion. Cannot be used by small children.
Flixonase – 780 rub. (120 doses). Most cheap analogue, has an additional effect. Eliminates lacrimation and swelling of the nasopharynx. Can be used without antihistamines for allergies.
Avamis – 725 rub. (120 doses). The closest analogue in composition and action. Cannot be used as a prophylactic agent.
Polydex – 295 rub. (200 doses). Combined analogue, used for wide range diseases. There are serious contraindications. Not for use by teenagers under 15 years of age.
Nasobek – 180 rub. (200 doses). Increases human immunity. Improves mucus production, making it easier to clear the sinuses. It is strictly prohibited for pregnant women up to the 12th week.
Tafen nasal - 420 rubles. (200 doses). You can feel the effect of the analogue only 2-3 days after taking it. Eliminates inflammation, reduces allergic reactions.

Suitable for children:

Avamis from 2 years;
Nazarel, Flixonase from 4 years.

Only a doctor can select a replacement drug. Analogues do not fully correspond to the composition of Nasonex and may cause unexpected side effects.

Even after a medical prescription of one of the analogues, Nasonex and generics cannot be combined with each other. You should also not use medications containing glucocorticoids.

GCS for local use.
Drug: NASONEX®
Active substance of the drug: mometasone
ATX coding: R01AD09
KFG: GCS for intranasal use
Registration number: P No. 014744/01-2003
Registration date: 02/11/03
Owner reg. cert.: SCHERING-PLOUGH LABO N.V. (Belgium)

Nasonex release form, drug packaging and composition.

Nasal spray in the form of a white or almost white suspension.

1 dose
mometasone furoate (as monohydrate)
50 mcg

Excipients: dispersed cellulose BP 65 cps, glycerol, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, purified water.

120 doses (18 g) - plastic bottles (1) complete with a sprayer and protective cap - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Nasonex

GCS for local use. Has anti-inflammatory and anti-allergic effects. The local anti-inflammatory effect of the drug is manifested when it is used in doses at which systemic effects do not occur.

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 arachidonic acid metabolic products - cyclic endoperoxides, prostaglandins. Prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, and leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on late allergy reactions), inhibits the development of an immediate allergic reaction (by inhibiting the formation of arachidonic acid metabolites and reducing the release of inflammatory mediators from mast cells).

In studies with provocative tests with the application of antigens to the nasal mucosa, high anti-inflammatory activity of the drug was demonstrated, both in early and late stages. late stages allergic reaction. When compared with placebo, a decrease in the level of histamine and eosinophil activity was found, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.

Pharmacokinetics of the drug.

When administered intranasally, the systemic bioavailability of the drug is less than 0.1%. At the same time, mometasone furoate is practically not detected in blood plasma, even when using highly sensitive detection methods (with a sensitivity threshold of 50 pg/ml). A small amount of the active substance, which can enter the gastrointestinal tract during intranasal use, is absorbed to a small extent and is actively biotransformed during the “first pass” through the liver.

Indications for use:

Treatment of seasonal and year-round allergic rhinitis in adults, adolescents and children over 2 years of age;

Exacerbation of chronic sinusitis in adults (including the elderly) and children over 12 years of age (as an adjuvant as part of complex antibacterial therapy);

Prevention of moderate to severe seasonal allergic rhinitis (recommended 2-4 weeks before the start of the dusting season).

Dosage and method of administration of the drug.

For the treatment of seasonal and year-round rhinitis, adults (including elderly people) and children over 12 years of age are prescribed 2 injections into each nostril 1 time per day (total daily dose - 200 mcg). After achieving what you want clinical effect the dose of the drug for maintenance therapy is 100 mcg (1 injection into each nostril 1 time/day). If necessary, the dose of the drug can be increased to 4 injections into each nostril (total daily dose - 400 mcg). Children aged 2-11 years are prescribed 50 mcg (1 injection) into each nostril 1 time / day (total daily dose - 100 mcg).

Positive dynamics clinical symptoms observed, as a rule, within the first 12 hours after the first use of the drug.

For the treatment of exacerbations of chronic sinusitis in the composition complex therapy with antibiotics, adults (including elderly people) and children over 12 years of age are prescribed 100 mcg (2 injections) into each nostril 2 times a day. The total daily dose is 400 mcg. If necessary, an increase is possible daily dose up to 800 mcg (4 injections into each nostril 2 times a day). After the symptoms of the disease decrease, a dose reduction is recommended.

Stereotypical drug delivery (in which each button press releases 100 mg of suspension, corresponding to 50 mcg of pure mometasone furoate) is established after approximately 6-7 “calibration” presses. If the drug has not been used for 14 days or longer, then recalibration is necessary before use.

The bottle must be shaken vigorously before use.

Side effects of Nasonex:

Side effects observed in the treatment of seasonal and year-round allergic rhinitis: in adults - nosebleeds (i.e. obvious bleeding, as well as discharge of blood-stained mucus or blood clots), pharyngitis, burning sensation in the nose; irritation of the nasal mucosa. Nosebleeds, as a rule, stopped on their own and were not severe; they occurred with a frequency slightly higher than with placebo (5%), but equal to or less than with the administration of other intranasal corticosteroids studied, which were used as active controls (in some of them the frequency of nosebleeds was up to 15%) . The incidence of other side effects was comparable to that observed with placebo). In children - nosebleeds, headache, irritation in the nose, sneezing (the incidence is comparable to the incidence of side effects in children when using placebo).

Very rarely, with intranasal use of GCS, cases of perforation of the nasal septum or increased intraocular pressure have been reported.

Contraindications to the drug:

Children under 2 years of age;

Untreated infection involving the nasal mucosa;

Recent surgery or trauma to the nose (before the wound healed);

Respiratory tuberculosis (including latent), untreated fungal, bacterial, systemic viral infection(including those caused by the Herpes simplex virus with eye damage);

Hypersensitivity to the drug.

Use during pregnancy and lactation.

There have been no special, well-controlled studies of the safety of Nasonex during pregnancy and lactation. After intranasal use of the drug at the maximum therapeutic dose, mometasone is not detected in the blood plasma even at the minimum concentration; therefore, fetal exposure to the drug can be expected to be negligible and the potential for reproductive toxicity to be very low.

However, during pregnancy and lactation, as well as in women of childbearing age, Nasonex should be prescribed if the expected benefit from its use justifies the potential risk to the fetus and newborn. Newborns whose mothers used corticosteroids during pregnancy should be carefully examined to identify possible adrenal hypofunction.

Special instructions for the use of Nasonex.

After using Nasonex for 12 months, there were no signs of atrophy of the nasal mucosa. A study of biopsy samples of the nasal mucosa revealed that mometasone furoate tended to normalize the histological picture.

When using the drug for a long time (as with any long-term treatment), periodic examination of the nasal mucosa by an ENT doctor is necessary. If a local bacterial or fungal infection of the nose or pharynx develops, it is recommended to stop treatment with the drug and begin specific therapy. Irritation of the mucous membrane of the nasal cavity and pharynx that persists for a long time is an indication for discontinuation of the drug.

With long-term use of the drug, no signs of suppression of the function of the hypothalamic-pituitary-adrenal system were observed.

Patients who switch to treatment with Nasonex nasal spray after long-term therapy with systemic GCS require special attention. Discontinuation of systemic GCS in such patients may lead to adrenal insufficiency, which may require appropriate measures.

During the transition from treatment with systemic corticosteroids to treatment with Nasonex nasal spray, some patients may experience withdrawal symptoms from systemic corticosteroids (for example, joint and/or muscle pain, fatigue, depression), despite a decrease in the severity of symptoms associated with damage to the nasal mucosa; such patients must be specifically convinced of the advisability of continuing treatment with Nasonex nasal spray. Changing therapy may also reveal previously developed allergic diseases, such as allergic conjunctivitis and eczema, that were previously masked by systemic glucocorticoid therapy.

Patients who have undergone GCS therapy have a reduced immune reactivity and should be warned about the increased risk of infection when in contact with patients with infectious diseases (including chickenpox, measles).

Use in pediatrics

In placebo-controlled clinical trials in children, when Nasonex was used at a dose of 100 mcg/day for a year, no growth retardation was observed.

There are no data on the use of the drug in children under 2 years of age, so Nasonex cannot be recommended for use in this age group.

Drug overdose:

The drug has low (0.1%) systemic bioavailability, so it is unlikely that in case of overdose, any special measures will be required other than observation and subsequent administration at the recommended dose.

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

Interaction of Nasonex with other drugs.

The simultaneous use of Nasonex with loratadine did not lead to a change in the concentration of loratadine or its main metabolite in the blood plasma, and the presence of mometasone furoate in the plasma was not detected even at minimal concentrations.

Research drug interactions Nasonex has not been tested with other drugs.

Terms of sale in pharmacies.

The drug is available with a prescription.

Terms of storage conditions for the drug Nasonex.

The drug should be stored out of the reach of children at a temperature of 2° to 25°C. Shelf life: 3 years. Do not use after the expiration date stated on the package.