Nasonex - instructions for use, analogs, reviews and release forms (spray or nasal drops) of a drug for the treatment of rhinitis, sinusitis, adenoids and polyps in adults, children and pregnancy
In this article you can read the instructions for use of the drug Nasonex.
Table of contents:
- Nasonex - instructions for use, analogs, reviews and release forms (spray or nasal drops) of a drug for the treatment of rhinitis, sinusitis, adenoids and polyps in adults, children and pregnancy
- Nasonex - official instructions for use
- Hormonal drops Nasonex against the runny nose and features of their use
- Hormonal agents in the treatment of runny nose and sinusitis
- Nasonex, its composition and mechanism of action
- Use of Nasonex for allergic rhinitis and sinusitis
- Use of Nasonex for chronic runny nose and sinusitis
- Contraindications and possible side effects of Nasonex
- NAZONEX
Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Nasonex in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Nasonex in the presence of existing structural analogues. Use for the treatment of rhinitis, sinusitis, adenoids and polyps in adults, children, as well as during pregnancy and lactation.
Nasonex is a glucocorticosteroid for topical 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 the early and late stages of the 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.
When administered intranasally, the systemic bioavailability of the drug is less than 0.1%. At the same time, mometasone furoate (the active substance of the drug Nasonex) is practically not detected in the blood plasma. 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.
- 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 and severe seasonal allergic rhinitis (recommended 2-4 weeks before the start of the dusting season).
Dosed nasal spray (sometimes mistakenly called nasal drops).
Instructions for use and method of use
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 once a day (total daily dose). After achieving the desired clinical effect, the dose of the drug for maintenance therapy is 100 mcg (1 injection into each nostril once a day). If necessary, the dose of the drug can be increased to 4 injections into each nostril (total daily dose kg). Children aged 2-11 years are prescribed 50 mcg (1 injection) into each nostril once a day (total daily dose).
Positive dynamics of clinical symptoms are observed, as a rule, within the first 12 hours after the first use of the drug.
For the treatment of exacerbations of chronic sinusitis as part of 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. Total daily dosage kg. If necessary, the daily dose can be increased 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.
- nosebleeds (i.e., obvious bleeding, as well as blood-stained mucus or blood clots);
- pharyngitis;
- burning sensation in the nose;
- irritation of the nasal mucosa;
- headache;
- perforation of the nasal septum;
- increased intraocular pressure.
- children under 2 years of age;
- untreated infection involving the nasal mucosa;
- recent surgery or trauma to the nose (before the wound heals);
- respiratory tuberculosis (including latent), untreated fungal, bacterial, systemic viral infection (including caused by the Herpes simplex virus with eye damage);
- hypersensitivity to the drug.
Use during pregnancy and breastfeeding
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.
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 per 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.
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.
Drug interaction studies of Nasonex with other drugs have not been conducted.
Analogues of the drug Nasonex
Structural analogues of the active substance:
Nasonex - official instructions for use
The trade (patented) name of the drug is NAZONEX ®
Dosage form: dosed nasal spray.
1g spray contains:
Active substance: mometasone furoate (micronized, in the form of monohydrate) equivalent to mometasone furoate anhydrous - 0.5 mg.
Excipients: dispersed cellulose (microcrystalline cellulose treated with carmellose sodium), glycerol, citric acid monohydrate, sodium chytrate dihydrate, polysorbate 80, benzalkonium chloride (in the form of a 50% solution), phenylethanol, purified water.
The suspension is white or almost white.
Glucocorticosteroid for local use.
Mometasone is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and antiallergic effects when 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 (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 mucous membrane of the nasal cavity, high anti-inflammatory activity of mometasone was demonstrated in both 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.
Mometasone has negligible bioavailability (≤0.1%), and when administered by inhalation, it is practically undetectable in blood plasma, even when using a sensitive detection method with a detection threshold of 50 pg/ml. In this regard, there are no relevant pharmacokinetic data for this dosage form; (Mometasone suspension is very poorly absorbed from the gastrointestinal tract. The small amount of mometasone suspension that can enter the gastrointestinal tract after nasal inhalation even before excretion in urine or bile undergoes active primary metabolism.
NASONEX ® 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 may be prescribed for these infections as directed by a doctor).
After intranasal use of the drug at a therapeutic dose of 400 mcg per day, mometasone is not detected in the blood plasma even at minimal concentrations, therefore, it can be expected that the effect of the drug on the fetus will be negligible, and the potential toxicity with respect to reproductive function is very low.
However, due to the fact that special, well-controlled studies of the drug's effect in pregnant women have not been conducted, NASONEX ® should be prescribed to pregnant women or breastfeeding women only if the expected benefit from the drug's administration justifies the potential risk to the fetus or infant.
Infants whose mothers received corticosteroids during pregnancy should be carefully monitored for possible adrenal hypofunction.
Intranasally. 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 dosing device 6-7 times. After “calibration,” a stereotypical delivery of the drug is established, in which with each press of the dosing device, approximately 100 mg of a suspension containing mometasone furoate (in the form of 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 using it again.
Before each use, shake the spray bottle vigorously.
Adults (including older people) and adolescents over 12 years of age:
The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) into each nostril 1 time per day (total daily dose mkg). 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 kg).
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.
The recommended therapeutic dose is 1 inhalation (50 mcg) into each nostril 1 time per day (total daily dose kg).
To use the drug in young children, adult assistance is required. Adjuvant treatment of acute sinusitis or exacerbation of chronic sinusitis
Adults (including older people) and adolescents over 12 years of age:
The recommended therapeutic dose is 2 inhalations (50 mcg each) into each nostril 2 times a day (total daily dose 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 2 times a day (total daily dose -800 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.
Adults (including older people) 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 mcg).
After the symptoms of the disease have reduced, it is recommended to reduce the dose to 2 inhalations (50 mcg each) into each nostril 1 time per day (total daily dose kg).
In adults and adolescents: headache, nosebleeds (i.e., obvious bleeding, as well as the discharge of blood-stained mucus or blood clots), pharyngitis, burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa. Nosebleeds, as a rule, were moderate and stopped on their own, the frequency of their occurrence was slightly higher than with placebo (5%), but equal to or less than with the appointment of other nasal corticosteroids, which were used as an active control (in some of The incidence of nosebleeds remained up to 15%.The incidence of all other adverse events was comparable to the incidence of placebo.
In children: nosebleeds, headache, irritation in the nose, sneezing. The incidence of these adverse events in children was comparable to the incidence when using placebo.
Rarely, immediate hypersensitivity reactions ([eg, bronchospasm, shortness of breath) have been reported.
Very rarely - anaphylaxis, angioedema, disturbances of taste and smell. Also very rarely, with intranasal use of GCS, cases of perforation of the nasal septum and increased intraocular pressure were observed.
With long-term use of GCS in high doses, as well as with the simultaneous use of several GCS, inhibition of the function of the hypothalamic-pituitary-adrenal system is possible. Due to the low systemic bioavailability of the drug.
Combination therapy with loratadine was well tolerated by patients. However, no effect of the drug on the plasma concentration of loratadine or its main metabolite was noted.
As with any long-term treatment, patients using NASONEX ® nasal spray for several months or longer should be periodically examined by a physician for possible changes in the nasal mucosa.
If a local fungal infection of the nose or throat develops, it may be necessary to discontinue therapy with NASONEX ® nasal spray and undergo special treatment. Irritation of the mucous membrane of the nose and pharynx that persists for a long time can also serve as a reason to discontinue treatment with NASONEX ® nasal spray.
In placebo-controlled clinical trials in children, when NASONEX nasal spray was used at a daily dose of 100 mcg for a year, no growth retardation was observed in children.
With long-term treatment with NASONEX ® nasal spray, 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 glucocorticosteroids 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 signs of adrenal insufficiency appear, systemic glucocorticosteroids should be resumed and other necessary measures taken. During the transition from treatment with systemic glucocorticosteroids to treatment with NASONEX ® nasal spray, some patients may experience initial symptoms of systemic glucocorticosteroid withdrawal (for example, joint and/or muscle pain, fatigue and depression), despite a decrease in the severity of symptoms associated with the lesion nasal mucosa; such patients must be specifically convinced of the advisability of continuing treatment with NASONEX ® nasal spray. The transition from systemic to local glucocorticosteroids may also reveal pre-existing allergic diseases such as allergic conjunctivitis and eczema that were masked by systemic glucocorticosteroid therapy.
Patients treated with glucocorticosteroids have a potentially reduced immune responsiveness and should be warned of their increased risk of infection if exposed to patients with certain infectious diseases (eg, chickenpox, measles), as well as the need for medical advice if such contact, happened.
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 medical consultation is required.
When using NASONEX ® nasal spray for 12 months, there were no signs of atrophy of the nasal mucosa; In addition, mometasone furoate tended to contribute to the normalization of the histological picture when examining biopsy specimens of the nasal mucosa.
Nasal spray dosed 50 mcg/dose.
18 g (120 doses) of suspension in white polyethylene bottles, equipped with a dosing device and closed with a cap. 1 bottle along with instructions for use in a cardboard box.
Do not use after expiration date.
Out of reach of children; at temperatures from 2 to 25 °C.
Schering-Plough Labo N.V., Industriepark 30, B-2220, Heist op den Berg, Belgium (own subsidiary of Schering-Plough Corporation/USA).
Schering-Plough Central East AG, Lucerne, Switzerland.
Shering-Plough LLC, Russia: Moscow, Shabolovka st., 10, building 2.
Source: http://medi.ru/instrukciya/nazoneks_309/
Hormonal drops Nasonex against the runny nose and features of their use
With improper treatment or weakened immunity, a runny nose of infectious origin can become chronic or complicated by sinusitis. The second most common form of rhinitis, allergic, is characterized by a persistent, long course and difficulties in determining the correct treatment tactics and in choosing medications.
Hormonal agents in the treatment of runny nose and sinusitis
For proper treatment of infectious rhinitis, it is necessary to take medications of various types. These should be vasoconstrictors that relieve swelling of the nasal mucosa and restore nasal breathing, antiseptics and drugs that improve the drainage of secretions.
When a runny nose becomes chronic or when sinusitis (usually sinusitis) develops, the treatment regimen includes antibacterial agents and, if necessary, medications containing synthetic glucocorticosteroids. The prescription of hormonal drugs for severe chronic runny nose or sinusitis is intended to reduce the body's inflammatory response.
For a runny nose of allergic origin and vasomotor rhinitis, medications with hormones are most often used. This is explained by their pronounced antiallergic effect and the ability to suppress the body’s atypical reaction to an antigen. Hormonal drugs used topically as nasal drops are characterized by an excellent therapeutic effect, which occurs quickly and lasts a long time.
Nasonex, its composition and mechanism of action
Nasonex is a hormonal drug; it includes the synthetic corticosteroid mometasone in combination with auxiliary compounds that give the dosage form the appearance of a white suspension and a stable state. Nasal drops or spray contain 50 mcg of active ingredient, mometasone furoate, in one dose.
According to the instructions for use, Nasonex has a strong anti-allergic and anti-inflammatory effect. This is explained by the fact that mometasone prevents the release of inflammatory mediators, that is, biochemical compounds that trigger an inflammatory process in the body in response to the introduction of foreign agents.
Histamine, leukotrienes, prostaglandins remain blocked by mometasone. In addition, Nasonex inhibits the proliferation of cells involved in the inflammatory response. Macrophages, neutrophils, eosinophils are unable to take part in inflammation caused by infectious microflora or an allergic agent.
The anti-inflammatory effect of Nasonex in the form of nasal drops remains quite strong at any stage of the allergic process. The drug actively blocks histamine and prostaglandins, inhibits cell proliferation both when the initial signs of allergy appear and when the clinical picture develops.
Nasonex can be widely used to treat not only existing allergic symptoms, but also to prevent them, before the expected onset of antigen action. Like all hormonal agents, mometasone, along with its anti-inflammatory effect, has the property of suppressing local immunity. This must be taken into account when prescribing it by the attending physician.
According to the instructions for use, Nasonex is not absorbed into the systemic circulation and is not detected in the blood plasma by any methods. Therefore, its pharmacokinetics (behavior of the substance in the body, interaction with other compounds, metabolism and excretion) have not been sufficiently studied.
The exclusively local effect of mometasone explains the lack of its effect on the pituitary-adrenal system and on the formation of its own hormones. It has been proven that if a small amount of medication enters the stomach from the nasopharynx when drops are instilled into the nose, mometasone immediately undergoes breakdown and is excreted by the kidneys or liver.
Use of Nasonex for allergic rhinitis and sinusitis
Based on the instructions for use, the drug can be used for allergic rhinitis of seasonal, episodic or year-round type, as well as for all sinusitis of allergic origin. It is prescribed for spring and autumn hay fever, for constant runny nose and sneezing on house dust or animal hair, and is required in complex treatment when inflammation of the conjunctiva of the eyes is associated with an allergen, which is manifested by redness of the mucous membrane and profuse lacrimation.
Nasonex acts gently and effectively, without damaging the epithelial layer of the mucous membranes and without drying them out. This property is very important when prescribing the drug prophylactically for patients suffering from hay fever.
The effect of using mometasone occurs within a few hours and lasts about a day. Therefore, the drug is not prescribed more than once a day. Symptoms of allergic rhinitis (profuse nasal secretions, sneezing, itching and burning in the nose) stop quickly and completely. The duration of the course depends on the severity of the underlying disease and the presence of concomitant pathologies.
Nasonex is also indicated for vasomotor rhinitis, which is based on a violation of the nervous regulation of vascular tone. The product helps strengthen the walls of capillaries, reducing the release of blood plasma into the interepithelial space and reducing the amount of nasal discharge. Using Nasonex, the patient is protected from sudden rhinorrhea during nervous tension, when leaving a warm home into extreme cold or from a dark room into bright light.
Nasonex is used in the treatment of allergic rhinitis or sinusitis only in combination with other medications. Vasoconstrictors, antihistamines, barrier agents and mast cell stabilizers are needed in therapy. Their compatibility with each other is very important so that the effect of complex treatment becomes as complete as possible. The negative effect of Nasonex nasal drops on local immunity is compensated by the prescription of immunomodulatory drugs.
The effectiveness of therapy for allergic rhinitis and sinusitis depends on medications that are correctly selected by the attending physician and complement each other.
According to the instructions for use, a bottle of Nasonex with nasal drops often has a spray nozzle and is used as a spray. Before taking it, you need to make a few test presses to adjust the operation of the dispenser. After this, the exact content of mometasone in each spray is achieved: 50 mcg. The bottle should be shaken before each dose.
Based on the instructions for use, for the treatment of seasonal, episodic or year-round allergic rhinitis, Nasonex is prescribed to adults and children over 12 years of age according to the following regimen. The daily dose is 200 mcg, that is, 2 sprays into the nose once a day.
As symptoms decrease, the dose is reduced to 100 mcg per day, that is, 1 dose in each nostril 1 time per day. For children aged 2-11 years, the daily dose is 100 mcg, 50 mcg once a day. The duration of the treatment course is determined by the doctor and depends on many factors.
As a preventive course, Nasonex is prescribed for hay fever, when the beginning of the flowering of a dangerous plant is precisely known. The duration of the course is 2-3 weeks before the allergen begins to act, the dosage is 1 injection into the nose once a day.
Use of Nasonex for chronic runny nose and sinusitis
When a runny nose becomes chronic, the inflammatory process in the mucous membrane becomes constant and sluggish. The patient is concerned about nasal congestion, the presence of mucopurulent nasal secretions, and impaired sense of smell. If chronic sinusitis occurs, the nasal contents become purulent and more abundant, and the voice acquires a nasal tone.
In such situations, the joint prescription of antibacterial agents and corticosteroids is justified. Broad-spectrum antibiotics have bactericidal properties, that is, they affect the microflora itself, the cause of the disease, and synthetic hormonal drugs regulate the inflammatory process and are used as an adjuvant.
According to the instructions for use, Nasonex for exacerbations of sinusitis and chronic runny nose is prescribed 2 doses 2 times a day in each nasal passage. Age category: adults and children over 12 years old. Nasonex is not recommended for younger children in such situations.
When the severity of the clinical picture decreases and a therapeutic effect is achieved, the dose can be reduced to 1 injection 2 times a day, and then to 1 dose into the nose 1 time a day. The regimen of hormonal therapy for sinusitis is determined only by a doctor. He also calculates the duration of the course, monitors the patient’s condition, and adjusts treatment if side effects occur.
Contraindications and possible side effects of Nasonex
Nasonex is not prescribed in the presence of erosions or boils of the mucous membrane, as well as after a recent injury to the nose or surgery on it. The presence of respiratory tract tuberculosis or systemic infection is an absolute contraindication. Nasonex drops are not prescribed to children under 2 years of age.
The fact that mometasone does not distribute through the systemic bloodstream has been proven, but despite this, the drug is not recommended during pregnancy at any stage and during lactation. In each specific case, the question of prescribing hormonal drugs is decided by the doctor strictly individually. They can be taken if treatment with other means does not have the expected effect.
Side effects during treatment with Nasonex occur, but rarely and to an insignificant degree. This may include a feeling of irritation and burning in the nose, sneezing, or headache. Sometimes nosebleeds are observed (about 5%), the development of inflammation of the pharyngeal mucosa. Isolated cases of perforation of the nasal septum and increased eye pressure have been reported with prolonged and uncontrolled use of hormonal nasal drops.
Nasonex does not inhibit the formation of its own corticosteroids and is not addictive. After completing the course, withdrawal syndrome does not develop. Treatment of allergic rhinitis, sinusitis or chronic rhinitis with Nasonex can occur over several months. During this time, it is necessary to undergo regular examination by an ENT doctor. If any changes occur in the mucous membrane of the nasopharynx or a fungal infection occurs, the treatment regimen must be adjusted.
The hormonal drug Nasonex has a powerful therapeutic effect. With proper use and proper combination with other drugs, you can quickly and effectively cope with various forms of rhinitis and sinusitis. The main thing is constant medical monitoring of the patient’s condition and strict adherence to all recommendations.
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NAZONEX
Nasal spray dosed 50 mcg/1 dose in the form of a white or almost white suspension.
Excipients: dispersed cellulose (microcrystalline cellulose treated with carmellose sodium) - 20 mg, glycerol - 21 mg, citric acid monohydrate - 2 mg, sodium citrate dihydrate - 2.8 mg, polysorbate 1 mg, benzalkonium chloride (in the form of a 50% solution) — 0.2 mg, purified water mg.
60 doses (10 g) - polyethylene bottles (1) complete with a dosing device - cardboard packs.
120 doses (18 g) - polyethylene bottles (1) complete with a dosing device - cardboard packs.
120 doses (18 g) - polyethylene bottles (2) complete with a dosing device - cardboard packs.
120 doses (18 g) - polyethylene bottles (3) complete with a dosing device - cardboard packs.
GCS for local use. It has anti-inflammatory and antiallergic effects when 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 (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, the 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 (compared with placebo) in histamine concentrations and eosinophil activity, as well as a decrease (compared with baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.
When administered intranasally, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of the detection method of 0.25 pg/ml).
Mometasone is very poorly absorbed from the gastrointestinal tract.
Metabolism and excretion
A small amount of the active substance that can enter the gastrointestinal tract after intranasal administration undergoes active metabolism during the “first pass” through the liver. Excreted in urine and bile.
— 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;
- 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 (over 18 years of age).
- hypersensitivity to the components of the drug;
- 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);
- childhood and adolescence (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;
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.
The drug is used intranasally.
Treatment of seasonal or year-round allergic rhinitis
Adults (including elderly patients) and adolescents from 12 years of age
The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) into each nostril 1 time/day (total daily dose). Upon achieving a therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 inhalation in each nostril 1 time / day (total daily dose kg).
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 1 time per day (total daily dose). 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.
Children aged 2 to 11 years
The recommended therapeutic dose is 1 inhalation (50 mcg) into each nostril 1 time / day (total daily dose mcg).
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
The recommended therapeutic dose is 2 inhalations (50 mcg each) into each nostril 2 times a day (total daily dose).
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). 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 nasal passage 2 times a day (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).
After the symptoms of the disease have reduced, it is recommended to reduce the dose to 2 inhalations (50 mcg each) into each nostril 1 time per day (total daily dose kg).
Rules for using the drug 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 by pressing the dispensing device 10 times until splashes appear, which indicates the drug is ready for use.
You should tilt your head and inject the medicine into each nostril as recommended by your doctor.
If the nasal spray has not been used for 14 days or longer, press the dispenser nozzle 2 times until it sprays.
Before each use, shake the bottle vigorously.
Cleaning the dispensing nozzle
It is important to clean the dispensing nozzle regularly to prevent it from malfunctioning. Remove the cap that protects the nozzle from dust, then carefully remove the spray tip. It is necessary to thoroughly rinse the spray tip and 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, which may result in the wrong dose being given.
Dry the cap and tip in a warm place. After this, you need to attach the spray tip to the bottle and screw the dust cap back onto the bottle. When using the nasal spray for the first time after cleaning, you must recalibrate by pressing the dispensing nozzle 2 times.
Adults and teenagers
Adverse events associated with the use of the drug (>1%) identified during clinical trials in patients with allergic rhinitis or nasal polyposis, and during post-registration use of the drug, regardless of the indication for use, are presented in Table 1. Adverse reactions are listed according to with the MedDRA systemic organ classes classification. Within each systemic organ class, adverse reactions are classified by frequency of occurrence.
Nosebleeds, as a rule, were moderate and stopped on their own, the frequency of their occurrence was slightly higher than when using placebo (5%), but equal or less than when prescribing other intranasal corticosteroids, which were used as an active control (in some of In them, the incidence of nosebleeds was up to 15%). The incidence of all other adverse events was comparable to that observed with placebo.
*identified with a frequency of “rarely” when using the drug 2 times a day for nasal polyposis
** detected when using the drug 2 times a day for nasal polyposis
Disorders of the respiratory system, chest and mediastinal organs: nosebleeds (6%), irritation of the nasal mucosa (2%), sneezing (2%).
Nervous system disorders: headache (3%).
The incidence of these adverse events in children was comparable to the incidence when using placebo.
When using intranasal corticosteroids, the development of systemic side effects is possible, especially with long-term use of intranasal corticosteroids in high doses (see section "Special instructions").
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.
The drug has low systemic bioavailability (<1%, with a sensitivity of the detection method of 0.25 pg/ml), so it is unlikely that in case of accidental or intentional overdose, any special measures will be required, other than observation with the possible subsequent resumption of the drug at the recommended dose.
Combination therapy with loratadine was well tolerated by patients. However, no effect of the drug on the concentration of loratadine or its main metabolite in the blood plasma was noted. In these studies, mometasone furoate was not detected in blood plasma (with a sensitivity of the detection method of 50 pg/ml).
As with any long-term treatment, patients using Nasonex nasal spray for several months or longer should be periodically examined by a doctor for possible changes in the nasal mucosa. It is necessary to monitor patients receiving intranasal corticosteroids for a long time. Possible development of growth retardation in children. If growth retardation is detected in children, it is necessary to reduce the dose of intranasal corticosteroids to the lowest that allows for effective control of symptoms. In addition, the patient should be referred to a pediatrician for consultation.
If a local fungal infection of the nose or throat develops, it may be necessary to discontinue treatment with Nasonex nasal spray and undergo special treatment. Irritation of the nasal and pharyngeal mucosa that persists for a long time may also serve as a reason to discontinue treatment with Nasonex nasal spray.
In placebo-controlled clinical studies in children, when Nasonex nasal spray was used at a daily dose of 100 mcg for a year, no growth retardation was observed in children.
With long-term treatment with Nasonex nasal spray, 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 signs of adrenal insufficiency appear, systemic corticosteroids should be resumed and other necessary measures taken.
When using intranasal corticosteroids, systemic side effects may develop, especially with long-term use in high doses. The likelihood of developing these effects is much less than with the use of oral corticosteroids. Systemic side effects may vary both in individual patients and depending on the GCS used. Potential systemic effects include Cushing's syndrome, characteristic Cushingoid signs, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly a number of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially in children).
During the transition from treatment with systemic corticosteroids to treatment with Nasonex nasal spray, some patients may experience initial withdrawal symptoms of systemic corticosteroids (for example, joint and/or muscle pain, fatigue and depression), despite a decrease in the severity of symptoms associated with mucosal damage nasal membranes. Such patients must be specifically convinced of the advisability of continuing treatment with Nasonex nasal spray. The transition from systemic to local GCS can also reveal allergic diseases such as allergic conjunctivitis and eczema that already existed but were masked by systemic GCS therapy.
Patients undergoing treatment with corticosteroids have a potentially reduced immune reactivity and should be warned about their increased risk of infection in case of contact with patients with certain infectious diseases (for example, chickenpox, measles), as well as the need for medical advice 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 medical consultation is required.
When using Nasonex nasal spray for 12 months, there were no signs of atrophy of the nasal mucosa. In addition, mometasone furoate tended to promote normalization of the histological picture when examining biopsy specimens of the nasal mucosa.
The effectiveness and safety of mometasone have not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis, and polyps that completely occlude the nasal cavity.
If unilateral polyps of an unusual or irregular shape are detected, especially those that are ulcerated or bleeding, additional medical examination is necessary.
Impact on the ability to drive vehicles and operate machinery
There is no data on the effect of Nasonex on the ability to drive a car or drive machinery.
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.
Contraindicated for seasonal and year-round allergic rhinitis - in children under 2 years of age, for acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, for polyposis - up to 18 years of age (due to the lack of relevant data).
In placebo-controlled clinical studies in children, when Nasonex was used at a dose of 100 mcg/day for a year, no growth retardation was observed.
The drug is available with a prescription.
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.
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