Nasonex instructions for use

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/

Nasonex

Description current as of 11/11/2015

• Latin name: Nasonex
• ATX code: R01AD09
• Active ingredient: Mometasone furoate
• Manufacturer: Schering-Plough Central East AG, Belgium

Compound

One dose of spray contains 50 mcg of anhydrous mometasone furoate and auxiliary components: dispersed cellulose (sodium carboxymethylcellulose and MCC), glycerin, citric acid, polysorbate-80, sodium citrate dihydrate, benzalkonium chloride solution, purified water.

Release form

• Dosed spray Nasonex Sinus. Polyethylene bottles 10 g, packaging No. 1. Each bottle is equipped with a protective cap and a spray nozzle. The contents of the bottle are designed for 60 doses, each of which contains 50 mcg of active substance.
• Nasonex metered spray. Polyethylene bottles 18 g, packaging No. 1. Each bottle is equipped with a protective cap and a spray nozzle. The contents of the bottle are designed for 140 doses, each of which contains 50 mcg of active substance.

The contents of the bottle are an opaque suspension of almost white or off-white color.

pharmachologic effect

The drug has anti-inflammatory activity and has an antiallergic effect.

Pharmacodynamics and pharmacokinetics

Nasonex - hormonal or not?

The active substance of the spray is a synthetic corticosteroid for local (inhalation) use, therefore, the drug Nasonex is hormonal.

Pharmacodynamics

A feature of mometasone furoate is its ability to relieve inflammation and inhibit the development of an allergic reaction, even when used in doses at which systemic effects do not develop.

The substance inhibits the release of inflammatory mediators, stimulates the production of lipomodulin, which is an inhibitor of phospholipase A. Due to this, the release of arachidonic acid is reduced and, accordingly, the synthesis of its metabolic products (Pg and endoperoxides) is suppressed.

Reduces the formation of a chemotaxis substance, influencing “late” (delayed) allergic reactions, and also prevents the development of an immediate allergic reaction.

Studies with provocative tests with the application of antigens to the nasal mucosa have shown that Nasonex nasal spray exhibits high anti-inflammatory activity both at the early and late stages of the development of an allergic reaction.

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

In approximately a third of patients (28%) with seasonal allergic rhinitis, a pronounced clinical effect was achieved within twelve hours after the first inhalation. In half of the patients, improvement occurred on average within 1.5 days (35.9 hours).

In addition, in patients suffering from seasonal runny nose, the drug showed significant effectiveness in reducing the severity of eye symptoms (itching, lacrimation, redness).

Pharmacokinetics

The bioavailability of mometasone when applied topically is negligible (does not exceed 0.1%).

The substance is practically undetectable in blood plasma. The suspension is very poorly absorbed from the digestive canal, and the small amount that can be swallowed and has time to be absorbed undergoes active metabolism even before excretion.

Metabolites are excreted primarily in bile and, in small quantities, in urine.

Indications for use

Indications for use of Nasonex are:

• allergic rhinitis (seasonal or year-round) in children, adolescents and adults;
• exacerbation of chronic sinusitis (the drug is prescribed as an adjunct to antibiotic therapy) in adolescents and adults;
• prevention of moderate/severe seasonal allergic rhinitis (it is considered optimal to start using the spray no later than 2 weeks before the expected start of the dusting period).

Children are prescribed Nasonex allergy spray from the age of two. For the treatment of sinusitis in pediatrics, it is used in children over twelve years of age.

Contraindications

Contraindications to the use of Nasonex are:

• intolerance to any of its constituent components;
• the presence of an untreated/undertreated local infection, provided that the nasal mucosa is involved in the process;
• active or latent tuberculosis infection of the respiratory tract;
• untreated bacterial, systemic viral or mycotic infection, as well as an infection caused by the herpes simplex virus with eye damage (in some cases, the drug can be prescribed as an exception as directed by the attending physician).

If the patient has recently suffered a nasal injury or nasal surgery, the use of the spray is contraindicated until the wound has healed.

Side effects

When treating allergic rhinitis in adults, the following are possible:

• pharyngitis;
• nosebleeds (bleeding may be obvious or blood may be present in the mucus released from the nose);
• irritation of the mucous membrane in the nasal cavity;
• burning sensation in the nose.

In children receiving Nasonex for the treatment of allergic rhinitis, the following was observed:

• nosebleeds;
• irritation of the nasal mucosa;
• headache;
• sneezing.

Nosebleeds usually stop on their own and are not severe. They occur with a frequency comparable to the frequency of their occurrence when using placebo (5%), but less or equal than when using other glucocorticosteroids for intranasal use.

Nasonex analogues were used for active control; with their use, the incidence of nosebleeds was up to 15%.

Other adverse reactions in the group of patients receiving mometasone developed with the same frequency as in patients who received placebo.

When prescribing the drug for sinusitis/sinusitis, when Nasonex is used as an adjuvant to relieve swelling of the drainage holes, reduce secretion production and facilitate the discharge of mucus from the paranasal sinuses, the following were recorded in adolescents and adults:

Bleeding was moderate, and the frequency of its occurrence when using the spray was only slightly higher than the frequency of its occurrence when using placebo (5% and 4%, respectively, for Nasonex and placebo).

Cases of development of ocular hypertension or perforation of the nasal septum have been reported extremely rarely when using endonasal corticosteroids.

Nasonex spray: instructions for use

General recommendations

The drug is intended for intranasal administration (used in the form of inhalations) of the suspension contained in the bottle. The procedure is carried out using a dosing nozzle, which is supplied with each bottle of Nasonex.

Before using the spray for the first time, it is “calibrated” by pressing the dosing device 6-7 times. “Calibration” allows you to establish a stereotypical supply of medicine. In this case, each press of the dosing device ensures the release of 100 mg of suspension into the nasal cavity, which contains 50 mcg of a chemically pure active substance.

Before use, the bottle must be shaken vigorously each time.

Instructions for use of Nasonex/Nasonex Sinus for allergic rhinitis

The standard prophylactic/therapeutic dose for adolescents over the age of twelve and adult patients (including the elderly) is two inhalations into each nasal passage as a single dose (200 mcg of mometasone per day).

After achieving the desired therapeutic effect, the dose is reduced to 100 mcg/day. (one inhalation in each nasal passage once).

If it was not possible to achieve the desired effect when using a therapeutic dose, the dose can be increased to 400 mcg/day. That is, the patient should take up to four inhalations once in each nasal passage. Reducing the severity of symptoms of allergic rhinitis is an indication for dose reduction.

Clinical improvement after the first use of mometasone is usually noticeable within 12 hours after the first inhalation.

For children under 11 years of age, it is recommended to take one inhalation into each nasal passage once for allergies. Total dose kg/day.

Since Nasonex is not a nasal drop, but a spray, when inhaling, you should keep your head straight, without throwing it back.

Instructions for Nasonex Sinus and Nasonex for exacerbation of sinusitis

For patients over twelve years of age, including the elderly, the recommended therapeutic dose is two inhalations into each nostril, 2 times a day. Total dose kg/day.

The drug is used as an adjuvant, complementing the main treatment.

If clinical improvement cannot be achieved using the drug at a standard dosage, the dose may be increased to 800 mcg/day. (four inhalations into each nasal passage, 2 times a day). After the severity of symptoms decreases, the dose should be reduced.

After 12 months of use of Nasonex, there were no signs of atrophy of the nasal mucosa; in addition, mometasone tended to improve the histological picture when examining a tissue sample of the nasal mucosa.

Nasonex for adenoids

Enlarged adenoids are a fairly common complication of allergic rhinitis in young children. Prescribing Nasonex to children with adenoids can relieve swelling and often prevent the need for surgical intervention.

Reviews of Nasonex for adenoids indicate that the effect is achieved by suppressing lymphoid tissue, but it takes quite a long time to achieve it. In addition, in cases of severe inflammation, the drug is not very effective.

As a hormonal agent, the spray also additionally suppresses local immunity, and therefore, after its discontinuation, inflammation in the adenoids may resume. External manifestations of inflammation are the appearance of mucus flowing down the back wall of the throat.

To relieve this condition, doctors recommend taking a course of anti-inflammatory treatment for adenoid vegetations. In this case, inhalations through a nebulizer with Cycloferon, supplemented by rinsing the nasopharynx using the nasopharyngeal shower method, which are carried out in an ENT office, may be effective.

Dr. Komarovsky recommends, as an addition to the treatment of adenoids, to reconsider the organization of the child’s lifestyle. Since one of the causes of enlarged adenoids is decreased immunity, it is very important that the immune system functions as well as possible.

To minimize the risk of an increase in the size of the pharyngeal tonsils, the child should eat properly, walk in the fresh air, temper himself, play sports and have as little contact as possible with household chemicals and dust.

After the inflammation disappears, it is usually not necessary to repeat the course of intranasal GCS.

Overdose

An overdose of mometasone develops with prolonged use of the drug in high doses, as well as in the case of simultaneous use of several corticosteroids. As a result, the function of the hypothalamic-pituitary-adrenal system may be inhibited.

The systemic bioavailability of mometasone is extremely low, so it is unlikely that in case of an intentional/accidental overdose, it will be necessary to take any measures other than monitoring the patient and then continuing to use Nasonex at the recommended dose.

Interaction

Patients tolerate combination therapy with Loratadine well. Drug interactions with other drugs have not been studied.

Terms of sale

Storage conditions

The spray bottle should be stored at a temperature of 2-25°C. Freezing the drug is unacceptable.

Best before date

special instructions

The bottle is calibrated. If the product is not used for more than 14 days, recalibration is required.

With long-term (several months) use of the spray, you should undergo periodic examinations by an otolaryngologist for possible changes in the nasal mucosa. If a local mycotic infection of the pharynx/nose develops, you should stop using Nasonex or undergo a course of special treatment.

Particularly careful medical supervision is required for patients who use Nasonex simultaneously with systemic corticosteroids, as well as patients to whom the drug was prescribed after discontinuation of corticosteroid therapy.

Withdrawal of systemic corticosteroids often leads to adrenal insufficiency, which may require appropriate measures. When switching from systemic corticosteroids to the use of a nasal spray, some patients may experience symptoms of corticosteroid withdrawal:

A change in therapy may cause symptoms of previously developed allergic diseases (for example, eczema or allergic conjunctivitis), which were previously masked by systemic glucocorticosteroid therapy.

In patients receiving treatment with corticosteroids, immune reactivity is potentially reduced. For this reason, they should be warned about the increased risk of infection if they come into contact with an infectious patient (including people with measles or chickenpox), and about the need to consult a doctor if such contact occurs.

In placebo-controlled trials in children, when the drug was used at a dose of 100 mcg for a year, growth was delayed in children. Also, with prolonged use of Nasonex, there are no signs of suppression of the function of the hypothalamic-pituitary-adrenal system.

In cell culture, mometasone furoate showed tenfold greater activity compared to other steroids, including Betameson, Dexamethasone, beclomethasone dipropionate, in suppressing the synthesis/release of interleukins (IL) 1, 5 and 6, TNF-α, as well as IL-4, IL- 5 and Th2 cytokines from human CD4+ T cells.

By suppressing the production of IL-5, the drug exhibits six times greater activity than betamethasone and beclomethasone dipropionate.

What can replace Nasonex?

What analogues are cheaper than Nasonex?

The price of Nasonex analogues is from 128 rubles. The most inexpensive substitute for Nasonex is Desrinit nasal spray.

What is better Nasonex or Avamis?

Avamys is available in the form of an aqueous spray for intranasal administration. Its active substance is fluticasone furoate (the concentration of the substance in one dose is 27.% 5 mcg).

Fluticasone and mometasone are the most modern drugs, which are characterized by a very high degree of affinity for GCS receptors and exceptional topical activity.

Both substances have extremely low absolute bioavailability. However, for mometasone this figure is slightly lower than for fluticasone - 0.1% versus 0.5%.

Among all existing corticosteroids for intranasal administration, mometasone has the lowest bioavailability and the fastest development of the therapeutic effect.

In addition, its use is permitted from the age of two, while fluticasone furoate in pediatric practice is used only for the treatment of children over six years of age. Even with long-term use, mometasone does not have a negative effect on the growth of the child.

Nasonex or Flixonase - which is better?

Flixonase is an endonasal aqueous spray based on micronized fluticasone propionate. The concentration of the active substance in one dose is 50 mcg.

The drug has a rapid anti-inflammatory effect on the nasal mucosa, and its anti-allergic effect appears 2-4 hours after the first inhalation.

The effect (in particular, reduction of nasal congestion) persists for 24 hours after a single administration of Flixonase at a dose of 200 mcg.

When used in therapeutic doses, the drug does not have any pronounced systemic activity and almost does not inhibit the hypothalamic-pituitary-adrenal system.

Systematic reviews of the comparative effectiveness and safety of fluticasone propionate and mometasone furoate conducted as part of the DERP project showed that the differences in their effectiveness are very small. However, it should be borne in mind that fluticasone propionate is characterized by higher bioavailability than mometasone. This figure varies from 0.5 to 2%.

It is significant that Flixonase in pediatrics can only be used from the age of four.

Results from studies conducted by the FDA showed that the reduction in the severity of symptoms of allergic rhinitis as assessed by patients in the fluticasone group was more pronounced (45%) compared with the mometasone group (36%) and the placebo group (11%).

Patients receiving fluticasone were less likely than patients receiving mometasone and placebo to use additional medications (eg, nasal constrictors) for relief: rates of use were 42%, 47%, and 58%, respectively, for fluticasone, mometasone, and placebo.

Side effects when using fluticasone were also recorded less frequently (in particular, pharyngitis and gastrointestinal disorders),

What is better Nasonex or Nazarel?

The active substance of Nazarel spray is fluticasone propionate (50 mcg/dose), therefore, comparing the effectiveness of the drug with the effectiveness of Nasonex, we can say that, as in the case of Flixonase and Avamys, it is comparable.

The research results and subjective feelings of patients taking different endonasal corticosteroids confirm that both drugs are effective and safe. However, the advantage of Nazarel is its significantly lower cost (about rubles for 120 doses).

Nasonex during pregnancy

After administration of the drug into the nasal cavity in the maximum permissible therapeutic dose, its active substance is not detected in the blood even in the minimum concentration.

Thus, its potential reproductive toxicity (including effects on male/female fertility and effects on the developing organism) is negligible.

However, due to the fact that well-controlled studies of the effect of mometasone furoate on the body when used during pregnancy and lactation have not been conducted, the spray should be prescribed to pregnant women, mothers who are breastfeeding, and women of childbearing age only in those cases. cases where the expected effect of therapy justifies the potential risk to the fetus/newborn.

Newborn infants whose mothers received corticosteroids during pregnancy should be examined for possible hypofunction of the adrenal cortex.

Reviews of Nasonex

Reviews of Nasonex Sinus/Nasonex are mostly good. More than 80% of patients who used the drug noted a very rapid improvement in their condition, calling the drug an indispensable assistant in the fight against seasonal and year-round allergic rhinitis.

Moreover, some patients who have been on vasoconstrictor drugs for years claim that it was Nasonex spray that helped them get rid of this addiction.

However, there are also those for whom the drug did not suit or did not give the expected result, which may be due to the body’s individual reaction to the prescribed treatment.

A separate group of reviews are reviews of Nasonex for children. For children, the spray is most often prescribed for adenoids, if the proliferation of lymphoid tissue is a consequence of allergies. Despite the fact that the drug is hormonal, mothers believe that it is better to undergo treatment with it than to send the child for surgery.

If we talk about the effectiveness of Nasonex for adenoids, then positive dynamics become noticeable quite quickly, but only if the treatment regimen is chosen correctly.

The big advantage of the drug is that its active substance is absorbed in negligibly small quantities and does not have systemic activity. Thanks to this, Nasonex, unlike most analogues, can be used from the age of two.

It should be noted that there are, although extremely rare, reviews in which mothers who used Nasonex to treat their child complain that after the end of the course of treatment, all the old drugs that were prescribed to the child before do not work and do not even provide temporary relief.

Doctors' reviews of Nasonex allow us to conclude that endonasal corticosteroids do not completely cure polypous rhinosinusitis and allergic rhinitis, but are able to completely - and as quickly as possible - relieve the symptoms of allergic rhinitis and significantly delay the timing of relapse of nasal polyp growth.

Drugs in this group are the only drugs whose clinical effectiveness in chronic polypous rhinosinusitis is confirmed by evidence-based medicine.

How much does Nasonex cost?

Price in Ukraine

Price of Nazonex Sinus (60 doses) in large cities of Ukraine (Kharkov, Kyiv, Dnepropetrovsk, etc.) UAH. You can buy Nasonex (drops, 140 doses) for an average of 485 UAH.

Nasonex price in Russian pharmacies

The price of Nasonex Sinus spray in St. Petersburg and Moscow is from 440 rubles, the cost of a bottle containing 120 doses of the drug is from 780 rubles.

Additionally

The manufacturer does not produce Nasonex nasal drops. The only dosage form of the drug is a metered-dose nasal spray.

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Source: http://medside.ru/nazoneks

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.

- 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 (over 18 years of age).

- hypersensitivity to the components of the drug;

- 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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Source: http://health.mail.ru/drug/nasonex/