Nasonex: instructions for use, analogues and reviews, prices in Russian pharmacies. Nasonex hormonal drops against the runny nose and features of their use Nasonex indications
N azonex is a topical hormonal drug used in the treatment of rhinitis of allergic etiology. It is also often prescribed for complicated or complicated runny nose.
This drug is highly effective and well tolerated. But if the patient is intolerant of the active substance, it is necessary to select an analogue of Nasonex or a cheaper replacement, since the cost of the original drug is quite high.
The main active ingredient of Nasonex is mometasone furoate, a glucocorticoid. Each dose contains 50 mcg of a hormonal substance. Thanks to this, the drug exhibits a pronounced anti-inflammatory and antiallergic effect, and therefore the main indications for use are:
- seasonal and chronic allergic rhinitis;
- acute course of sinusitis as part of complex therapy;
- exacerbation of chronic sinusitis;
- prevention of allergic rhinitis with moderate or severe course;
- acute form of rhinosinusitis with mild or moderate course;
- nasal polyps, which is accompanied by difficulty breathing and decreased sense of smell.
Dosage and rules of use
The first use of Nasonex begins with an initial preparatory “calibration”, which consists of 6-7 single presses of the dosing device.
This will establish a typical delivery of the main component, in which each press releases about 100 mg of mometasone furoate, that is, 50 mcg of pure glucocorticoid. “Calibration” must be repeated if the drug has not been used for 2 weeks.
Before each spraying, the bottle is shaken, since the drug is a suspension in which mometasone particles are evenly distributed.
If the nozzle becomes clogged, it must be carefully removed, rinsed under cold running water, and dried.
To achieve the maximum therapeutic effect, the drug should be used correctly:
- clean the nasal cavity of mucus and crusts using saline;
- close one nasal passage and insert the dispenser into the other;
- Raise your head slightly, then inhale deeply through your nose and press the spray nozzle;
- exhale through your mouth.
For children from 2 to 11 years of age, the therapeutic dose is one injection (50 mcg), for adolescents from 11 years of age and adults - 2 injections, that is, 100 mcg. Instructions for use suggest several treatment regimens with Nasonex:
- treatment of seasonal and chronic: for adult patients and children over 2 years of age, 1 therapeutic dose per nostril once a day. Maintenance therapy - 1 press, that is, 50 mcg of mometasone. In severe cases, a one-time dose increase to 4 presses is permissible, that is, 400 mg.
- As part of the auxiliary treatment of acute sinusitis: adult patients and adolescents over 12 years of age, one dose twice a day. In the absence of positive dynamics, the dose may be increased to 4 injections 2 times a day.
- Nasal polyps: Adults and adolescents over 18 years of age, therapeutic dose twice daily. After the symptoms have reduced, the drug is used once a day in the same dose.
As a preventative measure, Nasonex should be used 20 days before the flowering of a plant whose pollen is a potential allergen, at the above dose once a day.
Contraindications and side effects
Nasonex is contraindicated in cases of hypersensitivity to the components of the drug, tuberculous intoxication of the body, violations of the integrity of the nasal mucosa (the drug reduces the rate of tissue epithelization), viral, fungal, and bacterial infections of the nasal cavity.
Since appropriate clinical studies have not been conducted on the use of the drug in the treatment of nasal polyps in children under 18 years of age, Nasonex is used in this category of patients only as prescribed by a doctor.
For pregnant women and during lactation, the drug is prescribed only if the benefit to the mother outweighs the risk of possible complications in the development of the child.
When using Nasonex, side effects may occur such as migraine attacks and severe headaches, nasal bleeding, a burning sensation in the nose, irritation of the mucous membrane and the appearance of erosions, very rarely - perforation of the nasal septum, disruption of the adrenal glands, increased intraocular pressure, deterioration of vision and taste .
It is extremely rare for immediate allergic reactions to develop, including angioedema and anaphylaxis.
Nasonex's analogues are cheaper
Sometimes it becomes necessary to choose cheaper Nasonex analogues, the effectiveness of which will not be lower than the original product. The price of a drug with a volume of 60 doses varies from 420 to 500 rubles, 120 doses - from 700 to 870 rubles.
Analogs exhibit similar effects, but may differ in composition. At the same time, they also effectively cope with manifestations of allergies, inflammation, and asthma attacks.
The only generic (with the same composition as Nasonex) is the Czech “Desirint” costing 350 rubles for 140 doses. Both medications are identical, but the list of side effects of the substitute is longer and may occur during administration: anxiety, hyperactivity, sleep disturbances, glaucoma, cataracts.
The list of drugs with similar effects and lower cost is as follows:
- "Rinoclenil" (beclamethasone) - 200 doses 370 rubles;
- “Flixonase” (fluticasone propionate) - 120 doses 780 rubles;
- “Nazarel” (fluticasone propionate) - 120 doses 400 rubles;
- "Avamys" (fluticasone furoate) - 120 doses 725 rubles;
- “Nasobek” (beclamethasone) - 200 doses 180 rubles;
- "Tafen nasal" (budesonide) - 200 doses 420 rubles;
- “Polydexa” (dexamethasone, phenylephrine, polymyxin, neomycin) - 295 rubles;
- "Sinoflurin" (fluticasone propionate) - 120 doses 390 rub.
Only a doctor can select a similar substitute for Nasonex based on the previously collected anamnesis and the severity of symptoms. Self-medication in this case is dangerous due to side effects and can worsen the patient’s condition.
Analogs of Nasonex for children
Only the attending physician has the right to prescribe a hormonal drug or its replacement to a child. As a rule, Nasonex is used for severe allergies when other antihistamines are ineffective.
Children are most often prescribed the following list of analogues:
- “Flixonase”, approved for use from 4 years;
- "Avamys" can be used in the treatment of children over 2 years of age;
- "Nazarel" is suitable for children from 4 years old.
Nasonex or Avamis - which is better?
Avamis is a substitute for Nazonex, which is closest to it in terms of its mechanism of action. It is also allowed to be used in the treatment of children over 2 years of age, and the list of indications, contraindications and possible side effects is the same.
Avamis is better for children due to the following advantages: low cost and effectiveness in the treatment of adenoiditis in children, which is manifested by stabilization of breathing, adenoids do not enlarge, the nasal mucosa does not dry out, so there is no nasal bleeding, which is often observed in childhood when using Nasonex.
However, Avamis cannot be used as a prophylactic agent, unlike Nasonex.Nasonex or Flixonase
Flixonase is not the cheapest analogue of Nasonex. However, these drugs contain similar active ingredients, so the indications and contraindications for use are the same.
However, the original is approved for use from 2 years of age, and flixonase - only from 4 years of age.
Flixonase, unlike Nasonex, helps eliminate lacrimation, swelling, redness and itching of the eyelids. Thanks to this, the drug can be used without antihistamines, as monotherapy.
Nazarel or Nasonex - which is better?
Nazarel has a lower cost compared to Nasonex. It has a similar principle of action, exhibits a decongestant, anti-inflammatory, antihistamine effect, which appears 3 hours after the first injection.
Nazarel also helps reduce itching in the nose, eliminates sneezing, rhinitis, nasal congestion, discomfort in the maxillary sinuses, and alleviates eye allergy symptoms.
The therapeutic effect lasts for 24 hours after a single use of the spray. In addition, fluticasone has virtually no systemic effects, without affecting the functioning of the hypothalamic-pituitary-adrenal systems.
However, like Flixonase, according to the instructions, Nazarel is used to treat children over 4 years of age. Therefore, only Nasonex is suitable for patients under this age.
Nasonex or Nasobek
Nasobek is a cheaper replacement than Nasonex; the drug contains beclomethasone. Because of this, it exhibits an immunosuppressive effect, helping to restore local immunity.
Another advantage of nasobek is the reduction of mucus production, good tolerance by patients and the possibility of using it in the treatment of vasomotor rhinitis.
The disadvantages of the drug include the age restriction, according to which Nasobek can be used by children over 6 years of age. It is also not used as a prophylactic.
Nasobek is contraindicated in the first trimester of pregnancy.Desrinit or Nasonex
Desrinit is the only drug synonymous with Nasonex based on the active substance, it can be used intranasally and for inhalation, which is an undeniable advantage.
The active substance does not exhibit systemic effects because it has low bioavailability. Also, during treatment there is no effect of the drug on the state of the immune system.
The medicine is prescribed to relieve allergic rhinitis, diseases that are accompanied by inflammatory lesions of the nasopharynx, and reduces the risk of developing complications after infectious diseases.
According to the instructions, the indications for use of Nasonex and Desrinit are similar.
Which is better - Nasonex or Tafen Nasal
Tafen Nasal contains budesonide. This substance is also a glucocorticosteroid hormone, so it effectively inhibits the development of the inflammatory process, allergies, and prevents the production of histamine (one of the mediators of sensitization).
Just like Nasonex, the analogue is contraindicated in the treatment of fungal, viral, bacterial infections of the nasal cavity, in pregnant women and during lactation, and in patients with liver failure.
The effect of the drug begins only on the 2-3rd day, while improvement after using Nasonex begins 12 hours after the first injection.
Tafen Nasal can also be used to prevent allergic rhinitis for several months and treat runny nose of non-allergic nature. However, it is allowed for children only after reaching 6 years of age.
Nasonex or Polydexa
Polydexa is a combination drug containing dexamethasone, phenylephrine, polymyxin and neomycin. Thanks to this composition, the drug exhibits decongestant, vasoconstrictor effects, and is also active against pathogens of bacterial infections.
In view of this, Polydexa has a wider list of indications, as well as contraindications. The drug is not prescribed to children under 15 years of age, with intolerance to the components, a history of ischemic stroke and convulsions, severe arterial hypertension, coronary insufficiency, glaucoma, herpetic infection.
When using Nasonex and its analogues, you should remember:
- These drugs cannot be combined with others containing glucocortisteroids, as the risk of overdose increases;
- drug withdrawal is carried out gradually to avoid the development of “withdrawal syndrome”;
- the sprayer should be washed under running water at least once a week;
- with long-term use, the functioning of the adrenal glands should be monitored;
- Such drugs are used strictly according to the scheme and regularly.
Nasonex analogues have a similar spectrum of action and an identical list of side effects. However, only the attending physician can choose the most effective one in each specific case. After all, self-medication can lead to hormonal imbalance.
In contact with
Preparations for topical use in ENT practice containing Mometasone (Mometasone, ATC code R01AD09):
Nasonex - instructions for use. The drug is a prescription, the information is intended for healthcare professionals only!
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 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, 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 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.
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, a stereotyped delivery of the medicinal substance is established, in which each press of the dosing device releases approximately 100 mg of a suspension containing mometasone furoate (as monohydrate) in an amount equivalent to 50 μg of mometasone furoate anhydrous. 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 an active control (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).
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, it is possible to prescribe the drug 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 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 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 corticosteroids to treatment with Nasonex® nasal spray, some patients may experience withdrawal symptoms of 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. A change in 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 undergone GCS therapy have a potentially reduced immune reactivity and should be warned about the increased risk of infection when contacting patients with infectious diseases (including chickenpox, 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 with the simultaneous use of several GCS, suppression of the hypothalamic-pituitary-adrenal system is possible.
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.
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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 an 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;
- Citric acid monohydrate;
- 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.
- Instructions for use Nasonex ®
- Composition of the drug Nasonex ®
- Indications of the drug Nasonex ®
- Storage conditions for the drug Nasonex ®
- Shelf life of Nasonex ®
ATX Code: Respiratory system (R) > Nasal preparations (R01) > Decongestants and other topical preparations (R01A) > Corticosteroids (R01AD) > Triamcinolone (R01AD11)
Release form, composition and packaging
nasal spray (suspension) dosed 50 mcg/1 dose: vial. 120 dosesReg. No.: 2477/97/02/07/11/12 dated 09/25/2012 - Valid
Nasal spray (suspension) dosed in the form of an opaque liquid of white or close to white color.
| 1 dose | |
| mometasone furoate (as monohydrate) | 50 mcg |
Excipients: dispersed cellulose, glycerol (glycerin), sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, purified water.
120 doses - polyethylene bottles (1) - cardboard boxes.
Description of the drug NASONEX ® based on officially approved instructions for use of the drug and made in 2011. Update date: 03/04/2011
GCS for local use. It has a pronounced anti-inflammatory effect, which manifests itself in doses at which systemic effects do not occur.
The mechanism of anti-inflammatory and antiallergic action of mometasone furoate is mainly associated with its ability to reduce the release of mediators of allergic reactions. Mometasone furoate significantly reduces the synthesis/release of leukotrienes from leukocytes in patients suffering from allergic diseases. Mometasone furoate has demonstrated in cell culture a high potential (at least 10 times greater activity than other steroids, including beclomethasone dipropionate, betamethasone, hydrocortisone and dexamethasone) to inhibit the synthesis/release of IL-1, IL-6 and TNF-α. It also significantly suppresses the production of Th 2 cytokines, IL-4 and IL-5 from human CD4+ T cells. Mometasone furoate is also at least 6 times more potent than beclomethasone dipropionate and betamethasone in inhibiting IL-5 production. In studies with provocative tests, with the application of antigens to the nasal mucosa, the high anti-inflammatory activity of Nasonex ® aqueous nasal spray was shown 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.
A pronounced clinical effect in the first 12 hours of using Nasonex ® aqueous nasal spray was achieved in 28% of patients with seasonal allergic rhinitis. On average (50%) relief occurred within 35.9 hours.
In clinical studies in patients with nasal polyps, pronounced clinical effectiveness of the drug Nasonex ® was observed in relation to nasal congestion, polyp size, and restoration of smell, compared with placebo.
Suction
Mometasone furoate, when administered as a nasal spray, has very low bioavailability (≤ 0.1%) and is practically undetectable in blood plasma, even when using a sensitive detection method with a detection threshold of 50 pg/ml. Therefore, there are no relevant pharmacokinetic data for this dosage form. Mometasone furoate is very poorly absorbed from the gastrointestinal tract.
Metabolism
The small amount of mometasone furoate suspension that can penetrate the gastrointestinal tract after intranasal inhalation undergoes active primary metabolism even before excretion in urine or bile.
- treatment of seasonal or year-round allergic rhinitis in adults and children aged 2 years and older;
- as an auxiliary therapeutic agent in the treatment with antibiotics of exacerbations of sinusitis in adults (including the elderly) and adolescents from 12 years of age;
- treatment of nasal polyps and associated symptoms, including nasal congestion and loss of smell in patients 18 years of age and older;
- prevention of moderate and severe seasonal allergic rhinitis (recommended 2-4 weeks before the expected start of the flowering season).
For treatment of seasonal and year-round rhinitis The recommended preventive and therapeutic dose is 2 injections (50 mcg each) into each nostril 1 time / day (total daily dose - 200 mcg). After achieving a therapeutic effect for maintenance therapy, it is advisable to reduce the dose to 1 injection into each nostril 1 time / day (total daily dose - 100 mcg). If it is not possible to achieve a clinical effect at the recommended therapeutic dose, the daily dose can be increased to 4 injections into each nostril (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 clinically manifested within the first 12 hours after the first use of the drug.
For treatment of sinusitisadults (including elderly people) and adolescents from 12 years of age The recommended therapeutic dose is 2 injections (50 mcg) into each nostril 2 times a day. The total daily dose is 400 mcg. If it is not possible to achieve a clinical effect at the recommended therapeutic dose, the daily dose can be increased to 4 injections into each nostril 2 times a day (total daily dose - 800 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.
At nasal polyps For adults (including for elderly patients) and adolescents aged 18 years and older The recommended dose is 2 injections (50 mcg) into each nostril 2 times a day (total daily dose - 400 mcg). After achieving a clinical effect, it is recommended to reduce the dose to 2 injections into each nostril 1 time / day (total daily dose - 200 mcg).
Before the first use of Nasonex ® nasal spray, it is necessary to carry out 6-7 "calibration" presses of the dosing device. After "calibration", a stereotypical supply of the drug is established, in which with each button press approximately 100 mg of a suspension of mometasone furoate containing 50 μg of mometasone is released ( one dose) 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.
If the nozzle is clogged, you should remove the plastic cap by carefully pressing on the white ring, easily remove the nozzle, rinse it with cold running water, dry it and replace it in its original place.
Side effects observed in clinical studies in the treatment of seasonal and perennial allergic rhinitis: headache (8%);
In children, the incidence of side effects, incl. The incidence of nosebleeds (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to the incidence of placebo.
Rarely - an immediate allergic reaction (for example, bronchospasm, dyspnea); very rarely - anaphylactic reaction and angioedema.
In isolated cases - disturbances of taste and smell.
Use as an adjuvant in the treatment of acute episodes of sinusitis: The incidence of side effects was comparable to that with placebo - headache (2%), pharyngitis (1%), burning sensation in the nose (1%) and irritation of the nasal mucosa (1%). Nosebleeds were moderate, and the incidence of nosebleeds with Nasonex was also comparable to the incidence of nosebleeds with placebo (5% and 4%, respectively).
For the treatment of nasal polyps The total number of side effects listed above was comparable to those with placebo and similar to the number observed in patients with allergic rhinitis.
Very rarely With intranasal use of corticosteroids, cases of perforation of the nasal septum or increased intraocular pressure have been reported.
Use during pregnancy and breastfeeding
There have been no special, strictly controlled studies of the use of Nasonex during pregnancy. 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 very low and the potential for reproductive toxicity to be very low.
Prescription of the drug during pregnancy and lactation, as well as in women of childbearing age, is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Newborns whose mothers received corticosteroids during pregnancy should be carefully examined to identify possible adrenal hypofunction.
The use of the drug for the treatment of young children should be done with the help of adults.
The drug should not be used in the presence of untreated local infection involving the nasal mucosa. Due to the fact that corticosteroids inhibit wound healing, such drugs should not be prescribed for local intranasal use in patients who have recently undergone surgery or trauma to the nose until the wounds have completely healed.
Nasonex should be administered with caution (or not at all) to patients with active or latent tuberculous respiratory tract infection, as well as untreated fungal, bacterial, systemic viral infection or Herpes simplex infection involving the eyes.
After treatment for 12 months with Nasonex ®, no symptoms of atrophy of the nasal mucosa were observed. In addition, under the influence of mometasone furoate, there was a tendency towards normalization of the histological picture when examining biopsy samples of the nasal mucosa. As with any long-term treatment, patients who use Nasonex ® nasal spray for several months or more should be periodically examined to identify possible changes in the nasal mucosa. If a local fungal infection of the nose or pharynx develops, discontinuation of Nasonex ® or special treatment may be required. Irritation of the nasal and pharyngeal mucosa that persists for a long time may also be an indication to discontinue treatment with this drug.
With long-term treatment with Nasonex, no signs of suppression of the function of the hypothalamic-pituitary-adrenal system were observed. When switching to treatment with Nasonex ® nasal spray after long-term therapy with systemic GCS, patients require special monitoring. 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, some patients may experience symptoms of corticosteroid withdrawal (for example, joint and/or muscle pain, fatigue and depression). Such patients must be specifically convinced of the advisability of continuing treatment with Nasonex. When changing therapy, previously developed allergic diseases, such as allergic conjunctivitis and eczema, which were previously masked by systemic GCS therapy, may also appear.
Patients receiving corticosteroids have a potentially reduced immune reactivity and should be warned about the increased risk of infection in case of contact with certain infectious diseases (for example, chicken pox, measles), as well as the need to consult a doctor if such contact occurs.
Use in pediatrics
In placebo-controlled clinical trials in children, when Nasonex ® was used at a daily dose of 100 mcg for a year, no growth retardation was observed in children.
The safety and effectiveness of Nasonex in the treatment of nasal polyps in children and adolescents under 18 years of age.
The drug has low (≤0.1%) systemic bioavailability, so it is unlikely that overdose will require any special measures other than observation and subsequent administration at the recommended dose.