Nazonex
Nasonex: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Prices in pharmacies
Latin name: Nasonex
ATX code: R01AD
Active ingredient: mometasone (mometasone)
Manufacturer: Schering-Plow Labo N. V. (Schering-Plow Labo, NV) (Belgium)
Description and photo updated: 2018-26-11
Prices in pharmacies: from 379 rubles.
Buy
Nasonex is a glucocorticosteroid (GCS) for intranasal use.
Release form and composition
The dosage form of Nasonex is a dosed nasal spray: a suspension of almost white or white color [10 g (60 doses) in polyethylene bottles, complete with a dosing device, 1 bottle in a cardboard box; 18 g (120 doses) complete with a dosing device, in a cardboard box 1, 2 or 3 bottles).
Composition of 1 spray dose:
- active substance: micronized mometasone furoate (in the form of monohydrate) - 50 mcg;
- auxiliary components: benzalkonium chloride (in the form of a 50% solution), glycerol, dispersed cellulose (microcrystalline cellulose treated with sodium carmellose), polysorbate 80, sodium citrate dihydrate, citric acid monohydrate, purified water.
Pharmacological properties
Pharmacodynamics
Mometasone furoate is a topical glucocorticosteroid that, when used in doses that do not cause systemic effects, has anti-inflammatory and anti-allergic effects.
Nasonex prevents marginal accumulation of neutrophils, thereby reducing the inflammatory exudate and production of lymphokines, inhibiting the migration of macrophages, and reducing the processes of infiltration and granulation.
Mometasone inhibits the release of inflammatory mediators from mast cells. It increases the production of lipomodulin, an inhibitor of phospholipase A, as a result of which the release of arachidonic acid decreases and, as a result, the synthesis of its metabolic products - prostaglandins and cyclic endoperoxides - is inhibited. These properties determine the ability of Nasonex to inhibit the development of an immediate type of allergic reaction. By reducing the formation of chemotaxis substance (influence on late allergy reactions), the drug reduces inflammation.
In studies with provocative tests in which antigens were applied to the nasal mucosa, a high anti-inflammatory efficacy of mometasone was established in the early and late stages of an allergic reaction. This effect was confirmed by a decrease (compared to placebo) in eosinophil activity and histamine concentration, and a decrease (compared to baseline) in the number of neutrophils, eosinophils, and epithelial cell adhesion proteins.
Pharmacokinetics
The systemic bioavailability of mometasone furoate with intranasal administration does not exceed 1% (with a sensitivity of the method of determination of 0.25 pg / ml).
Mometasone is very poorly absorbed from the gastrointestinal tract. A small amount of the drug, which can get here after injection into the nasal cavity, is actively metabolized during the first passage through the liver and is excreted in the bile and urine.
Indications for use
- seasonal and year-round allergic rhinitis in children from 2 years of age and adults;
- prevention (2–4 weeks before the beginning of the dusting season) of seasonal allergic rhinitis of moderate and severe course in adolescents from 12 years old and adults;
- acute rhinosinusitis with mild to moderately severe symptoms without signs of a severe bacterial infection in adolescents from 12 years of age and adults;
- nasal polyposis with impaired nasal breathing and smell in adults;
- acute sinusitis and exacerbation of chronic sinusitis in adolescents from 12 years of age and adults (including the elderly) - in addition to antibiotic therapy.
Contraindications
- a nasal injury with damage to the nasal mucosa or recent surgery - before the wound heals;
- children up to 2 years old - in the treatment of seasonal and year-round allergic rhinitis, up to 12 years old - with acute sinusitis and exacerbation of chronic sinusitis, up to 18 years old - with polyposis;
- the presence of individual hypersensitivity to any component in the composition of the drug.
According to the instructions, Nasonex should be used with caution in the following diseases / conditions: active or latent tuberculosis infection of the respiratory tract, untreated local infection involving the nasal mucosa in the process, untreated bacterial, fungal, systemic viral infection, or infection caused by Herpes simplex, with involvement of the eyes in the process.
Instructions for use of Nazonex: method and dosage
Nasonex is intended for intranasal use.
1 dose = 1 injection and contains 50 mcg of mometasone.
Treatments for seasonal or perennial allergic rhinitis:
- adolescents from 12 years old and adults, (including the elderly): the recommended therapeutic and prophylactic dose is 2 injections into each nasal passage once a day, after achieving the necessary therapeutic effect for maintenance therapy, the dose can be reduced to 1 injection per each nostril once a day. If it was not possible to achieve a decrease in symptoms, you can increase the daily dose to 4 injections of Nasonex in each nasal passage. After improvement of the condition, the dose should be reduced;
- children 2–11 years old: the recommended therapeutic dose is 1 injection into each nostril once a day. Young children require adult assistance when administering the drug.
The onset of action of Nasonex usually occurs 12 hours after the first dose.
In acute sinusitis and exacerbation of chronic sinusitis, adults and adolescents from 12 years old Nasonex are usually prescribed 2 injections into each nasal passage 2 times a day. If the condition does not improve, it is possible to increase the daily dose up to 4 injections into each nostril 2 times a day. After reducing the severity of symptoms, the dose should be reduced.
For the treatment of acute rhinosinusitis (in the absence of signs of severe bacterial infection) in adolescents from 12 years of age and adults, Nasonex is required for 2 doses in each nasal passage 2 times a day. If the condition worsens, you should consult your doctor.
With polyposis, adults, including elderly patients, are prescribed 2 injections into each nostril 2 times a day. As soon as the severity of the symptoms of the disease decreases, it is recommended to reduce the dose to 2 injections in each nasal passage once a day.
Rules for using Nazonex:
- The introduction of the spray is carried out using a special dispensing nozzle on the bottle.
- Before the first use of the drug, the calibration of the dosing device is required. To do this, you need to press it 10 times until a spray of spray appears - this indicates that the device is ready for use.
- When injecting the drug, tilt your head and inject a spray into each nostril as recommended by your doctor.
- If the product has not been used for more than 14 days, you need to double-press the dispensing nozzle until a spray appears.
- Shake the bottle well before each use.
To avoid malfunctioning of the dispensing nozzle, it must be cleaned regularly as follows:
- First remove the protective cap and then the spray tip.
- Rinse them in warm water and rinse well under running water.
- Dry in a warm place.
- Attach the tip to the bottle.
- Screw on the protective cap.
When using Nasonex for the first time after cleaning the nozzle, you need to calibrate - press the dispensing nozzle 2 times.
You should not try to open the nasal applicator with any sharp object, this will damage it and, as a result, deliver the wrong dose of the drug.
Side effects
The frequency of adverse reactions is classified as follows: very often - ≥ 1/10, often - from ≥ 1/100 to <1/10, rarely - from ≥ 1/1000 to <1/100, unspecified frequency - the frequency of these adverse reactions based on available data cannot be determined (post-registration observation data).
Side effects in adults and adolescents identified in clinical studies and registered during the post-registration period:
- from the respiratory system, organs of the chest and mediastinum: very often with nasal polyposis - nosebleeds; often for other indications - a burning sensation in the nose, irritation and / or ulceration of the nasal mucosa, nosebleeds (discharge of blood-stained mucus or blood clots, as well as obvious bleeding); unspecified frequency - nasal septum perforation;
- from the gastrointestinal tract: often with nasal polyposis - a feeling of irritation of the pharyngeal mucosa; unspecified frequency - disturbances in taste and smell;
- from the nervous system: often - headache;
- infectious and parasitic diseases: often - pharyngitis, upper respiratory tract infections (with nasal polyposis, these phenomena rarely occur);
- on the part of the organ of vision: unknown frequency - glaucoma, increased intraocular pressure;
- from the immune system: unknown frequency - hypersensitivity reactions, including shortness of breath, bronchospasm, angioedema, anaphylactic reactions.
The nosebleeds were mostly mild and stopped on their own. The incidence of their development only slightly exceeded that when using placebo (5%), while it was equal or even less than when using other intranasal corticosteroids used as active control (in some of them, nosebleeds occurred with a frequency of up to 15%). The incidence of the other side effects described above was comparable to that with placebo.
Side effects noted in children under 12 years of age:
- from the respiratory system, chest and mediastinal organs: 6% - nosebleeds, 2% - irritation of the nasal mucosa and sneezing;
- from the nervous system: 3% - headache.
The listed adverse reactions in children occurred with a frequency comparable to the frequency of their development when using placebo.
With prolonged use of Nazonex, especially in high doses, there is a likelihood of developing systemic side effects.
Overdose
In the case of prolonged use of Nazonex in high doses or the simultaneous use of another GCS, the risk of suppression of the hypothalamic-pituitary-adrenal system increases.
Given the low systemic bioavailability of mometasone furoate with intranasal administration, it is unlikely that in case of an overdose, special medical measures will be required, in addition to monitoring the patient's condition. In the future, the use of Nasonex can be resumed at the recommended dose.
special instructions
When using Nasonex for 12 months, no signs of atrophy of the nasal mucosa were detected. Moreover, the nasal spray helped to normalize the histological picture in the study of the biopsy of the nasal mucosa. Nevertheless, with long-term (for several months or more) use of Nasonex, patients should undergo regular examinations with a doctor in order to detect changes in the nasal mucosa in time, if any develop.
Signs of suppression of the function of the hypothalamic-pituitary-adrenal system during prolonged treatment were not observed. Patients who are transferred to Nasonex after prolonged therapy with systemic glucocorticosteroids should be under special supervision, since their cancellation can lead to the development of adrenal insufficiency. In the event of signs of adrenal insufficiency, it is necessary to resume taking GCS of systemic action and, if necessary, take other therapeutic measures.
In patients switching to Nasonex from systemic corticosteroids, the initial symptoms of their withdrawal (feeling of fatigue, depression, pain in muscles and / or joints) may develop, despite a decrease in symptoms associated with damage to the nasal mucosa. In this case, the use of Nazonex must be continued. When switching to intranasal therapy, it is also possible for the manifestation of allergic diseases that already existed, but masked by systemic GCS, for example, eczema or allergic conjunctivitis.
In children, GCS can cause growth retardation. In this case, it is necessary to reduce the dose of Nazonex to the minimum that can control the symptoms of the disease. Consultation of a pediatrician is required.
If a local fungal infection of the nose / pharynx develops, appropriate treatment is required and, probably, the cancellation of Nasonex. Discontinuation of drug therapy may also be required if irritation of the nasal / pharyngeal mucosa persists for a long time.
Patients receiving corticosteroids potentially have reduced immune reactivity, so they have an increased risk of infection through contact with patients with certain infectious diseases (for example, measles or chickenpox). Such patients should be warned about the necessary precautions. If contact has occurred, it is recommended to see a doctor. Immediate medical advice is required if signs of severe bacterial infection appear, such as fever, persistent and sharp toothache or pain on one side of the face, swelling in the periorbital / orbital region.
Nasonex, like other intranasal corticosteroids, can cause the development of systemic side effects, especially when used in high doses for a long time, although this risk is significantly lower compared to the use of oral corticosteroids. Symptoms may differ depending on the type of drug used and the individual sensitivity of the patient. Potentially possible systemic effects include: characteristic signs of Cushingoid, Cushing's syndrome, growth retardation in children and adolescents, suppression of adrenal function, glaucoma, cataracts, less often - behavioral and psychological effects, including sleep disturbance, psychomotor hyperactivity, anxiety, depression, aggression (especially in children).
The safety and efficacy of mometasone has not been studied for polyps that completely cover the nasal cavity, polyps associated with cystic fibrosis, and unilateral polyps. If unilateral polyps of an irregular or unusual shape, especially ulcerated and / or bleeding, are detected, additional medical examination is required.
Influence on the ability to drive vehicles and complex mechanisms
There are no data on the effect of the components of Nasonex on human cognitive, mental and motor functions.
Application during pregnancy and lactation
Special controlled studies on the safety of using Nasonex during pregnancy and breastfeeding have not been conducted. The drug can only be prescribed if the expected benefit outweighs the potential risks. Newborn babies whose mothers were treated with Nasonex during pregnancy should be carefully examined for possible adrenal hypofunction.
Pediatric use
Restrictions on the appointment of Nazonex to children depend on the indications:
- seasonal and year-round allergic rhinitis - up to 2 years;
- acute sinusitis and exacerbation of chronic sinusitis - up to 12 years;
- polyposis - up to 18 years.
In placebo-controlled clinical trials, Nasonex was used in children at a daily dose of 100 μg for a year. No growth retardation was detected
For violations of liver function
During the first passage through the liver, only a small amount of mometasone is actively biotransformed, which can enter the gastrointestinal tract due to intranasal administration of the drug. In this regard, in case of impaired liver function, dose adjustment of Nazonex is not required.
Drug interactions
Nasonex is well tolerated in combination with loratadine. At the same time, mometasone did not affect the concentration of loratadine or its main metabolite in the blood. Mometasone furoate was not detected in blood plasma in these studies (sensitivity of the method for determining 50 pg / ml).
Analogs
The analogues of Nazonex are Avecort, Asmanex Twistheiler, Gistan-N, Galazolin Allergo, Momat, Momat Rino, Dezrinit, Mometasone, Monovo, Momederm, Nosefrin, Mometasone-Akrihin, Silkaren, Elokom.
Terms and conditions of storage
Keep out of the reach of children at a temperature of 2–25 ° С. Avoid freezing.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Nazonex
Reviews about Nazonex are mostly positive. Patients notice a significant improvement in their condition after 2-3 use of the drug. For many patients, this remedy has helped to get rid of addiction caused by prolonged use of vasoconstrictors.
The active substance of the drug with intranasal administration is practically not absorbed, which makes it possible to use the spray for the treatment of allergic rhinitis in children from 2 years of age. In addition, Nasonex is often prescribed to children with adenoids, when the proliferation of lymphoid tissue is a consequence of an allergic disease. Despite the hormonal origin of the drug, many mothers consider its use as a better solution than surgery. It should also be noted that there are separate reviews in which mothers complain that after the end of the course of Nasonex therapy, the drugs prescribed to the child earlier ceased to produce the desired effect.
According to doctors, intranasal corticosteroids are the only drugs whose clinical efficacy in chronic polyposis rhinosinusitis has been confirmed by evidence-based medicine. Doctors say that Nasonex (like other nasal corticosteroids) is not able to completely cure allergic rhinitis and polypous rhinosinusitis, but it can stop the symptoms of rhinitis as quickly as possible, and also significantly delay the timing of recurrence of polyp growth.
Price for Nasonex in pharmacies
Approximate prices for Nazonex: 414-522 rubles. for a bottle containing 60 doses, 698–896 rubles. - for a bottle containing 120 doses.
Nasonex: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Nasonex 50 mcg / dose 60 doses nasal spray dosed 10 g 1 pc. 379 r Buy |
|
Nasonex nasal spray. 50mcg / dose 60 doses 10g 389 r Buy |
|
Nasonex 50 mcg / dose 120 doses nasal spray dosed 18 g 1 pc. RUB 631 Buy |
|
Nasonex nasal spray. 50mcg / dose 120 doses 18g RUB 830 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
