Composition and dosage form of the drug
The active component of the drug is mometasone furoate, a hormonal substance with a pronounced antiallergic effect. The therapeutic effect is observed when using microscopically small doses that are unable to influence the body systemically.
Nasonex is available in the form of a nasal spray: in plastic bottles of 18 g each, equipped with a dispenser nozzle. One package of the drug is designed for 140 doses. Nasonex Sinus spray of identical composition is produced in 10 g bottles containing about 60 therapeutic doses.
The solution is a liquid, opaque, whitish suspension with a concentration of 50 mcg of glucocorticosteroid per dose. Spray excipients: citric acid, glycerin, polysorbate, distilled water and others.
The mechanism of action of the drug Nasonex
Mometasone inhibits the release of inflammatory mediators. At the same time, it activates the release of a blocker of the enzyme phospholipase A, which is responsible for the intensity of the immune reaction to antigens. When using a nasal spray, nasal discharge and accompanying other signs of allergy are reduced: conjunctivitis, lacrimation, swelling, itching, hyperemia.
The drug is effective against rapidly developing intolerance and helps prevent delayed allergies. Symptoms as a result of use are reduced at all stages of the pathology. They can be completely eliminated within 1–2 days from the start of treatment.
When applied topically, the drug substances are absorbed into the systemic bloodstream in a negligible concentration, without causing harm to the body.
Nasonex
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 - 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 / 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 1 time per 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.
Children aged 2 to 11 years
The recommended therapeutic dose is 1 inhalation (50 mcg) into each nostril 1 time / day (total daily dose - 100 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 - 400 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.
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 - 400 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 / day (total daily dose - 200 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 by pressing the dispensing device 10 times until splashes appear, indicating that 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.
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%, 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.
Who is Nasonex indicated for?
The use of the drug to prevent the appearance or exacerbation of allergic rhinitis is allowed for adults and children over 2 years of age. Nasonex helps:
- with allergic mucus discharge from the nose;
- with pathological reactions to pollen during flowering of plants, animal hair, exposure to other antigens.
In complex therapy, the drug is used to eliminate acute and chronic sinusitis. In these cases, its use is indicated for patients over 12 years of age.
Contraindications
Instructions for use of Nasonex require you to refuse treatment with it:
- in the presence of viral, bacterial, fungal inflammatory processes of the nasal mucosa, including those not completely cured;
- with herpes of the eye mucosa;
- with open and closed forms of tuberculosis;
- in case of hypersensitivity to the main substance or additional components of the drug.
Relative contraindications to the use of nasal spray: mechanical injuries of the nasal septum, disruption of the integrity of the mucous membrane, postoperative complications accompanied by bleeding. In these cases, it is necessary to wait until the tissues have completely healed.
Nasonex®
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.
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 over a long period of 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 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 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 in individual patients and depending on the glucocorticosteroid drug used. Potential systemic effects include Cushing's syndrome, Cushingoid features, 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 symptoms of systemic corticosteroid 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. Switching from systemic to topical 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 exposure 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.
With systemic and local (including intranasal, inhalation and intraocular) use of GCS, visual impairment may occur. If a patient has symptoms such as blurred vision or other visual disturbances, the patient should be advised to consult an ophthalmologist to identify possible causes of visual disturbances, including cataracts, glaucoma or rare diseases such as central serous chorioretinopathy (CSC), which have been observed in a number of cases with systemic and local use of GCS.
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.
Adverse reactions when using Nasonex spray
During treatment with the drug, the following are occasionally observed:
- headache;
- a feeling of dryness, burning and itching of the mucous membrane in the sinuses and larynx;
- pharyngitis;
- bloody discharge from the nose;
- sneezing, coughing;
- increased lacrimation, photophobia.
Side effects in most cases are observed in the first 1–2 days of using the medication. Subsequently, unwanted reactions decrease and disappear on their own. If negative symptoms increase, additional consultation with an otolaryngologist and discontinuation of the drug are required.
Instructions for use of Nasonex spray
Before first use, the bottle nozzle must be calibrated by checking its functionality: press several times. The spray is sprayed intranasally, carefully inserting the tip of the dispenser into each nostril. In this case, the head must be slightly moved back.
- For allergic rhinitis in adults and adolescents, the product is sprayed twice a day: 2 pumps in each nostril. When symptoms decrease, reduce the daily dose by half.
- If signs of allergy persist, it is permissible to increase the number of injections to 4 once. In case of severe pathology, repeat the procedure twice a day.
- Children under 12 years of age are allowed to administer the medicine once a day, one injection into each nostril.
No negative health consequences have been recorded with a single overdose of the drug. Regularly exceeding the volume of the spray can provoke disturbances in the functioning of the pituitary gland and hypothalamus.
During the treatment period, it is important to stay as little as possible in places where allergens accumulate, to avoid dusty rooms, abundantly flowering parks and gardens.
Nasonex, 1 piece, 18 g, 50 mcg/dose, metered nasal spray
Intranasally.
Nasonex® is used in the form of intranasal inhalation of a suspension contained in a spray bottle. Inhalations are 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 stereotypical delivery of the drug is established, in which with each press of the button approximately 100 mg of mometasone furoate suspension is released, containing mometasone furoate monohydrate in an amount equivalent to 50 μg of chemically pure mometasone furoate. 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.
Treatment of seasonal or year-round allergic rhinitis
For adults (including the elderly) and adolescents over 12 years of age, the usually recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) into each nostril, once (total daily dose 200 mcg). After achieving the desired therapeutic effect for maintenance therapy, it is advisable 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 noted clinically within the first 12 hours after the first use of the drug.
Children 2–11 years of age: the recommended therapeutic dose is 1 inhalation (50 mcg) into each nostril once a day (total daily dose is 100 mcg).
Auxiliary treatment of exacerbations of sinusitis
Adults (including the elderly) and adolescents over 12 years of age: the recommended therapeutic dose is 2 inhalations (50 mcg) into each nostril 2 times a day (total daily dose 400 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.
After 12 months of treatment with Nasonex® nasal spray, 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.
