Instructions for use Allertec Naso spray nasal suspension 50 mcg bottle with pump-dispenser with sprayer 140 doses
Composition
active ingredient: mometasone furoate;
1 dose contains 50 mcg of mometasone furoate monohydrate (calculated as anhydrous form);
Excipients: benzalkonium chloride solution, glycerin, polysorbate-80, microcrystalline cellulose, carmellose sodium, citric acid monohydrate, sodium citrate, water for injections.
Dosage form
Nasal spray, metered dose, suspension.
Main physicochemical properties: white or almost white viscous suspension.
Pharmacotherapeutic group
Anti-edematous and other drugs for topical use in diseases of the nasal cavity. Corticosteroids. ATX code R01A D09.
Pharmacological properties
Pharmacodynamics
Mometasone furoate is a synthetic corticosteroid for topical use that has a pronounced anti-inflammatory effect. The local anti-inflammatory effect of mometasone furoate is manifested in doses at which systemic effects do not occur.
The mechanism of anti-inflammatory and antiallergic action of mometasone furoate is mainly related to its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly reduces the synthesis/release of leukotrienes from leukocytes of patients suffering from allergic diseases. Mometasone furoate has demonstrated 10-fold greater activity in cell culture than other steroids, including beclomethasone dipropionate, betamethasone, hydrocortisone and dexamethasone, in inhibiting the synthesis/release of IL-1, IL-5, IL-6 and TNFα. It is also a potent inhibitor of the production of Th2 cytokines, IL-4 and IL-5 from human CD4+ T cells. Mometasone furoate is also 6-fold more active than beclomethasone dipropionate and betamethasone in inhibiting the production of IL-5.
Pharmacokinetics
The bioavailability of mometasone furoate when administered as a nasal spray is < 1% in plasma (based on data obtained using a sensitive method, the lower limit of quantification is 0.25 pg/mL). Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that can be swallowed and absorbed undergoes extensive first-pass metabolism before being excreted primarily as metabolites in the bile and, to some extent, in the urine.
Indication
Treatment of seasonal or perennial allergic rhinitis in adults and children aged 2 years and over. Prophylactic treatment of moderate to severe allergic rhinitis is recommended to begin 4 weeks before the expected start of the pollen season. As an adjunct therapy to antibiotic treatment of acute episodes of sinusitis in adults (including the elderly) and children aged 12 years and over. Treatment of symptoms of acute rhinosinusitis without evidence of severe bacterial infection in adults and children aged 12 years and over. Treatment of nasal polyps and associated symptoms, including nasal congestion and loss of smell, in patients aged 18 years and over.
Contraindication
Hypersensitivity to the active substance or to any inactive component of the drug.
The drug should not be used in the presence of untreated localized infection with lesions of the nasal mucosa.
Because corticosteroids have the effect of inhibiting wound healing, patients who have recently had nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Interaction with other medicinal products and other types of interactions
ALLERTEC® NAZO was used concomitantly with loratadine, with no effect on the plasma concentrations of loratadine or its main metabolite, and mometasone furoate was not detected in plasma, even at minimal concentrations. The combination therapy was well tolerated by patients.
Concomitant use of mometasone with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic adverse reactions. Such combinations should be avoided unless the expected benefit of treatment outweighs the potential risk of systemic corticosteroid adverse reactions, in which case careful monitoring for systemic corticosteroid adverse reactions should be performed.
Data on interactions with other drugs are not presented.
Application features
The use of the drug in young children must be carried out with the help of adults.
The drug should not be used in the presence of untreated local infection with damage to the nasal mucosa.
After 12 months of treatment with ALLERTEC® NAZO, there was no evidence of atrophy of the nasal mucosa; in addition, mometasone furoate contributed to the normalization of the histological picture of the nasal mucosa. As with any long-term treatment, patients using the drug for several months or more should be periodically examined for possible changes in the nasal mucosa. In the event of the development of a local fungal infection of the nose or pharynx, it may be necessary to discontinue therapy with the drug or to conduct appropriate treatment. Irritation of the nasal mucosa and pharynx that persists for a long time may also be an indication for discontinuation of treatment with the drug.
Although the drug controls nasal symptoms in most patients, concomitant use of appropriate adjunctive therapy may result in additional relief of other symptoms, particularly ocular symptoms.
Patients who are transferred to nasal spray therapy after long-term systemic corticosteroid therapy should be closely monitored. Discontinuation of systemic corticosteroids in such patients may result in adrenal insufficiency, which may require resumption of systemic corticosteroid therapy and the use of other appropriate treatment.
When switching from systemic corticosteroid therapy to ALLERTEC® NAZO, some patients may experience corticosteroid withdrawal symptoms (e.g. joint and/or muscle pain, fatigue and depression) in addition to relief of nasal symptoms. Such patients should be specifically advised to continue treatment with the spray. Switching therapy may also reveal allergic diseases (e.g. allergic conjunctivitis, eczema, etc.) that have developed previously and were masked by systemic corticosteroid therapy.
Patients taking corticosteroids may potentially have reduced immune reactivity and should be warned about the increased risk of infection when in contact with patients with certain infectious diseases (such as chickenpox, measles), as well as the need to consult a doctor if such contact occurs.
The potential risk of Cushing's syndrome may occur with prolonged use of the drug at high doses.
Very rare cases of nasal septal perforation or increased intraocular pressure have been reported following the use of intranasal corticosteroids.
In placebo-controlled clinical trials in children treated with the drug at a daily dose of 100 mcg for 1 year, no growth retardation was observed.
Patients should be advised to seek immediate medical attention if they develop signs or symptoms of a serious bacterial infection, such as fever, severe unilateral facial pain or toothache, orbital or periorbital swelling/edema, or worsening of symptoms after initial improvement.
Visual disturbances
Visual disturbances may occur with systemic or topical corticosteroids. If a patient experiences blurred vision or other visual disturbances, they should consult an ophthalmologist to evaluate possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous retinopathy, which has been reported with systemic and topical corticosteroids.
Use during pregnancy or breastfeeding
No special studies of the drug have been conducted in pregnant women.
As with other intranasal corticosteroids, ALLERTEC® NAZO should be used in pregnant and lactating women only if the potential benefit justifies the potential risk to the woman, fetus, or infant. Infants whose mothers have used corticosteroids during pregnancy should be carefully observed for possible adrenal hypofunction.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
Treatment of seasonal or perennial allergic rhinitis. The recommended prophylactic and therapeutic dose of the drug for adults (including the elderly) and children over 12 years of age is 2 sprays (50 mcg each) into each nostril once a day (total daily dose – 200 mcg). After achieving a therapeutic effect, for maintenance therapy, it is advisable to reduce the dose to 1 spray into each nostril once a day (total daily dose – 100 mcg).
If the symptoms of the disease cannot be alleviated by using the drug in the recommended therapeutic dose, the daily dose can be increased to the maximum: 4 sprays into each nostril once a day (total daily dose - 400 mcg). After the symptoms of the disease have subsided, it is recommended to reduce the dose.
For children aged 2–11 years, the recommended therapeutic dose is 1 spray (50 mcg) in each nostril once daily (total daily dose – 100 mcg).
Adjunctive treatment of acute episodes of sinusitis. For adults (including the elderly) and children aged 12 years and over, the recommended therapeutic dose is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).
If relief of symptoms is not achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 sprays in each nostril 2 times a day (total daily dose - 800 mcg). After relief of symptoms, it is recommended to reduce the dose.
Acute rhinosinusitis. The recommended therapeutic dose for adults and children aged 12 years and over is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).
Nasal polyps. For patients aged 18 years and over (including the elderly), the recommended dose is 2 sprays (50 mcg) in 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 sprays in each nostril 1 time a day (total daily dose – 200 mcg).
Using a nasal spray
Before using a new bottle of the drug, it should be calibrated. Calibration is carried out by approximately 10 presses of the dosing device, while establishing a stereotypical delivery of the drug substance, in which each press releases approximately 100 mg of suspension containing 50 mcg of mometasone (one dose). If the nasal spray has not been used for 14 days or longer, before the next use, it is necessary to spray again by 2 presses until full delivery is observed.
After using the specified number of doses in the vial or after 2 months from the date of first use, the vial should be discarded.
Procedure for administering the drug:
1. Shake the bottle vigorously before each use.
2. Before each use, the nose should be thoroughly cleaned of mucus.
3. Place the tip in the nasal passage and close the other nostril with your finger, as shown in Fig. 2. Tilt your head forward, keeping the bottle upright.
4. Inhale through your nose and press the bottle nozzle once with your fingers.
5. Exhale through your mouth. Repeat step 4 for a second spray into the same nasal passage.
6. Remove the spray from the nasal passage and continue breathing through the mouth.
7. You must repeat steps 3-6 for the second nostril.
After using the spray, wipe the spray nozzle of the bottle with a clean cloth and close it with a protective cap.
It is important to clean the dispenser regularly. Remove the protective cap and sprayer and rinse them with warm running water, dry them and replace them. Do not try to clean the nozzle with a needle or other sharp object, as this will damage the dispenser.
Regular cleaning of the nozzle is very important.
Children
In placebo-controlled clinical trials in children receiving ALLERTEC® NAZO at a daily dose of 100 mcg for one year, no growth retardation was observed.
The safety and efficacy of ALLERTEK® NAZO have not been studied in the treatment of nasal polyps in children under 18 years of age, symptoms of rhinosinusitis in children under 12 years of age, or seasonal or perennial allergic rhinitis in children under 2 years of age.
Overdose
Due to the fact that the systemic bioavailability of the drug is < 1% (according to the results of a sensitive method, the lower limit of quantification is 0.25 pg/ml), it is unlikely that in case of overdose, other measures will be required, except for monitoring the patient's condition with subsequent use of the drug at the recommended dose.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of the function of the hypothalamic-pituitary-adrenal axis.
Adverse reactions
During clinical trials in seasonal and perennial allergic rhinitis, the following adverse events were reported with ALLERTEC® NAZO: headache (8%), epistaxis (i.e., obvious bleeding, bloody mucus, or blood clots) (8%), pharyngitis (4%), nasal burning (2%), irritation (2%), and ulceration (1%) of the nasal mucosa. These adverse events are typical of any nasal spray containing corticosteroids. Epistaxis was self-limiting and mild, occurring somewhat more frequently than with placebo (5%), but less frequently than with other intranasal corticosteroids studied and used as active controls (some of which had an incidence of up to 15%). The incidence of other adverse events was comparable to that seen with placebo.
In children, the incidence of adverse events, including nosebleeds (6%), headache (3%), nasal irritation (2%), and sneezing (2%), was comparable to that seen with placebo.
Isolated cases of taste and smell disorders have been reported.
When using ALLERTEC® NAZO nasal spray as an adjunct in the treatment of acute sinusitis, the following adverse events were observed, the incidence of which was comparable to that with placebo: headache (2%), pharyngitis (1%), nasal burning sensation (1%), and nasal mucosal irritation (1%). Epistaxis was moderate and the incidence of epistaxis with ALLERTEC® NAZO spray was also comparable to that with placebo (5% and 4%, respectively).
In patients with nasal polyps and acute rhinosinusitis, the total number of adverse events listed above when using ALLERTEK® NAZO spray was comparable to that when using placebo and similar to the number observed in patients with allergic rhinitis.
Upper respiratory tract infection was reported in 1% of patients treated with ALLERTEC® NAZO for the treatment of nasal polyps, which was comparable to placebo.
Very rarely, cases of nasal septal perforation or increased intraocular pressure have been reported with intranasal use of corticosteroids.
Rare cases of glaucoma and/or cataracts have been reported with the use of intranasal corticosteroids.
Cases of blurred vision have been reported with the use of corticosteroids - frequency unknown (see section "Special warnings and precautions for use").
Expiration date
2 years.
The shelf life after first opening is 2 months.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
60 or 120 or 140 doses of suspension in a PET bottle with a dosing pump-dispenser-sprayer, which releases 1 dose of the drug, closed with a cap. 1 bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
“Farmea”/Farmea
Location of the manufacturer and its business address
10 rue Bouche Thomas, ZAC d'Orgemont, 49000 Angers, France
Applicant
Medana Pharma Joint Stock Company/Medana Pharma Spolka Akcijna
