Description
Packaging
Bottle 120 doses.
Pharmacological action of
Nazonex – GCS for intranasal use. It 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.
Indications
Treatment of allergic rhinitis (seasonal and year-round) in adults, adolescents and children from 2 years old
Exacerbation of sinusitis (complex therapy with antibiotics) in adults (including senile age) and children from 12 years old
Prevention of seasonal allergic rhinitis of moderate and severe course (recommended 2-4 weeks before the expected start dusting season).
Contraindications
Hypersensitivity to any component of the
preparation Presence of untreated local infection involving the mucous membrane of the nasal cavity
Recent surgical intervention or trauma to the nose (before wound healing)
Tuberculous tuberculous infection, active or bacterial, viral systemic infection or infection caused by Herpes simplex with eye damage (as an exception, the appointment of the drug in these cases is possible as directed by a doctor caution)
Children under 2 years old (no application of the safety data).
Pregnancy and lactation
After intranasal administration of the drug at the maximum therapeutic dose, mometasone is not detected in blood plasma even at the minimum concentration, therefore, we can expect that its effect on the fetus will be negligible, and potential reproductive toxicity is very low.
However, since no special, well-controlled studies of the effect of the drug in pregnant women have been conducted, Nazonex should be prescribed to pregnant women, mothers, breast-feeding women or women of childbearing age only if the expected benefits of its administration justify the potential risk to the fetus and newborn.
Newborns whose mothers used GCS during pregnancy should be carefully examined to identify possible adrenal hypofunction.
Composition
1 dose contains:
Active ingredient:
Mometasone furoate (as monohydrate) 50 mcg
Excipients:
discontinuous cellulose BP 65 cps
Glycerol
Sodium citrate dihydrate
Citric acid monohydrate
Polysorbate 80
Benzalkonium chloride
Phenylethyl alcohol
Purified water
Dosage and Administration
Intranasal. Nasonex is used as an intranasal inhalation suspension contained in a spray bottle. Inhalations are carried out using a special metering nozzle on the bottle. Before the first use of the Nazonex nasal spray, it is necessary to calibrate it by pressing the metering device 6 7 times. After the calibration , a stereotypical delivery of the drug substance is established, in which with each press of a button, approximately 100 mg of mometasone furoate suspension containing mometasone furoate monohydrate in an amount equivalent to 50 μg of chemically pure mometasone furoate is released. If the nasal spray has not been used for 14 days or longer, a re-calibration is necessary before new use. Before each use, shake the spray bottle vigorously.
Treatment of seasonal or perennial allergic rhinitis in adults (including senile age) and adolescents from 12 years of age. The usual recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 micrograms each) in each nostril, once (total daily dose 200 micrograms) . 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 of 100 μg).
If the symptoms of the disease could not be reduced by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations per nostril once a day (total daily dose 400 mcg). After reducing the symptoms of the disease, a dose reduction is recommended. The onset of the drug is usually observed clinically during 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) per nostril once a day (total daily dose is 100 mcg).
For the treatment of exacerbations of chronic sinusitis as part of complex therapy with antibiotics for adults (i.e. including persons of senile age) and children from 12 years of age are prescribed 100 mcg (2 injections) in each nostril 2 times a day.
Adjunctive treatment of exacerbations of sinusitis Adults (including senile age) and adolescents from 12 years: the recommended therapeutic dose is 2 inhalations (50 micrograms) in each nostril 2 times a day (total daily dose 400 micrograms). The total daily dose is 400 mcg.
Side effects
In the treatment of seasonal or perennial allergic rhinitis.
In adults:
nosebleeds (obvious or secretion of stained mucus or blood clots)
pharyngitis,
burning sensation in the nose,
irritation of the nasal mucosa.
Nasal bleeding, as a rule, stopped on their own, were not severe, they occurred with a frequency slightly higher than when using placebo (5%), but equal to or less than when using other GCS for intranasal use, which were used as an active control (in some of them, the incidence of nosebleeds was up to 15%). The frequency of occurrence of all other adverse events was comparable with the frequency of their occurrence with the appointment of a placebo.
In children:
nosebleeds,
headache,
sensation of nose irritation,
sneezing.
The incidence of these adverse events in children was comparable to their incidence with placebo.
In the treatment of exacerbations of sinusitis (when using Nazonex spray as an adjuvant).
In adults and adolescents:
headache,
pharyngitis,
burning sensation in the nose,
irritation of the nasal mucosa.
Nasal bleeding was moderate, the frequency of occurrence with nasonex was also comparable to the frequency of nasal bleeding with placebo (5% compared with 4%, respectively).
Very rarely, with intranasal use of corticosteroids, there have been cases of perforation of the nasal septum or increased intraocular pressure.
Overdose
Symptoms: with prolonged use of corticosteroids in high doses, as well as with the simultaneous use of several corticosteroids, inhibition of the function of the hypothalamic-pituitary-adrenal system is possible.
Treatment: due to the low (less than 0.1%) systemic bioavailability, it is unlikely that any accidental or intentional overdose will require any measures other than monitoring the patient and then continuing treatment at the recommended dose.
Storage Conditions
In a dark place at a temperature not exceeding 25 ° C.
The Expiration of
is 3 years.
Conditions of dispatch from
pharmacies Prescription
Purpose
Antiallergic
Possible product names
NAZONEKS 50MKG / DOSE 120 DOSE NAZ SPRAY
NAZONEKS 50MKG. 120 DOSE NAZAL SPRAY
NAZONEX 50mcg / DOSE 120 DOSE NAZ SPRAY
Nazonex 50mcg / dose 120dose spray nasal
Nasonex 50mkg / dose nasal dosing spray. 120dose (18g) Fl. X1 (R)
Shering-Plow Labo N.V., Belgium
