Momat Rino Advance nasal spray dose. 140 mcg+50 mcg/dose fl 150 doses
Registration Certificate Holder
GLENMARK PHARMACEUTICALS (India)
Dosage form
Medicine - Momate Rhino Advance
Description
Dosed nasal spray
in the form of a white or almost white suspension.
1 dose
azelastine hydrochloride 140 mcg mometasone furoate 50 mcg
Excipients
: microcrystalline cellulose (Avicel RC-591) - 0.91 mg, sodium carmellose - 0.021 mg, dextrose - 3.5 mg, polysorbate 80 - 0.0175 mg, benzalkonium chloride - 0.014 mg, disodium edetate - 0.035 mg, neotame - 0.0007 mg, citric acid monohydrate - 0.0105 mg, sodium citrate - 0.021 mg, purified water - up to 70 mg.
150 doses - HDPE bottles (1) with a dosing device and a nasal adapter - cardboard packs.
Indications
Seasonal allergic rhinitis in adults (from 18 years of age).
Contraindications for use
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 process); children and adolescents under 18 years of age (due to the lack of relevant data); hypersensitivity to azelastine and mometasone.
Carefully:
respiratory tuberculosis (active and latent); untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, the drug can be used for these infections as prescribed by a doctor); untreated infection involving the nasal mucosa.
pharmachologic effect
A combined drug with antiallergic and anti-inflammatory effects for topical use.
Azelastine
is a histamine H1 receptor blocker, a phthalazinone derivative. It has antihistamine, antiallergic and membrane-stabilizing effects, reduces capillary permeability and exudation, inhibits the release of inflammatory mediators from mast cells (histamine, serotonin, leukotrienes, platelet-activating factor, etc.), causing bronchospasm and contributing to the development of early and late stages of allergic reactions and inflammation .
Mometasone
- synthetic corticosteroids for topical use. It has anti-inflammatory and antiallergic effects when 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).
Drug interactions
Azelastine -
With intranasal use of azelastine, no clinically significant interactions with other drugs were detected.
Mometasone furoate
— combination therapy with loratadine was well tolerated by patients. There was no observed effect of the drug on the concentration of loratadine or its main metabolite in blood plasma.
Dosage regimen
The drug is used intranasally.
Prescribe 1 dose of spray (azelastine hydrochloride - 140 mcg / mometasone furoate - 50 mcg) in each nasal passage 2 times a day, morning and evening.
The duration of treatment is 2 weeks.
Side effect
From the nervous system:
headache, dizziness.
From the respiratory system:
nosebleeds, discomfort in the nasal cavity (burning sensation, itching), ulceration of the nasal mucosa, sneezing, pharyngitis, sinusitis, upper respiratory tract infections.
From the digestive system:
dysgeusia, nausea.
For the skin and subcutaneous tissues:
rash, skin itching, urticaria.
Allergic reactions:
hypersensitivity, anaphylactoid reactions.
Other:
irritation of the pharyngeal mucosa, fatigue, drowsiness, weakness.
With long-term use of GCS in high doses, systemic side effects may develop, incl. glaucoma and cataracts.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
There have been no adequate and well-controlled studies of the drug in pregnant women.
In experimental studies, azelastine hydrochloride caused fetal toxicity in mice, rats and rabbits.
The use of the drug during pregnancy and breastfeeding is contraindicated.
Use in children
Restrictions for children - Contraindicated.
The use of the drug in children and adolescents under the age of 18 is contraindicated (due to the lack of relevant data).
Momat Rhino Advans
The list of adverse events below is based on data from clinical studies in seasonal and perennial allergic rhinitis, as well as data from post-registration use of individual components of the drug.
Seasonal allergic rhinitis
In a clinical study conducted in 560 patients aged 12 to 65 years with seasonal allergic rhinitis. 282 patients received azelastine hydrochloride + mometasone furoate (nasal spray) for an average of 14.94 days.
Overall, the safety profile of azelastine hydrochloride + mometasone furoate nasal spray was comparable to the profiles of the individual components used as monotherapy in the study, and was also consistent with the available published data on monotherapy with the individual components of the combination. A total of 18 adverse events associated with the use of azelastine hydrochloride + mometasone furoate nasal spray were reported in 11 of 282 patients. The most common adverse events recorded in the study were headache (5 cases) and dysgeusia (5 cases). Other adverse events were drowsiness (3 cases), lethargy (2 cases), nausea (1 case), dyspepsia (1 case) and sneezing (1 case). Most of these adverse events were mild in severity, and no serious adverse events were reported during the study.
In another clinical study conducted on 220 patients with seasonal allergic rhinitis, 55 patients received azelastine hydrochloride + mometasone furoate nasal metered spray, 1 spray in each nostril twice a day in the morning and evening, 55 patients received azelastine hydrochloride + nasal metered spray. mometasone furoate 2 injections into each nostril once a day, 55 patients dosed spray mometasone furoate and 55 patients dosed spray azelastine hydrochloride. The duration of treatment with these drugs was 14 days. During the entire study period, adverse events were identified in 51 participants (23%). During the study, the following adverse events were noted: drowsiness (0.9%), bitter taste in the mouth (3.6%), headache (2.7%), nosebleeds (1.8%), burning sensation in the nose after use ( 9.5%), sneezing after use (4.1%), increased appetite (0.5%), dry nose (4.1%), abnormal test results (0.9%), swelling of the nasal mucosa ( 0.5%), nasal congestion (0.5%), rhinorrhea (0.9%), sinus arrhythmia (0.9%), redness of the hands (red spots) (0.5%), dry eyes (0.5%), 5%), hemorrhagic exanthema (0.5%), abnormal urinalysis (0.5%), swelling of the eyelids (0.5%), burning sensation in the eye area (0.5%) and loss of smell (0.5%), 5%). Mild adverse events accounted for 74.5%, and moderate adverse events accounted for 25.5% of the total number of adverse events.
Year-round allergic rhinitis
In a clinical study conducted in 150 patients with perennial allergic rhinitis. 75 patients received azelastine hydrochloride nasal metered spray + mometasone furoate, and 75 patients received combination therapy of azelastine hydrochloride nasal metered spray and mometasone furoate nasal metered spray from different devices. The duration of treatment with these drugs was 28 days. During the entire study period, 51 adverse events were reported in 23 of 150 patients (15.33%). The most common adverse events reported in the study were headache (10 cases), nosebleeds (6 cases), excessive sneezing (5 cases), and mucosal burning sensation (4 cases). Most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study. A comparative analysis of the observed adverse events in the groups revealed no differences between the groups. During the study, 94.74% (18/19) of mild adverse events and 5.26% (1/19) of moderate adverse events were observed in the group of patients receiving azelastine hydrochloride + mometasone furoate nasal metered spray.
The following are adverse drug events reported with the use of individual components of the fixed-dose combination.
According to the World Health Organization (WHO), adverse events are classified based on systemic organ classes according to the frequency of their development as follows:
| Often | ≥ 1/10 |
| often | from≥ 1/100 to |
| infrequently | from≥ 1/1000 to |
| rarely | from≥ 1/10000 to |
| very rarely |
frequency unknown - based on available data, it is not possible to determine the frequency of occurrence.
Azelastine hydrochloride
Often:
after use, a substance-specific bitter taste may be felt (often due to improper use, namely by excessively tilting the head back during use), which in rare cases can cause nausea.
Infrequently:
Mild, transient irritation of the inflamed nasal mucosa may occur, with symptoms such as burning, itching, sneezing and nosebleeds.
Very rarely:
Hypersensitivity reactions (such as rash, itching, urticaria), anaphylactoid reactions, dizziness, fatigue, drowsiness, weakness (may be due to the disease itself) have been reported.
Mometasone furoate
Adverse events associated with the use of the drug (≥1%) identified during clinical trials in patients with allergic rhinitis or nasal polyposis, and during post-registration use of the drug, regardless of the indication for use, are presented below. Overall incidence of adverse events in patients treated for acute rhinosinusitis. was comparable to the incidence in patients with allergic rhinitis and when prescribed placebo.
Nosebleeds, as a rule, were moderate and stopped on their own, the frequency of their occurrence was slightly higher than when using placebo (5%), but equal or less than when prescribing other intranasal corticosteroids, which were used as an active control (in some of In them, the incidence of nosebleeds was up to 15%). The incidence of all other adverse events was comparable to that observed with placebo.
Infectious and parasitic diseases:
often - pharyngitis, upper respiratory tract infections*
Immune system disorders:
frequency not established - hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath.
Nervous system disorders:
often - headache.
Visual disorders:
frequency not established - increased intraocular pressure, glaucoma, cataracts, blurred vision (blurred vision).
Disorders of the respiratory system, chest and mediastinal organs:
very often - nosebleeds**; often - nosebleeds (i.e. obvious bleeding, as well as the release of blood-stained mucus or blood clots), burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa; frequency not established - perforation of the nasal septum.
Gastrointestinal disorders:
often - pharyngeal irritation (feeling of irritation of the pharyngeal mucosa)**; frequency not established - disturbance of taste and smell.
* — detected with a frequency of “rarely” when using the drug 2 times a day for nasal polyposis;
** — detected when using the drug 2 times a day for nasal polyposis.
When using intranasal corticosteroids, systemic side effects may develop, especially with long-term use of intranasal corticosteroids in high doses.
If you experience the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
