Momat Rhino, 50 mcg/dose spray 60 doses

Mometazon is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and anti-allergic effects when used in doses that do not develop systemic effects. Inhibits the release of inflammatory mediators. Increases production of lipomodulin, which is an inhibitor of phospholipase A, resulting in reduced release of arachidonic acid and, consequently, inhibition of the synthesis of products of arachidonic acid metabolism – cyclic endoperoxides, prostaglandins. It prevents marginal accumulation of neutrophils, which reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, leads to a decrease in infiltration and granulation processes.
Reduces inflammation by reducing the formation of chemotaxis substance (effect on
“late” allergic reactions), inhibits the development of an allergic reaction of the immediate type (due to the inhibition of production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).
In studies with provocation tests with application of antigens on nasal mucosa high anti-inflammatory activity of mometasone was demonstrated both in the early and in the late stage of allergic reaction. This was confirmed by a decrease (compared to placebo) in histamine levels and eosinophil activity, as well as a decrease (compared to baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.
In clinical studies it was found that mometazone furoate in the form of a dosed nasal spray reduces the severity of nasal symptoms of seasonal and year-round allergic rhinitis (nasal congestion, rhinorrhea, itching and sneezing). Reduction of the severity of symptoms of seasonal allergic rhinitis was noted within 11 hours after the first administration of the drug. Maximum favorable effect was usually noted within 1-2 weeks after the beginning of the drug administration.
Therapy with mometasone in the form of nasal spray significantly reduced nasal congestion in patients with seasonal allergic rhinitis.

Pharmacokinetics

In intranasal administration the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of 0.25 pg/ml determination method). Mometasone furoate in suspension form is very poorly absorbed in the gastrointestinal tract, and the small amount of mometasone suspension that may enter the gastrointestinal tract by intranasal administration undergoes active primary metabolism before excretion with urine or bile.

Indications

Treatment of seasonal and year-round allergic rhinitis in adults (elimination of symptoms such as pain and pressure in the paranasal sinuses, nasal congestion, runny nose, sneezing, itchy nose, lacrimation) from 18 years of age.

Pharmacological effect

Mometasone is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and antiallergic effects when used in doses at which systemic effects do not develop. 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 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).
In studies with provocative tests with the application of antigens to the nasal mucosa, the high anti-inflammatory activity of mometasone was demonstrated in both the early and late stages of the allergic reaction. This was confirmed by a decrease (compared to placebo) in histamine levels and eosinophil activity, as well as a decrease (compared to baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.
Clinical studies have shown that mometasone furoate in the form of a dosed nasal spray reduces the severity of nasal symptoms of seasonal and year-round allergic rhinitis (nasal congestion, rhinorrhea, itching and sneezing). A decrease in the severity of symptoms of seasonal allergic rhinitis was observed within 11 hours after the first administration of the drug. The maximum beneficial effect was usually observed within 1-2 weeks after starting the drug.
Treatment with mometasone nasal spray significantly reduced nasal congestion in patients with seasonal allergic rhinitis.

Pharmacokinetics

When administered intranasally, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of the detection method of 0.25 pg/ml). Mometasone furoate in the form of a suspension is very poorly absorbed from the gastrointestinal tract, and the small amount of mometasone suspension that can enter the gastrointestinal tract during intranasal administration undergoes active primary metabolism before excretion in the urine or bile.

Special instructions

Please read this leaflet carefully before you start using this medication because it contains important information for you.
• Save the instructions, you may need them again.
• If you have any questions, consult your doctor.
• The medicine you are using is intended for you personally and should not be given to others because it may harm them even if they have the same symptoms as you.

The drug is indicated for intranasal use only.
Momat Rino should not be used for more than 3 months. If it is necessary to use the drug for more than 3 months, consult a doctor.
As with any long-term treatment, patients using Momat Rhino nasal spray for several months or longer should be periodically examined by a doctor 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 any changes occur, you must notify your doctor.

If a local fungal infection of the nose or throat develops, it may be necessary to discontinue therapy with Momat Rhino and undergo special treatment. Irritation of the nasal and pharyngeal mucosa that persists for a long time may also serve as a reason to discontinue treatment with Momat Rhino.

If a patient experiences symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported with the use of systemic and topical corticosteroids.
Patients who switch to treatment with Momat Rino 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 range of psychological or behavioral effects including psychomotor hyperreactivity, sleep disturbance, anxiety, depression, or aggression (especially in children).

During the transition from treatment with systemic corticosteroids to treatment with Momat Rhino 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 damage to the nasal mucosa. Such patients must be convinced of the advisability of continuing treatment with Momat Rhino. 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 suffering from certain infectious diseases (eg, chickenpox, measles), as well as the need for medical advice if such exposure occurs. If signs of a significant 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 mometasone furoate in the form of a 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.
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 and irregular shape are detected, especially those that are ulcerated and bleeding, it is necessary to conduct an additional medical examination.
Momat Rino contains benzalkonium chloride, which may cause irritation to the nasal mucosa.

Impact on the ability to drive vehicles and machinery

There is no data on the effect of the drug on the ability to drive a car or drive machinery.

Active ingredient

Mometasone

Composition

1 dose contains:

Active substances:

mometasone furoate monohydrate 51.72 mcg, which corresponds to the content of mometasone furoate 50 mcg.

Excipients: Avicel RC-591 (microcrystalline cellulose, carmellose sodium) – 2 mg, glycerol – 2.1 mg, citric acid monohydrate – 0.2 mg, sodium citrate dihydrate – 0.28 mg, polysorbate 80 – 0.01 mg, benzalkonium chloride – 0.02 mg, water d/i – up to 100 mg.

Pregnancy

Before using Momat Rino during pregnancy and breastfeeding, you should consult your doctor.
There have been no properly designed and well-controlled studies of the drug in pregnant women. As with the use of other intranasal corticosteroids, Momat Rhino should be prescribed to pregnant or breastfeeding women only if the expected benefit from the drug justifies the potential risk to the fetus or infant. Infants whose mothers received corticosteroids during pregnancy should be carefully monitored for possible adrenal hypofunction.

Contraindications

Hypersensitivity to any of the components of the drug.
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 processes).
Children under 18 years of age.

With caution

Before using the drug Momat Rino, you should consult a doctor if you have a tuberculosis infection (active or latent) of the respiratory tract, an untreated fungal, bacterial, systemic viral infection or an infection caused by Herpes simplex with eye damage (as an exception, the drug can be prescribed for the listed infections as directed by a doctor), the presence of an untreated local infection involving the mucous membrane of the nasal cavity.

Side Effects

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. The overall incidence of adverse events in patients treated for acute rhinosinusitis was comparable to the incidence in patients with allergic rhinitis and placebo. Adverse reactions are listed according to the Med DRA systemic organ class classification. Within each systemic organ class, adverse reactions are classified by frequency of occurrence.
Nosebleeds were generally mild and self-limiting, and their incidence was slightly higher than with placebo (5%), but equal to or less than with other intranasal corticosteroids that were used as active controls (some of which had an incidence of nosebleeds of up to 15%). The incidence of all other adverse events was comparable to that observed with placebo.
The frequency of adverse reactions is given in accordance with the following classification: very often (>1/10), often (>1/100, 1/1000, 1/10,000, <1/1000), very rarely (<1/10,000, including individual reports); for adverse reactions during post-marketing surveillance, the frequency has not been established (cannot be determined based on available data).
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 GCS, systemic side effects may develop, especially with long-term use of intranasal GCS 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.

Interaction

Combination therapy with loratadine was well tolerated by patients. However, no effect of the drug on the concentration of loratadine or its main metabolite in the blood plasma was noted. In these studies, mometasone furoate was not detected in blood plasma (with a sensitivity of the detection method of 50 pg/ml).
If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Momat Rhino.
Concomitant use with CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, medicinal products containing cobicistat) may increase the risk of systemic side effects. Coadministration of these drugs should be avoided unless the benefits of treatment outweigh the risk of systemic corticosteroid side effects. In this case, the patient should be carefully monitored for systemic side effects of corticosteroids.

Overdose

With long-term use of GCS in high doses, as well as with the simultaneous use of several GCS, inhibition of the function of the hypothalamic-pituitary-adrenal system is possible. Due to the low systemic bioavailability of the drug (< 1%, with a sensitivity of the detection method of 0.25 pg/ml), it is unlikely that in case of accidental or intentional overdose, any measures other than observation will be required with the possible subsequent resumption of the drug at the recommended dose. In case of overdose, consult a doctor.

Storage conditions

In a place protected from light at a temperature of 15 to 25 ° C. Do not freeze. Keep out of the reach of children.

Shelf life

2 years.

Manufacturer

Glenmark Pharmaceuticals Ltd, India