Momat Rhino, spray 50 mcg/dose 120 doses

ATC code: R01AD09.

Pharmacological properties: Pharmacodynamics

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 that reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, leads to decrease of infiltration and granulation processes.

It reduces inflammation due to decrease of chemotaxis substance formation (effect on “late” allergy reactions), inhibits development of immediate allergic reaction (caused by inhibition of arachidonic acid metabolites production and decrease of inflammatory mediators release 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 early and in late stage of allergic reaction. This was confirmed by a decrease (compared to placebo) in the level of histamine 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 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 observed within ‑12 weeks after the beginning of the drug administration.

Therapy with mometasone preparation in form of nasal spray significantly reduced nasal congestion in patients with seasonal allergic rhinitis.‑

When administered intranasally 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

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

Active ingredient

Mometazone

Composition

Active ingredient: Mometasone furoate monohydrate – 51.72 mcg, in terms of mometasone furoate – 50.00 mcg.
Excipients: Avicel RC591 [microcrystalline cellulose, sodium carmellose] – 2.00 mg, glycerol – 2.10 mg, citric acid monohydrate – 0.20 mg, sodium citrate dihydrate – 0.28 mg, polysorbate80 – 0.01 mg, benzalkonium chloride – 0.02 mg, water for injection – up to 100 mg.

How to take, the dosage

The suspension contained in the bottle is inhaled using a special dispensing nozzle on the bottle.

Use the drug only according to the indications, the method of administration and in the doses specified in the instructions. If after 14 days of treatment no improvement or aggravation of symptoms or appearance of new symptoms occurs, consult a physician. Do not take Momat Rhino without physician’s consultation for more than 3 consecutive months.

Recommended dose is 2 inhalations (50 mcg each) into each nostril once a day (total daily dose – 200 mcg). Upon achieving therapeutic effect for maintenance therapy the dose may be reduced to 1 inhalation per nostril once a day (total daily dose – 100 micrograms).

The drug action is usually clinically observed within 12 hours after the first use of the drug.

Recommendations for patients on the drug administration

Preparation of the nasal spray for use

The bottle of Momat Rhino, nasal dosed spray has a dust cap that protects the dosing nozzle and prevents it from contamination. Remember to remove it before use and put it back after use.

Shake the bottle gently.

Take the bottle so that your index and middle finger is on each side of the dispensing nozzle and your thumb is at the bottom of the bottle. Do not pierce the nasal applicator.

Point the dispensing nozzle away from you and make 10 finger presses until a fine spray.

If the nasal spray has not been used for 7 or more days, you must re-pump the bottle by making 2 presses on the dispensing nozzle until a uniform spray appears.

Application of the nasal spray

Carefully shake the bottle and remove the dust cap.

Take a light exhalation through the nose.

Close one nostril and insert the dispensing nozzle into the other nostril as shown. Slightly tilt your head forward holding the bottle vertically.

Begin to inhale slowly and gently with the open nostril and, while inhaling, inject the spray into the nostril by making a single pressure with your fingers.

Make an exhalation through your mouth. Repeat step 4 to inject a second dose of spray into the same nostril, if necessary.

Remove the dispensing nozzle from that nostril and exhale through your mouth.

Repeat steps 3 to 6 for the other nostril.

After using the spray, gently wipe the dispensing nozzle with a clean handkerchief or tissue and close it with the dust cap.

Shake the bottle before each use. The bottle should be disposed of after completing the stated number of squeezes.

Cleaning the Dispensing Nozzle

It is important to clean the dispensing nozzle regularly; otherwise it may not work properly.

Remove the dust cap and gently pull out the dispensing tip.

Rinse the dispensing tip and dust cap in warm water and then rinse under the tap.

Do not try to restore the passage of the nasal applicator with a pin or other sharp objects – this will cause damage to the applicator and you will not be able to get the correct dose of the medication.

Dry the cap and nozzle in a warm place.

Put the dispensing nozzle back in its former place and put on the dust cap.

Before the first use after cleaning you should re-pump the bottle by 2 presses on the dispensing nozzle.

Interaction

Combination therapy with loratadine was well tolerated by patients. No effect of the drug on plasma concentrations of loratadine or its major metabolite was observed. In these studies mometasone furoate was not detected in blood plasma (with sensitivity method of determination of 50 pg/ml).

If you use the above or other medicines (including over-the-counter) before using the drug Momat Rhino, consult your doctor.

Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, medicines containing cobicistat) may increase the risk of systemic side effects. Concomitant administration of these drugs should be avoided unless the benefits of treatment outweigh the risk of systemic side effects of the corticosteroid. In this case, the patient should be closely monitored to detect systemic side effects of corticosteroids.

Special Instructions

Read these instructions carefully before you begin using this medication as they contain important information for you.

Keep the instructions, you may need them again.

If you have any questions, consult your doctor.

The product you are taking is for your own personal use and you should not give it to anyone else as it may cause them harm even if you have the same symptoms as you do.

It is only indicated for intranasal use.

You should not use Momat Rhino for more than 3 months. As with any long-term treatment, patients receiving Momat Rhino nasal spray for several months or longer should periodically be examined by a physician for possible nasal mucosal changes.

Patients receiving intranasal GCS for a long time should be monitored. Growth retardation in children is possible. If any changes occur, the physician should be notified.

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

If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR), whose development has been reported after use of systemic and topical corticosteroids.

Patients who switch to treatment with Momat Rhino after long-term therapy with systemic glucocorticosteroids require special attention. Withdrawal of systemic glucocorticosteroids in such patients may lead to insufficiency of adrenal function, subsequent recovery of which may take up to several months. In case signs of adrenal insufficiency occur, systemic glucocorticosteroids should be resumed and other necessary measures should be taken.

The use of intranasal GCS may cause systemic side effects, especially with prolonged use in high doses. The likelihood of developing these effects is significantly lower than when using oral GCS. Systemic side effects may vary both in individual patients and depending on the glucocorticosteroid drug used. Potential systemic effects include Cushing’s syndrome, characteristic cushingoid signs, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly, a number of psychological or behavioral effects including psychomotor hyperreactivity, sleep disturbance, anxiety, depression, or aggression (especially in children).

During the transition from systemic glucocorticosteroid treatment to treatment with Momat Rhino Nasal Spray, some patients may experience initial symptoms of withdrawal from systemic glucocorticosteroids (e.g., joint and/or muscle pain, fatigue and depression) despite a reduction in symptoms associated with nasal mucosal damage. Such patients should be persuaded to continue treatment with Momat Rhino. Switching from systemic to topical glucocorticosteroids may also reveal pre-existing but masked by systemic glucocorticosteroid therapy, such as allergic conjunctivitis and eczema.

Patients treated with glucocorticosteroids have potentially compromised immune reactivity and should be warned of their increased risk of infection if they come into contact with patients suffering from certain infectious diseases (e.g., chickenpox, measles) and the need for medical consultation if such contact has occurred. If signs of significant bacterial infection (e.g., fever, persistent and severe pain on one side of the face or toothache, swelling of the orbital or periorbital area) are present, immediate medical consultation is required.

No signs of nasal mucosal atrophy were observed during 12 months of use of mometasone furoate as a nasal spray. In addition, mometasone furoate tended to promote normalization of the histologic picture when nasal mucosal biopsy specimens were examined.

The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, polyps associated with mucoviscidosis, and polyps that completely enclose the nasal cavity.

If unilateral polyps of unusual and irregular shape, especially ulcerated and bleeding polyps are detected, further medical examination should be performed.

Momat Rhino contains benzalkonium chloride, which may irritate the nasal mucosa.

Contraindications

Hypersensitivity to any of the drug components.

Recent nasal surgery or trauma with damage to the nasal cavity mucosa – until the wound healing (due to the inhibitory effect of GCS on healing processes).

Childhood under 18 years.

With caution. Before using Momat Rhino a doctor should be consulted in case of tuberculosis infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye involvement (as an exception, the drug may be prescribed for the above mentioned infections on the doctor’s instruction), presence of an untreated local infection with involvement of the nasal cavity mucosa.

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 when given placebo. Adverse reactions are listed according to the Med DRA classification of systemic-organ classes. Within each system-organ class, adverse reactions are classified by frequency of occurrence.

Nasal bleeding was generally moderate and stopped on its own, with a slightly higher incidence than with placebo (5%) but equal or lower than with other intranasal GCS prescriptions that were used as active controls (some had a rate of up to 15% of nasal bleeding). The incidence of all other adverse events was comparable to that of placebo administration.

The frequency of adverse reactions is given according to the following classification: Very common (>1/10), common (>1/100, <1/10), infrequent (>1/1000, <1/100), rare (>1/10 000, <1/1000), very rare (<1/10 000, including individual reports); for adverse reactions during post-registration follow-up the incidence has not been determined (cannot be determined based on available data).

Infectious and parasitic diseases: frequently – pharyngitis, upper respiratory tract infections.

Immune system disorders: frequency is not determined – hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath.

Nervous system disorders: often – headache.

Visual system disorders: frequency is not determined – increase in intraocular pressure, glaucoma, cataract, visual impairment (blurred vision).

Respiratory system, thorax and mediastinum disorders: very common – nasal bleeding**; common – nasal bleeding (i.e., clear bleeding, and secretion of blood stained mucus or blood clots), burning sensation in the nose, nasal mucosa irritation, nasal mucosa ulceration; frequency is not established – nasal septum perforation.

Gastrointestinal tract disorders: frequently – irritation of the pharynx (sensation of irritation of the pharyngeal mucosa)**; frequency is not determined – disorders of taste and smell.

* – revealed with the frequency “rarely” when using the drug 2 times a day for nasal polyposis;

** – revealed when using the drug 2 times a day for nasal polyposis.

The use of intranasal GCS may cause systemic side effects, especially with prolonged use of intranasal GCS in high doses.

If you have side effects indicated in the instructions or they worsen, or if you notice any other side effects not indicated in the instructions, inform your doctor.

Overdose

In case of prolonged use of GCS in high doses, as well as in case of simultaneous use of several GCS, inhibition of hypothalamic-pituitary-adrenal system function is possible. Due to low systemic bioavailability of the drug (1%, at sensitivity level of determination – 0,25 pg/ml) it is unlikely that in case of accidental or intentional overdose any measures will be required beside the monitoring with possible resumption of therapy in recommended dose.

In case of overdose a physician should be consulted.

Pregnancy use

A physician should be consulted before using Momat Rhino during pregnancy and breastfeeding.

Appropriately designed and well-controlled studies of the drug in pregnant women have not been conducted. As with other intranasal GCSs, Momat Rhino should be administered to pregnant or breastfeeding women only if the expected benefits of prescribing the drug justify the potential risk to the fetus or infant. Infants whose mothers have received GCS during pregnancy should be carefully screened for possible adrenal hypofunction.

Similarities

Desrinit spray, Nosefrine, Mometasone, Rialtris, Momeyd