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

Active ingredient

Composition

1 dose contains:

The active ingredients:

mometasone furoate monohydrate 51.72 mcg, corresponding to 50 mcg of mometasone furoate.

Excipients: avicel RC-591 (microcrystalline cellulose, sodium carmellose) – 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.

How to take, the dosage

Intranasal.
Inhalation of the suspension contained in the bottle is carried out 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. You should 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 noted within 12 hours after the first use of the drug.
Advice for patients on the use of the drug

Preparing the nasal spray for use

The bottle of Momat Rhino nasal spray has a dust cap that protects the dispensing tip and prevents it from getting dirty. Remember to remove it before use and put it back after use.
1. Shake the bottle gently.
2. Hold the bottle so that your index and middle finger is on each side of the dispensing tip and your thumb is on the bottom of the bottle. Do not pierce the nasal applicator.
3. Point the dispensing tip away from you and finger-press 10 times to obtain a fine spray.
If the nasal spray has not been used for 7 days or more, re-pump the bottle by pressing 2 times on the dispensing tip until a homogenous spray is produced.

Please apply the nasal spray

1. Shake the bottle gently and remove the dust cap
2. Gently exhale through your nose.
3. Close one nostril and insert the dispensing tip into the other nostril. Slightly tilt your head forward holding the bottle vertically.
4. Begin to inhale slowly and carefully with your open nostril and, while breathing in, inject the spray into your nostril by pressing once with your fingers.
5. Exhale through your mouth. Repeat step 4 to inject a second dose of spray into the same nostril, if necessary.
6. Remove the dispensing nozzle from that nostril and exhale through your mouth.
7. 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 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 tip

– It is important to clean the dispensing tip on a regular basis; otherwise it may not function properly.
– Remove the dust cap and gently remove the dispensing tip.
– Rinse the dispensing tip and dust cap in warm water and then rinse under the faucet.
– Do not attempt to re-pipe the nasal applicator with a pin or other sharp object ? This will damage the applicator and you may not get the correct dose of medication.
– Dry the cap and nozzle in a warm place.
– Refit the dispensing tip and put the dust cap back on.
– Before first use after cleaning, re-pump the bottle with 2 taps on the dispensing tip.

Interaction

The combination therapy with loratadine was well tolerated by patients. No effect of the drug on plasma concentrations of loratadine or its main metabolite was observed. In these studies, mometasone furoate was not detected in blood plasma (at the sensitivity of the 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, medicinal products 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 for systemic side effects of corticosteroids.

Special Instructions

Read these instructions carefully before you start using this medicine as they contain important information for you.
– Keep the instructions, you may need them again.
– If you have any questions, talk to your doctor.
– The product you are taking is meant for you and should not be given to others as it may cause them harm even if you have the same symptoms as you do.

It is indicated for intranasal use only.
Momat Rhino should not be used for more than 3 months. Consult a physician if more than 3 months is necessary.
As with any long-term treatment, patients who use Momat Rhino nasal spray for months or longer should periodically be monitored by a physician for possible nasal mucosal changes.
Patients receiving intranasal GCS for a long time should be monitored. Growth retardation may occur in children. 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 treatment with Momat Rhino and provide specific treatment. Prolonged irritation of the nasal and pharyngeal mucosa may also be a reason to discontinue treatment with Momat Rhino.

If a patient develops symptoms such as blurred vision or other visual disturbances, he or she 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), the development of which has been reported after systemic and topical corticosteroid use.
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. If signs of adrenal insufficiency occur, systemic glucocorticosteroids should be restarted and other appropriate measures taken.

In intranasal GCS use, systemic side effects may develop, especially with long-term use at high doses. The likelihood of these effects is much lower than with 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 hyperresponsiveness, sleep disturbance, anxiety, depression, or aggression (especially in children).

At the time of transition from systemic glucocorticosteroid treatment to treatment with Momat Rhino Nasal Spray, some patients may experience initial withdrawal symptoms 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 reduced 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 occurs. 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.
Nasal mucosal atrophy has not been observed for 12 months when using mometasone furoate as a nasal spray. In addition, mometasone furoate tended to normalize the histologic picture when nasal mucosa 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 or irregular shape, particularly ulcerated or bleeding polyps are detected, further medical evaluation should be performed.
Momate Rhino contains benzalkonium chloride, which may irritate the nasal mucosa.

Influence on ability to drive vehicles, machinery

There are no data on the effect of the drug on the ability to drive or operate moving machinery.

Contraindications

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

With caution

Before using the drug Momat Rhino should be consulted with a physician 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 infections on the doctor’s indication), presence of untreated local infection with involvement of the nasal 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 the period of 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 to 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, no frequency was established (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 – increased intraocular pressure, glaucoma, cataracts, 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 determined – nasal septum perforation.
Gastrointestinal tract disorders: often – irritation of the pharynx (sensation of irritation of the pharyngeal mucosa)**; frequency is not established – disorders of taste and smell.
* – revealed with the frequency “rarely” when using the drug 2 times a day in case of nasal polyposis;
** – revealed when using the drug 2 times a day in case of nasal polyposis.
The use of intranasal GCS may cause systemic side effects, especially with prolonged use of intranasal GCS in high doses.
If you experience or worsen the side effects listed in the instructions, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Pregnancy use

Similarities