Allergy spray Manat Rino analogues. Directory of medicines. Acute form of rhinosinusitis, not complicated by severe bacterial infection

In this article you can read the instructions for use of the drug Momat. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Momat in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Momat analogues in the presence of existing structural analogues. Use for the treatment of psoriasis, dermatitis and allergic rhinitis in adults, children, as well as during pregnancy and lactation. Composition of the hormonal drug.

Momat- a drug with antiallergic and anti-inflammatory effects for local use and in ENT practice.

Mometasone (the active ingredient of the drug Momat) 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 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).

Azelastine, a phthalazinone derivative, is a long-acting antiallergic drug. Azelastine is a selective blocker of histamine H1 receptors, has an antihistamine, antiallergic and membrane-stabilizing effect, reduces capillary permeability and exudation, stabilizes mast cell membranes and prevents the release of biologically active substances from them (histamine, serotonin, leukotrienes, platelet-activating factor and others), causing bronchospasm and promoting the development of early and late stages of allergic reactions and inflammation.

Compound

Mometasone furoate + excipients.

Azelastine hydrochloride + Mometasone furoate + excipients (Momat Rhino Advance).

Mometasone furoate + Salicylic acid + excipients (Momate C).

Pharmacokinetics

Mometasone furoate

When administered intranasally, the systemic bioavailability of mometasone furoate is less than 1% (with a sensitivity of the detection method of 0.25 pg/ml). The mometasone suspension is very poorly absorbed from the gastrointestinal tract, and the small amount of mometasone suspension that can enter the gastrointestinal tract after nasal inhalation undergoes active primary metabolism even before excretion in the urine or bile.

Azelastine hydrochloride

Bioavailability after intranasal administration is about 40%. Intranasal administration in patients with allergic rhinitis causes an increase in plasma levels of azelastine compared to healthy volunteers. Metabolized in the liver by oxidation with the participation of the cytochrome P450 system to form the active metabolite desmethylazelastine. It is excreted mainly by the kidneys in the form of inactive metabolites.

Indications

For cream:

  • inflammatory phenomena and itching in dermatoses amenable to glucocorticosteroid therapy.

For ointment:

  • inflammatory phenomena and itching in dermatoses (psoriasis, atopic dermatitis, seborrheic dermatitis), amenable to glucocorticosteroid therapy, in adults and children over 2 years of age.

For spray:

  • seasonal allergic rhinitis in adults over 18 years of age.

Release forms

Dosed nasal spray (Momat Rino Advance) (sometimes mistakenly called nasal drops).

Cream for external use 0.1%.

Ointment for external use 0.1%.

Ointment for external use (Momat S).

Instructions for use and method of use

Ointment or cream

Externally. A thin layer of Momat ointment or cream is applied to the affected areas of the skin once a day. The duration of treatment is determined by its effectiveness, tolerability of the drug, as well as the presence and severity of side effects.

Nasal spray

The drug is used intranasally (in the nose). Inhalation of the suspension contained in the bottle is carried out using a special dispensing nozzle on the bottle.

Prescribe 1 dose of spray (azelastine hydrochloride 140 mcg/mometasone furoate 50 mcg) in each nostril 2 times a day in the morning and evening. The duration of treatment is 2 weeks.

Instructions for use of the bottle with dispensing device

1. Remove the protective cap.

2. Before using the nasal spray for the first time, it is necessary to “calibrate” it by pressing the dispensing device about 10 times. If the nasal spray has not been used for 7 days or longer, it may need to be re-calibrated by pressing the dispenser about 2 times, or pressing the cap until it sprays when pressed. It is necessary to place the index and middle fingers on the sides of the nasal adapter, and the thumb on the bottom of the bottle and, while inhaling through the nose, press. Do not puncture the nasal adapter. When spraying, do not direct into eyes.

3. Before use, clean the nostrils if possible. Pinch one nostril and insert the end of the nasal adapter into the other nostril, keeping the bottle vertical. Press the adapter quickly and firmly. Do not spray on the nasal septum.

4. Exhale through your mouth.

5. Repeat the steps described in step 3 for the other nostril.

6. Wipe the nasal adapter with a clean cloth and put on the protective cap.

Instructions for cleaning the nasal adapter

1. Remove the protective cap.

2. Carefully remove the nasal adapter by pulling upwards.

3. Rinse the nasal adapter with cold running water on both sides and dry. Do not use any auxiliary objects (such as needles or sharp objects) to clean the adapter to avoid damaging it.

4. Rinse the protective cap with cold running water and dry.

5. Place the nasal adapter in its original place. Make sure the bottle stem is placed in the center of the nasal adapter.

6. Perform calibration by pressing the dosing device 2 times, or pressing the lid until a fine dispersion begins to come out steadily when pressed. Do not spray into eyes.

7. Put on the protective cap.

Momat S ointment

Externally. A thin layer of ointment should be applied to the affected areas of the skin 2 times a day, morning and evening. The maximum daily dose is 15 g.

Side effect

Cream and ointment

  • mild or moderate burning sensation at the site of application of the ointment;
  • peeling;
  • irritation, maceration of the skin;
  • dry skin;
  • folliculitis;
  • acne (rosacea);
  • hypopigmentation;
  • perioral dermatitis;
  • allergic contact dermatitis;
  • the appearance of atrophic stripes of the skin;
  • prickly heat;
  • secondary infections;
  • hypertrichosis;
  • in children, suppression of the function of the hypothalamic-pituitary-adrenal system with the development of Cushing's syndrome is possible.

Spray in the nose

  • headache;
  • dysgeusia (unpleasant taste) as a result of improper use, namely, when the head is tilted too far back during administration;
  • dizziness (may be caused by the disease itself);
  • feeling of irritation of the pharyngeal mucosa;
  • nausea;
  • nosebleeds;
  • discomfort in the nasal cavity (burning sensation, itching);
  • ulceration of the nasal mucosa;
  • sneezing;
  • pharyngitis;
  • sinusitis;
  • upper respiratory tract infections;
  • hypersensitivity;
  • anaphylactoid reactions;
  • hives;
  • rash;
  • skin itching;
  • fatigue;
  • drowsiness;
  • weakness (may be caused by the disease itself);
  • glaucoma;
  • cataract.

Contraindications

Cream and ointment

  • rosacea;
  • perioral dermatitis;
  • bacterial, viral (Herpes simplex (herpes simplex), chickenpox, Herpes zoster) or fungal skin infections;
  • tuberculosis, syphilis;
  • post-vaccination reactions;
  • children under 2 years of age (for ointment);
  • pregnancy (use on large areas of skin, long-term treatment);
  • lactation period (use in high doses and/or for a long time);
  • hypersensitivity to GCS or to the components of the drug.

Nasal spray

  • 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 any of the components of the drug.

Use during pregnancy and breastfeeding

There have been no properly designed and well-controlled studies of the drug in pregnant women.

Azelastine hydrochloride is capable of causing intrauterine toxicity in mice, rats and rabbits.

The use of Momat during pregnancy and breastfeeding is contraindicated.

Use in children

The use of Momat Rino Advance is contraindicated in children and adolescents under 18 years of age (due to the lack of relevant data).

The ointment is contraindicated in children under 2 years of age.

special instructions

As with any long-term treatment, patients using Momat Rhino Advance nasal spray for several months or longer should be periodically examined by a doctor for possible changes in the nasal mucosa, perforation of the nasal septum (very rare) and the possible development of systemic side effects. If a local fungal infection of the nose or throat develops, it may be necessary to discontinue treatment with Momat Rhino Advance nasal spray and undergo special treatment. If persistent irritation of the nasopharynx develops, it is necessary to decide on stopping therapy.

Patients who switch to treatment with Momat Rhino Advance nasal spray after long-term treatment with systemic glucocorticosteroids (GCS) require special attention. Withdrawal of systemic corticosteroids in such patients can lead to insufficient adrenal function, 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.

During the transition from treatment with systemic corticosteroids to treatment with Momat Rhino Advance nasal spray, some patients may experience initial withdrawal symptoms of systemic corticosteroids (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 specifically convinced of the advisability of continuing treatment with Momat Rhino Advance nasal spray. The transition from systemic to local GCS can also reveal pre-existing allergic diseases, such as allergic conjunctivitis and eczema, that were masked by systemic GCS therapy.

When intranasal steroids are used in doses higher than recommended, or at recommended doses in sensitive patients, systemic effects of corticosteroids and suppression of adrenal function may develop. If such changes occur, the use of Momat Rhino Advance nasal spray should be gradually discontinued, in accordance with the procedures adopted for stopping the use of oral corticosteroids.

Patients undergoing treatment with corticosteroids have a potentially reduced immune reactivity and should be warned about their increased risk of infection in case of contact with patients with certain infectious diseases (for example, chickenpox, measles), as well as the need for medical advice if such contact occurs .

If signs of a severe 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.

GCS for nasal and inhalation use can cause the development of glaucoma and/or cataracts. Therefore, patients with changes in vision, as well as patients with a history of increased intraocular pressure, glaucoma and/or cataracts, should be closely monitored.

Impact on the ability to drive vehicles and operate machinery

In rare cases, fatigue, fatigue, dizziness and weakness, which may be a consequence of the disease itself, may develop when using Momat Rhino Advance nasal spray. In such cases, you should avoid driving a vehicle and working with complex mechanisms.

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. 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).

Analogues of the drug Momat

Structural analogues of the active substance:

  • Avecort;
  • Asmanex Twisthaler;
  • Galazolin Allergo;
  • Gistan N;
  • Desrinitis;
  • Momat Rhino Advance;
  • Momat S;
  • Momederm;
  • Mometasone;
  • Mometasone furoate;
  • Monovo;
  • Nasonex;
  • Nosephrine;
  • Silkaren;
  • Uniderm;
  • Elokom;
  • Elokom Lotion;
  • Elokom S.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

pharmachologic effect

Preparation for external use.

Mometasone is a synthetic corticosteroid with anti-inflammatory, antipruritic and antiexudative effects. GCS induce the release of lipocortin proteins that inhibit phospholipase A2, controlling the biosynthesis of inflammatory mediators (prostaglandins, leukotrienes) by inhibiting the release of their common precursor - arachidonic acid.

Pharmacokinetics

Suction

Absorption of Momat ointment and cream is negligible. 8 hours after a single application of the drug to intact skin (without an occlusive dressing), about 0.7% (ointment) and 0.4% (cream) of the active substance are found in the systemic circulation.

Metabolism

Mometasone is extensively metabolized in the liver.

Removal

It is excreted mainly by the kidneys and in small amounts with bile. T1/2 of mometasone from Momat ointment is approximately 5.8 hours.

Indications

Inflammatory phenomena and itching in dermatoses (psoriasis, atopic dermatitis, seborrheic dermatitis), amenable to glucocorticosteroid therapy, in adults and children over 2 years of age.

Dosage regimen

Externally. A thin layer of Momat ointment or cream is applied to the affected areas of the skin 1 time. The duration of the course of treatment is determined by its effectiveness, tolerability of the drug, as well as the presence and severity of side effects.

Side effect

From the endocrine system: when using external forms of GCS for a long time and/or for treatment on large areas of skin, or using occlusive dressings, especially in children and adolescents - adrenal insufficiency, Cushing's syndrome.

Dermatological reactions: rarely - skin irritation, dry skin, burning sensation, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, skin maceration, secondary infection, signs of skin atrophy, stretch marks, prickly heat; in less than 1% of cases - the formation of papules and pustules.

Allergic reactions: rarely - itching, allergic contact dermatitis.

Contraindications

  • rosacea;
  • perioral dermatitis;
  • bacterial, viral (Herpes simplex, chickenpox, Herpes zoster) or fungal skin infections;
  • tuberculosis, syphilis;
  • post-vaccination reactions;
  • children under 2 years of age;
  • pregnancy (use on large areas of the skin, long-term treatment);
  • lactation period (use in large doses and/or for a long time);
  • hypersensitivity to GCS or to the components of the drug.

Caution should be exercised when applying the drug to intertriginous skin and facial skin, using with occlusive dressings, on large areas of skin and/or for a long period of time (especially in children).

Pregnancy and lactation

The safety of mometasone furoate during pregnancy and lactation (breastfeeding) has not been established.

GCS penetrate the placental barrier. Long-term treatment and the use of large doses during pregnancy should be avoided due to the risk of negative effects on fetal development.

GCS are excreted in breast milk. In cases where GCS is intended to be used in large doses and/or for a long time, breastfeeding should be stopped.

special instructions

When applying the drug to large areas of skin for a long time, especially when using occlusive dressings, signs of suppression of the function of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome may develop.

Avoid contact of Momat ointment and cream with the mucous membrane of the eye.

Propylene glycol contained in Momat may cause irritation at the site of application. In such cases, use of the drug should be discontinued and appropriate treatment should be prescribed.

It should be borne in mind that GCS can change the manifestations of some skin diseases, making diagnosis difficult. In addition, the use of GCS may cause a delay in wound healing.

With long-term therapy with GCS, sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be discontinued gradually, for example, by switching to an intermittent treatment regimen before stopping it completely.

Use in pediatrics

The safety and effectiveness of mometasone furoate when used topically in children for periods exceeding 6 weeks have not been studied. Due to the fact that in children the ratio of surface area to body weight is greater than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and developing Cushing's syndrome with external use of GCS. Long-term treatment of children with GCS can lead to impaired growth and development. Children should receive the minimum dose of the drug sufficient to reduce the effect.

Overdose

Symptoms: inhibition of the function of the hypothalamic-pituitary-adrenal system, including secondary adrenal insufficiency.

Treatment: symptomatic, if necessary, correct the electrolyte balance, discontinue the drug (with long-term therapy - gradual withdrawal).

Drug interactions

Drug interaction studies of Momat ointment and cream with other drugs have not been conducted.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25°C; do not freeze. Shelf life - 2 years.

Momat Rino Advance is a combined antiallergic drug for local use (glucocorticosteroid + H1-histamine receptor blocker).

Release form and composition

The drug is available in the form of a dosed nasal spray, which is a suspension of white or almost white color (150 doses each in polyethylene bottles with a dosing device and a nasal adapter, one bottle in a cardboard package and instructions for use of Momata Rino Advance).

Composition per dose of spray:

  • active ingredients: mometasone furoate – 50 mcg, azelastine hydrochloride – 140 mcg;
  • auxiliary components: dextrose, benzalkonium chloride, carmellose sodium, citric acid monohydrate, neotame, Avicel RC-591 (sodium carmellose and microcrystalline cellulose), polysorbate-80, disodium edetate, sodium citrate, water for injection.

Pharmacological properties

Pharmacodynamics

Mometasone is a synthetic GCS (glucocorticosteroid). In small doses that do not lead to the development of systemic effects, it has anti-inflammatory and antiallergic activity. Mometasone increases the production of lipomodulin, which inhibits phospholipase A, an enzyme that slows down the release of arachidonic acid and its metabolic products (cyclic endoperoxides, prostaglandins).

Mometasone furoate prevents the accumulation of neutrophils at the vascular walls, resulting in a decrease in the production of lymphokines and the volume of inflammatory exudate; inhibits macrophage migration; slows down the processes of granulation and infiltration. Mometasone affects the final stages of allergies (by reducing the formation of a chemotaxis substance) and inhibits the development of anaphylactic shock and other immediate allergic reactions.

Azelastine is a phthalazinone derivative and is a long-acting antiallergic drug. Azelastine is a selective blocker of H1-histamine receptors that has antiallergic, membrane-stabilizing and antihistamine effects. It reduces exudation and capillary permeability, stabilizes mast cell membranes, preventing the release of leukotrienes, serotonin, histamine, platelet-activating factor and other biologically active substances that cause bronchospasm and contribute to the development of inflammation, as well as early and late allergic reactions.

Pharmacokinetics

When administered intranasally, the bioavailability of mometasone for systemic absorption does not exceed 1%. The drug is very poorly absorbed from the gastrointestinal tract. Mometasone, which enters the digestive system after inhalation and is absorbed into the blood, undergoes a primary passage through the liver and is metabolized before being excreted in urine or bile.

The bioavailability of azelastine hydrochloride after inhalation of Momata Rhino Advance is about 40%. The maximum plasma concentration is observed after 2–3 hours. After intranasal administration of a daily dose of azelastine hydrochloride (0.56 mg), its average equilibrium concentration in plasma is 0.65 ng/ml (2 hours after taking the drug). Administration of a double dose (1.12 mg per day) leads to a steady-state average plasma concentration of 1.09 ng/ml. Despite the high absorption, the systemic effect of azelastine hydrochloride after intranasal administration is approximately 8 times lower than after taking azelastine orally at a daily dose of 4.4 mg (the therapeutic oral dose of the drug for allergic rhinitis). In patients with allergic rhinitis, after intranasal administration of azelastine hydrochloride, its plasma concentration increases compared to healthy volunteers.

Azelastine hydrochloride is 80–90% bound to plasma proteins. Metabolism occurs in the liver with the participation of the cytochrome P 450 system, resulting in the formation of desmethyl azelastine (an active metabolite). The main route of elimination is through the kidneys. The drug is excreted primarily in the form of inactive metabolites. T 1/2 of azelastine averages 20 hours, and desmethylazelastine - approximately 45 hours.

Indications for use

Momat Rhino Advance is used for the symptomatic treatment of year-round and seasonal allergic rhinitis.

Contraindications

Absolute (the drug is strictly contraindicated):

  • recent surgery or trauma to the nose with damage to the mucous membrane of the nasal cavity (before the final healing of the wound, since corticosteroids slow down the healing process);
  • children and adolescents up to 18 years of age;
  • period of pregnancy and lactation;
  • hypersensitivity to the main or auxiliary components of the drug.

Momat Rino Advance is used with caution for the following diseases (the drug can only be used as prescribed by the attending physician):

  • tuberculosis infection in active or latent form;
  • the presence of untreated infections of various origins (fungal, systemic viral, bacterial, as well as infections caused by Herpes simplex with eye damage);
  • local untreated infection with damage to the mucous membranes of the nasal cavity.

Momat Rino Advance: instructions for use (dosage and method)

Spray Momat Rino Advance is used intranasally by inhalation of the suspension contained in the bottle. Spraying is carried out using a special dispensing nozzle on the bottle.

Instructions for using the dispensing device with a nasal adapter:

  1. Calibrate the nasal spray before first use by pressing the dispensing device repeatedly (approximately 6 presses). Re-calibration is required if the product has not been used for 7 days or longer. In this case, it is necessary to press the dispensing device 2 or more times (until splashes appear).
  2. Before spraying the spray, it is advisable to clean the nostrils, then, holding one nostril with your finger and tilting your head slightly forward, insert the tip of the nasal adapter into the other nostril (keep the bottle in a vertical position). Press the adapter with a quick and sharp movement. It is not recommended to spray the drug onto the nasal septum.
  3. Exhale through your mouth.
  4. Repeat the steps described in point 3 for the second nostril.
  5. Wipe the adapter with a cloth and close with the protective cap.
  • Remove the protective cap from the bottle.
  • Carefully pull the nasal adapter up and remove it.
  • Rinse the adapter on both sides with running cold water and dry. To clean the adapter, do not use needles, sharp objects or other aids to avoid damaging it.
  • Rinse the protective cap with cold running water and dry it.
  • Place the adapter back and ensure that the bottle stem is in the center of the nasal adapter.
  • After cleaning the adapter, perform calibration by pressing the dosing device 2 or more times (until a stable fine dispersion appears). The spray should not be sprayed into the eyes.
  • Place the cap on the bottle.

Patients with mild renal impairment (creatinine clearance 79 ml/min or more) do not require dose adjustment. In case of moderate or severe renal impairment (creatinine clearance 10–79 ml/min), Momat Rhino Advance is used with caution and under close medical supervision.

For patients with impaired liver function, the drug is prescribed in normal doses.

Side effects

In general, Momat Rhino Advance is well tolerated. Undesirable side effects are usually mild and do not require discontinuation of treatment. The safety profile of the combination of mometasone furoate and azelastine hydrochloride is comparable to the profiles of the components of the drug separately.

The following side effects have been reported with the use of azelastine hydrochloride:

  • common: bitter taste in the mouth after inhalation (usually caused by excessive tilting of the head while spraying), which can cause nausea (rare);
  • uncommon: mild, transient irritation of the nasal mucosa with itching, burning, sneezing and nosebleeds;
  • very rarely: fatigue, weakness, dizziness, drowsiness, hypersensitivity reactions (urticaria, itching, rash), anaphylactoid reactions.

Side effects of Momat Rino Advance due to the content of mometasone furoate:

  • respiratory system: very often – nosebleeds; often - irritation, burning and ulceration in the nose; frequency unknown – perforation of the nasal septum;
  • gastrointestinal tract: often – sore throat (when using the drug twice a day to treat nasal polyposis); frequency unknown – disorder of smell and taste;
  • nervous system: often – headache;
  • organ of vision: frequency unknown - cataracts, increased intraocular pressure, glaucoma;
  • immune system: frequency unknown - hypersensitivity reactions, including shortness of breath, bronchospasm, angioedema and anaphylactic reactions;
  • infectious diseases: often - pharyngitis, upper respiratory tract infections (occurs infrequently when treating nasal polyposis and using the drug twice a day).

In case of long-term therapy with large doses, nasal corticosteroids may cause systemic adverse reactions.

In children, mometasone furoate caused the following adverse reactions, with a frequency comparable to placebo: headache, sneezing, nosebleeds, nasal irritation.

Overdose

Cases of overdose of Momat Reno Advance with intranasal administration have not been registered.

Accidental ingestion of azelastine (in large doses) may cause disturbances in the cardiovascular and nervous systems (tachycardia, decreased blood pressure, confusion, drowsiness). Treatment is symptomatic.

Taking high doses of corticosteroids for a long time can lead to depression of the hypothalamic-pituitary-adrenal system. The bioavailability of mometasone is low, therefore, in case of accidental or intentional overdose of Momat Rino Advance, no measures to eliminate intoxication are required. The patient is monitored, and in the future it is possible to resume therapy in recommended doses.

special instructions

When using azelastine hydrochloride (in this dosage form), there are no special instructions that must be followed during treatment.

The following notes are relevant for drugs that contain mometasone furoate (including Momat Rino Advance nasal spray):

  • immunosuppression: GCS suppress the immune system, so patients being treated with these drugs should be warned about the high risk of infection in case of contact with patients with measles, chickenpox and some other infectious diseases. If such contact has taken place, it is necessary to consult a doctor for advice;
  • local nasal action: with long-term use of the nasal spray (several months or more), the nasal mucosa should be periodically examined for possible changes. Discontinuation of the drug is required in patients with a constantly present feeling of irritation of the nasopharynx, as well as with the development of a localized fungal infection of the nasopharynx. It is not recommended to use mometasone furoate in persons with perforation of the nasal septum. Nosebleeds that develop during treatment are usually mild and stop on their own;
  • systemic effects of GCS: in the case of long-term therapy with large doses of GCS, systemic side effects may occur, but the likelihood of their occurrence is much less than when taking oral GCS. Possible systemic effects include: Cushing's syndrome, growth retardation (in childhood), the appearance of Cushingoid features, glaucoma, cataracts, suppression of adrenal function; rarely - psychological and behavioral disorders (anxiety, sleep disorders, psychomotor hyperactivity, aggression, depression). Isolated cases of increased intraocular pressure after the use of GCS for intranasal administration have also been described. The use of doses significantly higher than recommended can lead to clinically significant suppression of adrenal function, therefore, during planned surgical operations, as well as during periods of stress, when taking high doses of corticosteroids is necessary, the advisability of additional use of systemic corticosteroids should be considered;
  • Nasal polyps: For the treatment of certain polyps (polyps causing complete sinus obstruction; unilateral polyps; cystic fibrosis polyps), the safety and effectiveness of the nasal spray have not been studied. Additional study is required when using the drug in patients with unilateral polyps characterized by heterogeneous or unusual appearance, especially in the presence of bleeding or ulceration;
  • Non-nasal symptoms: Concomitant use of mometasone furoate with additional medicinal products may result in a reduction in other (non-nasal) symptoms, especially ophthalmic ones.

One of the auxiliary components of Momata Rino Advance (benzalkonium chloride) can cause bronchospasm and irritation of the nasal mucosa, particularly in patients with hypersensitivity.

Impact on the ability to drive vehicles and complex mechanisms

Very rarely, when using Momat Reno Advance, fatigue, weakness, dizziness and fatigue develop. Despite the fact that these symptoms may be directly related to the disease itself, during the treatment period you should avoid driving vehicles and working with other potentially dangerous and complex mechanisms.

Use during pregnancy and lactation

Spray Momat Rino Advance is contraindicated in pregnant and lactating women.

No special human studies have been conducted on the safety of the drug for the fetus or breastfed child. However, azelastine hydrochloride is known to cause intrauterine toxicity in rabbits, rats and mice.

Use in childhood

Momat Rino Advance is contraindicated for use in children and adolescents under 18 years of age.

For impaired renal function

For mild renal impairment (creatinine clearance is 79 ml/min or more), Momat Rhino Advance is used in normal doses. If the creatinine clearance value is from 10 to 79 ml/min (moderate and severe renal impairment), the nasal spray is prescribed with caution and under strict medical supervision.

For liver dysfunction

There is no need for dose adjustment of Momat Rhino Advance for patients with impaired liver function.

Drug interactions

Mometasone and azelastine are metabolized by different receptors, so no drug interactions between the substances are expected for this combination (in fixed doses).

Azelastine hydrochloride, when administered intranasally, does not enter into clinically significant drug interactions with other substances and drugs.

Mometasone in combination with loratadine is well tolerated by patients, without changing the plasma concentration of loratadine, as well as its main metabolite.

Analogues

There is no information about analogues of Momata Rino Advance.

Terms and conditions of storage

Store out of reach of children and protected from light at a temperature of +15...+25 °C. The drug should not be frozen.

Shelf life – 2 years.

Momat Rino Advance is used intranasally. Inhalation of the drug is carried out using a dosing nozzle. One dose of spray contains 50 mcg of mometasone, 140 mcg of azelastine hydrochloride. The dosage of the drug for allergic rhinitis is 1 dose in each nasal passage twice a day (morning, evening). The duration of the course is 14 days.

Contraindications

The drug is contraindicated in the following conditions:

  • Recent surgery, nasal injury, while there is damage to the mucous membrane (before it heals). The contraindication is due to the inhibitory effect of GCS on wound healing.
  • Hypersensitivity to components.
  • In childhood and adolescence up to 18 years.

Care is taken to treat the nasal cavity for tuberculosis of the ENT organs in the latent or active phase. Momat Rhino Advance is also used with caution for fungal infections of the nose, untreated bacterial infection, systemic viral infection caused by the Herpes simplex virus with damage to the organs of vision. All of the listed diseases can be treated with the drug only as prescribed by a doctor and under his supervision.

Pregnancy and lactation

Contraindicated. Detailed studies on the use of the drug in pregnant women have not been conducted, but since azelastine hydrochloride can have a toxic effect on the embryos of laboratory animals, the use of the drug during pregnancy and lactation is prohibited.

Overdose

To date, no cases of overdose have been identified (with intranasal use). When taking azelastine orally, it is possible to develop disorders of the central nervous system - lethargy, confusion, drowsiness, decreased blood pressure, tachycardia. Treatment is symptomatic. Long-term use of corticosteroids in large doses and in combination with systemic treatment with them can lead to inhibition of the pituitary gland, hypothalamus, and adrenal glands.

Side effects

  • From the gastrointestinal tract - irritation of the pharyngeal mucosa, nausea.
  • From the nervous system – headache, dizziness.
  • On the skin – rash, itching.
  • From the respiratory system - nosebleeds, burning, itching in the nose, sneezing, sinusitis, pharyngitis, ulceration of the nasal cavity.
  • From the immune system - hypersensitivity, urticaria, anaphylaxis.
  • Other reactions – drowsiness, weakness, increased fatigue.

The drug can give an unpleasant taste in the mouth if used incorrectly - excessive tilting of the head back when administering the drug. Long-term local administration of corticosteroids can increase intraocular pressure and provoke the development of cataracts and glaucoma.

Compound

The main active ingredients are mometasone furoate and azelastine hydrochloride. Additional substances - microcrystalline cellulose, sodium carmellose, polysorbate 80, dextrose, benzalkonium chloride, neotame, disodium edetate, sodium citrate, citric acid monohydrate, purified water.

Pharmacology and pharmacokinetics

Azelastine is a long-acting antiallergic component. It has an antiallergic, antihistamine, membrane-stabilizing effect, reduces capillary permeability and exudate production.

Mometasone is a synthetic corticosteroid for topical use, has an anti-inflammatory, antiallergic effect, and inhibits the release of allergy mediators.

The bioavailability of azelastine after intranasal administration is 40%, the maximum plasma concentration is observed after 2-3 hours. Communication with blood proteins – 80-90%. The drug is metabolized in the liver and excreted by the kidneys in the form of inactive metabolites. The half-life of azelastine is 20 hours. The bioavailability of mometasone when administered intranasally is less than 1%, so there are no systemic effects from its use.

Other

The shelf life of the drug is 2 years. Should be stored at a temperature of 15-25 degrees in a place inaccessible to children, protected from light. Dispensed with a doctor's prescription.

Momat Rhino Advance is a combined two-component drug for intranasal use in otorhinolaryngological practice for the treatment of seasonal allergic rhinitis. The therapeutic effect of the drug is determined by the pharmacological effects of its individual components. Azelastine is a long-acting antiallergic agent. Selectively blocks H1-histamine receptors, stabilizes mast cell membranes, makes capillary walls less permeable, reduces exudation, and prevents the release of allergy mediators from cells (histamine, leukotrienes, platelet-activating factor). Mometasone is a glucocorticosteroid produced synthetically. Has local anti-inflammatory and antiallergic effects. Prevents the release of pro-inflammatory mediators. Stimulates the production of lipocortin protein, which suppresses the activity of the enzyme phospholipase A, which, in turn, reduces the production of arachidonic acid and inhibits the production of inflammatory mediators prostaglandins. Prevents the adhesion of neutrophil granulocytes to endothelial cells, which reduces exudation and production of cellular immunity mediators, lymphokines, prevents the migration of histophagocytes, and reduces infiltration (penetration and accumulation of substances or particles in tissues that are not their normal component). Reduces inflammation, suppresses immediate hypersensitivity. The peak concentration of azelastine when sprayed into the nasal passages is observed after 2-3 hours. It is well absorbed through the mucous membrane of the nasal cavity, but despite this, its systemic effect is 8 times lower than after taking the tablet form of azelastine for the treatment of allergic rhinitis. After nasal inhalation, mometasone penetrates into the gastrointestinal tract only in a minimal amount and, even before elimination from the body, undergoes intense metabolic transformations. Single dose - 1 press into each nasal passage. Frequency of application - twice a day in the morning and evening. The duration of the medication course is 2 weeks.

Possible unwanted side effects associated with taking the drug: cephalalgia, metallic taste in the mouth (if the head is tilted too far back during injection), nausea, discomfort in the throat, nosebleeds, burning and itching in the nose, sneezing, inflammation of the mucous membrane larynx, paranasal sinuses, upper respiratory tract infections. With prolonged use at submaximal and maximum doses, systemic unwanted side effects are possible, including glaucoma and cataracts. The drug is not prescribed after recent surgical interventions on the nose or other mechanical damage to the nasal mucosa, in case of individual intolerance to any active or auxiliary component, during pregnancy and during breastfeeding. In pediatric practice, the drug is not used due to the lack of clinical data on its effectiveness and safety in patients of this age category. Particular caution should be exercised when prescribing the drug during an active infection of the eyes or nasal mucosa. When using the drug as part of long-term drug courses, regular medical examination is required to check for the presence of dystrophic changes in the mucous membrane and the manifestation of systemic undesirable side effects. Local fungal infection of the nasopharynx may require discontinuation of pharmacotherapy. Persons taking glucocorticosteroids should be informed that, due to reduced immunity, they are at increased risk of contracting certain infections. Glucocorticosteroids (including those for intranasal use) can have a negative effect on the organs of vision, incl. cause cataracts and glaucoma, so patients at risk should be under medical supervision while taking the drug.

Pharmacology

A combined drug with antiallergic and anti-inflammatory effects for local use in ENT practice.

Azelastine, a phthalazinone derivative, is a long-acting antiallergic drug. Azelastine is a selective blocker of histamine H1 receptors, has an antihistamine, antiallergic and membrane-stabilizing effect, reduces capillary permeability and exudation, stabilizes mast cell membranes and prevents the release of biologically active substances from them (histamine, serotonin, leukotrienes, platelet-activating factor and others) , causing bronchospasm and contributing to the development of early and late stages of allergic reactions and inflammation.

Mometasone is a synthetic corticosteroid 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).

Pharmacokinetics

Azelastine hydrochloride

Suction and distribution

Bioavailability after intranasal administration is about 40%. Cmax in blood plasma after intranasal use is achieved within 2-3 hours. When administered intranasally at a daily dose of 0.56 mg of azelastine hydrochloride, the average Cmax of azelastine hydrochloride in plasma 2 hours after administration is 0.65 ng/ml. Doubling the total daily dose to 1.12 mg resulted in a steady-state mean plasma azelastine concentration of 1.09 ng/mL. However, despite the relatively high absorption in patients, systemic exposure after intranasal administration is approximately 8 times lower than after oral administration of a daily dose of 4.4 mg of azelastine hydrochloride, which is a therapeutic oral dose for the treatment of allergic rhinitis. Intranasal administration in patients with allergic rhinitis causes an increase in plasma levels of azelastine compared to healthy volunteers.

Other pharmacokinetic data have been studied when administered orally.

Binding to blood proteins is 80-90%.

Metabolism and excretion

Metabolized in the liver by oxidation with the participation of the cytochrome P450 system to form the active metabolite desmethylazelastine.

It is excreted mainly by the kidneys in the form of inactive metabolites. T 1/2 of azelastine is about 20 hours, its active metabolite desmethylazelastine is about 45 hours.

Mometasone furoate

When administered intranasally, the systemic bioavailability of mometasone furoate is<1% (при чувствительности метода определения 0.25 пг/мл). Суспензия мометазона очень плохо всасывается из ЖКТ, и то небольшое количество суспензии мометазона, которое может попасть в ЖКТ после носовой ингаляции, еще до экскреции с мочой или желчью подвергается активному первичному метаболизму.

Release form

Nasal spray dosed in the form of a white or almost white suspension.

Excipients: microcrystalline cellulose (Avicel RC-591) - 0.91 mg, carmellose sodium - 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.

Dosage

The drug is used intranasally. Inhalation of the suspension contained in the bottle is carried out using a special dispensing nozzle on the bottle.

Prescribe 1 dose of spray (azelastine hydrochloride 140 mcg/mometasone furoate 50 mcg) in each nostril 2 times a day in the morning and evening. The duration of treatment is 2 weeks.

Instructions for use of the bottle with dispensing device

1. Remove the protective cap.

2. Before using the nasal spray for the first time, it is necessary to “calibrate” it by pressing the dispensing device about 10 times. If the nasal spray has not been used for 7 days or longer, it may need to be re-calibrated by pressing the dispenser about 2 times, or pressing the cap until it sprays when pressed. It is necessary to place the index and middle fingers on the sides of the nasal adapter, and the thumb on the bottom of the bottle and, while inhaling through the nose, press. Do not puncture the nasal adapter. When spraying, do not direct into eyes.

3. Before use, clean the nostrils if possible. Pinch one nostril and insert the end of the nasal adapter into the other nostril, keeping the bottle vertical. Press the adapter quickly and firmly. Do not spray on the nasal septum.

4. Exhale through your mouth.

5. Repeat the steps described in step 3 for the other nostril.

6. Wipe the nasal adapter with a clean cloth and put on the protective cap.

Instructions for cleaning the nasal adapter

1. Remove the protective cap.

2. Carefully remove the nasal adapter by pulling upwards.

3. Rinse the nasal adapter with cold running water on both sides and dry. Do not use any auxiliary objects (such as needles or sharp objects) to clean the adapter to avoid damaging it.

4. Rinse the protective cap with cold running water and dry.

5. Place the nasal adapter in its original place. Make sure the bottle stem is placed in the center of the nasal adapter.

6. Perform calibration by pressing the dosing device 2 times, or pressing the lid until a fine dispersion begins to come out steadily when pressed. Do not spray into eyes.

7. Put on the protective cap.

Overdose

Currently, there are no cases of drug overdose with intranasal use.

Symptoms: in case of an overdose of azelastine as a result of accidental ingestion, disorders of the nervous system may occur (drowsiness, confusion, tachycardia, hypotension).

Treatment: symptomatic therapy. With long-term use of GCS in high doses, as well as with the simultaneous use of several GCS, suppression of the hypothalamic-pituitary-adrenal system is possible. Due to the low systemic bioavailability of the drug, it is unlikely that in the event of an accidental or intentional overdose, any measures other than observation will be required, with the possible subsequent resumption of the drug at the recommended dose.

Interaction

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. 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).

Side effects

The incidence of side effects is determined as follows: very often (>1/10); often (<1/10, >1/100); infrequently (<1/100, >1/1000); rarely (<1/1000, >1/10,000); very rarely (<1/10 000).

From the nervous system: often - headache, dysgeusia (unpleasant taste) as a result of improper use, namely, with excessive tilting of the head back during administration; very rarely - dizziness (may be caused by the disease itself).

From the digestive system: rarely - a feeling of irritation of the pharyngeal mucosa, nausea.

From the respiratory system: often - nosebleeds, discomfort in the nasal cavity (burning sensation, itching), ulceration of the nasal mucosa, sneezing, pharyngitis, sinusitis, upper respiratory tract infections.

From the immune system: very rarely - hypersensitivity, anaphylactoid reactions, urticaria.

From the skin and subcutaneous tissues: very rarely - rash, itching.

Other: very rarely - fatigue, drowsiness, weakness (may be caused by the disease itself).

With long-term use of GCS in high doses, systemic side effects may develop, incl. glaucoma and cataracts.

Indications

Seasonal allergic rhinitis in adults over 18 years of age.

Contraindications

  • 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 any of the components of the drug.

The drug should be prescribed with caution in case of tuberculosis infection (active and latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for these infections as directed by a doctor), the presence of untreated infections involving the nasal mucosa.

Features of application

Use during pregnancy and breastfeeding

There have been no properly designed and well-controlled studies of the drug in pregnant women.

Azelastine hydrochloride is capable of causing intrauterine toxicity in mice, rats and rabbits.

The use of the drug during pregnancy and breastfeeding is contraindicated.

Use in children

The use of the drug in children and adolescents under the age of 18 is contraindicated (due to the lack of relevant data).

special instructions

As with any long-term treatment, patients using Momat Rhino Advance nasal spray for several months or longer should be periodically examined by a doctor for possible changes in the nasal mucosa, perforation of the nasal septum (very rare) and the possible development of systemic side effects. If a local fungal infection of the nose or throat develops, it may be necessary to discontinue treatment with Momat Rhino Advance nasal spray and undergo special treatment. If persistent irritation of the nasopharynx develops, it is necessary to decide on stopping therapy.

Patients who switch to treatment with Momat Rhino Advance nasal spray after long-term treatment with systemic GCS require special attention. Withdrawal of systemic corticosteroids in such patients can lead to insufficient adrenal function, 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.

During the transition from treatment with systemic corticosteroids to treatment with Momat Rhino Advance nasal spray, some patients may experience initial withdrawal symptoms of systemic corticosteroids (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 specifically convinced of the advisability of continuing treatment with Momat Rhino Advance nasal spray. The transition from systemic to local GCS can also reveal pre-existing allergic diseases, such as allergic conjunctivitis and eczema, that were masked by systemic GCS therapy.

When intranasal steroids are used in doses higher than recommended, or at recommended doses in sensitive patients, systemic effects of corticosteroids and suppression of adrenal function may develop. If such changes occur, the use of Momat Rhino Advance nasal spray should be gradually discontinued, in accordance with the procedures adopted for stopping the use of oral corticosteroids.

Patients undergoing treatment with corticosteroids have a potentially reduced immune reactivity and should be warned about their increased risk of infection in case of contact with patients with certain infectious diseases (for example, chickenpox, measles), as well as the need for medical advice if such contact occurs .

If signs of a severe 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.

GCS for nasal and inhalation use can cause the development of glaucoma and/or cataracts. Therefore, patients with changes in vision, as well as patients with a history of increased intraocular pressure, glaucoma and/or cataracts, should be closely monitored.

Impact on the ability to drive vehicles and operate machinery

In rare cases, fatigue, fatigue, dizziness and weakness, which may be a consequence of the disease itself, may develop when using Momat Rhino Advance nasal spray. In such cases, you should avoid driving a vehicle and working with complex mechanisms.



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