Allergy spray Manat Rino analogues. Directory of medicines. Seasonal and year-round allergic rhinitis

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instructions for use

Release form and composition

Dosed nasal spray 1 dose active substance: mometasone furoate monohydrate 51.72 mcg (equivalent to 50 mcg of mometasone furoate) excipients: Avicel RC-591 (MCC, 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 for injection - up to 100 mg

Description of the dosage form

White to almost white, translucent to opaque consistency, thick suspension.

Pharmakinetics

When administered intranasally, the systemic bioavailability of mometasone furoate is<1% (при чувствительности метода определения 0,25 пг/мл). Суспензия мометазона очень плохо всасывается в 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.

Pharmadynamics

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, PG. 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).

Indications

seasonal and year-round allergic rhinitis in adults, adolescents and children from 2 years of age;

acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents over 12 years of age (as an auxiliary therapeutic agent in antibiotic treatment);

acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients 12 years of age or older;

preventive treatment of moderate and severe seasonal allergic rhinitis in adults and adolescents from 12 years of age (recommended 2-4 weeks before the expected start of the dusting season);

nasal polyposis, accompanied by impaired nasal breathing and sense of smell in adults (over 18 years of age).

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 process);

children's age (for seasonal and year-round allergic rhinitis - up to 2 years, for acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, for polyposis - up to 18 years) - due to the lack of relevant data.

With caution: 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, the drug can be prescribed for these infections as directed by a doctor); the presence of an untreated local infection involving the nasal mucosa.

Use during pregnancy and breastfeeding

There have been no properly designed and well-controlled studies of the drug in pregnant women. As with the use of other nasal corticosteroids, Momat Rino 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.

Side effects

Adults and teenagers. 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.

Adverse reactions are listed according to the system-organ class classification; adverse reactions are classified by frequency of occurrence. Nosebleeds, as a rule, were moderate and stopped on their own, the frequency of their occurrence was slightly higher than when using placebo (5%), but equal or less than when prescribing other intranasal corticosteroids, which were used as an active control (in some of In them, the incidence of nosebleeds was up to 15%).

The incidence of all other adverse events was comparable to that observed with placebo.

The frequency of adverse reactions is established as follows: very often (≥1/10); often (≥1/100,<1/10); редко (≥1/1000, <1/100). Для нежелательных реакций в период пострегистрационного наблюдения частота не установлена (не может быть определена на основании имеющихся данных).

From the immune system: frequency has not been established - hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath.

From the nervous system: often - headache.

From the organ of vision: frequency not established - increased IOP, glaucoma, cataract.

From 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.

From the gastrointestinal tract: often - pharyngeal irritation (feeling of irritation of the pharyngeal mucosa)**; frequency not established - disturbance of taste and smell.

From the respiratory system, chest and mediastinal organs: nosebleeds (6%), irritation of the nasal mucosa (2%), sneezing (2%).

From the nervous system: headache (3%).

The incidence of these adverse events in children was comparable to the incidence when using placebo.

When using intranasal corticosteroids, systemic side effects may develop, especially with long-term use in high doses.

*Revealed 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.

Interaction

Combination therapy with loratadine is well tolerated by patients. There is no observed effect of the drug on the plasma concentration of loratadine or its main metabolite.

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%, при чувствительности метода определения 0,25 пг/мл) маловероятно, что при случайной или намеренной передозировке потребуется принятие каких-либо мер помимо наблюдения с возможным последующим возобновлением приема препарата в рекомендованной дозе.

special instructions

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 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 nasal spray 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 this drug.

Patients who switch to treatment with Momat Rino 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 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 mucosal damage nasal membranes; such patients must be specifically convinced of the advisability of continuing treatment with Momat Rino nasal spray.

The transition from systemic to local GCS can also cause pre-existing allergic diseases, such as allergic conjunctivitis and eczema, that were masked by systemic GCS therapy.

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, chicken pox, 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.

The effectiveness and safety of mometasone have not been studied in the treatment of unilateral, irregularly shaped polyps, bleeding polyps, polyps associated with cystic fibrosis, and polyps that completely occlude the nasal cavity. Unilateral polyps that are irregular in shape or bleeding should be further examined.

With long-term use of nasal corticosteroids in high doses, systemic side effects may develop. The likelihood of developing these effects is much less than with the use of systemic corticosteroids and may vary in individual patients, as well as between different corticosteroids.

Potential systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly, a number of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially in children).

It is recommended to regularly monitor the growth of children receiving long-term therapy with mometasone. If growth slows, therapy should be reconsidered in order to reduce the dose of mometasone to the minimum effective dose to control the symptoms of the disease. In addition, the patient should be referred to a pediatrician for consultation.

Treatment with GCS in higher doses than recommended may lead to clinically significant suppression of adrenal function. If it is known that high doses of corticosteroids are used, it is necessary to consider the possibility of additional use of systemic corticosteroids during periods of stress or planned surgical intervention.

Impact on the ability to drive vehicles and engage in other activities. No data.

Conditions for dispensing from pharmacies

On prescription.

Discussion of the drug Momat rhino in the posts of mothers

Active ingredients

Azelastine hydrochloride
- mometasone furoate (mometasone)

Release form, composition and packaging

Dosed nasal spray 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, - 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.

pharmachologic effect

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

Azelastine, a phthalazinone derivative, is a long-acting antiallergic agent. 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, 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 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).

Pharmacokinetics

Azelastine hydrochloride

Suction and distribution

Bioavailability after intranasal administration is about 40%. Cmax in the blood 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.

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.

Carefully the drug should be prescribed for 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, the drug can be prescribed for the listed infections as directed by a doctor), the presence of an untreated infection with involvement of the nasal mucosa in the process.

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.

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.

For the skin and subcutaneous tissues: very rarely - rash, itchy skin.

Others: 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.

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: carrying out 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.

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).

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 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.

Pregnancy and lactation

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 childhood

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

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, protected from light at a temperature of 15 to 25°C; do not freeze. Shelf life - 2 years.

Instructions:

Clinical and pharmacological group

Release form, composition and packaging

Cream for external use 0.1% white.

Excipients: white soft paraffin, white beeswax, propylene glycol monostearate.

5 g - aluminum tubes (1) - cardboard packs.

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.

Dosage

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

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.

Use during 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.

Side effects

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.

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.

Indications

For cream

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

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

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 (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.

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).

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

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.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Registration numbers

Momat Rino Advance is a drug with antiallergic combined action for local use. The blocking substance included in the product stops H-1 histamine receptors, thereby achieving a quick relief effect when allergic reactions occur. In addition, Mamat Rhino Advance has anti-inflammatory properties, which makes it possible to use a spray or drops during the off-season to relieve the symptoms of colds.

Pharmacological action and release form

Dosage forms of release – bottles of nasal spray, 1 bottle in a cardboard package. The product is a white liquid suspension, enclosed in a high-density polyethylene bottle, complemented by a dosing device (cap). One bottle is designed for 150 doses of the drug.

The combined action drug is often used in ENT practice for the treatment of allergic reactions. Thanks to the glucocorticosteroid compound mometasone furorate, Momat Rhino Advance quickly eliminates the effects of allergies and fights inflammation in the nasopharynx. The positive effect is achieved by spraying mometasone onto the nasal mucosa, thereby increasing the natural generation of lipomodulin. Reaction with phospholipase reduces the concentration of arachidonic acid, which leads to a decrease in symptoms.

Important! The spray reduces the allergic symptom, and the membrane-stabilizing effect in this case only complements the effect, eliminating the marginal accumulation of neutrophils. Reducing the number of lymphokine compounds, stopping the migration of macrophages, slowing down infiltration, granulation and their subsequent deactivation provides positive dynamics in alleviating symptoms even in the most difficult cases.

Instructions for use, composition of the product

Before taking Momat Rhino Advance, you should review the composition of the product and indications. The instructions for use recommend using the drug only intranasally, that is, for injection into the nasal passages. Inhalations are carried out using a nozzle specially equipped on the bottle.

Important! Doctors' recommendations are clear - the use of the drug must be approved by a doctor. Particular care should be taken in case of infection of the nasal mucosa, latent or active form of tuberculosis, or the presence of a systemic viral/fungal disease affecting the eyes.

The spray contains the following components:

1. azelastine hydrochloride, mometasone furorate – the main substances;
2. Avicel PC, citric acid monohydrate, sodium citrate, polysorbate-80, neotame, disodium edetate, dextrose, benzalkonium chloride, sodium carmellose, raw water – excipients.

Azelastine hydrochloride is the main substance that is a derivative of phthalazinone. It is this component that has a membrane-stabilizing, antiallergic, antihistamine effect and reduces capillary permeability and exudation. Suspension of the release of biologically active substances from cells that cause bronchospasms is a direct obstacle to the development of inflammation in the middle and late stages of allergy.

Mometasone furorate is a synthetic glucocorticosteroid and, when applied topically, shows high antiallergic and anti-inflammatory effects. Having the ability to increase the production of lipomodulin, it inhibits the synthesis of arachidonic acid metabolism. It is especially important that this composition minimizes the formation of a chemotaxis substance, influencing the late manifestations of allergic reactions.

Side effects

Momat Rhino Advance nasal spray should be used only as prescribed by a doctor in doses that do not cause systemic addiction. Otherwise, side effects of the drug may occur. Contributing factors may include:

1. From the nervous system: bitter taste in the mouth, headaches, dizziness;
2. From the gastrointestinal tract: irritation of the pharyngeal mucosa, nausea, extremely rarely - vomiting;
3. Anaphylactoid-type reactions and hypersensitivity reactions from the immune system are extremely rare;
4. Sneezing, discomfort in the nasal area, ulceration of the mucous membrane - reactions from the respiratory system.

Important! If the patient experiences nosebleeds, sinusitis or pharyngitis, the drug should be stopped immediately.

The skin rarely reacts to the drug, mainly urticaria and itching appear. However, this may be a manifestation of an allergic reaction, for which the medicine is taken to relieve the symptoms. Long-term use of the drug increases the risk of systemic addiction and the development of effects characteristic of GCS, including eye damage: glaucoma, cataracts.

As for a drug overdose, there may be central nervous system disorders, hypotension, and tachycardia. Symptomatic therapy will be required. Long-term use of the drug simultaneously with other corticosteroids can lead to inhibition of the hypothalamic-pituitary-adrenal system. In this case, it is necessary to temporarily discontinue the medication to stabilize the patient's condition. After normalization, therapy continues in the doses indicated by the doctor.

Directions for use and doses

The instructions for use of the drug limit the use of the drug and prescribe exclusively the nasal method of using the composition. The norm for adults is 1 dose twice a day in each nostril. Take morning and evening, course of treatment is 14 days. Initial use requires calibration of the bottle and dispenser; it is best to press the dispenser 5-6 times, releasing a stream of spray into the air. This way, the bottle will contain the right amount of air for the pump so that the spray is dispensed in the optimal amount for each procedure. If the medicine is not used for a long time, the dispenser should be pressed until the substance splashes before use.

Directions for use:

1. Clear the nasal passages as much as possible;
2. Remove the cap from the bottle;
3. Take the bottle, holding the adapter between the middle and index fingers of your hand, hold the bottom of the bottle with your thumb;
4. Place the adapter in the nostril, press the dosing device while taking a sharp breath. Sometimes it is recommended to close the other nostril;
5. Exhale through your mouth;
6. Repeat the procedure with the second nostril.

Spraying the nasal agent onto the oral mucosa and into the eyes is not recommended. After use, the nasal adapter should either be wiped with a clean cloth, or removed and rinsed in warm water, then dried.

Analogues of the drug

Today Momat Rhino Advance has no identical analogues. But there are products that contain the same basic remedy: Dezrinit, Nasonex. The analogues are incomplete, so their use should be discussed with the treating doctor. As a last resort, analogues that have a similar antiallergic effect are acceptable: Allergodil.

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, which 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

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.

Dosage regimen

Externally. A thin layer of Momat ointment or cream is applied to the affected areas of the skin 1 time per day. The duration 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 for use

- 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 (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.

WITH caution The drug should be applied to intertriginous skin and facial skin, used with occlusive dressings, on large areas of skin and/or for a long period of time (especially in children).

Use during pregnancy and breastfeeding

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.

Use in children

Contraindication: children under 2 years of age (for ointment.

WITH caution should be used with occlusive dressings, on large areas of skin and/or for a long period of time (especially in children). 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.

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

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.