Nasonex - instructions for use, for children, cheap analogues

Exhausting allergies, chronic sinusitis, polyps in the nasal cavity... It’s not a pleasant set. But even with it one can and must fight. Most often, the attending physician prescribes Nasonex spray. The drug has anti-inflammatory and antiallergic effects. It is based on mometasone furoate, which belongs to the group of glucocorticoids and is considered a synthetic drug.

an analogue of adrenal hormones, corticosteroids (GCS) for topical use.

Nasonex copes well with allergic rhinitis

Mometasone suppresses inflammatory and allergic reactions of various types when used in doses at which systemic effects do not develop. The therapeutic effect is observed 12 hours after the start of use.

Despite the fact that Nasonex is a hormonal drug, it does not affect other organs and systems except the nose.

A small dosage and use only in the nasal area ensures a very low concentration of mometasone in the blood. Also, it is worth noting that Nasonex is not addictive.

Indications

The main indications for the use of Nasonex spray are:

allergic rhinitis (seasonal or year-round), which is accompanied by constant rhinorrhea and swelling of the nasal mucosa;
exacerbation of chronic sinusitis (the drug is prescribed as an adjunct to antibiotic therapy) in adolescents and adults;
polyps of the nasal cavity, which lead to disruption of full respiratory function.

Children are prescribed Nasonex allergy spray from the age of two. For the treatment of sinusitis in pediatrics, it is used in children over twelve years of age.

Nasonex drops can be taken by children from 2 years of age

Also, the spray is used to prevent moderate/severe seasonal allergic rhinitis. Nasonex must be used 2 weeks before the expected start of the dusting period.

Pharmacodynamics

Beclomethasone dipropionate, a synthetic corticosteroid for topical use, has anti-inflammatory, antiallergic and immunosuppressive effects. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, inhibits the release of arachidonic acid. Prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and the production of lymphokines, inhibits the migration of macrophages, reduces the intensity of the processes of infiltration and granulation, and the formation of a chemotaxis substance. Reduces swelling of the nasal mucosa and mucus production. Improves mucociliary transport. It is well tolerated during long-term treatment, does not have mineralocorticoid activity, and has virtually no resorptive effect.

The therapeutic effect of Nasobek, unlike local vasoconstrictors for the treatment of rhinitis, does not appear immediately when administered intranasally. Relief from rhinitis symptoms usually becomes noticeable within a few days of starting treatment.

Contraindications

Before starting to use the drug, be sure to carefully read the instructions. The spray, since it is a medicinal product, has contraindications for use:

recent surgical interventions on the nasal cavity;
open wound surfaces, bleeding scratches and cracks in the nasal cavity;
increased individual sensitivity to the components of the drug;
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.

The drug is used with caution in the following conditions:

tuberculosis in active or latent form;
viral, bacterial or fungal processes;
herpetic infection in the nose;
infection of unknown origin.

Nasobek

Nasobek (beclomethasone dipropionate) is a local glucocorticosteroid obtained synthetically. Eliminates inflammation and signs of allergies, suppresses local immunity. Stimulates the production of lipocortin protein, which suppresses the production of the phospholipase A enzyme and prevents the release of arachidonic acid. Prevents the accumulation of neutrophils near the walls of blood vessels (the so-called marginal standing), suppresses the process of release of exudate into the inflammatory focus, reduces the reproduction of cytokines, and prevents the migration of monocytes. Helps eliminate swelling of the nasal mucosa and reduces mucus secretion. Improves the transport of pathogenic agents by the mucociliary system. With a long course of medication, it is well tolerated by patients. It does not have mineralocorticoid activity (does not retain sodium and water in the body and does not stimulate the excretion of potassium). It is used for allergic inflammation of the nasal mucosa of a seasonal and year-round nature, vasomotor rhinitis (inflammation of the mucous membrane due to impaired tone of the blood vessels of the nasal cavity). The therapeutic effect of Nasobek when instilled into the nasal cavity does not manifest itself so quickly, the effect of vasoconstrictors-decongestants. An improvement in the clinical picture is usually observed a few days after the start of the drug course. The drug practically does not enter the systemic circulation. After introduction into the nasal cavity, it quickly penetrates the mucous membrane. Some of the drug is ingested and is subsequently inactivated in the liver.

Nasobek is contraindicated in case of individual intolerance to beclomethasone dipropionate, hemorrhagic diathesis, frequent bleeding from the nasal cavity, the first trimester of pregnancy, viral and fungal infections. In pediatric practice, the drug is used starting from the age of 6 years. Lactation is not a direct contraindication to taking Nasobek, but if it is necessary to use this drug during breastfeeding, special care must be taken. Before using the medicine, you should clean your nasal passages. Frequency of use: 2-4 times a day, 50 mcg in each nostril. If there is improvement, the number of appointments is reduced. When using the drug in the doses specified in the instructions for use, unwanted side reactions develop relatively rarely. Possible sneezing, drying of the nasal mucosa, irritation, allergic manifestations, fungal contamination of the nasopharynx, headaches. With prolonged use in submaximal and maximum doses, systemic adverse reactions may occur, including adrenal insufficiency and signs of hypercortisolism. It is necessary to exclude the possibility of Nasobek getting into the eyes. Before using the drug for the first time or during a long break between its uses, it is recommended that the first dose be released into the air.

Side effects

When prescribing the drug, the following adverse reactions may occur:

pharyngitis;
headache;
nosebleeds (bleeding may be obvious or blood may be present in the mucus released from the nose);
irritation of the mucous membrane in the nasal cavity;
burning sensation in the nose.

One of the side effects of Nasonex may be headache.

In children receiving Nasonex for the treatment of allergic rhinitis, the following was observed:

nosebleeds;
irritation of the nasal mucosa;
headache;
sneezing;
very rarely: bronchospasm, shortness of breath, anaphylaxis, angioedema, disturbances of taste and smell, perforation of the nasal septum and increased intraocular pressure.

Directions for use and doses

Intranasally.

Before using Nasobek, the nasal passages must be free. Adults and children over 6 years of age: 1 dose (50 mcg) in each nasal passage 2–4 times a day (200–400 mcg). The dose is then reduced depending on the patient's response. The maximum daily dose is 400 mcg.

Directions for correct use:

Before using the spray for the first time, remove the plastic strip between the bottle cap and the nasal applicator.

1. Before use, shake the bottle slightly and then remove the cap of the nasal applicator.

2. Hold the bottle between your thumb and index finger so that the bottom of the bottle rests on your thumb and your index and middle fingers rest on either opposite side of the bottom of the applicator.

3. Before the first use of the drug or in case of a week-long break in use, the first dose should be released into the free space.

4. Exhale lightly through your nose.

5. The nasal passage into which the drug will not be injected should be clamped with a finger, and the end part of the applicator should be inserted into the free nasal passage. Then tilt your head slightly so that the bubble is in a perpendicular position.

6. After this, inhale lightly through the open nasal passage and at the same time press the nasal applicator and administer the dose.

7. Exhale through your mouth.

8. When re-introducing the drug into the same nasal passage, repeat the operations described in paragraphs 6 and 7.

9. When introducing the drug into the other nasal passage, repeat the operations described in paragraphs 4, 5, 6 and 7.

After finishing using the drug, you should clean the end of the applicator with a clean cloth and return the cap to its place.

Cleaning the nasal applicator:

The nasal applicator should be cleaned at least once a week to prevent the possibility of clogging.

To do this, lightly press the bottom of the bottle and remove the nasal applicator from the bottle.

The applicator and cap are rinsed with warm water and allowed to dry. After this, the applicator and cap are placed on the bottle.

How to take Nasonex

The drug is intended for intranasal administration of the suspension contained in the bottle through a dosing nozzle. The dose of the drug sprayed into the nasal cavity is determined by the doctor depending on the severity of the disease.

Before using the spray for the first time, it is “calibrated” by pressing the applicator 6-7 times. This action allows you to establish the delivery of the drug into the nasal cavity in a therapeutic dose of 100 mg.

Taking Nasonex

Before each use, the bottle must be shaken vigorously.

For direct use, the end of the dispensing nozzle must be inserted into the nasal passage and pressed on the applicator (1 press = 1 spray). The head and bottle with the drug must be kept strictly vertical.

If Nasonex has not been used for 14 days or more, it is necessary to re-calibrate by pressing the applicator 2 times. It is also important to clean the dispensing nozzle regularly to prevent it from malfunctioning.

Pharmacokinetics

Absorption from the gastrointestinal tract is low. T1/2 - 15 hours. Communication with plasma proteins - 87%.

The main part of the drug (35–76%), regardless of the route of administration, is excreted within 96 hours in the feces, mainly in the form of polar metabolites, 10–15% by the kidneys.

Nasonex during pregnancy

Due to the fact that there are no clinically proven studies of the effect of the active substance - mometasone furoate - on the body of a pregnant woman, the fetus and during lactation, the drug is prescribed with caution starting from the second trimester, and only when the expected effect of therapy justifies the potential risk to the fetus/newborn .

Nasonex during pregnancy

When using the drug during pregnancy, newborns should be carefully monitored for adrenal hypofunction.

Nasonex for children

According to the instructions for use, Nasonex spray can be used by children from 2 years of age. The prescription of the drug depends not only on the age of the child, but also on the disease being diagnosed.

seasonal and year-round allergic rhinitis - for children from 2 years of age;
acute sinusitis or exacerbation of chronic sinusitis - from 12 years of age;
acute rhinosinusitis with mild and moderate symptoms without signs of severe bacterial infection - from 12 years of age;
preventive treatment of moderate and severe seasonal allergic rhinitis - from 12 years of age (recommended two to four weeks before the expected start of the dust season);
Nasal polyposis, accompanied by impaired nasal breathing and sense of smell, is not prescribed for children.

Nasonex for allergies

Nasonex is used to treat seasonal or year-round allergic rhinitis in adults and adolescents over 12 years of age. The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) into each nasal passage once (total daily dose of mometasone - 200 mcg/day). Clinical improvement after the first use of Nasonex is observed within 12 hours.

After achieving the desired therapeutic effect and to maintain it, the dose is reduced to 100 mcg/day. (one inhalation into each nostril once).

If the symptoms of the disease do not decrease, then, in agreement with the attending physician, it is possible to increase the daily dose to 400 mcg/day. When the patient's condition improves, the dose of the drug must be reduced.

For children aged 2-11 years with allergies, it is recommended to take one inhalation in each nasal passage once. The total dose is 100 mcg/day.

Nasobek, nasal spray 50 mcg/dose, 200 doses

Manufacturer

Teva Pharmaceutical Enterprises Ltd., Israel

Compound

1 dose contains: active ingredient beclomethasone dipropionate 50 mcg; excipients: benzalkonium chloride solution (500 g/l) 0.04 mg, phenylethyl alcohol 256 mcg, polysorbate-80 5 mcg, glucose (anhydrous) 5 mg, microcrystalline cellulose and carmellose sodium 1000 mcg, concentrated hydrochloric acid qs, purified water up to 0.1 g.

pharmachologic effect

Pharmacotherapeutic group: glucocorticosteroid for local use
ATC code: R01AD01

Pharmacological properties

Pharmacodynamics

Beclomethasone is a synthetic glucocorticosteroid (GCS) for topical use that has anti-inflammatory, antiallergic and immunosuppressive effects. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, and inhibits the release of arachidonic acid. Prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and the production of lymphokines, inhibits the migration of macrophages, reduces the intensity of the processes of infiltration and granulation, and the formation of a chemotaxis substance. Reduces swelling of the nasal mucosa and mucus production. Improves mucociliary transport. It is well tolerated during long-term treatment, does not have mineralocorticoid activity, and has virtually no resorptive effect.

Pharmacokinetics

When administered by inhalation in recommended doses, it does not have significant systemic activity. After intranasal use, it is quickly absorbed into the nasal mucosa. Part of the administered beclomethasone is swallowed. Most of the beclomethasone that enters the gastrointestinal tract (GIT) is inactivated during the “first pass” through the liver. Absorption from the gastrointestinal tract is low. Communication with plasma proteins - 87%. The elimination of beclomethasone dipropionate and the highly active metabolite beclomethasone-17-monopropionate is characterized by high plasma clearance (150 and 120 l/h), the half-lives are 0.5 hours and 2.7 hours, respectively. The main part of beclomethasone (35-76%), regardless of the method of administration, is excreted through the intestines within 96 hours, mainly in the form of polar metabolites, 10-15% by the kidneys.

Indications

Prevention and treatment of seasonal and year-round allergic and vasomotor rhinitis.

Use during pregnancy and breastfeeding

Allowed only if the expected benefit to the mother outweighs the possible risk to the fetus. When treating with Nasobek during breastfeeding, caution should be exercised.

Contraindications

Hypersensitivity to beclomethasone and other components of the drug, hemorrhagic diathesis, nosebleeds, pulmonary tuberculosis, children under 6 years of age, pregnancy (first trimester), viral and fungal diseases. With caution: Ulcerations of the nasal septum, recent surgical interventions in the nasal cavity, recent trauma to the nose, glaucoma, pregnancy (II-III trimesters), breastfeeding period.

Side effects

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (≥ 1/10); often (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (<1/10000, including isolated cases); unknown - there is insufficient data to estimate the frequency of the phenomenon in the population.

Immune system disorders: rarely - hypersensitivity reactions, including skin rash, hives, redness and swelling of the face, eyes, lips, throat; very rarely - shortness of breath and/or bronchospasm, anaphylactic reactions.

From the nervous system: rarely - disturbance of olfactory and taste sensations, headache.

From the organ of vision: rarely - increased intraocular pressure, including glaucoma; very rarely - cataract; unknown - blurred vision, central serous chorioretinopathy (CSR) (see section "Special instructions").

From the respiratory system, chest organs and mediastinum: rarely - dryness and irritation of the nasopharynx, sneezing, nosebleeds, ulceration of the nasal mucosa, perforation of the nasal septum.

Other: unknown - with long-term use in high doses, the development of adrenal insufficiency and growth retardation in children is possible (see also section "Special instructions").

Interaction

There have been no reported cases of interaction of beclomethasone in this dosage form (nasal spray) with other drugs. Compared to other glucocorticosteroids, the metabolism of beclomethasone is less dependent on the CYP3A isoenzyme. However, in case of combined use with potent CYP3A inhibitors (for example, ritonavir, cobicistat-containing drugs), it is necessary to monitor the possible development of systemic side effects of glucocorticosteroids in patients.

How to take, course of administration and dosage

Intranasally.

Adults and children over 6 years old

2 doses (100 mcg) in each nasal passage 2 times a day (400 mcg/day). The maximum daily dose is 400 mcg/day. Some patients are recommended to use one dose (50 mcg) in each nasal passage 3-4 times a day.

When a therapeutic effect is achieved, the dose should be reduced to one dose (50 mcg) twice a day in each nasal passage (200 mcg/day). Each patient should be prescribed the lowest possible dose to provide effective symptom control.

The patient should be explained that the therapeutic effect is achieved after several days of treatment.

If after three weeks of therapy there is no improvement in the patient's condition, it is recommended to stop using the drug.

Elderly patients

no dose adjustment is required.

Recommendations for patients on the use of the drug

Before using the drug, it is necessary to clean the nasal passages.

When using for the first time, you should unlock the spray mechanism: press the dispenser several times until a cloud of aerosol appears. If the drug has not been used for several days, the spray mechanism should be unlocked again.

Before using the drug for the first time, remove the plastic protective half-ring located between the screw-on part and the dosing nasal applicator.

Before use, shake the bottle slightly and then remove the nasal applicator cap.
Place the bottle between your thumb and forefinger so that the bottom of the bottle rests on your thumb and your index and middle fingers rest on either opposite side of the bottom of the applicator.
Before using the drug for the first time or in case of a long break in use, the first dose should be sprayed into the air.
Exhale lightly through your nose.
The nasal passage into which the drug will not be injected should be clamped with a finger, and the applicator should be inserted into the free nasal passage. Then tilt your head slightly so that the bottle is in a perpendicular position.
Inhale lightly through the open nasal passage and at the same time press the nasal applicator and inject a dose of the aerosol.
Exhale through your mouth.
When re-introducing the drug into the same nasal passage, repeat the operations described in paragraphs 6 and 7.
When introducing the drug into the other nasal passage, repeat the operations described in paragraphs 5, 6, 7, 8.

After finishing using the drug, you should clean the end (upper) part of the applicator with a clean cloth and return the cap to its place.

Cleaning the applicator

The nasal applicator should be cleaned at least once a week to prevent the possibility of clogging.

To do this, lightly press the bottom of the applicator and detach the nasal applicator.

Rinse the applicator and cap with warm water and allow to dry.

After this, put the applicator and cap back on the bottle.

Overdose

Short-term use of the drug in doses exceeding the maximum recommended dose may cause depression of hypothalamic-pituitary-adrenal function, which does not require emergency treatment. Treatment can be continued in the prescribed doses, the hormonal feedback mechanism will be restored in 1-2 days.

Special instructions

Systemic side effects of nasal corticosteroids can occur primarily when high doses are administered over a long period of time. The likelihood of adverse reactions occurring is significantly less than with treatment with oral corticosteroids. Possible systemic effects include: Cushing's syndrome, characteristic Cushingoid signs, adrenal suppression, growth retardation in children and adolescents, cataracts and glaucoma, behavioral changes (especially in children): hyperactivity, sleep disorders, excitability, depression or aggression.

With long-term use of the drug Nasobek in children, it is necessary to monitor the dynamics of their growth. If growth slows, consider reducing the dose of nasal corticosteroids, if possible, to the minimum effective dose that controls the course of the disease.

Particular attention should be paid to patients during the period of their transition from systemic hormonal therapy to the drug Nasobek, during which a violation of the hypothalamic-pituitary-adrenal system may occur.

Nasobek should also be used with caution in patients with glaucoma, ulceration of the nasal septum and recent nasal trauma.

The use of Nasobek in higher doses than recommended may lead to clinically significant suppression of adrenal function. If the patient uses the drug in higher doses than recommended, the possibility of additional use of systemic corticosteroids should be assessed in case of planned surgery or during periods of stress.

In most patients, Nasobek eliminates the symptoms of seasonal allergic rhinitis, but in some cases, with very high concentrations of allergens in the air, additional therapy may be needed, especially to relieve eye symptoms.

Infectious diseases of the nasal cavity and paranasal sinuses require appropriate therapy, but are not contraindications to the use of the drug Nasobek.

Benzalkonium chloride, a preservative contained in the drug Nasobek, with long-term use increases the risk of swelling of the nasal mucosa. If such a reaction occurs, it is recommended to use medications that do not contain benzalkonium chloride. If medications that do not contain benzalkonium chloride are not available, medications that have a different dosage form should be selected.

Visual disturbances have been reported with systemic and local use of glucocorticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, consider referring the patient to an ophthalmologist to evaluate possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR).

Impact on the ability to drive vehicles and machinery

The drug Nasobek does not have or has a slight negative effect on the ability to drive vehicles and machinery. However, caution should be exercised when performing activities that require psychomotor speed.

Release form

Nasal spray dosed 50 mcg/dose. 200 doses in a plastic bottle equipped with a screw-on mechanical dosing applicator with a protective cap and a plastic protective half-ring to protect against accidental pressing. 1 bottle along with instructions for use in a cardboard box, on which additional protective stickers can be applied.

Storage conditions

Store at a temperature not exceeding 25 ºС, in a place protected from light. Do not freeze. KEEP OUT OF THE REACH OF CHILDREN.

Best before date

4 years. After opening the bottle for the first time, the drug must be used within 6 months. Do not use after the expiration date.

Active substance

Beclomethasone

Conditions for dispensing from pharmacies

On prescription

Dosage form

nasal spray

Purpose

For children as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Pregnant women in the 2nd and 3rd trimester as prescribed by a doctor, Children over 6 years old, For adults as prescribed by a doctor

Indications

Allergic rhinitis, Hay fever, Allergy, Runny nose

Information in the State Register of Medicines

Barcode and weight

Barcode: 8594737184314 Weight: 0.050 kg

Nasonex for adenoids

Enlarged adenoids are a fairly common complication of allergic rhinitis. Nasonex relieves swelling and often prevents the need for surgery.

A similar effect is achieved by suppressing lymphoid tissue. But it should be borne in mind that in case of severe inflammation, Nasonex is ineffective. Also, the hormonal nature of the drug suppresses the immune system to some extent, so after discontinuation of the drug, inflammation in the adenoids may resume (especially in children). To relieve this condition, it is recommended to undergo a course of anti-inflammatory treatment of adenoid vegetations. And also strengthen your immune system, eat right, walk in the fresh air, play sports and have as little contact with household chemicals and dust as possible.

Analogs of the drug Nasonex

Synonyms for Nasonex spray with the same active ingredient are: Desrinit, Rizonel, Asmanex Twistheiler, Momat Rino and Nosephrine.

Nasonex spray analogues

Analogues of Nasonex with a similar therapeutic effect (dosage form: spray): Flutinex, Avamis, Flixonase, Beclonazal, Beclomethasone, Fluticasone, Tafen, Rinoklenil, Polydexa, Nasobek, Nazarel, Budoster, Aldecin.

Nasal drops with GCS: Benacap, Benarin.

Before replacing Nasonex, you should definitely consult with your doctor regarding contraindications, dosage and duration of therapy.

Nasonex or Avamis?

Nasonex and Avamis have similar therapeutic effects, routes of administration and indications. The active component of Avamis spray is fluticasone furoate, Nasonex is mometasone furoate. Both substances are characterized by a very high degree of affinity for GCS receptors and exceptional local activity. However, among all existing corticosteroids for intranasal administration, mometasone has the lowest bioavailability and the fastest development of the therapeutic effect. In addition, Nasonex based on mometasone is approved for use in children from the age of two, while Avamis in pediatric practice is used only for the treatment of children over six years of age. Mometasone furoate has a more gentle effect on the body and does not have a negative effect.

But Avamis has fewer contraindications than Nasonex spray.

Do not forget that, despite the similarity of these two medications, only the attending physician can prescribe or replace one drug with another.

Nasonex or Desrinit?

The main differences between Nasonex and Dezrinit are price and manufacturer. Nasonex is an original drug produced in Belgium. And Dezrinit is a generic produced in Israel. The original drug always contains components of a higher degree of purification. Therefore, its effectiveness is higher and its tolerability is better. The active substance of the drugs is identical - mometasone. The composition contains minor differences in auxiliary components that do not affect the overall therapeutic effect.

Nasonex is more often used for children, because the drug has less side effects than its analogue.

Remember that even if the composition is the same, taking medications must be coordinated with your doctor, who will suggest the optimal solution for a specific disease.