Instruction for use: Beclazone

ATX Code R03BA01 Beclomethasone

Pharmacological group

Glucocorticosteroids

Nosological classification (ICD-10)

J30 Vasomotor and allergic rhinitis

Allergic rinopatiya, Allergic rhinosinusopathy, Allergic respiratory diseases, Allergic rhinitis, nasal allergy, Seasonal Allergic Rhinitis, Vasomotor rhinitis, Long-allergic rhinitis, Perennial allergic rhinitis, Perennial allergic rhinitis, Year-round or seasonal allergic rhinitis, Year-round allergic rhinitis nature, Rhinitis allergic vasomotor, Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic rhinitis, Edema of the nasal mucosa, Edema of the nasal mucosa, Swelling of the mucosa of the nasal cavity, Swelling of the nasal mucosa, Swelling of the nasal mucosa, pollen disease, Permanent allergic rhinitis, rhinoconjunctivitis, rhinosinusitis,rhinosinusopathy, Seasonal allergic rhinitis, Seasonal Allergic Rhinitis, Haymarket rhinitis, Chronic allergic rhinitis, Allergic respiratory diseases

J33.0 Polyp of the nasal cavity

Polyposis of the nose, Resection of nasal cavity polyps

J33.1 Polyposis degeneration of the sine

Polyposis of the nose

Composition and form of release

Spray for nasal application Dosed 1 dose

Beclomethasone dipropionate 50 μg

Auxiliary substances: dispersed cellulose; glycerol; Propylene glycol; Sodium citrate dihydrate; Acid lemon monohydrate; Polysorbate 80; Benzalkonium chloride; purified water

In cylinders PE (polyethylene) to 8.5 g (with a dosing device and mouthpiece); In a pack of cardboard 1 bottle.

Description of dosage form

White opaque suspension without visible foreign matter.

pharmachologic effect

Pharmacological action - anti-inflammatory, anti-allergic.

Pharmacodynamics

Beclomethasone dipropionate - GCS, has anti-inflammatory, anti-allergic and immunosuppressive effects.

It inhibits the release of inflammatory mediators from mast cells, increases the production of lipomodulin, which inhibits phospholipase A, reduces the release of arachidonic acid, inhibits the synthesis of metabolic products of arachidonic acid-cyclic endoperoxides, PG.

Reduces the edema and secretion of the glands of the nasal mucosa, improves mucociliary transport. Virtually does not have mineralocorticoid activity and resorptive effect after inhalation.

Pharmacokinetics

Absorption - low, with inhalation mode of administration in the recommended doses does not have a clinically significant systemic activity. After inhalation, it is possible to swallow part of the administered dose with saliva. Most of the drug, trapped in the digestive tract (gastrointestinal tract), is inactivated with the effect of "first passage" through the liver. Binding to plasma proteins - 87%. T1 / 2 - 15h.

The main part of the preparation (35-76%) is excreted within 96 hours with the calves, mainly in the form of polar metabolites, 10-15% - by the kidneys.

Indications

Allergic rhinitis (seasonal or year-round);

Vasomotor rhinitis;

Polyposis of the nose (in combination therapy).

Contraindications

Hypersensitivity to any of the components of the drug;

Tuberculosis (including latent) of the respiratory system;

Systemic infections (bacterial, fungal, viral, including infection caused by Herpes simplex, with eye damage);

Recent surgery or trauma to the nose

Hemorrhagic diathesis;

Frequent nasal bleeding;

Children under 6 years of age (safety and efficacy of the drug have not been established).

Carefully:

Concomitant infectious disease requiring antibiotics;

arterial hypertension;

Recently suffered myocardial infarction;

Ulceration of the nasal septum;

glaucoma;

Amebiasis;

Severe hepatic impairment;

Hypothyroidism;

pregnancy;

Lactation period.

pregnancy and lactation

Aldecin® can be used in pregnant and lactating women only if the possible benefits of treatment for a woman justifies the potential risk to the fetus or newborn. Newborns of women who received SCS during pregnancy should be examined to identify a possible reduction in the function of the adrenal cortex.

Side effects

Allergic reactions (urticaria, itching, angioedema, reddening of the skin), nasopharyngeal infections caused by fungal flora, rhinorrhea, epistaxis, burning sensation or irritation of the nasal mucosa, dry nose, sneezing, smelling impairment, increased eye pressure, glaucoma, violation Appetite, dyspepsia, nausea, diarrhea, headache, dizziness, arterial hypertension, difficulty breathing.

When nasal SCS is used in large doses for a long time, cases of perforation of the nasal septum are noted. Side effects that are characteristic of systemic SCS may also occur with treatment with Aldecin® if the drug is used in doses exceeding the recommended levels, or the patient has an increased sensitivity to GCS, or has recently been treated with systemic SCS. With the development of such symptoms and side effects, Aldecin® should be discontinued, gradually reducing the dose.

Interaction

Clinically significant types of interaction between inhaled corticosteroids and other drugs have not been identified.

Phenobarbital, phenytoin, rifampicin, and other inducers of microsomal oxidation decrease efficiency.

Methandrostenolone, estrogens, beta2-adrenostimulants, theophylline and orally administered glucocorticosteroids enhance the effect.

Increases the effect of beta-adrenostimulyatorov.

Dosing and Administration

Intranasal, in the form of inhalations.

Adults and adolescents from 12 years: the recommended dose is 1-2 inhalations in each half of the nose 4 times a day, depending on the severity of the symptoms.

Children from 6 to 11 years: the recommended dose - 1-2 inhalations in each half of the nose 2 times a day, depending on the severity of the symptoms.

The maximum daily dose should not exceed 16 inhalations (0.8 mg) in adults and 8 in inhalations (0.4 mg) in children aged 6 to 11 years. When the therapeutic effect is achieved, the drug is canceled, gradually reducing the dose.

A guide for patients on the proper performance of inhalation

Before the first application of the nasal spray, it is necessary to calibrate it by pressing the dosing device 6-7 times. After "calibration", a stereotyped drug supply is established. If the spray has not been used for 14 days or longer, then a new "calibration" is required before a new application.

Before carrying out the inhalation, the nasal passages should be released. Vigorously shake the bottle. Insert the nasal applicator, keeping it in an upright position, into the nostril - towards the inner corner of the eye. In this case, the second nostril should be closed, pressing a finger, and head slightly tilt forward.

Do not spray the spray directly onto the nasal septum!

Then, take a deep breath through the nose with the simultaneous pressing of the spray and exhale through the mouth. Inhalation in the second nostril is similar.

To obtain a single dose of 100 mcg, patients should perform inhalation as described above twice.

Overdose

Symptoms: when used in very high doses, systemic effects of SCS, including suppression of adrenal function and symptoms of hypercorticism, can be observed.

Treatment: with the appearance of such symptoms, the dose should be reduced.

special instructions

Do not pierce the nozzle of the bottle with a needle or wire. It is necessary to protect the eyes from getting the drug.

The therapeutic effect of Aldecin®, in contrast to local vasoconstrictors for the treatment of rhinitis, with intranasal application is not immediately apparent. Relief of symptoms of rhinitis usually becomes noticeable within a few days from the start of treatment.

Patients who have a decrease in immunity against the background of SCS therapy should be warned of the danger of contact with patients with certain infections (eg, chicken pox, measles) and the need to consult a doctor in case of such contact. This is of particular importance for children.

Because the drug slows wound healing, patients who have recently suffered an injury or nose surgery should not use Aldecin® nasal spray until the wound is completely healed.

Storage conditions

At a temperature not exceeding 25 ° C. (Do not freeze).

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.