Pharmacodynamics. After topical application of beclomethasone 17,21-dipropionate has a powerful anti-inflammatory and vasoconstrictor effect. beclomethasone dipropionate is a precursor of an active substance with a weak affinity for cc-receptors. it is hydrolyzed by esterases to form the active metabolite of beclomethasone-17-monopropionate, which has high local anti-inflammatory activity.
Beclomethasone dipropionate provides a prophylactic baseline treatment for hay fever when used before allergen exposure. With regular use of beclomethasone, dipropionate prevents recurrence of allergy symptoms.
Pharmacokinetics. After intranasal administration of beclomethasone dipropionate, systemic absorption was determined by measuring the concentration of its active metabolite, beclomethasone 17-monopropionate (B-17-MP), the absolute bioavailability of which after intranasal administration is 44%. Beclomethasone dipropionate is very quickly excreted from the circulation, and after intranasal administration, its plasma concentration cannot be measured (50 pg / ml). Metabolism occurs in all tissues with the participation of esterases. The main metabolic product is an active metabolite (beclomethasone 17-monopropionate). Plasma protein binding is moderately high (87%). T½ for beclomethasone dipropionate is 0.5 hours and for beclomethasone 17-monopropionate - 2.7 hours. After oral administration of beclomethasone dipropionate, about 60% of the dose is excreted in the feces within 96 hours, mainly in the form of free and conjugated polar metabolites. About 12% of the dose was excreted in the urine as free and conjugated polar metabolites. Renal clearance of beclomethasone dipropionate and its metabolites is negligible.
Prevention and treatment of perennial and seasonal allergic rhinitis.
Beconase should be used for intranasal use only. Shake well before use.
Adults: 2 injections into each nasal passage 2 times a day or 1 injection into each nasal passage 4 times a day.
The maximum daily dose should not exceed 8 injections (400 mcg).
To obtain the full therapeutic effect, regular use of the preparation is necessary. After the first few injections, maximum relief is not achieved.
Do not use for more than 3 months without consulting a doctor.
Children. The preparation is not recommended for use in children.
Hypersensitivity to any of the components of the preparation. tuberculosis, candidomycosis, severe attacks of ba. childhood.
From the immune system: hypersensitivity reactions, including: often (≥1 / 100 and 1/10) - rash, urticaria, pruritus, erythema; very rarely (1/10 000) - angioedema, shortness of breath and / or bronchospasm, anaphylactoid / anaphylactic reactions.
From the nervous system: often (≥1 / 100 and 1/10) - a feeling of an unpleasant aftertaste, smell.
From the side of the organ of vision: very rarely (1/10 000) - increased intraocular pressure, glaucoma or cataract.
From the respiratory system: often (≥1 / 100 and 1/10) - dryness and irritation of the nose and throat, nosebleeds; cough, paradoxical bronchospasm, dyspnea; very rarely (1/10 000) - isolated cases of perforation of the nasal septum.
With prolonged use of beclomethasone, especially in high doses, candidiasis, decreased adrenal cortex function, osteoporosis, and growth retardation in children are possible.
The systemic effect of nasal corticosteroids can be noted when used in high doses for a long time.
Infectious and inflammatory diseases of the nasal passages and paranasal sinuses are not a specific contraindication for the appointment of baconase, but in this case, appropriate therapy should be carried out.
Beconase should be prescribed with caution to patients when they are transferred from treatment with systemic corticosteroids, given the possibility of impaired adrenal function, as well as to patients with adrenal insufficiency.
After recent surgery in the nasal cavity and nasal trauma, and in the presence of ulcers of the nasal mucosa due to an increased risk of perforation of the nasal septum, you should consult your doctor before using Beconase. A systemic effect of nasal corticosteroids is possible, in particular when high doses are used for a long time. This systemic effect is less likely than with the use of oral corticosteroids and may differ in both individual patients and with the use of different corticosteroid drugs. Systemic effects can include Cushing's syndrome, cushingoid symptoms, adrenal suppression, cataracts, glaucoma, and (less commonly) mental and behavioral disorders, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children). You should not use this medication continuously for more than 1 month without medical supervision. If the patient is using other preparations in any dosage form that contain corticosteroids, as well as for the treatment of asthma, you should consult your doctor before using Beconase.
If the dose of intranasal beclomethasone is exceeded, with individual hypersensitivity or as a result of recent systemic use of steroids, systemic effects may develop, including growth retardation.
Although Beconase controls the symptoms of seasonal allergic rhinitis in most cases, in some particularly severe cases associated with the presence of allergens in the summer, additional treatment may be necessary, especially for ocular symptoms.
Pregnancy. There is insufficient evidence of the safety of using the preparation during pregnancy. The use of corticosteroids in animals during pregnancy can lead to fetal abnormalities, including a cleft palate and intrauterine growth retardation. Therefore, there may be a very low risk of such exposures to the fetus. However, it should be noted that changes in fetal development in animals occur after relatively high systemic exposure. Beconase Spray delivers beclomethasone dipropinate directly to the nasal mucosa and thus minimizes systemic exposure.
The use of beclomethasone dipropionate during pregnancy should be avoided unless, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus.
Lactation. There have been no specific studies investigating the penetration of beclomethasone dipropionate into animal milk. It can be assumed that beclomethasone dipropionate passes into milk, but doses used for direct nasal spray have a low potential to increase concentrations in breast milk.
Prescribing the preparation to women during breastfeeding is possible only if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the child.
The ability to influence the reaction rate when driving or working with other mechanisms. Does not affect.
Not described. the effect of beclomethasone can be enhanced when used simultaneously with other corticosteroids or stimulants of β-adrenergic receptors.
The only negative effect that can occur after inhalation of high doses of the preparation in a short period is suppression of the function of the hypothalamic-pituitary-adrenal system. this condition does not require urgent care. baconase can be continued at the recommended dosage. the function of the hypothalamic-pituitary-adrenal system will recover in 1-2 days.
In this case, proceed as clinically indicated or as recommended by the national poison control center (if available).
There is no specific treatment for beclomethasone dipropionate overdose.
In case of overdose, if necessary, the patient should be provided with appropriate supervision.
At a temperature not exceeding 30 ° C, out of the reach of children. do not refrigerate.
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