Instructions Beconase nasal spray suspension 50 mcg/dose bottle 180 doses
Composition
active ingredient: 1 dose (100 mg of suspension) contains beclomethasone dipropionate 50 mcg;
excipients: sodium carboxymethylcellulose - microcrystalline cellulose, anhydrous glucose, benzalkonium chloride, phenylethyl alcohol, polysorbate 80, purified water.
Dosage form
Nasal spray, suspension.
Main physicochemical properties: white opaque suspension without any visible foreign particles.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Anti-edematous and other drugs for local use in diseases of the nasal cavity. Corticosteroids. ATX code R01A D01.
Pharmacological properties
Pharmacodynamics
After topical application of beclomethasone 17,21-dipropionate exhibits potent anti-inflammatory and vasoconstrictive effects. Beclomethasone dipropionate is a precursor of the active substance with weak affinity for glucocorticoid receptors. It is hydrolyzed by esterases to form the active metabolite beclomethasone-17-monopropionate, which has high local anti-inflammatory activity.
Beclomethasone dipropionate provides prophylactic basic treatment of hay fever when used before exposure to the allergen. With regular use, beclomethasone dipropionate prevents the 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 rapidly eliminated from the circulation, and its plasma concentration cannot be measured after intranasal administration (< 50 pg/ml). Metabolism occurs in all tissues with the participation of esterases. The main metabolic product is the active metabolite (beclomethasone 17-monopropionate). Plasma protein binding is moderately high (87%). The plasma half-life for beclomethasone dipropionate is 0.5 hours and for beclomethasone 17-monopropionate is 2.7 hours. After oral administration of beclomethasone dipropionate, approximately 60% of the dose is excreted in the feces within 96 hours, mainly as free and conjugated polar metabolites. Approximately 12% of the dose is excreted as free and conjugated polar metabolites in the urine. Renal clearance of beclomethasone dipropionate and its metabolites is negligible.
Indication
Prevention and treatment of perennial and seasonal allergic rhinitis.
Contraindication
History of hypersensitivity to the active substance or to any of the excipients listed in the "Composition" section. Tuberculosis, candidiasis, severe attacks of bronchial asthma. Children's age.
Interaction with other medicinal products and other types of interactions
Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and interactions are generally unlikely.
However, the possibility of systemic effects cannot be excluded when strong CYP3A inhibitors (e.g. ritonavir, cobicistat) are used concomitantly. Therefore, caution and appropriate monitoring are recommended when these drugs are used concomitantly.
Application features
Infectious-inflammatory diseases of the nasal passages and paranasal sinuses are not a specific contraindication for the administration of Beconase, but in this case, appropriate therapy should be carried out.
Beconase should be administered with caution to patients when transferring them from treatment with systemic steroids, bearing in mind the possibility of impaired adrenal function, as well as to patients with adrenal insufficiency.
After recent nasal surgery and trauma, and in the presence of nasal mucosal ulcers, due to an increased risk of nasal septal perforation, a doctor should be consulted before using Beconase. Systemic effects of nasal corticosteroids may occur, particularly when high doses are used for prolonged periods. Such systemic effects are less likely than with oral corticosteroids and may vary between patients and between corticosteroid preparations. Systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, cataracts, glaucoma and (less commonly) mental and behavioural disorders, including psychomotor hyperactivity, sleep disorders, restlessness, depression or aggression (especially in children).
Treatment with doses higher than recommended may cause clinically significant adrenal suppression. If the recommended doses of beclomethasone are exceeded, additional systemic corticosteroid therapy is required during periods of stress or elective surgery.
This medicine should not be used continuously for more than 1 month without medical supervision. If the patient is taking other medicines in any dosage form that contain corticosteroids, as well as medicines for the treatment of asthma, a doctor should be consulted before using Beconase.
If the dosage of intranasal beclomethasone is exceeded, in case of individual hypersensitivity or due to recent systemic steroid use, systemic effects, including growth retardation, may occur.
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 period, additional treatment may be necessary, especially for visual symptoms.
Visual impairment.
Visual disturbances may occur with systemic and topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should consult an ophthalmologist to evaluate possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSR), which has been reported with systemic and topical corticosteroids.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
Pregnancy. There is insufficient evidence of the safety of the medicinal product during pregnancy. The use of corticosteroids in animals during pregnancy may cause foetal malformations, including cleft palate and intrauterine growth retardation. Therefore, there may be a very small risk of such effects on the foetus. However, it should be noted that changes in foetal development in animals occur after relatively high systemic exposure. Beconase, a spray, delivers beclomethasone dipropionate directly to the nasal mucosa and thus minimises systemic exposure.
The use of beclomethasone dipropionate during pregnancy should be avoided unless, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding. Specific studies investigating the excretion of beclomethasone dipropionate in animal milk have not been conducted. It can be assumed that beclomethasone dipropionate is excreted in milk, but the doses used for direct nasal spray have a low potential to increase its concentration in breast milk.
The drug should only be prescribed to women during breastfeeding if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the child.
Fertility: There are no data on the effect on fertility.
Method of administration and doses
Beconase should be prescribed for intranasal use only. Shake well before use.
Adults: 2 sprays in each nostril 2 times a day or 1 spray in each nostril 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 drug is necessary. After the first few injections, maximum relief of the condition is not achieved.
Do not use for more than 3 months without consulting a doctor.
Children
The medicine is not recommended for use in children.
Overdose
The only harmful effect that may occur after inhalation of large doses of the drug in a short period of time is suppression of the function of the hypothalamic-pituitary-adrenal system. This condition does not require emergency care. The use of Beconase can be continued in recommended doses. The function of the hypothalamic-pituitary-adrenal system will recover after 1–2 days.
In this case, it is necessary to act according to clinical indications or according to the recommendations of the national poisons center (if available).
There is no specific treatment for beclomethasone dipropionate overdose.
In case of overdose, the patient should be provided with appropriate supervision if necessary.
Adverse reactions
Immune system disorders: hypersensitivity reactions including: (common: > 1/100 and < 1/10) rash, urticaria, pruritus, erythema; (very rare: < 1/10,000) angioedema, swelling of the eyes, face, lips and throat, dyspnoea and/or bronchospasm, anaphylactoid/anaphylactic reactions.
Nervous system: (common: > 1/100 and < 1/10) unpleasant taste, smell.
On the part of the organs of vision: (very rare: < 1/10,000) increased intraocular pressure, glaucoma or cataract; (frequency unknown: cannot be estimated from the available data) blurred vision.
Respiratory system: (common: > 1/100 and < 1/10) dryness and irritation of the nose and throat, epistaxis; cough, paradoxical bronchospasm, dyspnea; (very rare: < 1/10,000) isolated cases of nasal septum perforation.
With long-term use of beclomethasone, especially in high doses, candidiasis, decreased adrenal cortex function, osteoporosis, and growth retardation in children are possible.
Systemic effects of nasal corticosteroids may occur when used in high doses for prolonged periods.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Do not store in the refrigerator.
Packaging
100 doses or 180 doses in a polypropylene bottle connected to a dosing device, nasal adapter and cap; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Glaxo Wellcome SA/ Glaxo Wellcome SA
Location of the manufacturer and its business address
Avenida de Extremadura 3, Pol. Ind. Allendeduero, 09400 Aranda de Duero, Burgos, Spain/ Avenida de Extremadura 3, Pol. Ind. Allendeduero, 09400 Aranda de Duero, Burgos, Spain.
