Beclomethasone Orion Pharma - instructions for use, dose, side effects, contraindications

Excipients : polysorbate 80, dextrose, microcrystalline cellulose, benzalkonium chloride, sodium hydroxide solution (1M) or hydrochloric acid solution (1M), purified water.

Description:

White or almost white finely dispersed suspension, odorless.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.01 Beclomethasone

Pharmacodynamics:

Glucocorticosteroid of local action has anti-inflammatory and antiallergic effect. It inhibits the release of inflammatory mediators, increases the production of lipocortin (annexin), an inhibitor of phospholipase A2, which leads to a decrease in the formation of arachidonic acid and the products of its transformation.

Reduces inflammation by reducing the formation of the chemotaxis substance (this explains the effect on the "late" reaction of allergy), inhibits the development of an "immediate" allergic reaction (due to inhibition of the production of metabolites of arachidonic.acid and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the action of beclomethasone, the number of mast cells in the mucous membrane of the nasal cavity decreases, the marginal accumulation of neutrophils, inflammatory exudate and production of cytokines, the migration of macrophages is inhibited, the intensity of the processes of infiltration and granulation decreases, which plays a significant role in the development of allergic rhinitis.

In therapeutic doses, it has an active local effect without development; side effects, characteristic of systemic glucocorticosteroids. The therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate, in some patients - in 2-3 weeks.

Pharmacokinetics:

Quickly absorbed into the nasal mucosa. Part of the injected drug is swallowed. Absorption from the gastrointestinal tract is low. The connection with plasma proteins is 87%.

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

Indications:Seasonal and all-the-year-round allergic rhinitis, vasomotor rhinitis.

Contraindications:

Hypersensitivity, ulceration of the nasal septum, recent surgical interventions in the nasal cavity, recent nose trauma, children's age (under 6 years).

Carefully:

Tuberculosis of respiratory organs (including latent), herpes of the eye, glaucoma, systemic infections (fungal, bacterial, viral), severe hepatic insufficiency, adrenal insufficiency, simultaneous reception with other glucocorticosteroids (SCS), pregnancy, lactation.

Pregnancy and lactation:

During pregnancy and lactation beclomethasone should be used with caution and only if the benefits of using it for the mother exceed the potential risk to the fetus and the baby.

Dosing and Administration:

Intranasally.

Adults (including elderly patients) and children over 12 years of age: for 1-2 metered sprays (50-100 μg) in each nasal passage 2 times a day (200-400 μg per day).

The maximum daily dose is 8 doses (400 mcg).

Children aged 6 to 12 years: the initial dose is 50 μg (1 metered spray), if necessary 100 μg (2 metered sprays) 2 times a day in each nasal passage.The maximum daily dose is 400 mcg. The daily dose is divided into 2-4 admission.

When the therapeutic effect is achieved, the drug is canceled, gradually reducing the dose.

Side effects:

From the respiratory system: pain in the nasal cavity and throat, dryness and irritation of the mucosa of the nasal cavity and upper respiratory tract, rhinorrhea, cough, sneezing, nasal. bleeding, ulceration of the mucous membrane of the nasal cavity, perforation of the nasal septum, rarely - atrophy of the mucosa.

From the nervous system: headache, dizziness, drowsiness.

From the sense organs: pain in the eyes, visual impairment, congestion hyperemia, increased intraocular pressure, decreased taste sensations, an unpleasant aftertaste and odor.

Allergic reactions: skin rash, hives, bronchospasm.

Other: Myalgia, candidiasis of the oral cavity and upper respiratory tract (long-term use and / or high doses - more than 400 mcg / day), growth retardation in children (with prolonged use) is possible.

Overdose:

When using high doses of beclomethasone (more than 1 to 1.5 mg / day), systemic side effects are possible: increased blood pressure, contractility of the myocardium, bone resorption, erosive lesions of the gastrointestinal tract, bleeding, suppression of the function of the adrenal cortex.

In this case, the dose should be reduced to the recommended dose. Function of the hypothalamic-pituitary-adrenal system is restored after 1-2 days.

Interaction:

Significant interactions of beclomethasone with topical application with other drugs have not been identified.

Inductors of microsomal oxidation (including phenobarbital, phenytoin, rifampicin) reduce efficiency.

Methandienone, estrogens, 6ta2-adrenostimulants, theophylline and orally administered glucocorticosteroids increase the effect.

Special instructions:

With prolonged use in high doses, systemic effects may develop. In children with prolonged therapy, growth retardation is possible. If growth slows, the treatment regimen should be revised to reduce the dose of glucocorticosteroids, if possible, to a minimum, ensuring the preservation of effective control of clinical manifestations.

Patients who have a decrease in immunity against the background of therapy with GCS (especially children) should avoid contact with patients with chicken pox and measles.When contacting a patient with measles, the administration of a specific immunoglobulin is recommended.

Because the drug slows wound healing, patients with ulceration of the nasal septum, after recent surgical procedures in the nasal cavity, recent nose trauma should not take the drug until the wound is completely healed.

Patients with long-term and systemic therapy receiving SCS need control of the function of the adrenal cortex (possibly additive action).

To ensure a full therapeutic action, the drug must be used regularly. It is necessary to protect eyes from getting the drug.

Form release / dosage:

Spray nasal dosed, 50 mcg / dose.

Packaging:For 9 ml (70 doses), 10 ml (80 doses), 23 ml (200 doses) of the preparation in a plastic bottle made of high-density polyethylene, with a pump attached to the mouth of the vial, with a plastic nasal tip and a plastic protective cap for the nasal tip . For 1 bottle in a cardboard box with instructions for use.

Storage conditions:

Store at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years. After autopsy: 6 months.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-001428

Date of registration:12.01.2012

Expiration Date:12.01.2017

The owner of the registration certificate:Orion Corporation Orion Pharma Orion Corporation Orion Pharma Finland

Manufacturer: & nbsp

ORION CORPORATION ORION PHARMA Finland

Representation: & nbspORION CORPORATION ORION PHARMA ORION CORPORATION ORION PHARMA Finland

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Beclomethasone Orion Pharma (Beklometasone Orion Pharma)