BEKLAZON IVF

Active material: Beklometazon
When ATH: R03BA01
CCF: GCS for inhalation
When CSF: 04.03
Manufacturer: NORTON WATERFORD (Ireland)

Pharmaceutical form, composition and packaging

Aerosol for inhalation dose, When spraying on glass forms a slick white.

Excipients: ethanol, gidroftoralkan (HFA-134a).

200 doses – aluminum cylinders with inhalation device (1) – plastic cases (1) – packs cardboard.

Excipients: ethanol, gidroftoralkan (HFA-134a).

200 doses – aluminum cylinders with inhalation device (1) – plastic cases (1) – packs cardboard.

Pharmacological action

SCS for inhalation use. Anti-inflammatory and anti-allergic effect.

It stops the release of mediators of inflammation, increases lipomodulina products – the inhibitor fosfolipaza and, reduces the release of arachidonic acid, inhibits the synthesis of prostaglandins. It prevents the accumulation of neutrophils boundary, reducing the formation of inflammatory exudate and products limfokinov, inhibits the migration of macrophages, that leads to a slow infiltration and granulation processes.

It increases the number of active β-adrenoceptor, neutralizes them desencitizatiou, restores the patient's response to bronchodilators, allowing to reduce the frequency of their use.

Under the effect of beclomethasone reduced number of mast cells in bronchial mucosa, decreases edema of epithelium and secretion of mucus bronchial disorders. The relaxation of smooth muscles bronchi, reduces their giperreaguosti improves and spirometric.

Possesses mineralokortikoidna activity.

In therapeutic doses does not cause side effects, typical system SSC.

In intra application eliminates swelling, hyperemia of the mucosa of the nasal cavity.

Therapeutic effect is usually 5-7 days of course use beklometazon.

External and local application has anti-allergic and anti-inflammatory effect.

Pharmacokinetics

After inhalation of the doses, that gets into the respiratory tract, absorbed in the lungs. In lung tissue rapidly hydrolyses to beclomethasone dipropionate beclomethasone monpirpionata, that, in turn, hydrolyses to beclomethasone.

Part dose, which inadvertently swallowed, to a large extent inaguiruetsa in “first pass” through the liver. The liver is the process of transforming beklometazon dipropionata in beclomethasone monpirpionat and then to polar metabolites.

Plasma protein binding of the active substance, located in the systemic blood, is 87%.

The on / in a T_1/2 beclomethasone and beclomethasone dipropionate-17.21 constitute approximately 30 m. Displays up 64% with the feces and to 14% in the urine within 96 h mostly in the form of free and conjugated metabolites.

Testimony

For inhalation use: treatment of bronchial asthma (incl. with the ineffectiveness of bronchodilators and/or kromoglikata sodium, as well as hormone-dependent bronchial asthma heavy currents in adults and children).

For intranasal use: Prevention and treatment of year-round and seasonal allergic rhinitis, including rhinitis with hay fever, vasomotor rhinitis.

For external and local application: in combination with antimicrobial means – infectious and inflammatory diseases of the skin and ear.

Dosage regimen

In inhalation introduction average dose for adults is 400 mg / day, multiplicity of application – 2-4 times / day. If necessary, the dose may be increased to 1 g / day. Dose for children – 50-100 g, multiplicity of application – 2-4 times / day.

In intra dose is 400 mg / day, multiplicity of application 1-4 times / day.

External and topically applied dose depends on the evidence and the dosage form of the drug.

Side effect

The respiratory system: hoarseness, feeling of irritation in the throat, chikhaniye; rarely – cough; in a few cases – eosinophilic pneumonia, paradoxical bronchospasm, by intranasal application – perforation of the nasal septum. Possible candidiasis of the oral cavity and upper respiratory tract, especially with prolonged use, passing a local antifungal therapy without stopping treatment.

Allergic reactions: rash, hives, itch, Erythema and swelling of the eyes, person, lips and larynx.

Effects, due to systemic action: loss of function of the adrenal cortex, osteoporosis, Cataract, glaucoma, growth retardation in children.

Contraindications

For inhalation and intranasal use: severe attacks of asthma, intensive therapy, tuberculosis, candidiasis of the upper respiratory tract, I trimester of pregnancy, hypersensitivity to beklometazonu.

Pregnancy and lactation

In II and III trimestrah pregnancy is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus. Newborn, mothers who receive beclomethasone in pregnancy, You should carefully examine the lack of napochechnikov.

If necessary, use during lactation should decide the issue of termination of breastfeeding.

Cautions

Beclomethasone is not intended for cupping acute asthma attacks. It also should not be used in patients with severe attacks of bronchial asthma, requiring intensive therapy. Should strictly abide by the recommended route of Administration dosage form to be used.

With the utmost care and under the close supervision of a physician, you should apply the beclomethasone in patients with adrenal insufficiency.

Transfer of patients, constantly receiving GKS inside, the inhaled form, you can only produce in stable condition.

In the case of the likelihood of paradoxical bronchospasm for 10-15 minutes before the introduction of beklometazon spend inhalation bronchodilator (eg, salbutamol).

With the development of candidiasis of the oral cavity and upper respiratory tract infections shows local antifungal therapy without termination of treatment beklometazonom. Infectious-inflammatory diseases of nasal cavity and paranasal sinuses when assigning appropriate therapy are not contraindications for the treatment of beklometazonom.

Preparations for inhalation use, contain in 1 dose 250 mcg beclomethasone, not intended for children under the age of 12 years.

Drug Interactions

If you are applying beklometazon with other GCS for system or intranasal use may increase oppression napochechnikov crust. Prior to inhalation use of beta-adrenostimuljatorov may improve clinical efficacy of beclomethasone.