Klenil UDV

General characteristics. Structure:

Active agent: beclomethasone Dipropionas of 800 mkg.

Excipients: sodium chloride, polysorbate 20, sorbitan laurate, the water purified.

Pharmacological properties:

As active KLENIL® UDV ingredient contains beclomethasone, derivative a cortisone. Beclomethasone - inhalation глюкортикостероид (GKS), in the recommended doses has antiinflammatory effect, reduces expressiveness of symptoms of bronchial asthma and frequency of exacerbations of a disease, at the same time has the smaller frequency of side effects, than system GKS.
Under the influence of beclomethasone the quantity of mast cells in a sliziyosty cover of bronchial tubes decreases, epithelium hypostasis, slime secretion by bronkhiyoalny glands decreases, hyperreactivity of bronchial tubes, regional accumulation of neutrophils, inflammatory exudate and products of cytokines, is braked a migrayotion of macrophages, intensity of processes of infiltration and a granuyolyation decreases, indicators of function of external respiration improve. Recovers reaction of the patient to bronchodilators, allowing to reduce the frequency of their use.
Has no mineralokortikoidny activity. In therapeutic doses makes active local impact without development of the side effects characteristic of system GKS.

Pharmacokinetics. Researches of pharmacokinetics of beclomethasone showed that after inhalation of a high dose only 20-25% of drug are soaked up.
The inhalated beclomethasone quickly is absorbed by lungs; its absorption is preceded by intensive transformation of beclomethasone into its active metabolite beclomethasone-17-monopropionate (B-17-MP). System bioavailability of B-17-MP is provided for 36% at the expense of lungs, and also due to absorption by bodies of the digestive tract (DT) of the swallowed part of an ingalyayotsionny dose. Absolute bioavailability after inhalation makes око­ло 2% and 62% of a nominal dose in relation to not changed beclomethasone and B-17-MP, respectively. Communication with proteins of plasma - 87%. Beclomethasone is characterized by very high rate of clearance (150 l/h and 120 l/h respectively) from a big circle of blood circulation for the account a deystyoviya of the esterase which is present at the majority of fabrics. A key product of a meyotabolizm of beclomethasone - an active metabolite of B-17-MP. Less active metabolites are beclomethasone-21-monopropionate (B-21-MP) and бек­лометазон which are also formed as a result of metabolism, but their role in system influence of beclomethasone is very insignificant. The main part of beclomethasone is removed with a fecal masses in the form of polyaryony metabolites. With urine about 12% of the entered dose in the form of the free and conjugated polar metabolites are excreted. The period of a poluyovyvedeniye (T1/2) of beclomethasone and B-17-MP makes 0,5 and 2,7 h, sootvetstyovenno.

Indications to use:

Bronchial asthma.

Route of administration and doses:

It is inhalation. Drug is not intended for injections. Кленил® UDV needs to be applied by means of a special inhaler (the compressor nebulizer) equipped with a mouthpiece and a special mask. The dose of a prepayorat is selected individually.
Adults: 800 mkg (1 one-dose ampoule on one procedure of a nebulization) 1-2 times a day.
Children of 6 years: 400 mkg (a half of a one-dose ampoule on one procedure of a nebulization) 1-2 times a day. The one-dose ampoule has the mark corresponding to a half of a dose.

Instructions on use of Klenila® of UDV by means of the nebulizer:
To use a one-dose ampoule according to the following instructions:

To bend a one-dose ampoule in two directions.
To separate a one-dose ampoule from a strip above, then in the central part.
It is vigorous to stir up a one-dose ampoule before formation of homogeneous suspension, before full dispersion.
To open a one-dose ampoule, having turned a lid.
It is accurate to squeeze out contents of a one-dose ampoule in the appointed dose in the nebulizer camera.
If a half of a dose is used, the ampoule can be closed a reverse side of a cover.
Unused suspension should be utilized.

Note
After each inhalation rinse a mouth water. If the mask is used, be convinced that at inhalation the mask densely adjoins to the person. To wash up a face after inhalation.

Features of use:

Beclomethasone is not intended for stopping of bad attacks of bronchial asthma.
After purpose of inhalation GKS at some patients candidiasis of an oral cavity or throat can develop. At patients with anamnestic or datas of laboratory about earlier postponed infection it is a complication develops quickly. Carrying out rinsing of a mouth and throat after inhalations (prevention of candidiasis) is reasonable, and at emergence of initial signs of a fungal infection of a mucous membrane of an oral cavity - use of a nistayotin, flukonazol, Amphotericinum In, without treatment interruption by beclomethasone. Washing after inhalation it is possible to prevent damage of skin a century and a nose.
The infection of adnexal bosoms of a nose or nasal cavity should treat the corresponding drugs, however they are not specific contraindications to use of Klenila® of UDV.
Because of possible risk of weakening of function of adrenal glands special attention needs to be paid to patients who are transferred from peroral GKS on reception of Klenila® of UDV. At such patients it is necessary to reduce a dose of system GKS with special precaution and to control гипоталамо - pituitary and adrenal function. In stressful situations at such patients signs and symptoms of epinephral insufficiency can be shown. Such patients have to have a stock of GKS and at themselves - the warning card in which it has to be specified that they in stressful situations (such as injury, surgical intervention and. etc.) need additional system purpose of GKS (after elimination of a stressful situation the dose of steroids can be lowered again). Transfer from reception of system GKS into inhalation introduction can sometimes lead to manifestation of earlier being suppressed allergy forms, for example allergic rhinitis or eczema.
Upon transition from peroral GKS to Klenil® of UDV such symptoms as muscular pains or joint pains can be observed. In such cases temporary increase in a dose of peroral GKS can be necessary. In rare instances such symptoms as the feeling of fatigue, a headache, nausea and vomitings indicating system insufficiency of GKS can be observed. To store in vertical position, as shown in packaging. One-dose bottles can be stored within 3 months out of a protective package, in the place protected from light.
It is recommended to be careful at control of vehicles and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psikhomoyotorny reactions.

Side effects:

Hoarseness, irritation in a throat, cough, sneezing; the candidiasis of an oral cavity and upper respiratory tracts (at prolonged use and/or when using in high doses) passing when performing local protivoyogribkovy therapy without the treatment termination.
Emergence of a paradoxical bronchospasm (it is stopped by administration of inhalation bronchial spasmolytics), eosinophilic pneumonia is in certain cases possible; allergic reactions (rash, urticaria, itch, erythema; an eye, persons, lips, a throat swelled).
In rare instances there can be symptoms caused by systemic action of beclomethasone including adrenal insufficiency, an Icenco-Cushing syndrome, a growth inhibition at children and adults, decrease in mineral density of a bone tissue, alarm, a sleep disorder, a hyperactivity and irritability preferential at children, headaches, dizziness, a cataract, increase in intraocular pressure, a leukocytosis, a lymphopenia, an eosinopenia.

Interaction with other medicines:

Significant interactions of inhalation GKS with other medicines are not revealed.
Beclomethasone recovers reaction of the patient to beta-adrenergic agonists, allowing to reduce the frequency of their use. Phenobarbital, Phenytoinum, rifampicin , etc. inductors of microsomal enzymes of a liver reduce efficiency. Metandiyenon, estrogen, beta2-adrenomimetik, theophylline and orally appointed GKS strengthen action. Increases effect of beta-adrenergic agonists.

Contraindications:

Hypersensitivity to drug components, children's age up to 6 years, a tuberculosis infection of a respiratory organs. Pregnancy (I trimester) and lactation period.

With care:
Cirrhosis, glaucoma, hypothyroidism, system infections (bacterial, fungal, parasitic), viral infections of a respiratory organs, osteoporosis.

Pregnancy and lactation:
It is not recommended to apply Klenil® of UDV in the first 3 months of pregnancy, and in the subsequent its terms (II and III trimesters) drug should be used only when the advantage of use of drug for mother exceeds potential risk for a fruit. It is recommended to appoint the minimalyyony dose providing effective control of symptoms of bronchial asthma. It is not recommended to apply Klenil® of UDV in the period of a lactation.

Overdose:

At one-time inhalation of the doses exceeding average therapeutic sizes, perhaps some depression of function гипоталамо - pituitary and adrenal system that does not demand acceptance of any emergency measures, and treatment has to be continued. Function гипоталамо - pituitary and adrenal system is recovered in 1-2 days. At prolonged use of drug in the doses considerably exceeding recommended can develop system glucocorticosteroid эф­фект in the form of a hypercorticoidism and suppression of function of adrenal glands. In this case treatment has to be interrupted and measures for reduction of symptoms of oppression of bark of adrenal glands by means of the corresponding therapy are taken.

Storage conditions:

At a temperature not above 25 °C, in original packaging for protection against light, far from heating devices. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Suspension for inhalations of 800 mkg / 2мл.
On 2 ml in hermetically soldered plastic ampoule. The strip on 5 ampoules is located in an aluminum strip. On 4 strips with the application instruction place in a cardboard pack.