Klenil

General characteristics. Structure:

Active agents: beclomethasone Dipropionas of 0,050 mg

Excipients: ethanol of 7,683 mg; glycerin of 0,767 mg; норфлуран (1,1,1,2-tetraftoretan) 50,542 mg.

Pharmacological properties:

Beclomethasone has antiinflammatory and antiallergic effect. Under the influence of beclomethasone the quantity of mast cells in a mucous membrane of bronchial tubes decreases, hypostasis of an epithelium and secretion of slime bronchial glands decreases. Reduces hyperreactivity of bronchial tubes and improves indicators of function of external respiration.
Has no mineralokortikoidny activity. Recovers reaction of the patient to bronchodilators, allowing to reduce the frequency of their use. The therapeutic effect develops usually in 5-7 days of course use of beclomethasone.

Pharmacokinetics. In pulmonary fabric of beclomethasone Dipropionas is quickly hydrolyzed to beclomethasone of monopropionate which is in turn hydrolyzed to beclomethasone. A part of a dose which is unintentionally swallowed is substantially inactivated at "the first passing" through a liver. In a liver there is Dipropionas beclomethasone transformation process into beclomethasone monopropionate and then – in polar metabolites. Linkng with proteins of plasma of the active agent which is in a system blood-groove makes 87%. The main part of drug (35-76%) is removed during 96 h with a fecal masses, 10-15% - kidneys are preferential in the form of polar metabolites.

Indications to use:

Bronchial asthma easy and moderate severity.

Route of administration and doses:

The initial dose of Klenil® 50mkg/dose is selected taking into account severity of a disease. Depending on the individual answer of the patient, the dose of drug can be increased before emergence of clinical effect or to reduce to a minimal effective dose.

Adults (including patients of advanced age) and children are more senior than 12 years:
on 2 inhalations (100 mkg of beclomethasone) 4 times a day. In hard cases – 3-4 inhalations (150-200 mkg of beclomethasone) 4 times a day with further correction of a dose according to the achieved result.

Children up to 12 years:
1-2 inhalations (50-100 mkg of beclomethasone) 2-4 times a day according to the achieved result.

The maximum daily dose of drug at adults should not exceed 1000 mkg.

Take an inhaler big and index fingers.
Remove a protective cap from an inhaler mouthpiece.
Take a mouthpiece in a mouth, having densely clasped it with lips and completely exhale through a nose.
Make a long deep breath, having at the same time made pressing a barrel end face an index finger.
After a breath as long as possible hold the breath. After inhalation it is desirable to rinse a mouth water. For maintenance of purity of a mouthpiece it is recommended to wash out the last warm water in process of pollution.

Features of use:

Beclomethasone is not intended for stopping of bad asthmatic attacks. It also should not be applied at the heavy attacks of bronchial asthma demanding an intensive care. It is necessary to observe strictly recommended way of introduction for the used dosage form.
With extra care and under careful control of the doctor it is necessary to apply beclomethasone at patients with an active pulmonary tuberculosis, and also at adrenal insufficiency.
In case of probability of development of a paradoxical bronchospasm in 10-15 min. prior to administration of beclomethasone carry out inhalation of bronchodilators (for example, salbutamol).
At development of candidiasis of an oral cavity and upper respiratory tracts local antifungal therapy without the treatment termination is shown by beclomethasone. Infectious and inflammatory diseases of a nasal cavity and adnexal bosoms at purpose of the corresponding therapy are not a contraindication for treatment by beclomethasone.

Side effects:

Hoarseness, irritation in a throat, the cough, candidiasis of an oral cavity and upper respiratory tracts (at prolonged use and/or when using in high doses) passing when performing local antifungal therapy without the treatment termination.
In isolated cases emergence of a paradoxical bronchospasm (it is stopped by administration of inhalation bronchial spasmolytics), eosinophilic pneumonia, allergic reactions is possible.
At prolonged use in doses more than 1,5 mg/days are possible system side effects (depression of function of bark of adrenal glands, a cataract, increase in intraocular pressure).

Interaction with other medicines:

Significant interactions of beclomethasone with other medicines are not revealed. Phenobarbital, Phenytoinum, rifampicin, etc. inductors of a microsomal oxidation reduce efficiency. Methandrostenolone, estrogen, β2-адреностимуляторы, theophylline and orally appointed GKS strengthen action.
Beclomethasone increases effect β2-адреностимуляторов. The previous inhalation use β2-адреностимуляторов can increase clinical performance of beclomethasone.
Because of the maintenance of a small amount of ethanol manifestation of interaction at the patients with hypersensitivity accepting Disulfiramum or metronidazole is possible.

Contraindications:

Hypersensitivity, tubercular (active or inactive) infection.

Pregnancy and lactation
Use in II and in the III trimesters of pregnancy is possible only in that case when the estimated advantage for mother exceeds potential risk for a fruit. Newborns whose mothers received beclomethasone at pregnancy should be inspected carefully concerning insufficiency of function of adrenal glands.
In need of use in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

With care
Cirrhosis, epilepsy, system infections (bacterial, fungal, parasitic, virus), osteoporosis, pregnancy, lactation period.

Overdose:

At one-time inhalation of the doses exceeding sredneterapevtichesky 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.

Storage conditions:

List B. At a temperature not above 30 °C in the place protected from the sun, far from heating devices. Not to freeze. Is under pressure: not to subject to influence of high temperature, not to pierce, not to throw into fire, even empty.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

The aerosol for inhalations dosed 50 mkg / a dose, in the aluminum barrels containing 200 doses of drug with an inhaler is placed in a cardboard pack together with the instruction on a medical use.