Klenil

Klenil – a glucocorticosteroid (GKS) for topical administration.

Form of release and structure

Dosage forms: an aerosol for inhalations dosed and solution for inhalations (on 200 doses in aluminum barrels with the portioning device, in a pack a cardboard 1 barrel complete with an inhaler).

Active ingredient: beclomethasone Dipropionas, in 1 dose – 50 or 250 mkg.

Additional components: норфлуран (1,1,1,2-tetraftoretan), глицерол, ethanol.

Indications to use

• Bronchial asthma easy and moderate severity;
• Medium-weight and heavy bronchial asthma, including hormonedependent and not giving in to treatment by bronchodilators and/or sodium kromoglikaty.

Contraindications

Absolute:

• Tuberculosis;
• Children's age up to 4 years – for drug of 50 mkg / a dose, up to 6 years – for drug of 250 mkg / a dose;
• Lactation (or feeding should be stopped);
• Individual hypersensitivity to Klenil's components.

Relative (patients with the following states / diseases have to be during treatment under careful medical observation since there is a risk of development of complications):

• Cirrhosis;
• Epilepsy;
• Glaucoma;
• Cerebral pathology;
• Hypothyroidism;
• Osteoporosis;
• System infections (fungal, virus, bacterial, parasitic);
• Adrenal insufficiency.

With care and only if the expected advantage exceeds possible risks, medicine should be applied at pregnancy, especially in II and III trimesters.

Route of administration and dosage

Klenil apply in the form of inhalations.

The initial dose of drug is selected by the doctor depending on severity of a disease. If necessary the dose can be lowered to minimum effective, or increase until the clinical effect is reached.

The recommended doses for adult patients (including advanced age) and children are more senior than 12 years:

• Easy severity of bronchial asthma (the volume of the forced exhalation in 1 second _(OFV1) or the peak expiratory rate (PER) – more than 80%, and the daily dispersion of indicators of PSV does not exceed 20%): on 200-600 mkg a day;
• Moderate severity of bronchial asthma (_{OFV1 or PSV} – 60-80%, daily dispersion of indicators of PSV – 20-30%): on 600-1000 mkg a day;
• Heavy degree of bronchial asthma (_{OFV1 or PSV} – 60%, daily dispersion of indicators of PSV – 30%): 1000-2000 mkg a day (at heavy degree of a disease appoint Klenil containing 250 mkg in 1 dose).

The maximum daily dose for this category of patients should not exceed: at a moderately severe disease – 1000 mkg, at heavy degree – 2000 mkg.

The daily dose is divided into 3-4 inhalations.

The initial dose for children aged from 4 up to 12 years makes on 50-100 mkg 2 times a day, in hard cases the daily dose can be increased to 400 mkg in stages.

The most admissible daily dose for children of 4-12 years makes 500 mkg. At this age category of patients generally apply Klenil with contents 50 mkg in 1 dose. Drug of 250 mkg / a dose can be appointed only if the necessary daily dose exceeds 500 mkg.

Aerosol route of administration for inhalations:

• Before the first use, and also every time in case of a 3-day break in use of an inhaler it is necessary to remove a protective cap from a mouthpiece and to make single spraying in air;
• To take an inhaler index and big fingers;
• To remove a protective cap;
• To put a mouthpiece in a mouth and, having densely clasped it with lips, to exhale completely through a nose;
• To make a long deep breath, at the same time pressing a barrel end face an index finger;
• As long as possible to hold the breath;
• To rinse a mouth water.

The mouthpiece is recommended to be washed out warm water in process of pollution.

Side effects

• Local reactions: irritation in a throat, hoarseness of a voice, cough; at use of drug in high doses and/or for a long time – candidiasis of an oral cavity and upper respiratory tracts (in this case local antifungal therapy is appointed);
• System reactions: in isolated cases – allergic reactions; at prolonged treatment in high doses (more than 1500 mkg) – depression of function of bark of adrenal glands, increase in intraocular pressure, a cataract;
• Others: in isolated cases – eosinophilic pneumonia, a paradoxical bronchospasm (it is stopped by use of inhalation bronchial spasmolytics).

Special instructions

Klenil is not intended for stopping of bad asthmatic attacks. Also drug should not be used at the heavy attacks of bronchial asthma demanding carrying out an intensive care.

Infectious and inflammatory diseases of a nasal cavity and adnexal bosoms at use of the corresponding therapy are not a contraindication to Klenil's appointment.

If there is a risk of development of a paradoxical bronchospasm, in 10-15 minutes prior to use of beclomethasone carry out bronchodilator inhalation (for example, salbutamol).

In case of development of candidiasis of an oral cavity and upper respiratory tracts appoint local antifungal therapy, at the same time to cancel Klenil is not present need.

Drug with the maintenance of 250 mkg / a dose is not appointed to children aged up to 12 years, except for cases when expediency of use of high doses is proved by weight of a condition of the patient.

Newborn children, whose mothers during pregnancy received beclomethasone, should be inspected carefully regarding insufficiency of function of adrenal glands.

Medicinal interaction

Cases of clinically significant interaction of beclomethasone with other medicines are not established.

It must be kept in mind:

• Beta2-adrenostimulyatora, estrogen, methandrostenolone, theophylline and peroral glucocorticosteroids strengthen effect of beclomethasone;
• Inductors of a microsomal oxidation (including phenobarbital, rifampicin, Phenytoinum) reduce efficiency of beclomethasone;
• Beclomethasone strengthens action of beta2-adrenostimulyator;
• The previous inhalation use of beta2-adrenostimulyator increases clinical performance of Klenil.

As a small amount of ethanol is a part of drug, patients with hypersensitivity have a theoretical probability of interaction of Klenil with metronidazole and Disulfiramum.

Terms and storage conditions

To store at a temperature up to 30 ºС in the place unavailable to children, far from heat sources, including direct sunshine and heating devices. Not to freeze.

Cylinder, even empty not to subject to influence of high temperature, not to throw into fire, not to pierce.

Period of validity – 3 years.