Klenil - instructions for use, dose, side effects, contraindications

Beclomethasone has an anti-inflammatory and anti-allergic effect. Under the action of beclomethasone, the number of mast cells in the mucous membrane of the bronchi decreases, the epithelial edema decreases and the mucus secretion by the bronchial glands. Reduces the hyperreactivity of the bronchi and improves the function of external respiration.

Does not have mineralocorticoid activity. Restores patient's reaction to bronchodilators, allowing to reduce their frequency application. The therapeutic effect usually develops after 5-7 days of course use of beclomethasone.

Pharmacokinetics:

In the lung tissue of beclomethasone, dipropionate is rapidly hydrolyzed to beclomethasone monopropionate, which in turn hydrolyses to beclomethasone. Part of the dose, which is unintentionally swallowed, is largely inactivated by "first passing" through the liver.In the liver, the process of conversion of beclomethasone dipropionate into beclomethasone monopropionate and then - into polar metabolites. The binding with plasma proteins of the active substance in the systemic circulation is 87 %. The main part of the preparation (35-76%) is excreted within 96 hours with the calves, mainly in the form of polar metabolites, 10-15% - by the kidneys.

Indications:

Bronchial asthma of moderate and severe course (including hormone-dependent bronchial asthma, and also with insufficient effectiveness of bronchodilators and / or cromoglycate sodium).

Contraindications:

Hypersensitivity, the presence of tuberculosis (active and inactive) infection, children under 6 years.

Carefully:

Cirrhosis of the liver, epilepsy, cerebral pathology, systemic infections (bacterial, fungal, parasitic, viral), osteoporosis, pregnancy, lactation. Drugs containing 250 μg of beclomethasone in 1 dose are usually not prescribed for children under 12 years of age, except when the use of high doses is dictated by the severity of the patient's condition.

Pregnancy and lactation:

Application in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.Newborns, whose mothers received beclomethasone during pregnancy, should be carefully screened for the lack of adrenal function.

If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.

Dosing and Administration:

The initial dose of Clenil® 250 μg / dose is selected taking into account the severity of the disease. Depending on the patient's individual response, the dose of the drug can be increased to the appearance of a clinical effect or reduced to the minimum effective dose.

Adults (including elderly patients) and children over 12 years:

- bronchial asthma of mild severity (FEV or peak exhalation rate (PSV) more than 80%, diurnal spread of PSV parameters - less than 20%) - 200-600 mcg / day for 2 inhalations;

- bronchial asthma of moderate severity (FEV or PSV ~ 60-80%, diurnal spread of PSV parameters - 20-30%) - 600-1000 mcg / day for 2-4 inhalations;

- bronchial asthma of a serious degree (FEV or PSV - 60%, daily spread of PSV parameters - 30%) - 1000-2000 μg / day for 2-4 inhalations.

The maximum daily dose of the drug in adults should not exceed 1000 mcg, in very severe cases - 1500-2000 mcg / day for 3-4 doses.Use of Klenil 250 μg / dose in children aged 6 to 12 years is only indicated if the required daily dose is 500 μg or more.

Applying Clenil 250 mcg / dose should not be suddenly reversed.

1. Remove the protective cap to open the inhaler.

2. Deep breathe out by holding the inhaler aside, then insert the mouthpiece of the inhaler into your mouth.

3. Click on the bottom of the vial, take a deep breath.

After inhalation, it is advisable to rinse the mouth with water.

Application of Clenil® 250 μg / dose complete with a Jet system (jet®-system) does not require the coordination of inspiration with the pressure on the bottom of the vial with the drug. The pause between pressing and inhalation can reach 5-10 sec. Each pressing on the bottom of the vial liberates strictly one dose of the drug, the duration of depression does not matter. The Jet system does not need special cleaning. If necessary, the Jet system can be rinsed with warm water and dried, but it should not be done more than once a month.

Side effects:

Hoarseness, sore throat, cough, candidiasis of the oral cavity and upper respiratory tract (with prolonged use and / or use in high doses), taking place during local antifungal therapy without discontinuing treatment.

In isolated cases, the occurrence of paradoxical bronchospasm (it is stopped by the administration of inhalation bronchodilators), eosinophilic pneumonia, allergic reactions is possible.

With long-term use at doses of more than 1.5 mg / day, systemic side effects are possible (decreased adrenal cortex function, cataract, increased intraocular pressure).

Overdose:

With a single inhalation of doses exceeding the average therapeutic values, some decrease in the function of the hypothalamic-pituitary-adrenal system is possible, which does not require the adoption of any emergency measures, and treatment should be continued. Function of the hypothalamic-pituitary-adrenal system is restored after 1-2 days.

Interaction:

Significant interactions of beclomethasone with other drugs have not been identified. Phenobarbital, phenytoin, rifampicin and other inducers of microsomal oxidation reduce efficiency. Methandro-stenolone, estrogens, β₂-adrenostimulators, theophylline and orally administered GCS strengthen action.

Beclomethasone increases the effect β₂-adrenostimulators. Previous inhalation use β₂-adrenostimulants can increase the clinical efficacy of beclomethasone.

Due to the content of a small amount of ethanol, interaction in patients with hypersensitivity is possible, taking disulfiram or metronidazole.

Special instructions:

Beclomethasone is not intended for relief of acute asthmatic attacks. It should also not be used in severe asthma attacks requiring intensive care. The recommended route of administration for the dosage form to be used should be strictly observed.

With special care and careful monitoring of the doctor should apply beclomethasone in patients with active pulmonary tuberculosis, as well as with adrenal insufficiency.

The transfer of patients who constantly take systemic SCS to inhalation forms can be performed only with a stable course of asthma.

In the case of the possibility of developing paradoxical bronchospasm for 10-15 minutes before the administration of beclomethasone, bronchodilators (for example, salbutamol) are inhaled.

With the development of candidiasis of the oral cavity and upper respiratory tract, local antifungal therapy is indicated without discontinuing treatment with beclomethasone.Infectious and inflammatory diseases of the nasal cavity and paranasal sinuses in the appointment of appropriate therapy are not a contraindication for treatment with beclomethasone.

Form release / dosage:Aerosol for inhalations dosed with 50 μg / dose.

Packaging:

In aluminum canisters containing 200 doses of the preparation with the Jet® system, it is placed in a cardboard box together with instructions for medical use.

Storage conditions:

List B. At temperatures not higher than 30 ° C in a place protected from the sun, away from heating appliances. Do not freeze. It is under pressure: do not expose to high temperature, do not pierce, do not throw in the fire, even empty.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000419

Date of registration:23.07.2010 / 18.04.2013

Expiration Date:Unlimited

The owner of the registration certificate:Kiesi Pharmaceuticals SpAKiesi Pharmaceuticals SpA Italy

Manufacturer: & nbsp

CHIESI FARMACEUTICI, S.p.A. Italy

Representation: & nbspKEZI KEZI Italy

Information update date: & nbsp18.04.2013

Illustrated instructions

Instructions

Clenil® (Clenil®)