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

As an active ingredient, KLENIL® UDV contains beclomethasone, a derivative of cortisone. Beclomethasone - inhalation glucocorticoid (GCS), at recommended doses has anti-inflammatory effect, reduces the symptoms of bronchial asthma and the frequency of exacerbations of the disease, while it has a lower incidence of side effects than systemic GCS.

Under the action of beclomethasone, the number of mast cells in the bronchial mucosa decreases, the epithelial edema diminishes, the mucus secretion by the bronchial glands, the hyperreactivity of the bronchi, the neutrophil accumulation, the inflammatory exudate and the production of cytokines, the macrophage migration is inhibited, the intensity of the infiltration and granulation processes decreases, . Recovers reaction of the patient to bronchodilators, allowing to reduce the frequency of their use.

Does not have mineralocorticoid activity. In therapeutic doses, it has an active local effect without the development of side effects characteristic of systemic GCS.

Pharmacokinetics:

Studies of pharmacokinetics of beclomethasone have shown that after inhalation of a high dose only 20-25% of the drug is absorbed.

Inhalable beclomethasone quickly absorbed by the lungs; its absorption is preceded by an intensive conversion of beclomethasone into its active metabolite, beclomethasone-17-monopropionate (B-17-MP). Systemic biodosage of the B-17-MP is provided by 36% at the expense of the lungs, and also by absorption by the organs of the gastrointestinal tract ) of the swallowed portion of the inhalation dose. Absolute bioavailability after inhalation is about 2% and 62% of the nominal dose in relation to unchanged beclomethasone and B-17-MP, respectively. The connection with plasma proteins is 87%. Beclomethasone characterized by a very high clearance rate (150 l / h and 120 l / h, respectively) from a large range of circulation due to the action of esterase, which is present in most tissues.The main product of metabolism of beclomethasone is the active metabolite B-17-MP. Less active metabolites are beclomethasone-21-monopropionate (B-21-MP) and beclomethasone, which are also formed as a result of metabolism, but their role in systemic exposure to beclomethasone is very low.

The bulk of beclomethasone is excreted with the fecal masses in the form of polar metabolites. With urine, about 12% of the administered dose is excreted as free and conjugated polar metabolites. The half-life (T1 / 2) of beclomethasone and B-17-MP is 0.5 and 2.7 hours, respectively.

Indications:

Bronchial asthma.

Contraindications:

Hypersensitivity to the components of the drug, children under 6 years of age, tuberculosis infection of the respiratory system.

Pregnancy (I trimester) and lactation.

Carefully:

Cirrhosis of the liver, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic), viral respiratory infections, osteoporosis.

Pregnancy and lactation:

It is not recommended to apply Clenil® UDV in the first 3 months of pregnancy, and in the subsequent periods (II and III trimesters) the drug should be used Only in those cases when the benefit of using the drug for the mother exceeds the potential risk to the fetus. It is recommended to prescribe a minimum dose, which provides effective control of symptoms of bronchial asthma.

It is not recommended to apply Clenil® UDV during lactation.

Dosing and Administration:

Inhalation. The drug is not intended for injection. Clenil® UDV should be used with a special inhaler (compressor nebulizer), equipped with a mouthpiece and a special mask. The dose of the drug is selected individually.

Adults: 800 mcg (1 single-dose ampoule per procedure of nebulization) 1 2 times a day.

Children from 6 years old: 400 mcg (half a single-dose ampoule per procedure of nebulization) 1-2 times a day.

Single-dose ampoule has a mark corresponding to half the dose.

Instructions for use Klinila® UDV with the help of a nebulizer:

Use a single-dose ampoule according to the following instructions:

1) Bend the single-dose ampoule in two directions (Figure 1).

2) Separate the single-dose ampoule from the strip at the top, then in the central part (Figure 2).

3) Vigorously shake the single-dose ampoule until a uniform suspension is formed, until complete dispersion (Figure 3).

4) Open the single-dose ampoule by turning the cap as shown in the figure (Figure 4).

5) Carefully squeeze the contents of a single-dose ampoule at the prescribed dose into the nebulizer chamber (Figure 5).

6) If half the dose is used, the ampoule can be closed by the back side of the lid, as shown in the figure (Figure 6).

Unused slurry should be disposed of.

Note

After each inhalation, rinse your mouth with water.

If a mask is used, make sure that the mask is snug against the face when inhaled. Wash face after inhalation.

Side effects:

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

In some cases, the appearance of paradoxical bronchospasm (it is stopped by the administration of inhalation bronchodilators), eosinophilic pneumonia; allergic reactions (rash, hives, itching, erythema, swelling of the eyes, face, lips, pharynx).

In rare cases, symptoms caused by systemic effects of beclomethasone may occur, incl.adrenal insufficiency, Itenko-Cushing syndrome, growth retardation in children and adults, decreased bone mineral density, anxiety, sleep disturbance, hyperactivity and irritability predominantly in children, headaches, dizziness, cataracts, increased intraocular pressure, leukocytosis, lymphopenia, eosinopenia.

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. The function of the hypothalamic-pituitary-adrenal system is restored after 1-2 days.

With long-term use of the drug in doses much higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercorticoidism and suppression of adrenal function. In this case, treatment should be interrupted and measures taken to reduce the symptoms of suppression of the adrenal cortex with the help of appropriate therapy.

Interaction:

Significant interactions of inhaled glucocorticosteroids with other drugs have not been identified.

Beclomethasone restores patient's reaction to beta-adrenomimetics, allowing to reduce the frequency of their use.

Phenobarbital, phenytoin, rifampicin and other inducers of microsomal liver enzymes reduce efficacy.

Methandienone, estrogens, beta2-adrenomimetics, theophylline and orally administered GCS strengthen action.

Increases the effect of beta-adrenomimetics.

Special instructions:

Beclomethasone is not intended for relief of acute attacks of bronchial asthma.

After the appointment of inhaled glucocorticosteroids in some patients, candidiasis of the oral cavity or pharynx may develop. In patients with anamnestic or laboratory data on previously transmitted infection, this complication develops rapidly. It is advisable to rinse mouth and pharynx after inhalation (prophylaxis of candidiasis), and when there are initial signs of fungal infection of the oral mucosa - the use of nystatin, fluconazole, amphotericin B, without interruption of treatment with beclomethasone. By washing after inhalation, it is possible to prevent damage to the skin of the eyelids and nose.

Infections of the paranasal sinuses of the nose or nasal cavity should be treated with appropriate medications, however they are not specific contraindications to the use of Klinil® UDV.

Because of the possible risk of weakening the function of the adrenal glands, special attention should be given to patients who are transferred from oral GCS to Clenil® UDV. In such patients, it is necessary with special precaution to reduce the dose of systemic SCS and to control the hypothalamic-pituitary-adrenal function. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. Such patients should have a stock of GCS and, with them, a warning card, which should indicate that they are in stressful situations (such as trauma, surgery, etc.) need an additional systemic appointment of GCS (after elimination of the stress situation, the dose of steroids can be reduced again). Sometimes the transfer from the reception of systemic SCS to inhalation administration may lead to manifestation of previously suppressed forms of allergy, for example, allergic rhinitis or eczema.

When switching from oral GCS to Clenil® UDV, symptoms such as muscle pain or joint pain can be observed. In such cases, a temporary increase in the dose of oral GCS may be necessary.In rare cases, symptoms such as a feeling of fatigue, headache, nausea and vomiting, indicating a systemic failure of GCS, can be observed. Store in an upright position as shown on the package.

Single-dose vials can be stored for 3 months outside the protective package, protected from light.

Effect on the ability to drive transp. cf. and fur:It is advisable to use caution when driving vehicles and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form release / dosage:

Suspension for inhalation 800 μg / 2ml.

Packaging:2 ml in a hermetically sealed plastic ampoule. A strip of 5 ampoules is placed in an aluminum strip. 4 strips with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging to protect from light, away from heating appliances. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006574/10

Date of registration:09.07.2010

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: & nbsp25.01.2018

Illustrated instructions

Instructions

Clenil® UDV (Clenil® UDV)