Klenil UDV
Klenil UDV: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Clenil UDV
ATX code: R03BA01
Active ingredient: beclometasone (beclometasone)
Producer: Chiesi Farmaceutici SpA (Italy)
Description and photo update: 2019-12-07
Prices in pharmacies: from 799 rubles.
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Clenil UDV is an inhaled glucocorticosteroid (GCS) used for bronchial asthma.
Release form and composition
The drug is released in the form of a suspension for inhalation: opalescent, homogeneous, slightly sedimented, white, destroyed by shaking in an ampoule before opening it (2 ml in a hermetically sealed plastic ampoule, a strip of 5 ampoules in an aluminum strip, in a cardboard box 4 strips and instructions for application of Klenil UDV).
2 ml of suspension contains:
- active substance: beclomethasone dipropionate - 800 mcg;
- additional components: polysorbate 20, sorbitan laurate, sodium chloride, purified water.
Pharmacological properties
Pharmacodynamics
Beclomethasone, the active ingredient in Clenil UDV, is a cortisone derivative. The active substance is inhaled corticosteroids, which, when administered in recommended doses, exhibits anti-inflammatory activity, reduces the frequency of exacerbations of bronchial asthma and the severity of symptoms of the disease, and also has a lower frequency of adverse reactions compared to systemic corticosteroids.
Due to the effect exerted by beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema, bronchial hyperreactivity and mucus production by the bronchial glands decrease. The active substance also prevents the marginal accumulation of neutrophils, reduces the formation of inflammatory exudate and the production of cytokines, slows down the migration of macrophages, weakens the intensity of the processes of infiltration and granulation, and helps to improve the indicators of external respiration function (FVD).
By restoring the patient's response to bronchodilators, Clenil UDV reduces the frequency of their use. The drug does not demonstrate mineralocorticoid activity, in therapeutic doses it has an intense local effect without causing the appearance of disorders characteristic of systemic corticosteroids.
Pharmacokinetics
According to research results, after inhalation of beclomethasone in a high dose, only 20-25% of the drug is absorbed. The inhalable drug is rapidly absorbed by the lungs, before its absorption, there is an intensive biotransformation of the active substance into beclomethasone-17-monopropionate (B-17-MP) - the active metabolite of beclomethasone. The systemic bioavailability of B-17-MP reaches 36% as a result of absorption by the lungs, as well as absorption by the organs of the gastrointestinal tract (GIT) of the swallowed part of the inhalation dose. The absolute bioavailability after inhalation is approximately 2 and 62% of the nominal amount in relation to unchanged beclomethasone and B-17-MP, respectively. The agent binds to plasma proteins by 87%. Beclomethasone has a fairly high rate of clearance from the systemic circulation (150 and 120 l / h, respectively),due to the action of esterase, an enzyme localized in most tissues.
The metabolite B-17-MP is the main product of the transformation of the drug and demonstrates the highest activity when compared with other metabolites of the main substance - beclomethasone-21-monopropionate (B-21-MP) and beclomethasone (also formed during metabolism). The latter play a very minor role in the systemic effect of the drug.
Most of beclomethasone is excreted with feces in the form of polar metabolites, and with urine in the form of free and conjugated polar metabolites - about 12% of the dose taken. The half-life (T ½) of beclomethasone and B-17-MP is 0.5 and 2.7 hours, respectively.
Indications for use
Clenil UDV is recommended for the treatment of bronchial asthma.
Contraindications
Absolute:
- age up to 6 years;
- tuberculosis infection of the respiratory system;
- I trimester of pregnancy and lactation;
- hypersensitivity to the constituents of the product.
Relative (requires using Clenil UDV with caution):
- viral respiratory infections;
- systemic infections, including fungal, bacterial, parasitic;
- hypothyroidism;
- cirrhosis of the liver;
- osteoporosis;
- glaucoma.
Klenil UDV, instructions for use: method and dosage
Klenil UDV is administered by inhalation.
The drug is not intended for injection, it must be administered using a special inhaler (compressor nebulizer), which is equipped with a mouthpiece and a special mask. The dose of Klenil UDV is set individually.
The suspension for inhalation is administered 1–2 times a day, for one nebulization procedure, adults are recommended to use 800 μg of beclomethasone dipropionate (1 single-dose ampoule), children over 6 years old - 400 μg (½ single-dose ampoule). The ampoule has a mark corresponding to half the dose.
The drug contained in a single-dose ampoule should be used with a nebulizer according to the following instructions:
- Bend the ampoule in two directions.
- Detach the ampoule from the strip at the top, and then in the central part.
- Shake the separated ampoule vigorously until a homogeneous suspension forms in it, until complete emulsification.
- Open the ampoule by turning and removing the cap.
- Gently pushing the ampoule, squeeze its contents into the nebulizer chamber in the prescribed dose.
- In the case of using ½ dose, the ampoule with the remaining drug can be closed with the back of the cap.
Unused suspension must be disposed of.
After each inhalation administration of the product, rinse your mouth with water.
If you are using a nebulizer with a mask, you need to make sure that it fits snugly to the face when inhaled. After the procedure, you should wash your face.
Side effects
Against the background of drug therapy, violations such as sneezing, irritation in the throat, hoarseness, cough can be recorded; candidiasis of the oral cavity and upper respiratory tract (with a long course or the administration of high doses of beclomethasone), which passes after local antifungal therapy without canceling Clenil UDV.
Sometimes, when using Klenil UDV, it is possible to develop paradoxical bronchospasm (controlled by inhalation bronchodilators), eosinophilic pneumonia; allergic reactions including rash, urticaria, pruritus, erythema; swelling of the eyes, lips, face, pharynx.
It is extremely rare during treatment that symptoms may occur due to the systemic effect of beclomethasone: headaches, sleep disturbances, dizziness, anxiety, irritability and hyperactivity, mainly in children, decreased bone mineral density, growth retardation in children and adults, Itsenko-Cushing syndrome, adrenal insufficiency, increased intraocular pressure, cataract, lymphopenia, leukocytosis, eosinopenia.
Overdose
In the case of a single inhalation administration of doses exceeding the average therapeutic, some deterioration in the function of the hypothalamic-pituitary-adrenal system (HPA) is possible, in which treatment should be continued without resorting to any emergency measures since the HPA is restored, as a rule, after 1–2 day.
With prolonged use of Clenil UDV in doses significantly higher than recommended, a systemic effect of GCS in the form of hypercortisolism and suppression of the adrenal glands may occur. In this case, therapy should be interrupted and appropriate treatment prescribed to reduce the symptoms of adrenal cortex suppression.
special instructions
Klenil UDV for inhalation is not indicated for the relief of acute attacks of bronchial asthma.
During treatment with inhaled corticosteroids, some patients may experience candidiasis of the oral cavity or pharynx. In the presence of anamnestic or laboratory data on a previous infection, this complication develops more quickly.
During the period of therapy, it is advisable to rinse the mouth and pharynx after inhalation to prevent candidiasis, and in the event of the first signs of fungal lesions of the oral mucosa, to use amphotericin B, fluconazole, nystatin, without interrupting the course of treatment with Clenil UDV. Washing your face after inhalation can prevent damage to the skin of the eyelids and nose.
For the treatment of infections of the paranasal sinuses or nasal cavity, it is necessary to use the appropriate drugs, however, the development of these lesions is not a specific contraindication to the administration of inhaled GCS
In view of the aggravating threat of weakening of the adrenal glands, patients who are recommended to switch from taking oral corticosteroids to the use of Clenil UDV need special attention. In such patients, it is required to monitor the function of HPA and, with extreme caution, reduce the dose of systemic GCS. Also, such patients in stressful situations may develop symptoms and signs of adrenal insufficiency. Therefore, patients from this risk group should always have a reserve of corticosteroids and a warning card with them indicating that in stressful situations (including surgery, trauma), they should additionally be prescribed systemic corticosteroids. After the stressful situation has been eliminated, you can again reduce the dose of steroids.
In some cases, the transition from the use of systemic corticosteroids to inhalation use can cause manifestations of such previously suppressed forms of allergy as eczema or allergic rhinitis.
When a patient is transferred from treatment with oral corticosteroids to the administration of Clenil UDV, the likelihood of developing joint pain or muscle pains also increases, with the appearance of which a temporary increase in the dose of oral corticosteroids may be required. Also, in rare cases, undesirable effects in the form of nausea, vomiting, fatigue, headache, indicating systemic insufficiency of GCS, can be noted.
Single-dose vials can be stored without a protective bag for up to three months in a place protected from light.
Store plastic ampoules with the drug in an upright position, in accordance with the instructions on the package.
Influence on the ability to drive vehicles and complex mechanisms
Patients driving vehicles or other potentially dangerous, complex mechanisms should be careful during therapy.
Application during pregnancy and lactation
It is contraindicated to use Klenil UDV for inhalation in the first trimester of pregnancy. In the II and III trimesters, it is necessary to use a suspension for inhalation only in cases where the expected benefit of treatment for the mother significantly outweighs the possible threat to the health of the fetus. Pregnant women should be prescribed the minimum dose of the drug that can provide effective control of the clinical manifestations of bronchial asthma.
It is contraindicated to use Clenil UDV during breastfeeding.
Pediatric use
For children under 6 years of age, Klenil UDV therapy is contraindicated.
For violations of liver function
Patients with cirrhosis of the liver must use the drug with caution.
Drug interactions
When using inhaled GCS with other drugs / agents, no significant interactions have been identified.
- theophylline, β 2 -adrenomimetics, estrogens, methandienone, orally used GCS: the effect of Clenil UDV is enhanced;
- β-adrenomimetics: their effectiveness increases, the patient's reaction to these drugs is restored, which makes it possible to use them less often;
- inducers of microsomal liver enzymes, including phenytoin, phenobarbital, rifampicin: the effect of beclomethasone is weakened.
Analogs
The analogues of Klenil UDV are: Beclomethasone-aeronautical, Allergorus, Beklazon Eco, Klenil, Beclomethasone DS, Beklazon Eco Light Respiration, Beclomethasone, Beclospir.
Terms and conditions of storage
Store in its original packaging to protect from light, out of the reach of children and away from heating appliances, at a temperature not exceeding 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Klenil UDV
Reviews of Klenil UDV, found on medical websites, as a rule, confirm its effectiveness in the treatment of bronchial asthma. The use of a drug as a maintenance drug can prevent or reduce the frequency of attacks of the disease. Regular inhalations with the drug, according to reviews, make breathing easier and more free, and help improve overall well-being.
However, many patients report the presence of side effects during treatment, such as sore throat, severe cough, hoarseness. Sometimes they feel some unpleasant aftertaste after the administration of the product. In some cases, despite the effectiveness of Klenil UDV, patients had to refuse its use due to sleep disorders, headaches, heart palpitations, and decreased concentration.
Price for Klenil UDV in pharmacies
The price for Klenil UDV, suspension for inhalation (in an ampoule of 800 mcg / 2 ml), is 800-830 rubles per pack containing 20 ampoules.
Klenil UDV: prices in online pharmacies
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Drug name Price Pharmacy |
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Clenil UDV 400 μg / ml suspension for inhalation 2 ml 20 pcs. RUB 799 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
