Universal reference book for medicines
Product name: BENACORT ® (BENACORT)

Active substance: budesonide

Type: GCS for inhalation

Manufacturer: PULMOMED (Russia)
Composition, form of production and packaging
Powder for inhalation is small-crystalline, white or almost white.
1 dose
budesonide * 200 μg
Excipients: sodium benzoate.
100 doses - inhalers "Cyclochaler" (1) - polyethylene bags (1) - packs of cardboard.
200 doses - inhalers "Cyclochaler" (1) - polyethylene bags (1) - packs of cardboard.
Solution for inhalation is colorless or slightly yellowish, slight opalescence is allowed.
1 ml
budesonide * 250 μg
Auxiliary substances: nipagin, succinic acid, Trilon B, polyethylene oxide 400, propylene glycol, purified water.
2.2 ml - bottles (10) - packs of cardboard.
2.2 ml - bottles of dark glass (10) - packs of cardboard.
Solution for inhalation is colorless or slightly yellowish, slight opalescence is allowed.
1 ml
budesonide * 500 μg
Auxiliary substances: nipagin, succinic acid, Trilon B, polyethylene oxide 400, propylene glycol, purified water.
2.2 ml - bottles (10) - packs of cardboard.
2.2 ml - bottles of dark glass (10) - packs of cardboard.
* the non-proprietary international name recommended by WHO, the international name budesonide has been adopted in the Russian Federation.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
PHARMACHOLOGIC EFFECT
GCS for inhalation use. Has anti-inflammatory, anti-allergic and immunosuppressive effects. Increases the production of lipomodulin, an inhibitor of phospholipase A, inhibits the synthesis of arachidonic acid and its metabolic products (cyclic endoperoxides and prostaglandins). It prevents the accumulation of neutrophils, reduces inflammation and cytokine production, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, the formation of a chemotactic substance, inhibits the release of inflammatory mediators from mast cells.
Increases the number of active? -adrenoceptors, eliminating their desensitization (restores the patient's response to bronchodilators, reduces the frequency of their use), reduces the swelling of the bronchial mucosa, the production of mucus and reduces the hyperreactivity of the airways. Improves mucociliary transport.
Well tolerated with long-term use, does not have mineralocorticoid activity, practically does not have a resorptive effect.
Improvement of lung function is achieved a few hours after the administration of a single dose of the inhalation solution (with the aid of an inhaler). However, the therapeutic effect develops only after several days of regular use at recommended doses (on average 5-7 days).
The drug is designed to prevent attacks of bronchial asthma, and not to stop acute bronchospasm.
PHARMACOKINETICS
Suction and distribution
Systemic absorption of the drug is low. After inhalation, 20-25% reaches the small bronchi, part of the dose in the digestive tract is absorbed and almost completely (90%) is biotransformed in the liver to inactive metabolites. The bioavailability of the powder for inhalation is 10% for that part of the dose that has reached the gastrointestinal tract, and 28% for the pulmonary fraction. Bioavailability of the solution for inhalation is 38%, and 1/6 of this value is formed by swallowing a part of the drug.
C max budesonide in plasma is reached after 15-45 min and is 0.01 mmol / l. Binding to plasma proteins is 88%. V d is 3 l / kg.
Excretion
Has a high plasma clearance - 84 l / h. T 1/2 with an inhalation route of introduction is 2.8 hours. It is deduced up to 10% - through the intestine in the form of metabolites; 70% - by the kidneys.
Pharmacokinetics in special clinical cases
In patients with impaired liver function, budesonide can be longer in the body.
INDICATIONS
- bronchial asthma (as a basic anti-inflammatory therapy, with insufficient effectiveness of bronchodilators and / or cromoglycic acid, to reduce the dose of GCS for oral administration);
- chronic obstructive pulmonary disease with proven effectiveness of SCS.
DOSING MODE
Powder for inhalation
Inhalation of Benacort is carried out with the help of an individual portable inhaler Cyclochaler. The daily dose of the drug is set individually, taking into account the severity of the course of bronchial asthma and the maintenance dose of GCS for oral administration. The recommended initial dose is 400-1600 μg / day; supporting - 200-800 mcg. With an exacerbation of the course of bronchial asthma, the dose of the drug can be increased to 800-1600 μg / day. The maximum daily dose is 2000 mcg. The daily dose is administered for 2-4 inhalations. Duration of treatment to 3-12 months, depending on the severity of asthma. With hormone-dependent asthma with the use of GCS for oral administration to go on therapy with Benacort should be in a stable phase of the disease; with the first 14-20 days it is necessary to combine the inhalation of Benacorta with the continuation of the GCC intake. Then the dose of GCS for oral administration is gradually reduced, up to a complete cancellation (if possible).
Rules for the use of the inhaler "Cyclochaler"
Remove the protective cover, shake the inhaler, push the dispenser from the body of the inhaler to the stop and tap the base of the dispenser on the palm, then push the dispenser into the body. Make a full exhalation. Insert mouthpiece into mouth and draw deep and strong breath through it. Remove inhaler from mouth and hold breath for 10 seconds. When exhaled, exhaled air should not pass through the inhaler. If necessary, take a second inhalation through the inhaler. At the end of the procedure, a protective cover is put on the inhaler.
Solution for inhalation
Benacorta in the form of a solution for inhalations is used only with the help of a nebulizer.
The dosage regimen is set individually. The recommended initial dose for adults is 1-2 mg / day; maintenance dose - 0.5-4 mg / day. When the effect is achieved, the dose of the drug is gradually reduced to the minimum effective, necessary to maintain a stable state. In some cases it is possible to use the drug at higher doses (if necessary, to achieve a faster therapeutic effect).
Transition from reception of GCS inside to Benakort therapy is possible in a stable phase of the disease (in this case, during 10-14 days, inhalation and intake of GCS are combined inside, then gradually reduce the dose of GCS for oral administration until complete withdrawal).
1 bottle contains a single dose.
Rules of nebulizer application
Open the vial with the drug. Fill the nebulizer through the top hole with the required amount of the drug. Nebulization is performed in accordance with the instructions for the type of nebulizer used. The solution for inhalation can be diluted with 0.9% sodium chloride solution.
The volume of budesonide solution delivered to the patient's lungs by a nebulizer is variable and depends on several factors (including inhalation time, the level of the chamber filling, the technical characteristics of the nebulizer, the individual features of the external respiration function of the patient, the use of the mouthpiece or mask).
When using the mask, make sure that when the mask is inhaled, the mask fits snugly to the face, and the person should be washed after inhalation.
After each inhalation, rinse your mouth with water.
The nebulizer chamber and the mouthpiece or mask are washed with warm water, using a mild detergent (or in accordance with the manufacturer's instructions).
SIDE EFFECT
From the respiratory system: irritation of the mucous membranes of the oral cavity and pharynx, cough, hoarseness of the voice, sore throat, dry mouth, candidal stomatitis; rarely - paradoxical bronchospasm (usually as a result of improper technique of inhalation).
From the digestive system: rarely - nausea, taste changes, esophageal candidiasis.
From the side of the central nervous system: rarely - headache, nervousness, motor anxiety, depression, behavior change.
Other: rarely - petechiae.
When used in high doses (more than 2000 μg), it is possible to develop systemic effects of GCS.
CONTRAINDICATIONS
- pulmonary tuberculosis in active form;
- fungal, bacterial and viral infections of the respiratory system;
- Acute bronchospasm, asthmatic status (as a means of emergency therapy);
non-asthmatic bronchitis;
- children and adolescence under 16;
- Hypersensitivity to the components of the drug.
With caution appoint for cirrhosis, glaucoma, hypothyroidism, other bacterial, parasitic infections (including with amebiasis), osteoporosis.
PREGNANCY AND LACTATION
If you need to use Benacort during pregnancy and lactation (breastfeeding), you should correlate the intended benefit to the mother and the potential risk to the fetus. Data on the isolation of budesonide with breast milk are absent.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with impaired liver function, budesonide can be longer in the body. Be wary of cirrhosis of the liver.
APPLICATION FOR CHILDREN
The drug is contraindicated in children and adolescents under 16 years.
SPECIAL INSTRUCTIONS
Preliminary inhalation of adrenomimetics (salbutamol and its derivatives) expands bronchi and improves the flow of budesonide into the respiratory tract, thereby enhancing its therapeutic effect.
In bronchial asthma, Benacort can be used in combination with beta 2 -adrenostimulants, cromoglycic acid or nedocromil sodium, methylxanthines and ipratropium bromide.
Avoid contact with the solution for inhalation in the eyes.
Benacort in the form of a solution for inhalation can be prescribed to patients who can not use other forms of GCS for inhalation (elderly and senile persons).
One dose of inhalable powder contains 9.8 mg of sodium benzoate used as the carrier of the active ingredient; it has an antifungal effect and reduces the risk of developing candidiasis of the respiratory tract.
When switching from oral glucocorticosteroid therapy to therapy with Benacort in the form of a solution for inhalations, a reduction in the dose of GCS for systemic use should be carried out very slowly and in small doses, patients may initially develop symptoms that are not related to bronchial asthma (such as rhinitis, eczema, muscle and joint pain), fatigue, headaches, nausea, vomiting. After complete cancellation, prolonged follow-up is recommended (risk of developing adrenocortical insufficiency), as well as evaluation of the function of external respiration.
OVERDOSE
In acute overdose, clinical manifestations do not occur.
With long-term use in doses much higher than recommended, it is possible to develop systemic effects of GCS in the form of hypercorticism and suppression of adrenal function.
DRUG INTERACTION
When combined, phenobarbital, phenytoin, rifampicin reduce the effectiveness of Benacorte due to the induction of enzymes microsomal oxidation.
With the combined use of methandrostenolone, estrogens increase the effect of budesonide.
Until now, there is no information on the interaction of ketoconazole with budesonide for inhalation. However, a significant increase in the concentration of budesonide in the blood plasma should be expected.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry, dark place at a temperature of no higher than 25 ° C. Shelf life - 3 years.
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