Pulmicort suspension for inhalation 0.5 mg ml 2 ml N20
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Active ingredients
Budesonide
Release form
Suspension
Composition
Budesonide (micronized) 250 mcg. Auxiliary substances: sodium chloride, sodium citrate, disodium edetate (ethylenediaminetetraacetic acid sodium salt (disubstituted)), polysorbate 80, citric acid (anhydrous), purified water. 2 ml (1 dose) - single-dose polyethylene containers ) - envelopes from laminated foil (4) - packs of cardboard.
Pharmacological effect
GCS for inhalation use. Budesonide in recommended doses has an anti-inflammatory effect in the bronchi, reducing the severity of symptoms and the frequency of exacerbations of asthma with a lower incidence of side effects than when using systemic corticosteroids. Reduces the severity of bronchial mucous edema, mucus production, sputum formation and airway hyperreactivity. It is well tolerated during long-term treatment, does not possess mineralocorticoid activity. The time of onset of the therapeutic effect after inhalation of one dose of the drug is several hours. The maximum therapeutic effect is achieved within 1-2 weeks after treatment. Budesonide has a prophylactic effect on the course of bronchial asthma and does not affect the acute manifestations of the disease. A dose-dependent effect on cortisol content in plasma and urine has been shown in patients receiving Pulmicort. At recommended doses, the drug has a significantly smaller effect on adrenal function than prednisone at a dose of 10 mg, as was shown in ACTH tests.
Pharmacokinetics
AbsorptionAfter inhalation, budesonide is rapidly absorbed. In adults, the systemic bioavailability of budesonide, after inhalation of Pulmicort via a nebulizer, is approximately 15% of the total prescribed dose and about 40-70% of the delivered dose. Cmax in plasma is reached 30 minutes after the start of inhalation. Distribution and metabolismBinding to plasma proteins is on average 90%. Vd budesonide is about 3 l / kg. Budesonide undergoes intensive biotransformation (more than 90%) in the liver to form metabolites with low glucocorticoid activity. The glucocorticoid activity of the major metabolites (6β-hydroxy-budesonide and 16α-hydroxyprednisolone) is less than 1% of the glucocorticoid activity of budesonide.Budesonide is metabolized mainly by the enzyme CYP3A4. ExcretionBudesonide is excreted in the urine as unchanged or conjugated metabolites. Budesonide has a high system clearance (about 1.2 l / min). The pharmacokinetics of budesonide is proportional to the size of the dose administered. The pharmacokinetics in special clinical situations. The pharmacokinetics of budesonide in children and patients with impaired renal function have not been studied. In patients with liver diseases, the residence time of budesonide in the body may increase.
Indications
- bronchial asthma, requiring maintenance treatment of GCS; - chronic obstructive pulmonary disease (COPD).
Contraindications
- Children up to 6 months; - Hypersensitivity to budesonide. attention possible manifestation of systemic action of the SCS.
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
Observation of pregnant women who took budesonide did not reveal developmental abnormalities in the fetus; nevertheless, the risk of their development cannot be completely ruled out, therefore during pregnancy due to the possibility of worsening asthma, the minimum effective dose of the drug should be used. Budesonide is excreted in breast milk, however when using Pulmicort in therapeutic doses, the effect on the child was not observed. Pulmicort; can be used for chest vshoying.
Dosage and administration
The dose of the drug Pulmicort; set individually.In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug is administered at a time (at a time). In the case of receiving a higher dose, it is recommended to divide it into 2 doses. The initial dose for adults (including elderly patients) is 1-2 mg / day. Maintenance dose is 0.5-4 mg / day. In the case of severe exacerbations, the dose may be increased. For children aged 6 months and older, the recommended initial dose is 0.25-0.5 mg / day. If necessary, the dose can be increased to 1 mg / day. The maintenance dose is 0.25-2 mg / day. For all patients, it is desirable to determine the minimum effective maintenance dose. In case of need to achieve an additional therapeutic effect, an increase in the daily dose (up to 1 mg / day) of Pulmicort instead of a combination of the drug with GCS for oral administration can be recommended, thanks to lower risk of developing systemic effects. Patients receiving HSC for oral administration. Canceling GCS for oral administration should be initiated against the background of a stable state of health of the patient. Within 10 days, high doses of Pulmicort are prescribed; against the background of taking GCS inside the usual dose. In the future, over the course of a month, the dose of corticosteroids taken orally (for example, 2.5 mg of prednisolone or its analogue) should be gradually reduced to the minimum effective dose. In many cases, it is possible to completely refuse to take GCS inside. There is no data on the use of budesonide in patients with renal insufficiency or impaired liver function. Taking into account the fact that budesonide biotransformed in the liver, we can expect an increase in the duration of the drug in patients with severe cirrhosis of the liver. Using Pulmicort using the Nebulizer Pulmicort; used for inhalation using an appropriate nebulizer, equipped with a mouthpiece and a special mask. The nebulizer connects to the compressor to create the necessary air flow (5-8 l / min), the nebulizer filling volume should be 2-4 ml. Since Pulmicort; used in the form of a suspension using a nebulizer, gets into the lungs when inhaling, it is important to instruct the patient to inhale the drug through the mouthpiece of the nebulizer is calm and even. In cases where the child can not breathe through the nebulizer,a special mask is used. The patient should be informed of the need to carefully read the instructions for using the drug, as well as that ultrasonic nebulizers are not suitable for the use of Pulmicort in suspension. The suspension is mixed with a 0.9% solution of sodium chloride or with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide. The patient should remember that after inhalation, one should rinse the mouth with water to reduce the risk of developing oropharyngeal candidiasis and that to prevent skin irritation after using the mask, the face should be washed with water. You should also be aware that the diluted pulmicort suspension; should be used within 30 minutes. It is recommended to clean the nebulizer regularly in accordance with the manufacturer's instructions. The nebulizer chamber should be cleaned after each use. The nebulizer chamber and mouthpiece or mask should be washed with warm water using a mild detergent (according to the manufacturer’s instructions) . The nebulizer should be well rinsed and dried by connecting the chamber to the compressor or air inlet valve. Rules for using the Pulmicort using a nebulizer1. Before use, shake the container gently with a slight twisting motion. 3. Hold the container straight up and open it, turning and lifting the wing. Carefully place the open end container in the nebulizer and slowly squeeze the contents of the container. The container containing the single dose is marked with a line. If the container is turned over, this line will show a volume of 1 ml. If only 1 ml of the suspension is to be used, the contents of the container are squeezed out until the surface of the liquid reaches the level indicated by the line. The open container is stored in a place protected from light. An open container must be used within 12 hours. Before using the remaining liquid, gently shake the contents of the container with a rotating motion.
Side effects
On the part of the central nervous system: possible nervousness, irritability, depression, behavioral disturbances. In some cases, symptoms may occur due to systemic action of the GCS (including adrenal hypofunction). Others: rarely - bruising of the skin, irritation of the skin when using a nebulizer with a mask.
Overdose
In acute overdose with Pulmicort; clinical manifestations do not occur. With prolonged use of the drug in doses significantly higher than recommended, it is possible that systemic GCS effects may develop in the form of hypercorticism and suppression of adrenal function.
Interaction with other drugs
There was no interaction of budesonide with other drugs used in the treatment of bronchial asthma. When co-administered with ketoconazole (at a dose of 200 mg 1 time / day), the plasma concentration of budesonide (taken orally at a dose of 3 mg 1 time / day) increases by an average of 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increased on average 3 times. Information about such interaction when taking budesonide in the form of inhalation is absent, however, it is assumed that in this case we should also expect an increase in the concentration of budesonide in the blood plasma. If it is necessary to take ketoconazole and budesonide, you should increase the time between taking the drugs to the maximum possible. The possibility of reducing the dose of budesonide should also be considered. Another potential inhibitor of CYP3A4, itraconazole, also significantly increases the plasma concentration of budesonide. Preliminary inhalation of beta-adrenostimulyatory broadens the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect. reduce the effectiveness of Pulmicort (due to the induction of microsomal oxidation enzymes). Methandrostenolone, estrogens enhance the effects budesonide.
special instructions
To minimize the risk of oropharyngeal fungal infection, the patient should be instructed to thoroughly rinse the mouth with water after each inhalation of the drug. To prevent skin irritation after using a nebulizer with a mask, you should wash the face together. If such a combination is necessary, the time between taking the drugs should be increased to the maximum possible. Because of the possible risk of impaired adrenal function, special attention should be paid to patients who are transferred from systemic GCS to receiving Pulmicort. Also, special attention should be paid to patients who took high doses of GCS or have received the highest possible doses of inhaled GCS for a long time.In stressful situations, these patients may show signs and symptoms of adrenal insufficiency. At stresses or in cases of surgical intervention, it is recommended to carry out additional therapy with systemic corticosteroids. Particular attention should be paid to patients who are transferred from systemic to inhaled GCS (Pulmicort;) or in cases when impairment of pituitary-adrenal function can be expected. In such patients, it is necessary to carefully reduce the dose of GCS for systemic use and to monitor the performance of the hypothalamic-pituitary-adrenal system. This category of patients may require additional prescription of GCS for oral administration during stressful situations, such as trauma, surgery. When switching from oral GCS to Pulmicort; Patients may experience previously observed symptoms, such as muscle pain or joint pain. In such cases, it may be necessary to increase the dose of GCS for oral administration. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may be observed indicating systemic deficiency in the GCS. When switching from GCS for oral administration to inhalation, existing allergic reactions, rhinitis and eczema, which were previously stopped by systemic drugs, are sometimes possible. Pulmicort therapy, when applied 1 or 2 times a day, has shown efficacy in the prevention of asthma of physical effort. Use in pediatrics In children and adolescents receiving GCS treatment (any form) in those ix extended period, it is recommended to regularly monitor the growth figures. When prescribing GCS, the ratio of the expected benefit from the use of the drug and the potential risk of growth retardation should be assessed. The use of budesonide in doses up to 400 mcg / day in children over 3 years of age did not lead to systemic effects. Biochemical signs of the systemic effect of the drug can occur when using the drug in a dose of from 400 to 800 mg / day. When a dose of 800 mcg / day is exceeded, systemic effects of the drug are often encountered. The use of GCS for the treatment of bronchial asthma can cause growth impairment.The results of observations of children and adolescents who received budesonide for a long period (up to 11 years) showed that the growth of patients reached the expected standard indicators for adults. The effect on the ability to drive vehicles and control mechanismsPulmicort; does not affect the ability to drive a car or other mechanisms.