Pulmicort suspension for inhalations of 0,25 mg ml containers of 2 ml 20 pieces
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Active ingredients
Budesonide
Release form
Suspension
Composition
Active ingredient: Budesonide (budesonide) Active ingredient concentration (mg): 0, 25g
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 therapy with glucocorticosteroids. Chronic obstructive pulmonary disease (COPD). Stenosing laryngotracheitis (false croup)
Contraindications
Hypersensitivity to budesonide. Children age up to 6 months.
Precautionary measures
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, you should increase the time between taking the drugs to the maximum possible.
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 breast vexation.
Dosage and administration
Recommended initial dose: Children 6 months and older: 0.25-0.5 mg per day. If necessary, the dose can be increased to 1 mg / day. Adults / elderly patients: 1-2 mg per day. Dose with maintenance treatment: Children 6 months and older: 0.25-2 mg per day. Adults: 0.5–4 mg per day. In case of severe exacerbations, the dose may be increased.
Side effects
Often Respiratory tract: Oral pharyngeal candidiasis, mild irritation of the mucous membrane of the throat, cough, hoarseness,dry mouth.Redko. General: Angioedema. Skin: Bruises on the skin. Respiratory tract: Bronchospasm. Central nervous system: Nervousness, irritability, depression, behavioral disorders. angioedema, bronchospasm and anaphylactic reaction. Gastrointestinal tract: Nausea. Very rare. Laboratory findings: Decrease in bone mineral density (systemic effect). Orga s feelings: Cataract, glaucoma (systemic action) .Prinimaya into account the risk of oropharyngeal candidiasis, the patient should be carefully rinse your mouth with water after each inhalation of the drug. In rare cases, symptoms may occur due to the systemic action of glucocorticosteroids, including adrenal hypofunction and growth retardation in children. The severity of these symptoms probably depends on the dose of the drug, the duration of therapy, concomitant or previous therapy with glucocorticosteroids, as well as individual sensitivity. There have been cases of skin irritation when using a mask nebulizer. To prevent irritation after using the mask, the face should be washed with water.
Overdose
With an acute overdose of Pulmicort, there are no clinical manifestations. With prolonged use of the drug in doses significantly higher than recommended, systemic GCS effects in the form of hypercorticism and suppression of adrenal function may develop.
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
Due to the possible risk of impaired adrenal function, special attention should be paid to patients who are transferred from systemic corticosteroids to 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 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, it is sometimes possible that the existing allergic reactions, rhinitis and eczema, are exacerbated,previously treated with systemic drugs. Pulmicort therapy, when applied 1 or 2 times / day, showed efficacy in preventing physical asthma. Use in pediatrics In children and adolescents receiving GCS treatment (any form) for an extended period, it is recommended to regularly monitor growth rates. 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 µg / 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 µg / 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 patient growth reaches the expected standard indicators for adults. Impact on the ability to drive vehicles and control mechanismsPulmicort does not affect the ability to drive a car or other mechanisms .