Inhaled budesonide is rapidly absorbed. In adults, the systemic bioavailability of budesonide after inhalation Pulmicort nebulized suspension, approximately 15% of the doses, and about 40-70% of the delivered. Maximum plasma concentration is achieved after 30 minutes after the start of inhalation. Metabolism and Distribution Communication plasma protein is an average of 90%. The jelfa omnadren 250 volume of distribution of budesonide is about 3 l / kg. After intensive suction budesonide undergoes biotransformation (90%) in the liver with the formation of metabolites with low glucocorticosteroid activity. Glucocorticosteroid activity of the major metabolites, 6β-hydroxy-budesonide and 16α-hydroxyprednisolone is less than 1% of the glucocorticosteroid budesonide activity. Elimination Budesonide is metabolized primarily by CYP3A4 enzyme.Metabolites are excreted unchanged in the urine or in the conjugated form. Budesonide has a high systemic clearance (about 1.2 l / min). The pharmacokinetics of budesonide is proportional to the administered dose. The pharmacokinetics of budesonide in children and patients with renal impairment has not been studied. Patients with liver disease may increase residence time in the body of budesonide.
• Bronchial asthma requiring maintenance treatment with glucocorticosteroids.
• Chronic obstructive pulmonary disease (COPD).
• Constrictive laryngotracheitis (false croup)
• Hypersensitivity to budesonide.
• Children up to age 6 months.
Precautions (requires more careful monitoring of patients) in patients with fungal, viral, bakterialnymiinfektsiyami respiratory, liver cirrhosis; the appointment should take into account the possible manifestation of the systemic effects of glucocorticoids.
Use during pregnancy and lactation
Pregnancy: monitoring of pregnant women who took budesonide, did not reveal any abnormalities in the fetus, however we can not completely eliminate the risk of their development, so during pregnancy because of the possibility of deterioration of bronchial asthma should use the lowest effective dose of budesonide. Lactation: Budesonide penetrates in breast milk but not observed when using therapeutic doses Pulmicort child impact. Pulmicort can be used during jelfa omnadren 250 breastfeeding.
Dosing and Administration
The dose is adjusted individually. In the event that the recommended dose is less than 1 mg / day, the whole dose may be taken at one time – (simultaneously). In the case of receiving a higher dose is recommended it be divided into two steps. The recommended starting dose is: Children 6 months and older: 0.25-0.5 mg per day. If necessary, the dose may be increased to 1 mg / day. Adult / elderly patients: . 2.1 mg daily dose of the maintenance treatment: Children aged 6 months and over: . 0.25-2 mg per day Adults: 0.5 -4 mg. In case of severe exacerbations dose may be increased.
For all patients, it is desirable to determine the minimum effective maintenance dose. In the case of the need to achieve an additional therapeutic effect can be recommended to increase the daily dose (1 mg / day) Pulmicort instead of a combination drug with oral corticosteroids, due to the lower risk of systemic effects. Patients receiving oral glucocorticosteroids Abolition of oral corticosteroids should be started on the background of a stable state of health patient. Within 10 days, you need to take a high dose of Pulmicort in patients receiving oral glucocorticosteroids in the usual dose. Subsequently, during the month should gradually reduce the dose of oral corticosteroids (for example, 2.5 mg of prednisolone or its equivalent) to the minimum effective dose. In many cases, succeed:. Completely abandon receiving oral glucocorticosteroids Since Pulmicort applied as a slurry using a nebulizer to the lungs when breathing is important to instruct the patient to inhale the drug through a mouthpiece of the nebulizer quietly and smoothly. There jelfa omnadren 250 are no data on the use of budesonide in patients with renal insufficiency or hepatic impairment. Taking into account the fact that budesonide is obtained by biotransformation in the liver, can be expected to increase the duration of action of the drug in patients with severe liver cirrhosis. Constrictive laryngotracheitis (false croup): Children used months or older: 2 mg per day. Dose may be taken at one time (simultaneously) or divide it into two doses, 1 mg every 30 min.