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The exact mechanism of action of budesonide in the treatment of ulcerative colitis is not fully established. Budesonide inhibits many inflammatory processes, including cytokine production, cell activation of inflammatory infiltrate and expression of adhesion molecules on endothelial and epithelial cells. In doses that clinically correspond to prednisone, budesonide causes significantly less suppression of the gnopotamus-pituitary-adrenal axis and has less effect on inflammatory markers.
Data from clinical pharmacological and pharmacokinetic studies indicate that the mechanism of action of the drug Cortiment in the form of pills is based on local action in the intestine.
Budesonide is a GCS with anti-inflammatory, anti-allergic, anti-exudative and anti-edematous properties.
The technology of prolonged release MMX is characterized by a multi-matrix structure, covered with a gastro-resistant membrane, which dissolves in intestinal fluids with a pH level above 7.
When using the tablet budesonide gastroprotective layer protects it when passing through the stomach and duodenum in the lower intestine. When the protective layer dissolves, the intestinal fluid comes in contact with the matrix of hydrophilic polymers, which begins to swell before a viscous gel matrix is formed. The solvent, which penetrates through the gel matrix, releases the active substance from the lipophilic matrices. Budesonide is then released into the intestine at a controlled rate as it passes through the entire colon.
Budesonide is GCS, which is successfully used in the treatment of inflammatory bowel disease. It has a stronger local anti-inflammatory effect compared to many other corticosteroids, but does not reduce cortisol levels to the same extent as methylprednisolone, prednisolone, or hydrocortisone. Its affinity for the glucocorticoid receptor is approximately 200 times higher than that of hydrocortisone, and about 15 times higher than the affinity of prednisolone.
The assortment has not been studied in the pediatric population.
- induction of remission in patients with mild or moderate active ulcerative colitis.
1 tab. - budesonide 9 mg.
Excipients: stearic acid - 10 mg, soy lecithin - 10 mg, microcrystalline cellulose - 156 mg, hydroxypropyl cellulose - 60 mg, lactose monohydrate - 50 mg, colloidal silica - 2 mg, magnesium stearate - 3 mg.
The composition of the shell: methacrylic acid copolymer type A - 8 mg, methacrylic acid copolymer type B - 8 mg, talc - 7.9 mg, titanium dioxide - 4.5 mg, triethyl citrate - 1.6 mg.
Budesonide is marketed under different brands and generic names, and comes in different dosage forms:
|Brand name||Manufacturer||Country||Dosage form|
|Aerosol Service AG||Italy||Other|
|Budenit Steri-Neb||Ayvaks Pharmaceuticals||Czech||ampoules|
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Dosage and Administration
Adults and children over 6 years of age at the beginning of therapy, 100 mcg in each nasal passage 2 times / day. The usual maintenance dose is 50 mcg in each nostril 2 times / day or 100 mcg in each nostril 1 time a day in the morning. The maintenance dose should be the lowest effective dose that eliminates the symptoms of rhinitis. The maximum single dose is 200 mcg (100 mcg in each nostril), the maximum daily vine is 400 mcg for no more than 3 months.
For full therapeutic effect of the drug Budoster requires regular and correct use.
If the reception of the vine was missed, it should be taken as soon as possible, but not less than 1 hour before taking the next dose.
Children use the drug under the guidance of adults.
Local reactions:burning sensation; formation of crusts on the nasal mucosa, dizziness. The risk of a systemic effect, including suppression of adrenal function, growth retardation in children and adolescents, a decrease in bone mineral density, and symptoms of hypercorticism should be taken into account. cataracts and glaucoma when using budesonide in high vines. Very often - irritation of the mucous membrane of the cavity of the suit. At the beginning of therapy, for a short time, rhinorrhea, excoriation may occur. Often - sneezing; tickling and dry throat, pain in nose and throat. Infrequently - nasal bleeding; candidiasis of the mucous membrane of the pharynx and nasal cavity, in particular after prolonged therapy. Very rarely - atrophy of the mucous membrane, ulceration of the mucous membrane of the nasal cavity, perforation of the nasal septum; anosmia.
Allergic reactions:rarely - allergic reactions (including dermatitis, rash, urticaria).
From the digestive system:rarely - nausea, vomiting, gastralgia.
Since the cardiovascular system:very rarely - a sensation of heartbeat.
From the nervous system: rarely - myalgia, drowsiness, headache.
On the part of the respiratory system: very rarely - cough, nasal congestion.
WITHcaution:recent nasal surgery, recent nasal trauma, tuberculosis.
Phenytoin, phenobarbital, rifampicin may decrease the effectiveness, methandienone, estrogens, ketoconazole and other powerful inhibitors of the CYPZA4 isoenzyme increase.
Pregnancy and Lactation
The use of the drug Budoster during pregnancy is allowed only if the expected benefit to the mother exceeds the possible risk to the fetus. If necessary, the appointment of the drug during lactation breastfeeding should be discontinued.
The use of budesonide nasal spray in patients with respiratory tract infections is not recommended.
Patients should be informed that the effect of nasal spray budesonide is achieved on average in 5-7 days.
If after three months of treatment the symptoms of the disease do not decrease, the drug should be withdrawn.
When switching from treatment with systemic glucocorticosteroids to GCS for local use, there is a risk of developing adrenal insufficiency, and therefore, caution is required for the period of recovery of the function of the hypothalamic, hypophysial, adrenal system. Cancel the drug should be by gradually reducing the dose to normalize the function of the hypothalamic-pituitary-adrenal system. At the dose reduction stage, some patients may experience withdrawals of corticosteroids, such as muscle and / or joint pain, apathy, or depression. If such symptoms are detected, a temporary increase in the dose of systemic corticosteroids may be required, and subsequently - further cancellation at a slower pace.
To achieve a therapeutic effect in allergic rhinitis requires regular administration of the drug.
It is recommended to monitor the growth of children receiving long-term treatment of nasal GCS. The growth rate of the child slows down, the dose of nasal spray should be reduced.
Since the corticosteroids slow wound healing, care should be taken when prescribing Budoster to patients who have recently undergone trauma or nasal surgery.
Avoid contact with nasal spray budesonide in the eyes.
With long-term drug therapy, it is necessary to assess the condition of the nasal mucosa.
With long-term use of GCS for nasal use in children, it is recommended to conduct dynamic growth control. When growth is slowed down, the pediatrician should reconsider the way the drug is used, in order to reduce the dose and switch to the minimum therapeutic dose at which the symptoms of the disease can be controlled.
Influence on ability to drive motor transport and control mechanisms
Budoster does not affect the ability to drive a car or mechanisms.
Symptoms (for chronic overdose): acne, Cushing's syndrome, dysmenorrhea.
Treatment: gradual withdrawal of the drug.
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- Effectiveness of budesonide aerosol in ventilator-dependent preterm babies: A preliminary report
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- Jet nebulization of budesonide suspension into a neonatal ventilator circuit: Synchronized versus continuous nebulizer flow
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- Impact of constant and breath-synchronized nebulization on inhaled mass of nebulized budesonide in infants and children
- Efficacy of once-daily versus twice-daily administration of budesonide by Turbuhaler® in children with stable asthma
- Evaluation of pulsed and breath-synchronized nebulization of budesonide as a means of reducing nebulizer wastage of drug
- Note: Dissolution of aerosol particles of budesonide in Survanta™, a model lung surfactant
- The effect of budesonide mouthwash on oral chronic graft versus host disease
- Relationship between lung tissue and blood plasma concentrations of inhaled budesonide
- Pharmacokinetics of budesonide and formoterol administered via a series of single-drug and combination inhalers: four open-label, randomized, crossover studies in healthy adults
- SPE/RIA vs LC/MS for measurement of low levels of budesonide in plasma
- Simultaneous quantification of budesonide and its two metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, in human plasma by liquid chromatography negative electrospray ionization tandem mass spectrometry
- The use of on-line liquid chromatography/mass spectrometry and stable isotope techniques for the identification of budesonide metabolites
- Determination of (22R,S)budesonide in human plasma by automated liquid chromatography/thermospray mass spectrometry
- Pitfalls and success of experimental design in the development of a mixed MEKC method for the analysis of budesonide and its impurities
- Budesonide combined with UDCA to improve liver histology in primary biliary cirrhosis: A three-year randomized trial
- Oral budesonide in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid
- Safety and effectiveness of long-term budesonide treatment in maintaining remission in patients with mild-to-moderate Crohn's disease
- Oral budesonide for the therapy of post-liver transplant de novo inflammatory bowel disease: A case series and systematic review of the literature
- Budesonide induction and maintenance therapy for Crohn's disease during pregnancy
- Azathioprine is superior to budesonide in achieving and maintaining mucosal healing and histologic remission in steroid-dependent Crohn's disease
- Comparison of two dosing methods for induction of response and remission with oral budesonide in active pediatric Crohn's disease: A randomized placebo-controlled trial
- Budesonide treatment of patients with collagenous colitis restores normal eosinophil and T-cell activity in the colon
- Severe adrenal insufficiency complicating budesonide therapy for Crohn's disease