Budoster spray nasal dose 100mkg dose 10ml N1
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Active ingredients
Budesonide
Release form
Spray
Composition
In 1 dose: budesonide 100 mcg. Excipients: dextrose 2.38 mg, Avitsel (microcrystalline cellulose and carmellose sodium in the ratio 9: 1) 0.63 mg, potassium sorbate 0.06 mg, polysorbate 80 0.01 mg, disodium edetate 0.005 mg, hydrochloric acid to pH 4.5, purified water 47.8 mg.
Pharmacological effect
GKS. With inhalation use has anti-inflammatory, anti-allergic and anti-exudative effect, which leads to a decrease in bronchial obstruction. The mechanism of action is to inhibit the release of inflammatory and allergic mediators, as well as to reduce the reactivity of the respiratory tract to their action. In the process of treatment, respiratory function improves, the severity and frequency of dyspnea, asthma, coughing significantly decreases. The maximum clinical effect develops after 1-2 weeks of therapy. 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 hypothalamic-pituitary-adrenal axis and has less effect on inflammatory markers. Data from clinical pharmacological and pharmacokinetic studies indicate that the mechanism of action of budesonide when administered orally is based on local action in the intestine.
Indications
Bronchial asthma requiring maintenance therapy with glucocorticoids. For induction of remission in patients with mild or moderate active ulcerative colitis.
Contraindications
For inhalation use: increased sensitivity to budesonide. For oral administration: liver cirrhosis. infectious bowel disease. lactation period (breastfeeding). children and adolescents up to 18 years. hypersensitivity to budesonide.
Use during pregnancy and lactation
Overdose
Dosage and administration
Dose set depending on the evidence, age, dosage form.
Side effects
Cimetidine and omeprazole have no clinically significant effect on the pharmacokinetic parameters of budesonide when administered orally. However, under the influence of cimetidine may slow the metabolism of budesonide in the liver. Budesonide is characterized by lower systemic bioavailability compared with other corticosteroids, therefore, drug interactions may be less pronounced compared to many other drugs of this class. The risk of drug interaction may be increased in the elderly and patients with impaired renal or liver function.
special instructions
Cimetidine and omeprazole have no clinically significant effect on the pharmacokinetic parameters of budesonide when administered orally. However, under the influence of cimetidine may slow the metabolism of budesonide in the liver. Budesonide is characterized by lower systemic bioavailability compared with other corticosteroids, therefore, drug interactions may be less pronounced compared to many other drugs of this class. The risk of drug interaction may be increased in the elderly and patients with impaired renal or liver function.