布地奈德胶囊说明书

Full name of Budesonide capsule instructions: Budenofalk, Budesonide, Budesonide

Indications:

1. For patients with glucocorticoid-dependent or independent bronchial asthma and asthmatic chronic bronchitis.

2. Patients with mild to moderate colonic Crohn's disease and ulcerative colitis limited to the sigmoid colon can use this product for enema.

Usage and dosage:

Budesonide aerosol: In patients with severe asthma and discontinuation or reduction of oral glucocorticoids, the starting dose of budesonide aerosol is: Adults: 200 to 1600 mg per day, divided into 2 to 4 times (in mild cases, 200 to 800 mg per day, and in more severe cases, 800 to 1600 mg per day). Generally, 200mg is taken once, once in the morning and once in the evening, for a total of 400mg a day; when the condition is severe, 200mg is taken once, 4 times a day, for a total of 800mg a day. Children aged 2 to 7 years old: 200 to 400 mg per day, divided into 2 to 4 times. Children over 7 years old: 200 to 800 mg per day, divided into 2 to 4 times.

Usage and dosage of budesonide capsules: Adults generally use 1-2 mg of budesonide once, twice a day; children use 0.5-1 mg once, twice a day. The maintenance dose should be individualized, that is, the lowest dose to maintain no symptoms. It is recommended that adults take 0.5-1 mg twice a day and children 0.25-0.5 mg twice a day. 

Adverse reactions:

1%-10%: Respiratory tract: epistaxis (8%), pharyngitis (4%), bronchospasm (2%), cough (2%), nasal mucosa irritation (2%)

<1%: Post-marketing or case reports: anosmia, cataracts, nasal crusting, dizziness, fatigue, glaucoma, growth inhibition, headache, allergic reactions, increased intraocular pressure, mucosal ulcers, septal perforation, nausea, pharyngeal disorders (irritation, itchy throat, sore throat), wheezing

Mechanism of action:

Budesonide is a glucocorticoid with highly effective local anti-inflammatory effects. It can enhance the stability of endothelial cells, smooth muscle cells and lysosomal membranes, inhibit immune responses and reduce antibody synthesis, thereby reducing the release and activity of allergic active mediators such as histamine. It can also reduce the enzymatic process triggered when antigens and antibodies are combined, inhibit the synthesis and release of bronchoconstrictive substances and reduce the contractile response of smooth muscles. Acute, subacute and long-term toxicity studies have found that the systemic effects of budesonide, such as weight loss, lymphoid tissue and adrenal cortex atrophy, are weaker than or equivalent to other glucocorticoids. After systematic evaluation in six different experimental tests, Budesonide has no mutagenic or carcinogenic effects.