Budesonide中文的说明书

Is a first-line anti-inflammatory agent and locally acting corticosteroid indicated for the induction and maintenance of remission in mild to moderate ileocecal Crohn's disease (capsules) and ulcerative colitis (enema) as well as remission with active substances; for the treatment of bronchial asthma.

【Mechanism of action】

Budesonide is an anti-inflammatory corticosteroid with high glucocorticoid effects and weak mineralocorticoid effects. The affinity of budesonide for the glucocorticoid receptor reflects the intrinsic potency of the drug, which is 200 times that of cortisol and 15 times that of cortisol.

【Usage and Dosage】

Take once daily in the morning. Swallow whole. Do not chew or crush. For patients who are unable to swallow the entire capsule, open the capsule and pour the granules into a tablespoon of applesauce. Mix and consume entire contents within 30 minutes. Do not chew or crush. Follow with 8 ounces of water. Avoid grapefruit juice during treatment.

[Recommended dosage]:

1. Mild to moderately active Crohn's disease: Adults: 9 mg daily for up to 8 weeks; repeat the 8-week course of treatment for recurrent active disease.

Pediatrics 8 to 17 years weighing more than 25 kg: 9 mg once daily for up to 8 weeks, then 6 mg once daily for 2 weeks.

To maintain clinical remission in mild to moderate Crohn's disease, adults: 6 mg daily for up to 3 months; discontinue 3 months after completion of tapering. Continuation of treatment beyond 3 months has not been shown to provide substantial clinical benefit. When switching from oral prednisolone, begin tapering the prednisolone dose and simultaneously initiate Budesonide.

2. Hepatic impairment: Consider reducing dosage to 3 mg once daily in adult patients with moderate hepatic impairment (Child-Pugh Class B).

【Adverse reactions】

The most common adverse reactions (≥5%) of Budesonide in adults are: headache, respiratory tract infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.

【Notes】

1. Use with caution when the airway is infected with fungi, viruses or tuberculosis bacteria. 2. After inhaling Budesonide, rinse the mouth and pharynx with clean water to prevent the growth of fungi. 3. Children should take the dosage prescribed by the doctor and use it under the guidance of adults.