Budesonide

Budesonide delayed-release capsules are corticosteroid indicated for:

• Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients 8 years and older. (
  1.1 Treatment of Mild to Moderate Active Crohn’s Disease

  Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older.
  )
• Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. (
  1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease

  Budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults.
  )

• Take once daily in the morning.
• Swallow whole. Do not chew or crush.
• For patients unable to swallow an intact capsule, open the capsules and empty the granules onto one tablespoonful of applesauce. Mix and consume the entire contents within 30 minutes. Do not chew or crush. Follow with 8 ounces of water.
• Avoid consumption of grapefruit juice for the duration of therapy.

• Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment courses for recurring episodes of active disease.
• Pediatrics 8 to 17 years who weigh more than 25 kg: 9 mg once daily for up to 8 weeks, followed by 6 mg once daily in the morning for 2 weeks.

• Adults: 6 mg once daily for up to 3 months; taper to complete cessation after 3 months. Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
• When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating budesonide delayed-release capsules.

• Consider reducing the dosage to 3 mg once daily in adult patients with moderate hepatic impairment (Child-Pugh Class B). (
  2.4 Dosage Adjustment in Adult Patients with Hepatic Impairment

  Consider reducing the dosage of budesonide delayed-release capsules to 3 mg once daily for adult patients with moderate hepatic impairment (Child-Pugh Class B). Avoid use in patients with severe hepatic impairment (Child-Pugh Class C)

  [see Warnings and Precautions , Use in Specific Populations ]

  .
  ,
  5.1 Hypercorticism and Adrenal Axis Suppression

  Systemic effects such as hypercorticism and adrenal axis suppression may occur with use of corticosteroids, including budesonide delayed-release capsules

  [see Adverse Reactions , Clinical Pharmacology ]

  . Pediatric patients with Crohn's disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression than adults with Crohn's disease

  [see Use in Specific Populations , Clinical Pharmacology ]

  . Monitor patients for signs and symptoms of hypercorticism and adrenal axis suppression during treatment with budesonide delayed-release capsules.

  Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism and consider reducing the dosage in patients with moderate hepatic impairment (Child-Pugh Class B)

  [see Dosage and Administration , Use in Specific Populations , Clinical Pharmacology ]

  .

  Corticosteroids, including budesonide delayed-release capsules, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended.
  ,
  8.6 Hepatic Impairment

  Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to budesonide

  [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]

  . Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism and consider dosage reduction in patients with moderate hepatic impairment (Child-Pugh Class B)

  [see Dosage and Administration (2.4)]

  . No dosage adjustment is needed in patients with mild hepatic impairment (Child-Pugh Class A).
  )

Delayed-Release Capsules: 3 mg (