IBD STEROIDS








Budesonide (Uceris®)

Dosage forms

Tablet, extended-release (Uceris®)
  • 9 mg
Rectal foam
  • 2 mg per actuation
  • One canister contains 14 actuations
  • Comes in carton with 2 canisters

Dosing

Ulcerative colitis (tablet)
  • Active disease: 9 mg once daily for up to 8 weeks
  • May take without regard to food
  • Swallow whole. Do not cut, crush, or chew tablet.
Ulcerative colitis (foam)
  • Active disease: 1 metered dose (2 mg) twice a day for 2 weeks, then 1 metered dose once daily for 4 weeks
  • Foam is approved to treat disease that extends up to 40 cm from the anal verge

Generic / Price

  • Uceris tablet - YES/$$$$
  • Uceris foam - NO/$$$$

Mechanism of action

  • Budesonide is a corticosteroid. See corticosteroids for general information.
  • Uceris tablets contain a core that is enteric coated. The enteric coating dissolves in the small intestine, and the core begins to release budesonide in a time dependent matter. The therapeutic effect of budesonide is believed to occur through local effects in the colon.
  • Uceris foam is applied directly to the colonic mucosa through the rectum
  • Budesonide that is absorbed undergoes a high rate of first-pass metabolism (80 -90%). Budesonide has the potential to cause systemic side effects (e.g. HPA suppression), but the risk appears to be less than what is seen with other oral corticosteroids.

FDA-approved indications

Uceris tablet
  • Ulcerative colitis - induction of remission in patients with active, mild to moderate ulcerative colitis
Uceris foam
  • Ulcerative colitis - induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge

Side effects


Side effect Budesonide Placebo
Decreased blood cortisol 4.3% 0.4%
Upper abdominal pain 3.9% 1.9%

Drug interactions

  • CYP3A4 inhibitors - budesonide is a CYP3A4 sensitive substrate. Systemic exposure to budesonide is increased when taken with CYP3A4 inhibitors. Consider stopping Uceris if it is necessary to take a CYP3A4 inhibitor.
  • Grapefruit juice - grapefruit juice inhibits CYP3A4 and should not be taken with Uceris
  • Acid-reducing agents (PPIs, H2-blockers, etc.) - acid-reducing agents may affect the dissolution of Uceris tablets

Contraindications / Precautions

  • Corticosteroid precautions - see corticosteroids for general precautions regarding corticosteroids. Systemic exposure with Uceris is reduced compared to other oral steroids, so the risks with Uceris therapy are also likely reduced.
  • Hypothalamus-pituitary-adrenal (HPA) axis suppression - HPA suppression is a side effect of oral corticosteroids. Budesonide has reduced systemic exposure compared to other oral steroids, but some systemic exposure does occur. In one study, abnormal ACTH stimulation tests occurred in 47% of patients treated with Uceris tablets (9 mg daily) for 4 weeks and 79% of patients treated for 8 weeks. In studies involving Uceris foam, abnormal ACTH stimulation tests occurred in 37% of patients treated with Uceris foam for 6 weeks compared to 24% of patients treated with placebo.
  • Immunosuppression - immunosuppression may occur. Use caution in patients with active or quiescent infections (e.g. tuberculosis, parasitic infections, etc.)
  • Transferring from other systemic steroids - when transferring from other systemic corticosteroids (e.g. prednisone) to Uceris, the other systemic steroid should be tapered to avoid withdrawal reactions (e.g. HPA suppression).
  • Kidney disease - manufacturer makes no specific recommendation
  • Liver disease - since Uceris undergoes extensive first-pass metabolism, patients with moderate to severe liver disease may have increased systemic exposure to budesonide. Consider dose reductions in these patients.

Budesonide | Entocort® EC | Ortikos®

Dosage forms

Capsule, delayed-release (Entocort® EC)
  • 3 mg
Capsule, extended-release (Ortikos®)
  • 6 mg
  • 9 mg

Dosing

Crohn's disease (adults)
  • Treatment: 9 mg once daily for up to 8 weeks
  • Maintenance of remission: 6 mg once daily for up to 3 months
  • Treatment beyond 3 months has not been shown to be effective in clinical trials
  • When switching from oral steroids like prednisone to budesonide, prednisone tapering should begin concomitantly with initiating budesonide
  • Swallow capsules whole. Do not chew or crush. Entocort capsules may be opened and sprinkled on applesauce.
  • Do not consume grapefruit juice during therapy
Crohn's disease (8 - 17 years who weigh > 25 kg)
  • Treatment: 9 mg once daily for up to 8 weeks, followed by 6 mg once daily for 2 weeks
  • Swallow capsules whole. Do not chew or crush. Entocort capsules may be opened and sprinkled on applesauce.
  • Do not consume grapefruit juice during therapy

Generic / Price

  • Entocort: YES/$$ for #90
  • Ortikos: NO/$$$$ for #30

Mechanism of action

  • Budesonide is a corticosteroid. See corticosteroids for general information.
  • Budesonide enteric-coated capsules differ from other oral corticosteroids in that systemic absorption of the steroid is greatly reduced. Budesonide coated granules do not dissolve until they reach the small intestine. In theory, this provides localized delivery of budesonide to affected sections of the ileum and ascending colon.
  • Budesonide also undergoes a very high rate of first-pass metabolism in the liver (80 - 90%) further reducing its systemic availability.

FDA-approved indications

Mild to moderate active Crohn's disease involving the ileum and/or the ascending colon
  • Treatment: adults and pediatric patients 8 years and older who weight at least 25 kg
  • Maintenance of remission: adults

Side effects


Side effect Entocort Placebo
Headache 21% 18%
Acne 15% 13%
Easy bruising 15% 11%
Moon face 11% 4%
Respiratory infections 11% 7%
Nausea 11% 9%
Dizziness 7% 5%
Dyspepsia 6% 4%
Hirsutism 5% 2%

Drug interactions

  • CYP3A4 inhibitors - budesonide is a CYP3A4 sensitive substrate. Systemic exposure to budesonide is increased when taken with CYP3A4 inhibitors.

Contraindications / Precautions

  • Corticosteroid precautions - see corticosteroids for general precautions regarding corticosteroids. Systemic exposure with budesonide is reduced compared to other oral steroids, so the risks with budesonide therapy are also likely reduced. [12]
  • Hypothalamus-pituitary-adrenal (HPA) axis suppression - HPA suppression is a side effect of oral corticosteroids. Budesonide has reduced systemic exposure compared to other oral steroids, but some exposure does occur. In studies lasting 13 weeks, 59 - 84% of budesonide-treated patients had normal, unstimulated, plasma cortisol levels. In another study, 92% of budesonide-treated patients had normal adrenal function at one year compared to 75% of prednisone-treated patients (15 mg/day). The risk of HPA suppression appears to be lower with budesonide than with other oral steroids. [12]
  • Kidney disease - manufacturer makes no specific recommendation
  • Liver disease - since budesonide undergoes extensive first-pass metabolism, patients with moderate to severe liver disease may have increased systemic exposure to budesonide. Consider dose reductions in these patients.

Hydrocortisone | Colocort® | Cortenema® | Cortifoam®

Dosage forms

Enema (Colocort®, Cortenema®)
  • 100 mg/60 ml
  • Comes in box of 7 enemas
Rectal foam (Cortifoam®)
  • 80 mg per application
  • Comes in aerosol container that delivers a minimum of 14 applications

Dosing

Ulcerative colitis (Colocort, Cortenema)
  • Active disease: one enema (100 mg) nightly for 21 days
  • Effect typically seen within 3 - 5 days
  • In difficult cases, 2 - 3 months of therapy may be required
  • If therapy extends beyond 21 days, enemas should be tapered when discontinuing by giving every other day for 2 - 3 weeks
  • Enema effects reach the splenic flexure, and have been shown to be beneficial in some patients with transverse and ascending disease
Ulcerative colitis (Cortifoam)
  • Active disease: one applicatorful 1 - 2 times a day for 2 - 3 weeks, and every second day thereafter
  • Clinical response typically seen within 5- 7 days
  • Foam effects have been shown to reach ∼ 15 - 20 cm into the colon [8]

Generic / Price

  • Colocort®|Cortenema® (7 enemas) - YES/$
  • Cortifoam® (7 enemas) - NO/$$$$

Mechanism of action

  • Hydrocortisone is a corticosteroid. See corticosteroids for general information.
  • Hydrocortisone enemas and foam work locally in the colon to inhibit inflammation
  • Hydrocortisone in enemas and foam is also absorbed systemically. With enemas, 50% of the hydrocortisone is absorbed systemically. Systemic absorption from the foam may be greater.

FDA-approved indications

Colocort, Cortenema
  • Ulcerative colitis - adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.
Cortifoam
  • Ulcerative colitis - adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas

Side effects

  • Side effects with Colocort, Cortenema, and Cortifoam are not well-defined. Because a significant amount of systemic absorption occurs, side effects are generally the same as those seen with other systemic corticosteroids.
  • See corticosteroids for more

Drug interactions

  • Hydrocortisone undergoes significant systemic absorption. Drug interactions with hydrocortisone are the same as those seen with other systemic steroids.
  • See corticosteroids for more

Contraindications / Precautions

  • Corticosteroid precautions - see corticosteroids for general precautions regarding corticosteroids. Systemic exposure to hydrocortisone with enemas and foam is significant and carries similar risks as other systemic steroids.
  • Bowel defects - DO NOT USE in patients with obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas, and sinus tracts
  • Hypothalamus-pituitary-adrenal (HPA) axis suppression - HPA suppression is a side effect of oral corticosteroids. Hydrocortisone enemas and foam have significant systemic absorption. If enema therapy extends beyond 21 days, enemas should be tapered when discontinuing by giving every other day for 2 - 3 weeks. Foam should be given every other day after 2 - 3 weeks of therapy.
  • Kidney disease - manufacturer makes no specific recommendation. Use caution.
  • Liver disease - clearance is decreased. Use caution.


Pricing legend
  • $ = 0 - $50
  • $$ = $51 - $100
  • $$$ = $101 - $150
  • $$$$ = > $151
  • Pricing based on one month of therapy at standard dosing in an adult
  • Pricing based on information from GoodRX.com®
  • Pricing may vary by region and availability