Drug | United States trade name(s) | Dose in children | Dose in adults | Indication | Important side effects | Comments |
Glucocorticoids | ||||||
Prednisone or prednisolone | 1 to 2 mg/kg/day orally (maximum 60 mg/dose), then taper after 2 weeks if patient is in remission. | 40 to 60 mg/day orally, then taper after 2 weeks if patient is in remission. | Short-term induction therapy for moderate Crohn disease. | Facial swelling, moodiness, sleep disturbance, hirsutism, adrenal suppression (with physiologic doses for more than 2 to 3 weeks), hyperglycemia, osteoporosis, increased risk of varicella infection, cataracts, aseptic necrosis of bone. | Onset of action rapid (3 to 14 days). Long-term use causes growth failure; not appropriate for long-term use. | |
Budesonide (enteric coated) | Entocort EC Ortikos | Age ≥6 years: OR 0.45 mg/kg/day orally (maximum dose 9 mg/day), then taper[2]. | 9 mg/day orally, then taper. | Short-term induction therapy for mild to moderate Crohn disease affecting the ileum and right colon. | Similar to prednisone but fewer systemic effects including adrenal suppression. | May be less effective than prednisone. Pediatric dosing is based on limited data from clinical trials in children 6 years and older. Taper by 3 mg increments as tolerated for a total course of up to 3 months. |
Budesonide MMX | Uceris | 9 mg/day orally, then taper. | 9 mg/day orally, then taper. | FDA-approved for UC in adults; occasionally used for Crohn colitis. | Similar to prednisone but fewer systemic effects including adrenal suppression. | May be less effective than prednisone. Only available in 9 mg dose, so use is generally limited to older adolescents and adults. |
Methylprednisolone | Solu-Medrol | 1 mg/kg every 12 hours IV (maximum 30 mg/dose). | 25 to 35 mg every 12 hours IV. | Induction of remission in severe Crohn disease of the small bowel and colon. | As described above for other systemic corticosteroids. | |
Nutritional therapy | ||||||
Elemental or polymeric formula (no other food by mouth) | Dose to meet nutritional needs for 4 to 6 weeks. | Mucosal Crohn disease, growth failure. | Formulas may be administered orally or by nasogastric tube. | Efficacy 50 to 80%[4]. Patients may refuse or have difficulty adhering to regimen; may relapse rapidly after resuming regular diet. | ||
Anti-TNF inhibitors | ||||||
Infliximab (chimeric monoclonal antibody, 75% humanized) | Remicade and biosimilars (Renflexis, Inflectra) | Induction: 5 mg/kg/dose IV every 8 weeks (may increase to 10 mg/kg if response is incomplete, and/or decrease the interval between infusions). | Induction: 5 mg/kg/dose IV every 8 weeks (may increase to 10 mg/kg if response is incomplete, and/or decrease the interval between infusions). | Refractory Crohn disease. | Infusion reactions, infections, psoriasis. Increased risk of tuberculosis, histoplasmosis, and other opportunistic lung infections. Increased risk of lymphoma, including hepatosplenic T cell lymphoma. However, lymphoma risk has primarily been reported with the combination of thiopurines and infliximab. | Evaluate with tuberculin skin test or chest radiograph prior to starting therapy. Monitor CBC, AST, and ALT during therapy. Some experts use a higher initial dose (10 mg/kg) for patients with severe colitis and protein loss. |
Adalimumab (humanized monoclonal antibody) | Humira | Dose used in clinical trials in children[7]: Induction: ≥40 kg – 160 mg/dose subcutaneously on week 0, followed by 80 mg on week 2. Maintenance: (Start on week 4) ≥40 kg – 40 mg subcutaneously every 2 weeks. | Induction: 40 mg subcutaneously on alternate weeks thereafter. Some patients may require weekly maintenance therapy[8] or a higher maintenance dose. | FDA-approved for Crohn disease not responding to conventional therapies. May be used as first-line anti-TNF therapy (not only those who have failed infliximab). | Infections, increased risk of lymphoma and tuberculosis. | Evaluate with tuberculosis skin test prior to starting therapy. Monitor CBC, AST, and ALT during therapy. A citrate-free preparation is available, which reduces pain at the injection site. |
Other biologic agents | ||||||
Ustekinumab | Stelara | Dose not well established for children. One report that focused on adolescents used the same dosing that is recommended for Crohn disease in adults[9]. | Induction: 55 to 85 kg – 390 mg IV. >85 kg – 520 mg IV. Maintenance:90 mg subcutaneously every 8 weeks. | Refractory Crohn disease. | Infections, headache. | Primarily used for nonresponders to anti-TNF therapy. |
Vedolizumab | Entyvio | Dose not well established for children, but 6 mg/kg IV has been used off-label[10]. Give one dose at 0, 2, and 6 weeks, then every 8 weeks thereafter. | 300 mg IV at 0, 2 and 6 weeks, then every 8 weeks thereafter. Escalation by decreasing frequency to every 4 weeks has been reported. | Refractory Crohn disease. | Infections, development of anti-vedolizumab antibodies. | Favorable safety profile in adults. |
Immunomodulators | ||||||
Mercaptopurine (also known as 6-mercaptopurine [6-MP]) | Purinethol | 1 to 1.5 mg/kg/day orally¶ (maximum dose 150 mg/day)[3]. Much lower doses are used for patients with reduced TPMT activity (refer to "Comments"). | 1 to 1.5 mg/kg/day orally (maximum dose 150 mg/day)[3]. Much lower doses are used for patients with reduced TPMT activity (refer to "Comments"). | Maintenance of remission in medically refractory Crohn disease, especially for patients with growth failure or fistulizing disease. | Pancreatitis, myelosuppression, hepatitis, pneumonitis, opportunistic infections. Hypersensitivity (drug fever, arthritis, or rash), anorexia, nausea, vomiting. Increased risk of lymphoma (sometimes related to concomitant EBV infection). | Assess TPMT genotype or enzyme activity prior to starting therapy. Dose should then be modified based on the TPMT genotype or activity. Starting dosage of mercaptopurine should be modified based on the TPMT genotype or activity[5]:
Monitor CBC, AST, ALT, and amylase/lipase during therapy. Slow onset of therapeutic effects (3 to 4 months). Therapeutic drug level monitoring available. Possible risks of birth defects. Increased risk of lymphoma. |
Azathioprine | 1.5 to 2.5 mg/kg/day orally (maximum dose 200 mg/day)[3]. Much lower doses are used for patients with reduced TPMT activity (refer to "Comments"). | 1.5 to 2.5 mg/kg/day orally (maximum dose 200 mg/day)[3]. Much lower doses are used for patients with reduced TPMT activity (refer to "Comments"). | Same as mercaptopurine; these are maintenance agents only. | Same as mercaptopurine. | Assess TPMT genotype or enzyme activity prior to starting therapy. Starting dosage of azathioprine should then be modified based on the TPMT genotype or activity[5]:
Monitor CBC, AST, ALT, and amylase/lipase during therapy. Azathioprine is metabolized to mercaptopurine in the liver. Slow onset of therapeutic effects (3 to 4 months). Adverse effects are the same as mercaptopurine. | |
Methotrexate | Reumatrex Trexall | Induction: 15 mg once weekly. | Induction: 15 mg subcutaneously weekly. | Refractory Crohn disease. Primarily used as maintenance therapy. | Bone marrow suppression, hepatotoxicity, oral ulcers, nausea, pneumonitis. | Contraindicated in pregnancy. Monitor CBC, AST, and ALT during therapy. Folic acid 1 mg daily should be given to all patients. The oral route of administration also has been used for maintenance of remission[6]. |
Aminosalicylates (derivatives of 5-ASA) | ||||||
Mesalamine (time-released)* | Pentasa | 50 to 75 mg/kg/day orally in 3 to 4 divided doses (maximum 1 g/dose)[3]. | Induction: 2 to 4 g/day orally in 3 to 4 divided doses. | Maintenance of remission in mild mucosal Crohn disease in small bowel or colon. May also be useful for initial therapy in patients with mild disease. | Generally well tolerated. Rare reactions include rashes, pancreatitis, and interstitial nephritis (rare but serious). | Low efficacy (35 to 40% versus 30% for placebo in randomized studies). Capsules may be opened and sprinkled on soft food. Patient adherence can be a problem because of requirement for frequent dosing. Suggest monitoring BUN/creatinine, urine analysis, CBC, AST, and ALT (eg, twice yearly). |
Mesalamine (pH-released)* | Asacol | 50 to 80 mg/kg/day orally in 3 to 4 divided doses (maximum 1 g/dose). | 3.6 to 4.8 g/day orally in 3 to 4 divided doses. | Maintenance of remission in mild mucosal Crohn disease in ileum or colon. May also be useful for initial therapy in patients with mild disease. | As above. | Low efficacy (35 to 40% versus 30% for placebo in randomized studies). Patient adherence can be a problem because of requirement for frequent dosing. Suggest monitoring BUN/creatinine, urine analysis, CBC, AST, and ALT (eg, twice yearly). |
Sulfasalazine | Azulfidine Sulfazine | 50 to 75 mg/kg/day orally in 3 to 4 divided doses (maximum 1 g/dose). | Induction: 1 g orally 2 to 3 times daily. | Maintenance of remission in mild mucosal colonic Crohn disease. May also be useful for initial therapy in patients with mild disease. | Sulfasalazine consists of a 5-ASA component linked to sulfapyridine; hypersensitivity to the sulfonamide component is common (drug fever, arthritis, or rash). Headache, photosensitivity, leukopenia, hepatitis. Rare but serious reactions include pancreatitis, pericarditis, myocarditis, and pneumonitis. | To minimize side effects, start treatment at a low dose and increase to full dose as tolerated over 1 to 2 weeks. Low efficacy (35 to 40% versus 30% for placebo in randomized studies). Also give folic acid, 1 mg/day. Suggest monitoring BUN/creatinine, urine analysis, CBC, AST, and ALT (eg, twice yearly). Can be compounded into a suspension for children who cannot swallow pills. |
Antibiotics | ||||||
Ciprofloxacin | Cipro | Induction of remission: 20 to 30 mg/kg/day orally divided in 3 doses (up to 500 mg/dose)[3]. | Induction of remission: 250 to 500 mg orally 2 or 3 times dailyΔ. | Induction of remission in perianal or mucosal disease. Treatment of infectious complications (eg, abdominal or perianal abscess). | Hypersensitivity reactions. Risk of C. difficile colitis. Tendon inflammation and rupture, arthropathy, photosensitivity. | Moderate efficacy. Avoid in pregnancy. |
Metronidazole | Flagyl | Induction of remission: 20 to 30 mg/kg/day orally divided in 3 doses (up to 500 mg/dose)[3,11,12]. | Induction of remission: 250 to 500 mg orally 2 or 3 times dailyΔ. | Same as ciprofloxacin, postoperative recurrence. | Nausea, disulfiram reaction (occurs with ingestion of alcohol), alteration of taste. Peripheral neuropathy often develops with chronic use. | May delay recurrence of mucosal disease after surgical resection. Avoid in pregnancy◊. |
Azithromycin | Zithromax | Induction of remission: 7.5 mg/kg (max 500 mg). | Active Crohn disease, given in combination with metronidazole. | Nausea, potential cardiac toxicity. | Used off-label to treat active Crohn disease. |
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