Budesonide

Budesonide Brand Names

Entocort EC | Pulmicort | Rhinocort | Rhinocort Aqua | UCERIS

What is Budesonide

Budesonide is a corticosteroid that is administered via intranasal inhalation, oral inhalation, rectally, or orally to manage symptoms associated with allergic rhinitis, lung diseases (asthma or chronic obstructive pulmonary disease), ulcerative colitis, or inflammatory bowel disease (Crohn’s disease and ulcerative colitis), respectively.

Budesonide has potent glucocorticoid and weak mineralocorticoid activity. Intranasal budesonide allows for once-daily dosing for allergic rhinitis. Inhaled budesonide possesses high topical anti-inflammatory activity but low systemic activity.

Low-dose inhaled corticosteroids are considered first line therapy for mild persistent asthma during pregnancy according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group; budesonide is the preferred inhaled corticosteroid, due to the availability of safety information.

Orally inhaled corticosteroids (ICSs) are considered a preferred pharmacologic treatment in the long-term management of persistent asthma of various severities according to the 2007 guidelines of the Expert Panel of the NAEPP.

The NAEPP concluded that ICSs are the most potent and consistently effective class of medications for the long-term control of asthma in both adults and children. Superior efficacy of ICSs has been demonstrated over other long-term control medications including leukotriene receptor antagonists, cromolyn, and theophylline.

According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, budesonide may be used in combination with an inhaled long-acting beta-2 agonist (LABA) as initial therapy in group D (those with a high risk of exacerbation). Combination of a LABA with an ICS has the greatest likelihood of reducing exacerbations in patients with blood eosinophil counts of 200 cells/microL and higher.

An ICS combined with a LABA is more effective than the individual components in improving lung function and health status and reducing exacerbations in patients with exacerbations and moderate to very severe COPD; however clinical trials failed to demonstrate a statistically significant effect on survival.

Additionally, budesonide may be used for prevention of of exercise-induced bronchoconstriction (EIB); it may be a first-line choice for a controller agent to be added to an inhaled short-acting beta-2 agonist (SABA) to control EIB symptoms in patients who cannot be controlled by an inhaled SABA alone.

Oral budesonide has been shown to be superior to placebo and equivalent to prednisolone, but with fewer adverse reactions, in treating active Crohn’s disease.

An oral tablet formulation of budesonide, with a proprietary delivery system (MMX, a multi-matrix system) that delivers medicine to the colon, has been shown to be effective at inducing remission in patients with active, mild to moderate ulcerative colitis.

Several studies also indicate the benefit of oral budesonide in treating microscopic colitis and, specifically, collagenous colitis.

The FDA first approved budesonide in February 1994.

Indications

  1. allergic rhinitis
  2. asthma
  3. bronchospasm prophylaxis
  4. chronic bronchitis
  5. chronic obstructive pulmonary disease (COPD)
  6. colitis
  7. Crohn’s disease
  8. emphysema
  9. exercise-induced bronchospasm prophylaxis
  10. laryngotracheobronchitis (croup)
  11. perennial allergies
  12. seasonal allergies
  13. ulcerative colitis

Side Effects

  1. abdominal pain
  2. acne vulgaris
  3. adrenocortical insufficiency
  4. agitation
  5. alopecia
  6. anaphylactoid reactions
  7. anemia
  8. angioedema
  9. anorexia
  10. anxiety
  11. appetite stimulation
  12. arthralgia
  13. asthenia
  14. atopic dermatitis
  15. avascular necrosis
  16. back pain
  17. bronchospasm
  18. candidiasis
  19. cataracts
  20. chest pain (unspecified)
  21. Churg-Strauss syndrome
  22. confusion
  23. constipation
  24. contact dermatitis
  25. cough
  26. Cushing’s syndrome
  27. depression
  28. diaphoresis
  29. diarrhea
  30. dizziness
  31. drowsiness
  32. dysgeusia
  33. dysosmia
  34. dyspepsia
  35. dysphonia
  36. ecchymosis
  37. edema
  38. emotional lability
  39. eosinophilia
  40. epistaxis
  41. fatigue
  42. fever
  43. flatulence
  44. fluid retention
  45. flushing
  46. gastrointestinal fistula
  47. GI obstruction
  48. glossitis
  49. growth inhibition
  50. headache
  51. hematuria
  52. hemorrhoids
  53. hirsutism
  54. hoarseness
  55. hyperglycemia
  56. hyperkinesis
  57. hypertension
  58. hypertonia
  59. hypokalemia
  60. hypothalamic-pituitary-adrenal (HPA) suppression
  61. increased intracranial pressure
  62. infection
  63. insomnia
  64. irritability
  65. leukocytosis
  66. maculopapular rash
  67. malaise
  68. migraine
  69. myalgia
  70. nasal congestion
  71. nasal irritation
  72. nasal septum perforation
  73. nausea
  74. ocular hypertension
  75. ocular infection
  76. osteopenia
  77. osteoporosis
  78. otalgia
  79. palpitations
  80. pancreatitis
  81. paresthesias
  82. pharyngitis
  83. pruritus
  84. psychosis
  85. purpura
  86. pyuria
  87. rash
  88. rhinitis
  89. sinus tachycardia
  90. sinusitis
  91. skeletal changes
  92. syncope
  93. throat irritation
  94. tremor
  95. urticaria
  96. vasculitis
  97. vertigo
  98. visual impairment
  99. vomiting
  100. weight gain
  101. withdrawal
  102. xerostomia

Monitoring Parameters

  • pulmonary function tests (PFTs)

Contraindications

  • abrupt discontinuation
  • acute bronchospasm
  • adrenal insufficiency
  • breast-feeding
  • cataracts
  • children
  • corticosteroid hypersensitivity
  • corticosteroid withdrawal
  • Cushing’s syndrome
  • diabetes mellitus
  • edema
  • fungal infection
  • gastroenteritis
  • geriatric
  • GI perforation
  • glaucoma
  • growth inhibition
  • heart failure
  • hepatic disease
  • herpes infection
  • hypercortisolism
  • hyperglycemia
  • hypertension
  • hyperthyroidism
  • hypothalamic-pituitary-adrenal (HPA) suppression
  • hypothyroidism
  • immunosuppression
  • increased intracranial pressure
  • increased intraocular pressure
  • infants
  • infection
  • malnutrition
  • measles
  • milk protein hypersensitivity
  • myasthenia gravis
  • nasal septal perforation
  • nasal surgery
  • nasal trauma
  • neonates
  • ocular infection
  • osteoporosis
  • peptic ulcer disease
  • pregnancy
  • psychosis
  • renal disease
  • seizure disorder
  • status asthmaticus
  • surgery
  • thyroid disease
  • tobacco smoking
  • trauma
  • tuberculosis
  • varicella
  • viral infection
  • visual disturbance

Interactions

  • Abatacept
  • Acetaminophen; Aspirin, ASA; Caffeine
  • Acetaminophen; Butalbital
  • Acetaminophen; Butalbital; Caffeine
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
  • Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
  • Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
  • Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
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  • grapefruit juice
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