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

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