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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Budesonide (inhalation) is an adrenal cortex hormone that is FDA approved for the treatment of asthma, crohn's disease, allergic and non-allergic rhinitis, active ulcerative colitis (mild to moderate). There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, arthralgia, headache, epistaxis, nasal stinging/burning, respiratory tract infection, sinusitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Asthma
Dosing Information
Initial dose: 360 mcg via oral inhalation twice daily;180 mcg twice daily initially may be sufficient in some patients
Maximum dose: 720 mcg twice daily
Crohn's disease
Dosing Information
Induction of Remission:
Recommended dose: 9 mg orally once daily in the morning for up to 8 weeks; a repeat 8-week course may be given for recurring episodes; taper off oral prednisolone while concurrently initiating budesonide
Maintenance of Remission:
Recommended dose: 6 mg orally once daily for up to 3 months; after 3 months, taper to complete cessation (use beyond 3 months has not shown substantial clinical benefit)
Rhinitis, allergic and non-allergic
Dosing Information
Recommended dose: 64 mcg (one 32-mcg spray/nostril) once daily; titrate to minimum effective dose; may be able to reduce dose once symptoms are controlled
Maximum dose: 256 mcg/day (4 sprays/nostril once daily)
Ulcerative colitis (Mild to Moderate), Active
Dosing Information
Recommended dose (Uceris(TM)): 9 mg orally once daily in the morning for up to 8 weeks
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Budesonide in adult patients.
Non–Guideline-Supported Use
Nasal polyp
Dosing Information
Dose: 128 mcg intranasally once daily over 8 weeks or 400 mcg/day intranasally in 2 divided doses over 8 to 12 weeks
Ulcerative colitis, distal
Dosing information
Effective dose: 100 to 125 mL of a suspension containing 2 mg/100 mL once daily at bedtime (study dosage)or 2 mg (100 mL) as a rectal enema once daily at night for 4 to 8 weeks (Canadian manufacturer dosage)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Asthma
Dosing Information
Inhaler:
Recommended dose, 6 years or older: Initiate at 180 mcg via oral inhalation twice daily; 360 mcg twice daily may be required initially in some patients
Maximum dose: 360 mcg twice daily
Nebulization:
Recommended dose, 1 to 8 years: Based on previous therapy as follows
Rhinitis, allergic and non-allergic
Dosing information
Nasal route:
Recommended dose (6 years or older): 64 mcg (one 32-mcg spray/nostril) once daily; titrate to minimum effective dose; may be able to reduce dose once symptoms are controlled
Maximum dose: under 12 years, 128 mcg/day (2 sprays/nostril once daily); 12 years or older, 256 mcg/day (4 sprays/nostril once daily)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Budesonide in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Budesonide (inhalation) in pediatric patients.
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Budesonide (inhalation) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Budesonide (inhalation) in the drug label.