Budesonide (inhalation): Difference between revisions
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===== | =====Crohn's disease===== | ||
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===== | =====Rhinitis, allergic and non-allergic===== | ||
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===== | =====Ulcerative colitis (Mild to Moderate), Active==== | ||
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Revision as of 15:07, 18 September 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
|
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
- Dosage
Crohn's disease
- Dosing Information
- Dosage
Rhinitis, allergic and non-allergic
- Dosing Information
- Dosage
=Ulcerative colitis (Mild to Moderate), Active
- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1=
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Budesonide (inhalation) in adult patients.
Non–Guideline-Supported Use
Nasal polyp
- Dosing Information
- Dosage
Ulcerative colitis, distal
There is limited information regarding Off-Label Non–Guideline-Supported Use of Budesonide (inhalation) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Asthma
- Dosing Information
- Dosage
Rhinitis, allergic and non-allergic
There is limited information regarding FDA-Labeled Use of Budesonide (inhalation) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
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:
|
- 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.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Budesonide (inhalation) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Budesonide (inhalation) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Budesonide (inhalation) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Budesonide (inhalation) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Budesonide (inhalation) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Budesonide (inhalation) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Budesonide (inhalation) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Budesonide (inhalation) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Budesonide (inhalation) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Budesonide (inhalation) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Budesonide (inhalation) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Budesonide (inhalation) in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Budesonide (inhalation) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Budesonide (inhalation) in the drug label.
Pharmacology
There is limited information regarding Budesonide (inhalation) Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Budesonide (inhalation) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Budesonide (inhalation) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Budesonide (inhalation) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Budesonide (inhalation) in the drug label.
How Supplied
Storage
There is limited information regarding Budesonide (inhalation) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
{{#ask: Label Page::Budesonide (inhalation) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Budesonide (inhalation) in the drug label.
Precautions with Alcohol
- Alcohol-Budesonide (inhalation) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Entocort EC, Pulmicort, Pulmicort Turbuhaler, Rhinocort, Rhinocort Aqua, Pulmicort Flexhaler, Pulmicort Respules, Uceris.
Look-Alike Drug Names
There is limited information regarding Budesonide (inhalation) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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