Budesonide (inhalation): Difference between revisions

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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = 16,17-(butylidenebis(oxy))-11,21-dihydroxy-, (11-β,16-α)-pregna-1,4-diene-3,20-dione
|authorTag=
| image = Budesonide.png
 
| width = 200
 
| CAS_number = 51333-22-3
<!--Overview-->
| ATC_prefix = A07
 
| ATC_suffix = EA06
|genericName=
| ATC_supplemental = {{ATC|D07|AC09}}, {{ATC|R01|AD05}}, {{ATC|R03|BA02}}
 
| PubChem = 63006
 
| DrugBank = APRD00442
 
| C=25 | H=34 | O=6
|aOrAn=
| molecular_weight = 430.534 g/mol
 
| bioavailability = 100% (but large first pass effect)
a
| protein_bound = 85-90%
 
| metabolism = Hepatic [[CYP3A4]]
|drugClass=
| elimination_half-life = 2.0-3.6 hours
 
| excretion = Renal, Faecal
 
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
 
| pregnancy_US = C
|indication=
| pregnancy_category =
 
| legal_AU =  <!-- Unscheduled / S2 / S3 / S4  / S8 -->
 
| legal_CA = <!--                             / Schedule I, II, III, IV, V, VI, VII, VIII -->
 
| legal_UK = POM
|hasBlackBoxWarning=
| legal_US = <!-- OTC                  / Rx-only  / Schedule I, II, III, IV, V -->
 
| legal_status =
Yes
| routes_of_administration = Oral, Nasal, tracheal, rectal
 
}}
|adverseReactions=
{{SI}}
 
{{CMG}}
 
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
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|monitoring=
 
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* Description
 
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* Description
 
====Management====
 
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
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* ®<ref>{{Cite web | title =  | url =  }}</ref>


<!--Look-Alike Drug Names-->


|lookAlike=


==Overview==
* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
'''Budesonide''' is a [[glucocorticoid]] [[steroid]] for the treatment of [[asthma]], non-infectious [[rhinitis]] (including [[hay fever]] and other allergies), and for treatment and prevention of nasal polyposis. Additionally, it is used for [[inflammatory bowel disease]]. It is marketed by [[AstraZeneca]] as a  [[nasal]] inhalation with the brand name '''Rhinocort''' (in Denmark, as '''Rhinosol'''), as an oral inhalation with the brand name '''Pulmicort''', and as an enema and a modified-release capsule with the brand name '''Entocort'''. It is also sold in combination with [[formoterol]] (Oxis) in a single inhaler, with the brand name [[Symbicort]].


==Pharmacology==
<!--Drug Shortage Status-->
Budesonide has a high first pass [[metabolism]]. It has efficacy in the terminal [[ileum]] and the right [[Colon (anatomy)|colon]]. Budesonide in comparison with prednisolone has been associated with fewer bone density losses and unlike other corticosteroids has little influence on the hypothalamic-pituitary-adrenal axis which also limit the need of tapering before discontinuation. Overall, it has a lower incidence of systemic manifestations than similar medications.


==Side Effects==
|drugShortage=
Budesonide may cause:
}}
* nose irritation or burning
* bleeding or sores in the nose
* lightheadedness
* upset stomach
* cough
* hoarseness
* dry mouth


In addition the following should be reported:
<!--Pill Image-->
* Immediately if difficulty breathing or swelling of the face
* white patches in the throat, mouth, or nose
* irregular menstrual periods
* severe acne


==Recall==
{{PillImage
Pulmicort inhalers were recalled in 2002 because there was concern that they may not always have provided the full dosage.
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
 
|drugName=
==External links==
|NDC=
* [http://www.astrazeneca-us.com/pi/entocortec.pdf FDA Label (PDF)]
|drugAuthor=
* [http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601030.html National Institute of Health's Medline about Budesonide]
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


{{Antidiarrheals, intestinal anti-inflammatory/anti-infective agents}}
<!--Label Display Image-->
{{Nasal preparations}}
{{Asthma_and_copd_rx}}
{{Corticosteroids}}


{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


[[Category:Glucocorticoids]]
{{LabelImage
[[Category:Asthma]]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
[[Category:Pulmonology]]
}}


{{WikiDoc Help Menu}}
<!--Category-->
{{WikiDoc Sources}}


[[de:Budesonid]]
[[Category:Drug]]
[[hr:Budezonid]]
[[it:Budesonide]]
[[nl:Budesonide]]
[[pl:Budezonid]]
[[zh:布地奈德]]

Revision as of 14:37, 18 September 2014

Budesonide (inhalation)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Budesonide (inhalation) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • 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

Condition1
  • Dosing Information
  • Dosage
Condition2

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)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Budesonide (inhalation) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

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 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.

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 (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • 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

File:Budesonide (inhalation)01.png
This image is provided by the National Library of Medicine.

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

{{#ask: Page Name::Budesonide (inhalation) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

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

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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