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== Misuse or Abuse ==
== Misuse or Abuse ==
In its Fiscal Year 2010 Work Plan, the [[Office of the Inspector General]] (OIG) of the [[United States Department of Health and Human Services]], stated that it would be investigating whether the number of units of budesonide billed and paid for by Medicare in South Florida exceeds the amount of the drug actually distributed in the area. The OIG noted that its previous work had revealed "aberrant billing patterns" for inhaled budesonide in South Florida, and stated that it believes many of these billings may be fraudulent.<ref>[http://www.oig.hhs.gov/publications/docs/workplan/2010/Work_Plan_FY_2010.pdf OIG FY10 Work Plan] [[Office of the Inspector General]] (p. 26).</ref>
In its Fiscal Year 2010 Work Plan, the [[Office of the Inspector General]] (OIG) of the [[United States Department of Health and Human Services]], stated that it would be investigating whether the number of units of budesonide billed and paid for by Medicare in South Florida exceeds the amount of the drug actually distributed in the area. The OIG noted that its previous work had revealed "aberrant billing patterns" for inhaled budesonide in South Florida, and stated that it believes many of these billings may be fraudulent.<ref>[http://www.oig.hhs.gov/publications/docs/workplan/2010/Work_Plan_FY_2010.pdf OIG FY10 Work Plan] [[Office of the Inspector General]] (p. 26).</ref>

Unlike [[Over-the-counter drug|OTC]] [[nasal decongestant]]s, budesonide has not been shown to cause rebound nasal congestion.<ref>http://www.drugs.com/rhinocort.html</ref>


==See also==
==See also==

Revision as of 19:52, 16 February 2012

Budesonide
Clinical data
Trade namesRhinocort
AHFS/Drugs.comMonograph
MedlinePlusa608007
Routes of
administration
Oral, Nasal, tracheal, rectal
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability10-20% (first pass effect)
Protein binding85-90%
MetabolismHepatic CYP3A4
Elimination half-life2.0-3.6 hours
ExcretionRenal, Faecal
Identifiers
  • 16,17-(butylidenebis(oxy))-11,21-dihydroxy-, (11-β,16-α)-pregna-1,4-diene-3,20-dione
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.051.927 Edit this at Wikidata
Chemical and physical data
FormulaC25H34O6
Molar mass430.534 g/mol g·mol−1
3D model (JSmol)
  • O=C(CO)[C@]25O[C@@H](O[C@@H]5C[C@H]1[C@H]4[C@H]([C@@H](O)C[C@@]12C)[C@]/3(/C=C\C(=O)\C=C\3CC4)C)CCC
  • InChI=1S/C25H34O6/c1-4-5-21-30-20-11-17-16-7-6-14-10-15(27)8-9-23(14,2)22(16)18(28)12-24(17,3)25(20,31-21)19(29)13-26/h8-10,16-18,20-22,26,28H,4-7,11-13H2,1-3H3/t16-,17-,18-,20+,21+,22+,23-,24-,25+/m0/s1 checkY
  • Key:VOVIALXJUBGFJZ-VXKMTNQYSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Budesonide is a glucocorticoid steroid for the treatment of asthma and non-infectious rhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. In addition, it is used for Crohn's disease (inflammatory bowel disease).

It is marketed by AstraZeneca as a nasal inhalant under the brand name Rhinocort (in Denmark, as Rhinosol), as an oral inhalant under the brand name Pulmicort (in Israel, Budicort), and as either an enema or a modified-release oral capsule under the brand name Entocort. It is also sold in combination with formoterol (Oxis) in a single inhaler, under the brand name Symbicort. In Brazil it is marketed by Eurofarma under the brand name Noex. Entocort EC is an oral capsule marketed in the United States by Prometheus Laboratories.

A new formulation is in clinical trials for ulcerative colitis.[2]

Pharmacology

Budesonide has a high first-pass metabolism.[3] It has efficacy in the terminal ileum and the right 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 limits the need of tapering before discontinuation.[citation needed] Overall, it has a lower incidence of systemic manifestations than similar medications.

Side-effects

Budesonide may cause:[4]

  • nose irritation or burning
  • bleeding or sores in the nose
  • lightheadedness
  • upset stomach
  • cough
  • hoarseness
  • dry mouth
  • rash
  • sore throat
  • bad taste in mouth
  • change in mucus color
  • muscle cramps

In addition, the following symptoms should be reported immediately:

  • difficulty breathing or swelling of the face
  • white patches in the throat, mouth, or nose
  • irregular menstrual periods
  • severe acne
  • on rare occasions, behavioral changes — when these do occur, they seem to mostly affect children. For citation, see reference above.

Recall

Pulmicort inhalers were recalled by AstraZeneca in 2004 because there was concern that they may not always have provided the full dosage.[5]

Misuse or Abuse

In its Fiscal Year 2010 Work Plan, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services, stated that it would be investigating whether the number of units of budesonide billed and paid for by Medicare in South Florida exceeds the amount of the drug actually distributed in the area. The OIG noted that its previous work had revealed "aberrant billing patterns" for inhaled budesonide in South Florida, and stated that it believes many of these billings may be fraudulent.[6]

See also

References

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ http://www.genengnews.com/gen-news-highlights/positive-phase-iii-data-mean-cosmo-and-santarus-plan-2011-nda-for-ulcerative-colitis-drug/81244010/
  3. ^ http://www.pharmgkb.org/do/serve?objId=PA448681
  4. ^ BUDESONIDE - NASAL AEROSOL INHALER (Rhinocort) side effects, medical uses, and drug interactions
  5. ^ AstraZeneca Pulmicort recall
  6. ^ OIG FY10 Work Plan Office of the Inspector General (p. 26).