Budesonide (budesonide)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Budesonide is a synthetic, non-halogenated corticosteroid that has potent glucocorticoid and weak mineralocorticoid activity.
Budesonide is a synthetic, nonhalogenated corticosteroid. Budesonide has high glucocorticoid and weak mineralocorticoid activity. For further information on the pharmacology of corticosteroids,see Pharmacology in the Corticosteroids General Statement 68:04.
The exact mechanism(s) of action of corticosteroids in allergic rhinitis remains unknown, but may involve reductions in the following: number of mediator cells (basophils, eosinophils, T-helper cells, mast cells, and neutrophils) in the nasal mucosa, nasal reactivity to allergens, and release of inflammatory mediators and proteolytic enzymes. (See Pharmacology, in Fluticasone Propionate 52:08.08.)
When budesonide is administered intranasally, approximately 34% of a dose reaches systemic circulation. Mean peak plasma budesonide concentrations are achieved in about 0.7 hours.
Following administration of budesonide nasal spray at a dosage of 256 mcg daily for 7 days in healthy individuals, a small, but statistically significant reduction in the area under the plasma cortisol concentration-time curve (AUC0-24 hours) has been observed. A dose-related suppression of the HPA response was observed in patients receiving budesonide nasal spray at dosages ranging from 100-800 mcg daily for up to 4 days. However, in a 4-week clinical trial in adult patients receiving budesonide nasal spray at a dosage of 256 mcg daily, no significant differences in plasma cortisol concentrations, compared with placebo, were observed when measured before and 60 minutes after IM administration of a 0.25-mg dose of cosyntropin.
Budesonide is metabolized in the liver by the cytochrome P-450 (CYP) isoenzyme 3A4; the 2 main metabolites have less than 1% of affinity for glucocorticoid receptors than the parent compound. Budesonide is excreted in urine and feces as metabolites.
USES: Budesonide is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). Budesonide belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.
Generic name: budesonide
Pronunciation: (bue-DES-oh-nide)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Budesonide
Indications
The following indications are listed for Budesonide:
- Allergic Rhinitis
- Allergic Rhinitis Prevention
- Chronic Non-Allergic Rhinitis
- Perennial Allergic Rhinitis
Also known as: Allergic Rhinitis Prophylaxis, Atopic Rhinitis, Chronic Nonallergic Rhinitis, Non-Seasonal Allergic Rhinitis.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Known hypersensitivity to budesonide or any ingredient of the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects of budesonide occurring in 2% or more of patients receiving budesonide nasal spray and with an incidence more frequent than that of placebo include epistaxis, pharyngitis, bronchospasm, cough, and nasal irritation.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of intranasal budesonide have not been established in children younger than 6 years of age. Intranasal corticosteroids may cause growth suppression in children or adolescents, and clinicians should routinely monitor (e.g., via stadiometry) the growth of pediatric patients receiving these drugs. See Cautions: Pediatric Precautions, in the Corticosteroids General Statement 68:04.
Category C. (See Users Guide.) Hypoadrenalism may occur in infants of mothers receiving corticosteroid therapy during pregnancy. These infants should be carefully monitored.
Not known whether budesonide is distributed in milk. Caution is advised if the drug is administered in nursing women.
Although no overall differences in safety and efficacy were observed between geriatric and younger patients, frequency of epistaxis appears to increase with age. In addition, the possibility that some older individuals may exhibit increased sensitivity to the drug cannot be ruled out.
ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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