Budesonide

Registered South African indications:

• Allergic rhinitis

Contraindication

• Hypersensitivity to the active ingredient or any of its excipients
• Hepatic cirrhosis

Cautions

• Hepatic impairment
• Epistaxis
• Herpetic infection
• Recent nasal surgery
• Recent nasal trauma
• Nasal ulceration
• Active and latent tuberculosis
• Nasal and airway infections
• Chickenpox
• Measles
• Live vaccines
• Visual disturbance
• Concomitant treatment with ketoconazole
• Sucrase-isomaltase insufficiency
• Fructose intolerance
• Total lactase deficiency

Forms avail. in SA and covered in this monograph: nas

Seasonal and perennial allergic rhinitis 
Nasal polyps

• Nasal (nas): 1-2 actuations per nostril, 12-24hrly; Max dose: 4 actuations/24hrs

Use lowest effective dose for shortest effective treatment duration

Desired clinical effect appears within 1-2 weeks

Treatment should be initiated prior to exposure to allergens

Paed. forms avail. in SA and covered in this monograph: nas

Seasonal and perennial allergic rhinitis 
Nasal polyps

Younger than 6 years

• Not established for use

Between 6-12 years

• Nasal (nas): 32-64μg per nostril, dly; Max: 128μg/24hrs

Older than 12 years

• See adult dosage

Pregnancy

• Safe; no evidence of risk in studies
• Results from prospective epidemiological studies and from worldwide post-marketing experience indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during early pregnancy

Breastfeeding

• Compatible
• Budesonide is excreted in breast milk. At therapeutic doses of intranasal budesonide no effects on the breastfed infant are anticipated since maternal systemic exposure after intranasal administration is low, so minimal exposure to intranasal budesonide in breastfed infants is expected. Intranasal budesonide may, therefore, be considered for use during breastfeeding. Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants
• In a pharmacokinetic study, the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification. Based on data from inhaled budesonide and the fact budesonide exhibits linear PK properties within the therapeutic dosage intervals after nasal, inhaled, oral and rectal administrations at therapeutic doses of budesonide, exposure to the breastfed child is anticipated to be low
• As with other medicines, the administration of intranasal budesonide during breastfeeding requires that the benefits for the mother are weighed against the risk for the foetus or nursing infant

Fertility

• There is no data on the effect of budesonide on human fertility. Fertility was unaffected following budesonide treatment in animal studies

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dysphonia
• Psychomotor hyperactivity
• Sleep disorders
• Anxiety
• Depression
• Aggression
• Headache

Respiratory Disorders

• Nasal mucosal irritation
• Haemorrhagic secretions
• Epistaxis
• Nasal ulcer
• Nasal septum perforation
• Sneezing
• Pharyngitis
• Bronchospasm

Endocrine and Metabolic Disorders

• Adrenal suppression
• Growth retardation
• Cushings syndrome
• Cushingoid features

Musculoskeletal Disorders

• Muscle spasm
• Osteoporosis
• Contusions

Immune, Blood and Lymphatic Disorders

• Hypersensitivity reaction
• Anaphylactic reaction

Sensory Disorders

• Glaucoma
• Cataract

• CYP3A4 inhibitors

None routine. Specific cases may require

• Nasal examination
• Height (children)
• Hepatic Transaminsese (ALT, AST)

Aquanase 100μg - EML (Primary, Hospital)

All other formulations - Non-EML

Budesonide has a strong topical anti-inflammatory effect on the nasal mucosa and weak systemic effects after topical administration. It has a wide range of inhibitory activities against mast cells, eosinophils, neutrophils, macrophages and lymphocytes; and their inflammatory mediators histamine, eicosanoids, leukotrienes, and cytokines.

Nasal spray (per spray) 32μg

• Rhinocort Aqua (AstraZeneca) originator

Nasal spray (per spray) 50μg

• Inflanaze 50 (Ingelheim)

Nasal spray (per spray) 64μg

• Rhinocort Aqua (AstraZeneca) originator

Nasal spray (per spray) 100μg

• Aeromide nasal 100 (Forrester)
• Budeflam Aquanase (Cipla) 
• Inflanaze 100 (Ingelheim)
• Spec-Budesonide 100μg (Specpharm)

Also available in the following forms: Inhaler, turbuhaler, novoliser, nebuliser suspension, capsule and enema.