Budesonide/Formoterol

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Administration

  • Type: Inhaled corticosteroid
  • Dosage Forms: 80/4.5, 160/4.5 mcg/spray MDI
  • Routes of Administration: Inhaled
  • Common Trade Names: Symbicort

Adult Dosing

  • Asthma, maintenance
    • 2 puffs inhaled BID
      • Start: Dependent on severity of asthma
      • Max: 640 mcg/18 mcg/day
      • May increase to 160 mcg/4.5 mcg/day per spray after 1-2 weeks if started at 80 mcg/4.5 mcg/spray.
      • Taper to lowest effective dose.
  • COPD, maintenance
    • 2 puffs (160 mcg/4.5 mcg/ spray) inhaled BID
      • Max: 640 mcg/18 mcg/day

Pediatric Dosing

  • 5-11 yo
    • 2 puffs inhaled BID
      • Start: Dependent on severity of asthma
      • Max: 320 mcg/18 mcg/day
      • Taper to lowest effective dose. Use shortest effective treatment duration.
  • 12+ yo
    • 2 puffs inhaled BID
      • Start: Dependent on severity of asthma
      • Max: 640 mcg/18 mcg/day
      • Taper to lowest effective dose. Use shortest effect treatment duration.

Special Populations

  • Pregnancy Rating: C; Possible risk of delayed ossification based on animal data at 80x MRHD and risk with uterine contractility.
  • Lactation risk: L3; Safety unknown

Renal Dosing

  • Adult: Not defined
  • Pediatric: Not defined

Hepatic Dosing

  • Adult: Not defined. Caution in severe hepatic impairment.
  • Pediatric: Not defined. Caution in severe hepatic impairment

Contraindications

  • Allergy to class/drug
  • Asthma, acute
  • Bronchospasm, acute
  • COPD, acute deteriorating

Adverse Reactions

Serious

Common

Pharmacology

  • Half-life: Budesonide: 2.3 hr, Formoterol: 10 hr.
  • Metabolism: Budesonide: Liver, CYP450: 3A4 substreate. Formoterol: Liver extensively, CYP450: 2A6, 2C9/19, 2D6 substrate.
  • Excretion: Budesonide: Urine 60%, feces. Formoterol: Urine 59-62% (10% unchanged), feces 32-24%.

Mechanism of Action

  • Budesonide: Inhibits multiple inflammatory cytokine sand produces multiple glucocorticoid and mineralcorticoid effects. Exact mechanism unknown.
  • Formoterol: Selectively stimulates beta-2 adrenergic receptors, relaxing airway smooth muscle.

Comments

Black Box Warning: Long acting beta-2 adrenergic agonists (LABA) increase risk of asthma-related death. LABA use may increase risk of asthma-related hospitalization in pediatric and adolescent patients. Do not use corticosteroid/LABA combo if asthma adequately controlled on low-or medium-dose inhaled corticosteroids.

See Also

References