Mometasone furoate/Formoterol fumarate

Administration

• Type: Inhaled corticosteroid
• Dosage Forms: 100 mcg/5 mg/spray, 200 mcg/5 mcg/spray MDI
• Routes of Administration: Inhaled
• Common Trade Names: Dulera

Adult Dosing

• Prior medium dose inhaled steroid
  • 2 puffs (100 mcg/5 mcg/spray) inhaled BID
    • Max: 4 puffs/day
    • Taper to lowest effective dose. Use shortest effective treatment duration.
• Prior high dose inhaled steroid
  • 2 puffs (200 mcg/5 mcg/spray) inhaled BID
    • Max: 4 puffs/day
    • Taper to lowest effective dose. Use shortest effective treatment duration.

Pediatric Dosing

• 12+ yo, prior medium dose inhaled steroid
  • 2 puffs (100 mcg/5 mcg/spray) inhaled BID
    • Max: 4 puffs/day
    • Taper to lowest effective dose. Use shortest effective treatment duration.
• 12+ yo, prior high dose inhaled steroid
  • 2 puffs (200 mcg/5 mcg/spray) inhaled BID
    • Max: 4 puffs/day
    • Taper to lowest effective dose. Use shortest effective treatment duration.

Special Populations

• Pregnancy Rating: C; Possible risk of teratogenicity in animal data at 0.3-8x MRHD. Possible risk of delayed ossification at 80x MRHD.
• Lactation risk: L3; Safety unknown

Renal Dosing

• Adult: Not defined
• Pediatric: Not defined

Hepatic Dosing

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

Contraindications

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

Adverse Reactions

Serious

• Bronchospasm, paradoxical
• Asthma exacerbation
• Death, asthma-related
• Hypersenstivity reaction
• Anaphylaxis
• Adrenal Suppression
• Hypercorticism
• Growth suppression in peds pts
• Hypertension
• Hypotension
• Angina
• Cardiac arrest
• Arrhythmia
• Hypokalemia
• Hyperglycemia
• Glaucoma in long-term use
• Cataracts in long-term use

Common

• Nasopharyngitis
• Headache
• Sinusitis
• Candidiasis, oral
• Dysphonia

Pharmacology

• Half-life: Mometasone: 5 hr. Formoterol: 10 hr.
• Metabolism: Mometasone: Liver, CYP450: 3A4 substrate. Formoterol: Liver extensively, CYP450: 2A6, 2C9/19, 2D6 substrate.
• Excretion: Mometasone: Feces 74%, Urine 8%. Formoterol: Urine 59-62% (10% unchanged), feces 32-34%.

Mechanism of Action

• Mometasone: Exact mechanism of anti-inflammatory action unknown. Inhibits multiple inflammatory cytokines and produces multiple glucocorticoid and mineralcorticoid effects.
• 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.

References

Authors

Jonathan Warren