Ciclesonide

Administration

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

Adult Dosing

• Prior bronchodilator alone
  • 1 puff (80 mcg per spray) BID
    • Start: 1 puff inhaled BID
    • Max: 320 mcg/day
    • Taper to lowest effective dose
• Prior inhaled steroid
  • 1-2 puffs (80 mcg per spray) BID
    • Start: 1 puff inhaled BID
    • Max: 640 mcg/day
    • Taper to lowest effective dose
• Prior oral steroid
  • 2 puffs (160 mcg per spray) BID
    • Max: 640 mcg/day
    • Taper to lowest effective dose. Taper oral steroids gradually after >1 week

Pediatric Dosing

• 12+ yo, Prior bronchodilator alone
  • 1 puff (80 mcg per spray) BID
    • Start: 1 puff inhaled BID
    • Max: 320 mcg/day
    • Taper to lowest effective dose
• 12+ yo, Prior inhaled steroid
  • 1-2 puffs (80 mcg per spray) BID
    • Start: 1 puff inhaled BID
    • Max: 640 mcg/day
    • Taper to lowest effective dose
• 12+ yo, Prior oral steroid
  • 2 puffs (160 mcg per spray) BID
    • Max: 640 mcg/day
    • Taper to lowest effective dose. Taper oral steroids gradually after >1 week

Special Populations

• Pregnancy Rating: C; Risk of teratogenicity low based on animal data at 10x MRHD
• Lactation risk: L3; Safety unknown

Renal Dosing

• Adult: Not defined
• Pediatric: Not defined

Hepatic Dosing

• Adult: No adjustment
• Pediatric: No adjustment

Contraindications

• Allergy to class/drug
• Asthma, acute
• Bronchospasm
• Avoid abrupt withdrawal

Adverse Reactions

Serious

• Bronchospasm
• Hypersensitivity reaction
• Angioedema
• Adrenal suppression
• Hypercorticism
• Growth suppression (peds pts)
• Glaucoma
• IOP increase
• Cataracts

Common

• Headache
• Nasopharyngitis
• URI
• Sinusitis
• Nasal congestion
• Pharyngolaryngeal pain
• Arthralgia
• Extremity pain
• Back pain
• Hoarseness
• Candidiasis, oral
• Influenza
• Pneumonia
• Musculoskeletal chest pain
• Urticaria
• Dizziness
• Gastroenteritis
• Facial edema
• Fatigue
• Conjunctivitis

Pharmacology

• Half-life: 0.71 hr (parent); 6-7 hr (active metabolite)
• Metabolism: Liver; CYP450: 2D6, 3A4 (primary) substrate
• Excretion: Bile/feces 66%, urine <20%

Mechanism of Action

Exact mechanism of anti-inflammatory action unknown; inhibits multiple inflammatory cytokines and produces multiple glucocorticoid and mineral corticoid effects

References

• Lexicomp
• ACOG Committee on Practice Bulletins-Obstetrics, "ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 90, February 2008: Asthma in Pregnancy," Obstet Gynecol, 2008, 111(2 Pt 1):457-64. [PubMed 18238988]
• Alvesco (ciclesonide) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals; March 2018.
• Alvesco (ciclesonide) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada; January 2017.
• Bakhireva LN, Jones KL, Schatz M, et al, “Asthma Medication Use in Pregnancy and Fetal Growth,” J Allergy Clin Immunol, 2005, 116(3):503-9. [PubMed 16159616]
• Bateman E, Karpel J, Casale T, et al, “Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma,” Chest, 2006, 129(5):1176-87. [PubMed 16685007]
• Chmielewska M, Akst LM. Dysphonia associated with the use of inhaled corticosteroids. Curr Opin Otolaryngol Head Neck Surg. 2015; 23(3):255-259. [PubMed 25887975]
• Derendorf H, “Pharmacokinetic and Pharmacodynamic Properties of Inhaled Ciclesonide,” J Clin Pharmacol, 2007, 47(6):782-9 [PubMed 17412829]