Ciclesonide (Oral Inhalation)
(sye KLES oh nide)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol Solution, Inhalation:
Alvesco: 80 mcg/actuation (6.1 g); 160 mcg/actuation (6.1 g)
Brand Names: U.S.
- Corticosteroid, Inhalant (Oral)
Ciclesonide is a nonhalogenated, glucocorticoid prodrug that is hydrolyzed to the pharmacologically active metabolite des-ciclesonide following administration. Des-ciclesonide has a high affinity for the glucocorticoid receptor and exhibits anti-inflammatory activity. The mechanism of action for corticosteroids is believed to be a combination of three important properties − anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.
52% (lung deposition)
Vd: Ciclesonide: 2.9 L/kg; des-ciclesonide: 12.1 L/kg
Ciclesonide hydrolyzed to its active metabolite, des-ciclesonide via esterases in nasal mucosa and lungs; des-ciclesonide undergoes further hepatic metabolism primarily via CYP3A4 and to a lesser extent via CYP2D6
Feces (66%); urine (≤20% as active metabolite)
Onset of Action
>4 weeks for maximum benefit
Time to Peak
~1 hour (des-ciclesonide)
Ciclesonide: 0.7 hours; des-ciclesonide: 6-7 hours
Special Populations: Hepatic Function Impairment
Cmax of des-ciclesonide in patients with moderate to severe liver impairment increased 1.4- to 2.7-fold after oral inhalation.
Use: Labeled Indications
Asthma: Maintenance treatment of asthma as prophylactic therapy in patients ≥12 years of age.
Limitations of use: Not indicated for relief of acute bronchospasm.
Guideline recommendations: A low-dose inhaled corticosteroid (in addition to an as-needed, short-acting beta2-agonist) is the initial preferred long-term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a stepwise treatment approach (GINA 2017; NAEPP 2007).
Hypersensitivity to ciclesonide or any component of the formulation; primary treatment of acute asthma or status asthmaticus
Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Untreated fungal, bacterial, or tuberculosis infections of the respiratory tract; moderate to severe bronchiectasis
Asthma: Inhalation: Note: Titrate to the lowest effective dose once asthma stability is achieved:
US labeling (metered dose inhaler [MDI]):
Prior therapy with bronchodilators alone: Initial: 80 mcg twice daily (maximum dose: 160 mcg twice daily)
Prior therapy with inhaled corticosteroids: Initial: 80 mcg twice daily (maximum dose: 320 mcg twice daily)
Prior therapy with oral corticosteroids: Initial: 320 mcg twice daily (maximum dose: 320 mcg twice daily)
Canadian labeling (MDI): Initial: 400 mcg once daily; more severe asthma may require 400 mcg twice daily; maintenance: 100 to 800 mcg/day.
Asthma guidelines: Global Initiative for Asthma guidelines (GINA 2016): HFA inhaler (administer in divided doses twice daily):
"Low" dose: 80 to 160 mcg daily
"Medium" dose: >160 to 320 mcg daily
"High" dose: >320 mcg daily
Conversion: Conversion from oral to orally inhaled steroid: Initiation of oral inhalation therapy should begin in patients who have previously been stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin at least 1 week after starting inhaled therapy. Manufacturer's labeling recommends reducing prednisone dose no more rapidly than ≤2.5 mg/day on a weekly basis. In the presence of withdrawal symptoms, resume previous OCS dose for 1 week before attempting further dose reductions.
Refer to adult dosing.
Asthma: Inhalation: Note: Titrate to the lowest effective dose once asthma stability is achieved:
US labeling (MDI): Children ≥12 years and Adolescents: Refer to adult dosing.
Canadian labeling (MDI):
Children 6 to 11 years: Initial: 100 to 200 mcg once daily; maintenance: 100 to 200 mcg/day.
Children ≥12 years and Adolescents: Refer to adult dosing.
Asthma guidelines: Global Initiative for Asthma guidelines (GINA 2017): HFA inhaler (refers to available US products):
Children ≤5 years: "Low" dose: 160 mcg daily
Children 6 to 11 years:
"Low" dose: 80 mcg daily
"Medium" dose: >80 to 160 mcg daily
"High" dose: >160 mcg daily
Children ≥12 years and Adolescents: Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer labeling (has not been studied); however, dose adjustments may not be necessary as ≤20% of drug is eliminated renally.
Dosing: Hepatic Impairment
No dosage adjustment necessary.
Metered dose inhaler: Prime the inhaler by actuating 3 times before the first use or when the inhaler has not been used for more than 10 consecutive days; no need to shake inhaler before use.
Remove mouthpiece cover, place inhaler in mouth, close lips around mouthpiece, and inhale slowly and deeply. Press down on top of inhaler after slow inhalation has begun. Remove inhaler while holding breath for approximately 10 seconds. Breathe out slowly and replace mouthpiece on inhaler. Rinse mouth with water (and spit out) after inhalation. Do not wash or place inhaler in water. Clean mouthpiece using a dry cloth or tissue once weekly. Discard after the "discard by" date or after labeled number of doses has been used, even if container is not completely empty.
Store at 25°C (77°F); excursions to 15°C to 30°C (59°F to 86°F) permitted. Do not puncture. Do not use or store near open flame or heat; canister may burst if exposed to temperatures >49°C (120°F); do not throw canister into fire or incinerator.
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Central nervous system: Headache (≤11%)
Respiratory: Nasopharyngitis (≤11%)
1% to 10%:
Cardiovascular: Facial edema (≥3%)
Central nervous system: Dizziness (≥3%), fatigue (≥3%), voice disorder (1%)
Dermatologic: Urticaria (≥3%)
Gastrointestinal: Gastroenteritis (≥3%), oral candidiasis (≥3%)
Infection: Influenza (≥3%)
Neuromuscular & skeletal: Arthralgia (≥3%), back pain (≥3%), limb pain (≥3%), musculoskeletal chest pain (≥3%)
Ophthalmic: Conjunctivitis (≥3%)
Otic: Otalgia (2%)
Respiratory: Upper respiratory tract infection (≤9%), nasal congestion (≤6%), pharyngolaryngeal pain (≤5%), hoarseness (≥3%), pneumonia (≥3%), sinusitis (≥3%), paradoxical bronchospasm (2%)
<1%, postmarketing, and/or case reports: Angioedema (with swelling of lip/pharynx/tongue), cataract, chest discomfort, increased gamma-glutamyl transferase, increased intraocular pressure, increased serum ALT, nausea, palpitations, pharyngeal candidiasis, skin rash, weight gain, xerostomia
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).
• Bronchospasm: May occur with wheezing after inhalation; if this occurs, stop steroid and treat with a fast-acting bronchodilator.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox and measles should be avoided; use caution in patients with active or quiescent TB infections or in patients with ocular herpes.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.
• Thrush: Candida albicans infections (mostly mild to moderate) of the mouth and pharynx may occur with orally inhaled corticosteroid use; interruption of therapy may be necessary at times while antifungal therapy is employed; advise patients to rinse mouth after use.
• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other eosinophilic conditions (eg, vasculitic rash, decreased pulmonary function, cardiac complications) can occur.
• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus or for the relief of acute bronchospasm.
• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.
• Cardiovascular disease: Use with caution following acute MI; corticosteroids have been associated with myocardial rupture. Use with caution in patients with HF; long-term use has been associated with fluid retention and hypertension.
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.
• Hepatic impairment: Systemic exposure to the active metabolite is increased in moderate to severe impairment; however, dosage adjustments are not recommended in hepatic impairment; monitor for increased systemic effects, particularly in patients with severe hepatic impairment, including cirrhosis.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred with corticosteroids especially during initial treatment.
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.
• Renal impairment: Use in renally impaired patients has not been studied; however, ≤20% of drug is eliminated renally.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.
• Elderly: Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in elderly patients in the smallest possible effective dose for the shortest duration.
• Pediatric: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 cm per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.
• Discontinuation of therapy: Withdraw systemic therapy with gradual tapering of dose. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
Growth (adolescents and children via stadiometry) signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular effects (eg, cataracts, increased intraocular pressure, glaucoma); bone mineral density; signs/symptoms of oral candidiasis; FEV1, peak flow, and/or other pulmonary function tests
Pregnancy Risk Factor
Adverse events were observed in some animal reproduction studies. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Based on available data, an overall increased risk of congenital malformations or a decrease in fetal growth has not been associated with maternal use of inhaled corticosteroids during pregnancy (Bakhireva 2005; NAEPP 2005; Namazy 2004). Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, pre-eclampsia, preterm birth, low birth weight infants). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy (most information available using budesonide) (ACOG 2008; NAEPP 2005).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, rhinitis, pharyngitis, sinus pain, common cold symptoms, back pain, or painful extremities. Have patient report immediately to prescriber signs of infection, signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of Cushing’s disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing), difficulty breathing, wheezing, cough, severe loss of strength and energy, irritability, tremors, tachycardia, confusion, dizziness, sweating, thrush, angina, bone pain, joint pain, or vision changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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More about ciclesonide
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- Drug class: inhaled corticosteroids
Other brands: Alvesco