ciclesonide


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ciclesonide (inhalation)

(si-kless-o-nide) ,

Alvesco

(trade name)

Classification

Therapeutic: antiasthmatics
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Maintenance treatment of asthma as preventive therapy in patients ≥12 yr.Not for acute treatment of bronchospasm.

Action

Potent, locally acting anti-inflammatory and immune modifier.

Therapeutic effects

↓ frequency and severity of asthma attacks; improved asthma symptoms.

Pharmacokinetics

Absorption: Negligible oral bioavailability, action is primarily local.
Distribution: Unknown.
Metabolism and Excretion: Converted by esterases to des-ciclesonide, the active drug, which is subsequently metabolized by the liver. Some further metabolites may be pharmacologically active. Mostly eliminated in feces via biliary excretion; <20% of des-ciclesonide is excreted in urine.
Half-life: Ciclesonide—0.7 hr; Des-ciclesonide—6–7 hr;.

Time/action profile (improvement in symptoms)

ROUTEONSETPEAKDURATION
Inhalnwithin 24 hr1–4 wk†unknown
† Improvement in pulmonary function, ↓ airway responsiveness may take longer.

Contraindications/Precautions

Contraindicated in: Hypersensitivity to ciclesonide or any other ingredients in the formulation; Acute asthma/status asthmaticus.
Use Cautiously in: Geriatric: Consider age-related ↓ in cardiac, renal and hepatic function, concurrent disease state and drug therapy; consider lower initial dose; Obstetric: ↓ dose may be sufficient; Lactation: Many corticosteroids enter breast milk, hypercorticism may be seen with ↑ maternal doses; Pediatric: Safety and effectiveness in children <12 has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)

Ear, Eye, Nose, Throat

  • candida infection of mouth and pharynx
  • nasal congestion (most frequent)
  • nasopharyngitis (most frequent)
  • pharyngolaryngeal pain
  • cataracts
  • ↑ intraocular pressure

Endocrinologic

  • adrenal suppression (↑ dose, long term therapy)
  • ↓ growth (children)

Musculoskeletal

  • arthralgia (most frequent)
  • back pain (most frequent)
  • ↓ bone mineral density (↑ dose, long term therapy)
  • extremity pain (most frequent)

Miscellaneous

  • worsening of infections

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Inhalation (Adults ≥12 yr) Previous therapy with bronchodilators alone—80 mcg twice daily, may be ↑ to 160 mcg twice daily; Previous therapy with inhaled corticosteroids—80 mcg twice daily, may be ↑ to 320 mcg twice daily; Previous therapy with oral corticosteroids—320 mcg twice daily.

Availability

Aerosol inhalation (contains HFA-134A as a propellant): 80 mcg/actuation in 6.1 g cannisters of 60 actuations, 160 mcg/actuation in 6.1 and 9.6 g cannisters of 60 and 120 actuations

Nursing implications

Nursing assessment

  • Monitor respiratory status and lung sounds. Pulmonary function tests may be assessed periodically during and for several months following a transfer from systemic to inhalation corticosteroids.
  • Assess patients changing from systemic corticosteroids to inhalation corticosteroids for signs of adrenal insufficiency (anorexia, nausea, weakness, fatigue, hypotension, hypoglycemia) during initial therapy and periods of stress. If these signs appear, notify health care professional immediately; condition may be life-threatening.
  • Monitor for withdrawal symptoms (fatigue, weakness, nausea, vomiting, hypotension, joint or muscular pain, lassitude, depression) during withdrawal from oral corticosteroids.
  • Monitor growth rates in children receiving chronic therapy; lowest possible dose should be used.
  • Monitor patients with a change in vision or with a history of ↑ intraocular pressure, glaucoma, or cataracts closely.
  • Lab Test Considerations: Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic therapy. Children and patients using higher than recommended doses are at highest risk for HPA suppression.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for infection (Side Effects)

Implementation

  • When changing from oral to inhaled corticosteroids, taper oral dose slowly, no faster than prednisone 2.5 mg/day on a weekly basis, beginning after at least 1 wk of ciclesonide inhalation therapy.
  • After the desired clinical effect has been obtained, attempts should be made to ↓ dose to lowest amount required to control symptoms. Gradually ↓ as long as desired effect is maintained. If symptoms return, dose may briefly return to starting dose.
  • Inhalation: Allow at least 1 min between inhalations. Do not shake inhaler or use with spacer (See ).
    • If bronchospasm occurs right after ciclesonide dose, discontinue and administer short acting bronchodilator; notify health care professional.

Patient/Family Teaching

  • Instruct patient to use inhaler at regular intervals as directed. If a dose is missed, omit and take next regularly scheduled dose. Advise patient not to ↑ dose or discontinue medication, even if feeling better, without consulting health care professional; gradual ↓ is required. If asthma symptoms worsen, contact health care professional. Instruct patient to read Patient Leaflet before use.
  • Advise patient to follow instructions supplied. Before first-time use or if inhaler has not been used for more than 10 days, prime unit by actuating 3 times prior to dose. Do not shake inhaler. When dose indicator display window shows a red zone, 20 inhalations are left and refill is required; discard when indicator shows zero. Do not use actuator with other medications. Clean mouthpiece weekly with a clean dry tissue; do not wash or put any part of the inhaler in water.
  • Advise patients using inhalation corticosteroids and bronchodilator to use bronchodilator first and to allow 5 min to elapse before administering the corticosteroid, unless otherwise directed by health care professional.
  • Advise patient that inhalation corticosteroids should not be used to treat an acute asthma attack but should be continued even if other inhalation agents are used.
  • Instruct patient to notify health care professional if asthma worsens or if signs of adrenal insufficiency occur.
  • Patients using inhalation corticosteroids to control asthma may require systemic corticosteroids for acute attacks. Advise patient to use regular peak flow monitoring to determine respiratory status.
  • Advise patient to rinse mouth with water after treatment to ↓ risk of developing local candidiasis.
  • Caution patient to avoid smoking, known allergens, and other respiratory irritants.
  • Advise patient to notify health care professional if sore throat or mouth occurs or if exposed to anyone with chicken pox or measles.
  • Instruct patient to consult health care professional before taking other Rx, OTC, or herbal products.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Instruct patient whose systemic corticosteroids have been recently reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.

Evaluation/Desired Outcomes

  • Management of the symptoms of chronic asthma.
  • Improvement in asthma symptoms. Maximum benefit may take 4 wks or longer.

ciclesonide (nasal)

(si-kless-o-nide) ,

Omnaris

(trade name),

Zetonna

(trade name)

Classification

Therapeutic: allergy cold cough remedies
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Symptomatic management of seasonal/perennial allergic rhinitis.

Action

Acts as a potent, locally acting anti-inflammatory and immune modifier.

Therapeutic effects

Decreased symptoms of allergic rhinitis.

Pharmacokinetics

Absorption: <1% systemically absorbed following intranasal administration.
Distribution: Action is primarily local.
Protein Binding: >99%.
Metabolism and Excretion: Activated by enzymatic conversion to des-ciclesonide which is the pharmacologically active drug. Small amounts absorbed are metabolized by the liver.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
intranasal24–48 hr1–5 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: History of ↑ intraocular pressure, glaucoma, or cataractsImmunosuppression Obstetric / / Lactation: Safety not established; Pediatric: Children <6 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • cataracts
  • ear pain
  • epistaxis
  • glaucoma
  • local stinging
  • nasal perforation
  • nasal ulceration
  • nasopharyngitis

Endocrinologic

  • adrenal suppression (high-dose, long term therapy only)

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Ketoconazole ↑ blood levels; use cautiously.

Route/Dosage

Intranasal (Adults and Children ≥12 yr) Omnaris (for perennial allergic rhinitis only)—2 sprays in each nostril once daily (not to exceed 2 sprays in each nostril/day); Zetonna—1 spray in each nostril once daily (not to exceed 1 spray in each nostril/day).
Intranasal (Adults and Children ≥6 yr) Omnaris (for seasonal allergic rhinitis only)—2 sprays in each nostril once daily (not to exceed 2 sprays in each nostril/day).

Availability

Nasal spray (Omnaris): 50 mcg/actuation in 12.5–g bottle (delivers 120 metered sprays)
Nasal spray (Zetonna): 37 mcg/actuation in 6.1–g bottle (delivers 60 metered sprays)

Nursing implications

Nursing assessment

  • Monitor degree of nasal stuffiness, amount and color of nasal discharge, and frequency of sneezing.
  • Patients on long-term therapy should have periodic otolaryngologic examinations to monitor nasal mucosa and passages for infection or ulceration.
  • Patients previously treated with systemic corticosteroids for prolonged periods and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress.
  • Lab Test Considerations: Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic therapy. Children and patients using higher than recommended doses are at highest risk for HPA suppression.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for infection (Side Effects)

Implementation

  • Intranasal: Shake bottle gently before use to ensure a consistent amount is dispensed per actuation. For initial use, prime pump by actuating 8 times. If not used for 4 consecutive days, reprime with 1 spray or until a fine mist appears. Wipe applicator tip with a clean tissue and replace dust cap after each use. Discard bottle after 120 actuations following initial priming or after 4 mo after bottle is removed from foil pouch, whichever occurs first.
    • Patients also using a topical decongestant should be given decongestant 5–15 min before corticosteroid nasal spray. If patient is unable to breathe freely through nasal passages, instruct patient to blow nose gently in advance of medication administration.

Patient/Family Teaching

  • Advise patient to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose. Medication should be used at regular intervals for best effect.
  • Caution patient not to exceed maximal daily dose.
  • Instruct patient in correct technique for administering nasal spray (see ). Most nasal sprays include directions with pictures. Instruct patient to read patient information sheet prior to use. Shake well before use. Warn patient that temporary nasal stinging may occur.
  • Advise patients on immunosuppressive doses of cortiosteroids to avoid exposure to chickenpox or measles. If exposed, contact health care professional.
  • Inform patient that glaucoma and cataracts may occur with intranasal steroids. Advise patient to have regular eye exams and to notify health care professional if changes in vision occur during use.
  • Instruct patient to notify health care professional if symptoms do not improve within 1–2 wks for seasonal allergic rhinitis or 5 wks in perennial allergic rhinitis or if nasal discharge becomes purulent.

Evaluation/Desired Outcomes

  • Resolution of nasal stuffiness, discharge, and sneezing in seasonal or perennial rhinitis.

ciclesonide

A non-halogenated inhalation glucocorticoid with high local anti-inflammatory activity used to manage asthma.
References in periodicals archive ?
No drug interactions were noted when ciclesonide was administered concomitantly with albuterol or formoterol.
In the environmental exposure chamber, patients were administered a single dose (2 actuations per nostril) of either ciclesonide 200 [micro]g or placebo.
ZETONNA([R]) (ciclesonide) Nasal Aerosol is the third ciclesonide formulation marketed by Sunovion, with the others being ALVESCO([R]) (ciclesonide) Inhalation Aerosol in an HFA formulation for the maintenance treatment of asthma in adults and adolescents ages 12 and older, and OMNARIS([R]) (ciclesonide) Nasal Spray for the treatment of nasal symptoms of seasonal allergic rhinitis in adults and children age 6 and older and perennial allergic rhinitis in adults and children age 12 years of age and older.
Onset of Action of Ciclesonide Once Daily in the Treatment of Seasonal Allergic Rhinitis.
Formation of fatty acid conjugates of ciclesonide active metabolite in the rat lung after 4-week inhalation of ciclesonide.
Starting 1 week after the beginning of randomization and continuing throughout the study, patients receiving ciclesonide showed significantly greater reduction from baseline in their TNSS, compared with patients receiving placebo.
New efficacy data was presented for the first time at the 16th Annual European Respiratory Society (ERS) Congress confirming that a lower dose, or "stepping-down" to ciclesonide (Alvesco(R)), a once-daily, novel, inhaled corticosteroid (ICS) therapy for the treatment of asthma, is an equally effective maintenance treatment as twice-daily fluticasone propionate, another available asthma therapy.
Additionally, one poster presented results from a scintigraphy study utilizing a radiolabelled solution of ciclesonide nasal aerosol, which provided information on nasal cavity retention as measured by radioactivity after two minutes (Poster #339).
and Nycomed announced an exclusive development, marketing and commercialization agreement for ciclesonide in the United States.
Based on the outcomes, the German drug company Altana and partner Sanofi-Aventis applied in early March 2006 to the Food and Drug Administration for an indication in allergic rhinitis for ciclesonide (Alvesco).
Altana Submits NDS for Approval of Ciclesonide Nasal Spray in
NEW ORLEANS -- The investigational asthma drug ciclesonide does not suppress hypothalamic-pituitary-adrenal axis function, unlike traditional inhaled corticosteroids, Dr.