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Drugs reference index «Ciclesonide»

Ciclesonide
Ciclesonide


Ciclesonide

Pronunciation: (sye-KLES-oh-nide)Class: Corticosteroid

Trade Names:Omnaris- Spray, suspension 50 mcg

Pharmacology

Anti-inflammatory activity with a high affinity for the glucocorticoid receptor.

Pharmacokinetics

Absorption

Prodrug converted to active metabolite, des-ciclesonide, after topical administration. Negligible serum concentrations following intranasal administration. Des-ciclesonide C max below 30 pg/mL.

Distribution

Following IV administration, Vd of ciclesonide and des-ciclesonide are approximately 2.9 and 12.1 L/kg, respectively, and protein binding averages at least 99% for ciclesonide and its metabolite.

Metabolism

Des-ciclesonide is metabolized in the liver by the CYP3A4 isozyme and, to a lesser degree, CYP2D6.

Elimination

After IV administration, predominantly excreted in the feces (66%) and approximately 20% or less in the urine.

Special Populations

Hepatic Function Impairment

When administered by oral inhalation, dosage adjustments are not needed in patients with hepatic function impairment.

Indications and Usage

Treatment of nasal symptoms associated with seasonal or perennial allergic rhinitis.

Contraindications

Standard considerations.

Dosage and Administration

Perennial Allergic RhinitisAdults and Children 12 yr of age and older

Nasal inhalation 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril once daily (max, 200 mcg/day).

Seasonal Allergic RhinitisAdults and Children 6 yr of age and older

Nasal inhalation 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril once daily (max, 200 mcg/day).

General Advice

  • Before use, gently shake the nasal spray, then prime the pump by actuating 8 times.
  • If product is not used for 4 or more consecutive days, it should be gently shaken and primed with 1 spray or until a fine mist appears.

Storage/Stability

Store at 59° to 86°F. Do not freeze.

Drug Interactions

Ketoconazole

May increase des-ciclesonide exposure by about 3.6-fold. Coadminister with caution.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (7%).

EENT

Nasopharyngitis (7%); epistaxis (5%); pharyngolaryngeal pain (3%); ear pain (2%).

Precautions

Monitor

Closely monitor patients with a change in vision and with a history of glaucoma or cataracts.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Seasonal allergic rhinitis

Safety and efficacy not established in children younger 6 yr of age.

Perennial allergic rhinitis

Safety and efficacy not established in children younger than 12 yr of age. May cause a reduction in growth velocity when administered to children.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Adrenal insufficiency

Replacement of systemic corticosteroids with topical corticosteroids can be accompanied by signs of adrenal insufficiency. Some patients may experience symptoms of corticosteroid withdrawal (eg, depression, joint or muscular pain, lassitude). In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause severe exacerbation of symptoms.

Infection

Patients on drugs that suppress the immune system are more susceptible to infections (eg, chickenpox, measles).

Wound healing

Because of the inhibitory effect of corticosteroids on wound healing, patients experiencing recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Overdosage

Symptoms

There are no data available.

Patient Information

  • Instruct patient on the correct administration technique.
  • Warn patients taking immunosuppressant doses or corticosteroids to avoid exposure to measles and chickenpox, and, if exposed, to seek medical advise.
  • Caution patient not to spray into the eyes or onto the nasal septum.
  • Instruct patient to contact health care provider if symptoms do not improve within a reasonable time or if conditions worsen.

Copyright © 2009 Wolters Kluwer Health.

  • Ciclesonide Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)
  • ciclesonide inhalation Concise Consumer Information (Cerner Multum)
  • ciclesonide Inhalation Advanced Consumer (Micromedex) - Includes Dosage Information

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