Alvesco (ciclesonide)

The dose of ciclesonide administered by oral inhalation is expressed as the amount of drug delivered from the actuator of the inhaler per metered spray. The amount of drug delivered to the lungs depends on factors such as the patient's coordination between the actuation of the inhaler and inspiration through the delivery system.

Time to onset and degree of symptom relief varies between patients; maximum benefit may not be achieved for at least 4 weeks after initiation of ciclesonide. Once symptoms of asthma have been controlled, dosage of ciclesonide should be titrated to the lowest effective level to reduce the possibility of adverse reactions. If the patient does not respond adequately to the initial dosage after 4 weeks of therapy, higher dosages may provide additional asthma control. Safety and efficacy of ciclesonide dosages exceeding the manufacturer's maximum recommended dosages have not been established.

Ciclesonide is administered by oral inhalation using an oral aerosol inhaler with hydrofluoroalkane (HFA; non-chlorofluorocarbon) propellant. The aerosol inhaler should be actuated 3 times (away from the face) prior to the initial use or when the inhaler is unused for longer than 10 days. Patients receiving oral inhalation of ciclesonide should rinse their mouth with water after each dose to remove residual medication in the oropharyngeal area and to minimize the development of fungal overgrowth and/or infection.

No dosing information is available for this tab.

No dosing information is available for this tab.

Based on results of in vitro studies, C21-desisobutyryl-ciclesonide (des-ciclesonide) does not appear to inhibit or induce the metabolism of other drugs metabolized by cytochrome P-450 (CYP) isoenzymes. In addition, ciclesonide and des-ciclesonide do not appear to have the potential to induce major CYP isoenzymes based on results of in vitro studies. However, the inhibitory potential of ciclesonide on CYP isoenzymes has not been studied.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required.

Known hypersensitivity to ciclesonide or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in at least 3% of adults and children 12 years of age or older receiving ciclesonide oral inhalation aerosol in controlled clinical studies include headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, extremity pain, back pain, hoarseness, oral candidiasis, influenza, pneumonia, musculoskeletal chest pain, urticaria, dizziness, gastroenteritis, facial edema, fatigue, and conjunctivitis.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of ciclesonide oral inhalation aerosol have not been established in children younger than 12 years of age. Although safety and efficacy of the oral inhalation aerosol have been evaluated in pediatric patients (4-11 years of age), clinical studies have yielded inconsistent results regarding the efficacy of the drug. The adverse event profile of ciclesonide in these pediatric patients generally was similar to that observed in children receiving other inhaled corticosteroids. Ciclesonide oral inhalation aerosol has not been studied in children younger than 4 years of age.

Use of corticosteroids may lead to suppression of growth in children and adolescents. Therefore, pediatric patients receiving prolonged therapy with orally inhaled ciclesonide should be monitored periodically (e.g., via stadiometry) for possible adverse effects on growth and development. The benefits of corticosteroid therapy should be weighed against the possibility of growth suppression and the availability of safe and effective alternative therapies. Pediatric patients should be maintained on the lowest possible dosage of ciclesonide that controls asthma symptoms. (See Cautions: Pediatric Precautions, in the Corticosteroids General Statement 68:04.)

Category C. (See Users Guide.) Hypoadrenalism may occur in infants of women receiving corticosteroid therapy during pregnancy. These infants should be carefully monitored.

While it is not known whether ciclesonide is distributed into milk in humans, the drug is distributed into milk in rats. Because other corticosteroids are distributed into human milk, caution is advised if ciclesonide is administered in nursing women.

Clinical studies of ciclesonide oral inhalation aerosol did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. While other clinical experience with ciclesonide oral inhalation aerosol has not revealed age-related differences in response, dosage should be selected with caution in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients also should be considered.