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ALVESCO is a brand name for Ciclesonide, supplied as a aerosol, metered dose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 3 WARNINGS AND PRECAUTIONS ............................................................................... 4…
Verbatim from this product's HC label. Tap a section to expand.
Recommended Dose and Dosage Adjustment Adults and adolescents 12 years of age and older The recommended starting dose of ALVESCO (ciclesonide) therapy for most patients, whether previously maintained on either bronchodilators alone or inhaled corticosteroids, is 400 micrograms once daily.
The recommended dose range is 100 to 800 micrograms per day. ALVESCO can be administered as 1 or 2 puffs once daily either in the morning or evening. Some patients with more severe asthma may be more adequately controlled on 800 micrograms daily (administered as 400 micrograms twice daily).
As with all inhaled corticosteroids, the dose of ALVESCO should be adjusted according to individual response. Children 6-11 years of age The recommended starting dose of ALVESCO therapy for most patients, whether previously maintained on either bronchodilators alone or inhaled corticosteroids, is 100 to 200 micrograms once daily.
The recommended dose range is 100 to 200 micrograms per day, administered as 1 or 2 puffs once daily either in the morning or evening. As with all inhaled corticosteroids, the dose of ALVESCO should be adjusted according to individual response.
At present there is limited efficacy data regarding the use of ALVESCO in patients <6 years of age and therefore ALVESCO is not recommended for patients younger than 6 years. Symptoms can start to improve with ALVESCO within 24 hours of treatment.
Clinically, ALVESCO has been shown to improve lung function as measured by FEV1, peak expiratory flow, improved asthma symptom control, reduced exacerbations, and decreased need for inhaled beta2-agonists. It is important to gain control of asthma symptoms and optimize pulmonary function as soon as possible.
If there has been no improvement within one to two weeks, the patient should consult with their physician. Due to its prophylactic nature, ALVESCO should be taken regularly even when patients are asymptomatic. The patient should be aware that the benefit COPYRIGHT 2021 COVIS PHARMA GmbH Page 14 of 37 of ALVESCO depends on regular use even when they are experiencing no symptoms.
When patient symptoms remain under satisfactory control, the dose of ALVESCO should be titrated to the lowest dose at which effective control of asthma is maintained. Patients should be instructed to seek medical attention if their asthma symptoms worsen, or if their need for rescue medication increases.
Adverse Drug Reaction Overview Inhaled corticosteroid therapy may be associated with dose dependent increases in incidence of ocular complications, reduced bone density, suppression of HPA axis responsiveness to stress, and inhibition of growth velocity in children.
Although such events have been associated with inhaled corticosteroid therapy, no significant difference was detected between inhaled ALVESCO (ciclesonide) and placebo on HPA function and serum cortisol levels. See DETAILED PHARMACOLOGY.
Glaucoma may be exacerbated by inhaled corticosteroid treatment for asthma or rhinitis. In patients with established glaucoma who require long-term inhaled corticosteroid treatment, it is prudent to measure intraocular pressure before commencing the inhaled corticosteroid and to monitor it subsequently.
In patients without established glaucoma, but with a potential for developing intraocular hypertension, intraocular pressure should be monitored at appropriate intervals. In all patients who are receiving long-term inhaled corticosteroid therapy, intraocular pressure should be monitored at appropriate intervals (see Monitoring and Laboratory Tests).
In elderly patients treated with inhaled corticosteroids, the prevalence of posterior subcapsular and nuclear cataracts is probably low but increases in relation to the daily and cumulative lifetime dose. Cofactors such as smoking, ultraviolet B exposure, or diabetes may increase the risk.
A reduction of growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow growth of all children taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression if any child’s or adolescent’s growth appears slowed.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ciclesonide in Canada.
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Dose adjustments are not necessary in elderly patients, patients with liver impairment and patients with renal impairment. Missed Dose It is very important that ciclesonide is used regularly. If a dose is missed, the next dose should be taken when it is due.
Administration ALVESCO is for oral inhalation use only. To ensure the proper dosage and administration of the drug, the patient must be instructed by a physician or other health professional in the use of the inhalation aerosol (see CONSUMER INFORMATION).
Inhaler technique of patients should be checked regularly to make sure that correct method is used and inhaler actuation is synchronized with inhalation to ensure optimum delivery to the lungs. In patients who find co-ordination of a pressurized metered dose inhaler difficult, a spacer device (AeroChamber Plus®) may be used with ALVESCO.
If the inhaler is new or has not been used for one week or more, three puffs should be released into the air. No shaking is necessary as ALVESCO is a solution aerosol. The mouthpiece should be cleaned with a dry tissue or cloth weekly.
No part of the inhaler should be washed or put into water. Patients should be instructed to use the following technique to administer their medication: Instruct the patient to remove the mouthpiece cover, place the inhaler in their mouth, close their lips around the mouthpiece, and breathe in slowly and deeply.
After starting to breathe in through the mouth, the top of the inhaler should be pressed down. Then, patients should move the inhaler away from their mouth, and hold their breath for about 10 seconds, or as long as is comfortable.
The patient should not breathe out into the inhaler. Finally, patients should breathe out slowly, and replace the mouthpiece cover. COPYRIGHT 2021 COVIS PHARMA GmbH Page 15 of 37 Transferring a patient from an oral steroid to ALVESCO The patient should be in a relatively stable phase.
A high dose of ALVESCO should be given in combination with the oral steroid for about 10 days. Then the oral steroid should be gradually reduced to the lowest possible level. 0 mg of prednisone (or equivalent of another corticosteroid) at seven day intervals if the patient is under close observation.
0 mg of the daily dose of prednisone (or equivalent) every ten days. If withdrawal symptoms appear, the previous dose of the systemic drug should be resumed for a week before any further decrease is attempted. OVERDOSAGE Single doses of up to 3200 micrograms inhaled ALVESCO (ciclesonide) were administered to healthy volunteers and were well tolerated.
The potential for acute toxic effects following overdose of inhaled ciclesonide is low. The only effect that follows inhalation of large amounts of the drug over a short period of time may be temporary suppression of adrenal function, symptoms of which may include: weakness, nausea, and hypotension.
In such cases, treatment with ALVESCO should be continued at a dose sufficient to control asthma. Recovery of adrenal function can be verified by measuring plasma cortisol. If higher than recommended doses are administered continuously over prolonged periods, some degree of adrenal suppression may occur, therefore monitoring of adrenal reserve should be considered.
Gradual reduction of the inhaled dose may be required. Treatment with ALVESCO should be continued at a dose […]
In a one-year study, ALVESCO was shown to have no effect on growth rates compared to placebo when administered to pediatric patients at doses of up to 200 micrograms per day (see CLINICAL TRIALS). Osteoporosis and bone fracture are complications of long term asthma treatment with parenteral or oral steroids.
Inhaled corticosteroid therapy has also been associated with dose dependent bone loss, although the risk is much less with inhaled therapy than with oral and parenteral therapy. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse drug reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug- related adverse events and for approximating rates.
COPYRIGHT 2021 COVIS PHARMA GmbH Page 9 of 37 Use in adolescents and adults:
The clinical trial safety database for ALVESCO consists of a total of 9162 patients (740 adolescents and 8422 adults) treated with ALVESCO, 100 to 1600 micrograms per day, in clinical studies ranging in duration from 2 weeks to 1 year.
The majority of short-term trials had a randomized, blinded design. Three long-term studies were of open-label design. 6% of patients in placebo-controlled clinical trials experienced adverse events assessed as possibly related to treatment with ALVESCO by the investigator and/or sponsor (vs.
5% of patients treated with placebo). 4%), these were mild and did not require discontinuation of treatment with ALVESCO. 2% of patients treated with ALVESCO discontinued clinical trial participation due to an adverse event vs. 4% of patients in the placebo group.
4% vs. 8%). 9 1Assessed as possibly related to the treatment by investigator and/or sponsor. 2Paradoxical bronchospasm refers to a known adverse drug reaction of all inhaled drugs, which may be related to the active drug substance, excipients, or in the case of metered dose inhalers, to the cooling caused by the propellant or evaporation.
Suspected paradoxical bronchospasm includes the preferred terms: chest discomfort, chest pain, asthma, bronchospasm, cough, dyspnea, obstructive airways disorder, wheezing.
Dose Response Information:
The incidence of possibly treatment-related adverse events was generally comparable among the ALVESCO dose groups, with the exception of respiratory, thoracic and mediastinal disorders which showed a trend towards dose dependency. This could be due to the fact that the higher dose groups tended to include patients with more severe asthma.
Special Populations:
No safety signals specific for gender or for age were found in clinical trials. 0%). 1%). 1%). 1%). 1%). 1%). 1%). 4%), […]