Ciclesonide was not mutagenic in an Ames test or in a forward mutation assay and was not clastogenic in a human lymphocyte assay or in an in vitro micronucleus test.
However, ciclesonide was clastogenic in the in vivo mouse micronucleus test. The concurrent reference corticosteroid dexamethasone in this study showed similar findings.
The efficacy of ALVESCO was evaluated in six randomized, double-blind, placebo-controlled, parallel-group clinical trials in adult and adolescent patients 12 years of age and older with mild persistent to severe persistent asthma. These trials included a total of patients males and females of whom were adolescents years of age. The primary efficacy endpoint in four of the six trials was the mean change from baseline in pre-dose FEV 1 at endpoint last observation.
FEV 1 was measured prior to the morning dose of study medication at the end of the hour dosing interval for once daily administration, and at the end of the hour dosing interval for twice daily administration. In one of the six trials, the primary endpoint was the change from baseline in the average of the pre-dose FEV 1 at Weeks 12 and 16, and in another trial, reduction of oral corticosteroid use was the primary efficacy endpoint.
Additional efficacy variables were asthma symptoms, use of albuterol for rescue, AM PEF, nighttime awakenings, and withdrawal due to asthma worsening. The results of these trials, along with other trials that explored twice daily dosing, indicate that once daily dosing is not the optimum dosing regimen for ALVESCO. Four trials were designed to evaluate the efficacy of ALVESCO administered twice daily in patients with asthma who were previously maintained on bronchodilators alone, patients who were previously maintained on inhaled corticosteroids, and patients who were previously maintained on oral corticosteroids.
Patients Previously Maintained on Bronchodilators Alone. Patients Previously Maintained on Inhaled Corticosteroids. The efficacy of ALVESCO in asthma patients previously maintained on inhaled corticosteroids was evaluated in two randomized, double-blind, placebo-controlled trials of weeks treatment duration. Other measures of asthma control, AM PEF, symptoms, and need for rescue albuterol also showed improvement compared to placebo.
Patients Previously Maintained on Oral Corticosteroids. At the same time, patients on ALVESCO maintained asthma control as reflected by lung function, symptoms, and need for rescue albuterol. Two identically designed randomized, double-blind, parallel, placebo-controlled clinical trials of weeks treatment duration were conducted in patients aged 4 to 11 years with asthma but efficacy was not established.
In addition, one randomized, double-blind, parallel, placebo-controlled clinical trial did not establish efficacy in patients aged 2 to 6 years with asthma. Clinical trials have not been conducted in pediatric patients less than 2 years of age [see Pediatric Use 8. Each actuation of the inhaler delivers 80 mcg of ciclesonide from the actuator. Each actuation of the inhaler delivers mcg of ciclesonide from the actuator. The actuators are fitted with a dose indicator and should not be used with other inhalation aerosol medications.
The correct amount of medication in each actuation cannot be assured from the canister labeled to contain 60 actuations when the dose indicator display window shows zero even though the canister is not completely empty. The canister should be discarded when the dose indicator display window shows zero.
For optimal results, the canister should be at room temperature when used. Keep out of reach of children. Do not puncture. Do not use or store near heat or open flame. Never throw canister into fire or incinerator. Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic i.
Rinsing the mouth after inhalation is advised. Patients should be advised that ALVESCO is not a bronchodilator and is not intended for use as rescue medication for acute asthma exacerbations.
Acute asthma symptoms should be treated with an inhaled, short-acting beta 2 -agonist such as albuterol. The patient should be instructed to contact their physician immediately if there is deterioration of their asthma. Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex.
Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk and should be monitored and where appropriate, be treated for this condition. Patients should be informed that orally inhaled corticosteroids, including ALVESCO, may cause a reduction in growth velocity when administered to pediatric patients.
Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required.
Discard the inhaler when the indicator shows zero. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Corticosteroids are natural substances found in the body and reduce inflammation. ALVESCO Inhalation Aerosol is not a bronchodilator and does not treat sudden symptoms of an asthma attack such as wheezing, cough, shortness of breath, and chest pain or tightness.
Always have a fast-acting bronchodilator medicine rescue inhaler with you to treat sudden symptoms. Tell your healthcare provider about all the medicines you take , including prescription and non-prescription medicines, vitamins and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
It may harm them. If you would like more information, talk with your healthcare provider. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Do not use the actuator with a canister of medicine from any other inhaler. See Figure A. Step 1. Remove the cap from the mouthpiece. See Figure C. Step 2. Hold the actuator upright, between your thumb, forefinger, and middle finger with the mouthpiece pointing towards you. See Figure D. Step 3. Breathe out as fully as you comfortably can.
Close your lips around the mouthpiece, keeping your tongue below it. See Figure E. Take your finger completely off the center of the dose indicator and remove the inhaler from your mouth. Breathe out gently. See Figure F. Step 7. Rinse your mouth with water and spit it out. Do not swallow. Food and Drug Administration. Avoid spraying in eyes. Each 6. Dosage and Administration: See package insert for dosage information. For optimal results, canister should be at room temperature when used.
DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Drug Label Information Updated October 23, If you are a consumer or patient please visit this version. Approval: Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions 5.
Monitor patients periodically for signs of adverse effects on the oral cavity. Aerosol inhaler: The usual dose to relieve asthma symptoms is 1 to 2 inhalations also called "puffs" for people 12 years of age and older, and 1 puff for children 6 to 11 years of age. More puffs may be needed to relieve symptoms during a more severe attack.
The usual dose for long-term treatment of asthma is 1 to 2 puffs or 1 puff … From medbroadcast. Typical dosing for Alvesco ciclesonide The typical dose of Alvesco ciclesonide is 80 to mcg puffs by mouth twice a day; … From goodrx. It's the best inhaler I have had in many years. Before Zenhale I would take my puff of Brycanyl in … From philns.
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Sweet Sesame Dressing. It is important for them to know that it may take 4 weeks or longer after starting therapy for symptoms to improve. Patients should continue using Alvesco even when they are feeling better. Recommended dosages. The recommended starting dose and the highest recommended dose of Alvesco Inhalation Aerosol are listed in the following table. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions 5.
Using the Alvesco inhalation device properly is important to getting the medicine deep into the large and small airways of the lungs. Administration — How to use Alvesco. ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. Dosing information. Alvesco Inhalation Aerosol is available in 2 strengths—80 mcg or mcg.
Both are pressurized, metered-dose aerosol units fitted with a dose indicator. Prime Alvesco Inhalation Aerosol by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days.
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