Usual Adult Dose for Asthma - Maintenance

• For patients previously receiving bronchodilators alone:

Initial dose: 80 mcg via oral inhalation twice a day
Maximum dose: 160 mcg twice a day

• For patients previously receiving inhaled corticosteroids:

Initial dose: 80 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day

• For patients previously receiving oral corticosteroids:

Initial dose: 320 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day

Comments:

• Not indicated for the relief of acute bronchospasm.
• For patients who do not respond adequately to the starting dose after 4 weeks, may increase dose without exceeding maximum dose; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.
• For patients receiving oral corticosteroids, taper oral corticosteroids no more than once weekly beginning after the first week of inhaled therapy; patients should be carefully monitored for asthma instability during transition; once oral corticosteroid taper is complete, inhalation dose should be reduced to the lowest effective dose.
• In some countries, product labeling describes ex-valve dosing while some describes actuator dosing; 80 mcg from the actuator is 100 mcg from the valve, 160 mcg from the actuator is 200 mcg from the valve.

Use: As prophylactic therapy for the maintenance treatment of asthma

Usual Pediatric Dose for Asthma - Maintenance

12 years or older:

• For patients previously receiving bronchodilators alone:

Initial dose: 80 mcg via oral inhalation twice a day
Maximum dose: 160 mcg twice a day

• For patients previously receiving inhaled corticosteroids:

Initial dose: 80 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day

• For patients previously receiving oral corticosteroids:

Initial dose: 320 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day

Comments:

• Not indicated for the relief of acute bronchospasm.
• For patients who do not respond adequately to the starting dose after 4 weeks, may increase dose without exceeding maximum dose; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.
• For patients receiving oral corticosteroids, taper oral corticosteroids no more than once weekly beginning after the first week of inhaled therapy; patients should be carefully monitored for asthma instability during transition; once oral corticosteroid taper is complete, inhalation dose should be reduced to the lowest effective dose.
• In some countries, product labeling describes ex-valve dosing while some describes actuator dosing; 80 mcg from the actuator is 100 mcg from the valve, 160 mcg from the actuator is 200 mcg from the valve.

Use: As prophylactic therapy for the maintenance treatment of asthma

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Abrupt discontinuation after prolonged use is not recommended

Inhalation doses should be reduced to the lowest effective dose once asthma stability has been achieved

Oral Corticosteroids:

• Allow at least 1 week before initiating a taper with oral corticosteroid
• Prednisone should be reduced in increments not exceeding 2.5 mg per day on a weekly basis
• Monitor for signs of asthma instability including serial objective measure of airflow
• Monitor for signs of adrenal insufficiency

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For oral inhalation only
• Patients should rinse mouth with water (without swallowing) after each use
• Patients should receive instruction on proper use

Storage requirements:

• Store at 25C (77F); excursions between 15C and 30C (59F and 86F) are permitted.
• Contents under pressure: do not puncture; do not store or use near heat or open flame; or throw canister into fire or incinerator.

Preparation techniques: The manufacturer product information should be consulted for complete instructions.

• Inhaler should be primed prior to first use and when unused for 10 days in a row.
• Do not use actuator with a canister of medicine from any other inhaler; do not use inhalation aerosol canister with an actuator from any other inhaler.

General:

• This drug is not intended for acute asthma exacerbations; patients should treat acute asthma symptoms with an inhaled, short-acting beta 2-agonist, such as albuterol.
• Use with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
• Patients switching from oral corticosteroid treatment should do so gradually while monitoring HPA axis functions regularly; oral corticosteroid supplementation may be needed during periods of stress.

Monitoring:

• Monitor asthma signs and symptoms including serial objective measures of airflow
• Monitor bone mineral content in patients at high risk of decreased bone mineral density
• Monitor growth regularly in pediatric patients
• Regular eye examinations should be considered, especially in patients with a history of ocular changes or those experiencing visual changes
• Periodically assess oral cavity for signs and symptoms of Candida albicans infection
• Monitor for signs and symptoms of adrenal insufficiency
• Monitor adrenocortical function in patients transferring from corticosteroids with higher systemic effects.

Patient advice:

• Patients should understand that this drug is a corticosteroid; they should know the signs and symptoms of hypercorticism and adrenal suppression.
• Patients should understand that during times of stress, such as surgery or infection, additional oral supplementation may be necessary; they should discuss with their healthcare professional whether they need to carry a medical identification card identifying their corticosteroid use.
• Patients on immunosuppressant doses of corticosteroids should understand that a greater risk of infection exists; they should avoid exposure to chickenpox or measles and if exposed, they should consult their healthcare professional promptly.
• Patients should be instructed on proper inhaler technique and the importance of regular use.
• Patients should understand this drug is not intended to relieve acute asthma symptoms and a short acting bronchodilator should be used for that; if asthma symptoms do not respond to a short acting bronchodilator, or require higher or more frequent dosing, they should contact their healthcare professional for reevaluation of therapy.
• Patients should be instructed to rinse and spit after oral inhalation use to avoid infection; if infection develops, they should contact their healthcare professional.