Usual Adult Dose for Asthma - Maintenance

Initial doses should be based on previous asthma therapy and disease severity, including current control and risk of future exacerbations:

For patients not previously receiving inhaled corticosteroid (ICS): Initial dose: 40 to 80 mcg via oral inhalation twice a day

For patients switching from another ICS: Initial dose selection should be based on the previous ICS strength: 40 to 320 mcg via oral inhalation twice a day

• Maintenance dose: After 2 weeks, may increase dose for additional asthma control; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
• Maximum dose: 320 mcg twice a day

Comments:

• Onset and degree of improvement in asthma control is variable; improvements may occur within 24 hours, but may take 1 to 2 weeks; maximum benefit is usually achieved within 3 to 4 weeks.
• If asthma symptoms arise, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.
• In the US, the dose delivered from the actuator is the labeled dose; in some countries, the dose delivered from the valve (ex-valve) is the labeled dose; actuator doses of 80 and 40 mcg are equivalent to ex-valve doses of 100 and 50 mcg, respectively.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Pediatric Dose for Asthma - Maintenance

Initial doses should be based on previous asthma therapy and disease severity, including current control and risk of future exacerbations:

Age: 4 to 11 years:

• Initial dose: 40 mcg via oral inhalation twice a day
• Maintenance dose: After 2 weeks, may increase dose to 80 mcg twice daily for additional asthma control; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
• Maximum dose: 80 mcg twice a day

Age: 12 years or older:
For patients not previously receiving inhaled corticosteroid (ICS): Initial dose: 40 to 80 mcg via oral inhalation twice a day
For patients switching from another ICS: Initial dose selection should be based on the previous ICS strength: 40 to 320 mcg via oral inhalation twice a day

• Maintenance dose: After 2 weeks, may increase dose for additional asthma control; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
• Maximum dose: 320 mcg twice a day

Comments:

• Onset and degree of improvement in asthma control is variable; improvements may occur within 24 hours, but may take 1 to 2 weeks; maximum benefit is usually achieved within 3 to 4 weeks.
• If asthma symptoms arise, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.
• In the US, the dose delivered from the actuator is the labeled dose; in some countries, the dose delivered from the valve (ex-valve) is the labeled dose; actuator doses of 80 and 40 mcg are equivalent to ex-valve doses of 100 and 50 mcg, respectively.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Caution is advised on discontinuation.

For Patients on Systemic Corticosteroids:

• Oral corticosteroids should be weaned slowly; allow at least 1 week after starting inhaler before initiating taper of oral corticosteroid.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to any of the ingredients
• Primary treatment of status asthmaticus or acute asthma episodes where intensive measures are required

Safety and efficacy have not been established in patients younger than 4 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
For oral inhalation only; Rinse mouth with water (without swallowing) after each use

• Does not require priming before use
• Do not use with a spacer or a volume holding chamber

Storage requirements:

• Avoid exposure to extreme heat or cold
• QVAR(R): Store product resting on the concave end of the canister with plastic actuator on top
• Contents are under pressure; do not use or store near heat or open flame; exposure to temperatures above 49C (120F) may cause bursting; do not throw into fire or incinerate.
• Keep inhaler clean and dry at all times; mouthpiece should be cleaned weekly or as needed with a dry tissue or cloth; do not put any part of inhaler in water; inhaler should be replaced if placed in water

Preparation techniques:

• Dose counter: The dose counter will have a black dot in the viewing window until it has been primed. Once primed, the number of sprays left will be displayed in the viewing window in units of 2; the color in the viewing window will change to red when the number of sprays left is 20; when the dose counter reaches 0 (or after the expiration date of the product) discard product.
• Does not require shaking prior to use

General:

• This drug should not be used for the relief of acute bronchospasm.
• 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.
• Anticipate degree of adrenal suppression and what changes in systemic steroid levels may occur when switching between different corticosteroids, different formulations, or upon changing route of administration; patients switching from corticosteroid treatment with higher systemic effects to corticosteroids with lower systemic effects should be reduced gradually while monitoring HPA axis functions regularly.
• When changing from corticosteroids with high systemic effect to corticosteroids that are less systemically available, allergies (e.g., rhinitis, eczema) that were previously controlled may be unmasked.

Monitoring:

• Regularly assess lung-function
• Periodically assess oral cavity for signs and symptoms of Candida albicans infection
• Monitor for signs and symptoms of hypercorticism
• Monitor for signs and symptoms of adrenal insufficiency
• Monitor adrenocortical function in patients transferring from corticosteroids with higher systemic effects
• 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

Patient advice:

• Patients should be instructed on proper inhaler technique and the importance of regular use; patients should be instructed to rinse and spit after oral inhalation use to avoid infection; if infection develops, they should contact their healthcare professional.
• 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 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.