Usual Adult Dose for Asthma - Maintenance

FLEXHALER(R)
Initial dose: 360 mcg via oral inhalation twice a day: in some patients an initial dose of 180 mcg twice a day may be adequate
Maintenance dose: May increase dose in 1 to 2 weeks if response is not adequate; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
Maximum dose: 720 mcg twice a day

TURBUHALER(R)
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects

• Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:

• Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
• 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.

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

Usual Adult Dose for Crohn's Disease - Acute

Enteric coated capsules
Initial dose: 9 mg orally once a day in the morning for up to 8 weeks

• May repeat course for recurring episodes of active disease

Comments:

• Patients with mild to moderate active Crohn's disease involving the ileum and/or ascending colon have been switched from oral prednisolone to this drug with no reported episodes of adrenal insufficiency; prednisolone should be tapered while initiating therapy with this drug.
• Capsules should be swallowed whole; avoid grapefruit juice for the duration of therapy.
• Once patients symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150); maintenance dosing should be started.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Usual Adult Dose for Crohn's Disease - Maintenance

Enteric coated capsules:
6 mg orally once a day in the morning for up to 3 months

• If symptom control is maintained at 3 months, attempt to taper to complete cessation

Comments:

• Maintenance therapy should be started once symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150).
• Swallow capsules whole; avoid grapefruit juice for the duration of therapy.
• Continued maintenance treatment beyond 3 months has not been shown to provide substantial benefit.

Use: Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months.

Usual Adult Dose for Ulcerative Colitis

Extended-release tablets:
Initial dose: 9 mg orally once a day in the morning
Duration of therapy: Up to 8 weeks

Rectal Foam:
For Active Mild to Moderate Distal Ulcerative Colitis Extending up to 40 cm from the Anal Verge:
1 metered dose administered rectally twice a day for 2 weeks, then 1 metered dose administered rectally once a day for 4 weeks

Comments:

• Avoid grapefruit juice for the duration of therapy.

Use: For the induction of remission in patients with active, mild to moderate ulcerative colitis.

Usual Pediatric Dose for Asthma - Maintenance

Inhalation Suspension (administer via jet nebulizer):
Age: 1 to 8 years: Initial and maximum dose are based on prior asthma therapy:

• Previously treated with bronchodilators alone: 0.5 mg via oral inhalation once a day or 0.25 mg via oral inhalation twice a day; Maximum daily dose: 0.5 mg
• Previously treated with inhaled corticosteroids: 0.5 mg once a day or 0.25 mg twice a day; may increase up to 0.5 mg twice a day; Maximum daily dose: 1 mg
• Previously treated with oral corticosteroids: 1 mg once a day or 0.5 mg twice a day; Maximum daily dose: 1 mg

Comment: For symptomatic patients who do not respond to non-steroid therapy, an initial inhalation suspension dose of 0.25 mg once a day may be considered.

FLEXHALER(R) Inhalation Powder (oral inhaler):
Age: 6 to 12 years:

• Initial dose: 180 mcg via oral inhalation twice a day; some patients may require an initial dose of 360 mcg twice a day
• Maintenance dose: May increase dose after 1 to 2 weeks if response is not adequate; once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
• Maximum dose: 360 mcg twice a day

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age 6 to 12 years:

• Initial dose: 100 to 200 mcg via oral inhalation twice a day

Maintenance dose: Lowest dose that keeps patient symptom-free

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age: Over 12 years:
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects

• Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:

• Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
• If asthma symptoms arise between doses, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.
• Once daily dosing may be used unless it does not provide adequate control, then dosing should be administered as a divided dose, adjusting dose as needed.
• Once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.

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

Usual Pediatric Dose for Crohn's Disease - Acute

Age 8 years or older; weight greater than 25 kg

Enteric coated capsules:
9 mg orally once a day in the morning for up to 8 weeks; then 6 mg orally once a day for 2 weeks

Comments:

• Swallow capsules whole; avoid grapefruit juice for the duration of therapy.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Moderate to severe hepatic impairment: Due to increasing systemic exposure with increasing degree of hepatic impairment, patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism; discontinuation should be considered if signs and/or symptoms of hypercorticism develop.

Enteric Coated Capsules:
Severe hepatic impairment (Child-Pugh Class C): Avoid use
Moderate hepatic impairment (Child-Pugh Class B): Adults: Consider reducing the dose to 3 mg orally once a day

• Pediatric: Dose adjustments may be required; however, no specific guidelines have been suggested; caution is recommended.

Dose Adjustments

Elderly patients: Dose selection should be cautious, generally starting at the low end of the dose range.

Precautions

Safety and efficacy of enteric coated capsules have not been established in patients younger than 8 years
Safety and efficacy of extended-release tablets have not been established in patients younger than 18 years.
Safety and efficacy of inhaled powder (oral inhaler) have not been established in patients younger than 6 years.
Safety and efficacy of inhaled suspension (oral nebulizer) has been established in patients 12 months to 8 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Asthma: Inhalation Powder; Inhalation Suspension:

• For oral inhalation only; patients should rinse mouth with water (without swallowing) after each use
• Inhalation suspension: Administer via jet nebulizer

Extended-release Tablets; Enteric coated Capsules:

• Swallow whole; do not crush, chew, or break
• Take orally once a day in the morning

Rectal Foam:

• Administer rectally; not for oral use
• Empty bowels prior to use; may use in a standing, lying, or sitting position
• After evening administration, it is best not to empty bowels again until next morning, if possible

Storage requirements:
Oral inhaler:

• Store with cover tightly in place

Inhalation suspension:

• Store upright and protected from light; do not refrigerate or freeze
• Once foil envelope has been opened, keep ampules in the foil and use within 2 weeks; opened ampules should be used promptly

Rectal foam:

• Do not expose to heat or store above 49C (120F); do not refrigerate
• Flammable: Avoid fire, flame, or smoking during and immediately following administration
• Contents under pressure; do not puncture or incinerate

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

• Must prime inhaler prior to first use; number of doses remaining are displayed; discard when empty

Inhalation suspension:

• Administer via jet nebulizer connected to an air compressor with adequate air flow and with a mouthpiece or suitable face mask; ultrasonic nebulizers are not recommended.

Rectal foam:

• Attach applicator to the nozzle of canister by pushing firmly; each single-use applicator is coated with a lubricant, additional lubricant may be used if needed.
• Unlock canister by aligning notch to nozzle (twist dome).
• Warm canister in hands while shaking vigorously for 10 to 15 seconds.
• Turn canister upside down; insert applicator into rectum as far as it is comfortable; push pump dome down and hold for about 2 seconds; release pressure and hold applicator in place for 10 to 15 seconds; remove applicator from canister and dispose of in plastic bag provided.
• Twist notch on dome away from nozzle to lock between uses.

Compatibility:
Inhalation suspension: Do not mix with other nebulizer medications as the effects of mixing are not known.

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 and eczema) that were previously controlled may be unmasked.
• Pediatric patients with Crohn's disease may have slightly higher systemic exposure and increased cortisol suppression than adults with Crohn's disease.

Monitoring:

• 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
• Oral use: Periodically assess oral cavity for signs and symptoms of Candida albicans infection

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 avoid grapefruit juice during therapy and should check with their healthcare provider before taking any new medications, including herbal supplements and over the counter products.
• 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.
• Inform patients that rectal foam products may contain propellants which are flammable; appropriate precautions should be taken.