Usual Adult Dose for Chronic Obstructive Pulmonary Disease

Inhalation Aerosol:

• 2 inhalations (90 mcg) orally every 4 to 6 hours or
• 1 inhalation (45 mcg) orally every 4 hours

Inhalation Solution:

• Initial dose: 0.63 mg inhaled orally by nebulization three times a day (every 6 to 8 hours)
• For severe asthma, or if not responding to initial dose: 1.25 mg inhaled orally, by nebulization, three times a day

Comments:

• If higher doses of the inhalation solution are used, monitor closely for adverse systemic effects; evaluate risk and benefit of this dose.
• If a previously effective dosage fails to provide the usual response, it may be a sign of destabilization of asthma; reevaluate the patient and treatment and consider the use of corticosteroids.
• The safety and efficacy of the inhalation solution has not been evaluated when mixed together with other drugs in a nebulizer.

Uses: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease; asthma

Usual Adult Dose for Asthma

Inhalation Aerosol:

• 2 inhalations (90 mcg) orally every 4 to 6 hours or
• 1 inhalation (45 mcg) orally every 4 hours

Inhalation Solution:

• Initial dose: 0.63 mg inhaled orally by nebulization three times a day (every 6 to 8 hours)
• For severe asthma, or if not responding to initial dose: 1.25 mg inhaled orally, by nebulization, three times a day

Comments:

• If higher doses of the inhalation solution are used, monitor closely for adverse systemic effects; evaluate risk and benefit of this dose.
• If a previously effective dosage fails to provide the usual response, it may be a sign of destabilization of asthma; reevaluate the patient and treatment and consider the use of corticosteroids.
• The safety and efficacy of the inhalation solution has not been evaluated when mixed together with other drugs in a nebulizer.

Uses: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease; asthma

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease

Inhalation Aerosol:
Less than 4 years: Not approved
4 years or older:

• 2 inhalations (90 mcg) orally every 4 to 6 hours or
• 1 inhalation (45 mcg) orally every 4 hours

Inhalation Solution:
Less than 6 years old: Not approved
6 to 11 years:

• Recommended dose: 0.31 mg inhaled orally by nebulization three times a day
• Maximum dose: 0.63 mg inhaled orally three times a day

12 years or older:

• Initial dose: 0.63 mg inhaled orally by nebulization three times a day (every 6 to 8 hours)
• For severe asthma, or if not responding to initial dose: 1.25 mg inhaled orally, by nebulization, three times a day

Comments:

• If higher doses of the inhalation solution are used, monitor closely for adverse systemic effects; evaluate risk and benefit of this dose.
• If a previously effective dosage fails to provide the usual response, it may be a sign of destabilization of asthma; reevaluate the patient and treatment and consider the use of corticosteroids.
• The safety and efficacy of the inhalation solution has not been evaluated when mixed together with other drugs in a nebulizer.
• Recommended dose should not be exceeded.

Uses: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease; asthma

Usual Pediatric Dose for Asthma

Inhalation Aerosol:
Less than 4 years: Not approved
4 years or older:

• 2 inhalations (90 mcg) orally every 4 to 6 hours or
• 1 inhalation (45 mcg) orally every 4 hours

Inhalation Solution:
Less than 6 years old: Not approved
6 to 11 years:

• Recommended dose: 0.31 mg inhaled orally by nebulization three times a day
• Maximum dose: 0.63 mg inhaled orally three times a day

12 years or older:

• Initial dose: 0.63 mg inhaled orally by nebulization three times a day (every 6 to 8 hours)
• For severe asthma, or if not responding to initial dose: 1.25 mg inhaled orally, by nebulization, three times a day

Comments:

• If higher doses of the inhalation solution are used, monitor closely for adverse systemic effects; evaluate risk and benefit of this dose.
• If a previously effective dosage fails to provide the usual response, it may be a sign of destabilization of asthma; reevaluate the patient and treatment and consider the use of corticosteroids.
• The safety and efficacy of the inhalation solution has not been evaluated when mixed together with other drugs in a nebulizer.
• Recommended dose should not be exceeded.

Uses: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease; asthma

Renal Dose Adjustments

Use with caution.

Liver Dose Adjustments

Data not available

Dose Adjustments

• If clinically warranted due to insufficient bronchodilator response, the dose of the inhalation solution may be increased in elderly patients as tolerated, in conjunction with frequent clinical and laboratory monitoring, to the maximum recommended adult daily dose.

Precautions

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

Inhalation Solution: Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for oral inhalation only.

Inhalation Solution:

• Administer by nebulization using a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor.
• The safety and efficacy of the inhalation solution have been established only when administered using the PARI LC Jet and PARI LC Plus nebulizers, and the PARI Master Dura-Neb 2000 and Dura-Neb 3000 compressors.

Inhalation Aerosol:

• Avoid spraying in the eyes.
• Prime the inhaler before using for the first time and when it has not been used for more than 3 days by releasing 4 test sprays into the air, away from the face.
• Wash the actuator with warm water and air dry thoroughly at least once a week.

General: This drug is not a substitute for corticosteroids and may not be adequate to control asthma; consider adding a corticosteroid to the treatment with this drug.

Monitoring:

• Signs and symptoms of adverse systemic effects
• Metabolic: Potassium levels

Patient advice:

• Discontinue immediately if hypersensitivity reactions and/or paradoxical bronchospasm occur.
• Excessive use may be fatal; recommended dose should not be exceeded.