Usual Adult Dose for Asthma - Acute

Intravenous infusion solution:

• Dilute 5 mL of this drug (1000 mcg/mL) in 500 mL of Sodium Chloride Injection, or Sodium Chloride and Dextrose.
• Infusion rates can be started at 5 mcg/min, and can be increased to 10 mcg/min and 20 mcg/min at 15 at 30 minute intervals, if necessary.

Nebulizer inhalation solution:

• 2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes.

Comments:

• Never inject the IV infusion undiluted. Do not administer in the same infusion with other medications.
• Check the IV infusion for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
• Discard unused infusion solution 24 hours after preparation.

Uses:

• Relief of severe bronchospasm associated with acute exacerbations of chronic bronchitis and bronchial asthma, and acute attack of bronchospasm
• Treatment of status asthmaticus

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Acute

Intravenous infusion solution:

• Dilute 5 mL of this drug (1000 mcg/mL) in 500 mL of Sodium Chloride Injection, or Sodium Chloride and Dextrose.
• Infusion rates can be started at 5 mcg/min, and can be increased to 10 mcg/min and 20 mcg/min at 15 at 30 minute intervals, if necessary.

Nebulizer inhalation solution:

• 2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes.

Comments:

• Never inject the IV infusion undiluted. Do not administer in the same infusion with other medications.
• Check the IV infusion for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
• Discard unused infusion solution 24 hours after preparation.

Uses:

• Relief of severe bronchospasm associated with acute exacerbations of chronic bronchitis and bronchial asthma, and acute attack of bronchospasm
• Treatment of status asthmaticus

Usual Adult Dose for Bronchitis

Intravenous infusion solution:

• Dilute 5 mL of this drug (1000 mcg/mL) in 500 mL of Sodium Chloride Injection, or Sodium Chloride and Dextrose.
• Infusion rates can be started at 5 mcg/min, and can be increased to 10 mcg/min and 20 mcg/min at 15 at 30 minute intervals, if necessary.

Nebulizer inhalation solution:

• 2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes.

Comments:

• Never inject the IV infusion undiluted. Do not administer in the same infusion with other medications.
• Check the IV infusion for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
• Discard unused infusion solution 24 hours after preparation.

Uses:

• Relief of severe bronchospasm associated with acute exacerbations of chronic bronchitis and bronchial asthma, and acute attack of bronchospasm
• Treatment of status asthmaticus

Usual Adult Dose for Bronchospasm Prophylaxis

Inhalation powder: 2 inhalations (180 mcg) orally 15 to 30 minutes before exercise
Inhalation capsule: 1 inhalation (200 mcg) 15 minutes before exercise

Uses: Prevention of exercise-induced bronchospasm

Usual Adult Dose for Asthma - Maintenance

Inhalation powder:

• 1 or 2 inhalations (90 to 180 mcg) orally every 4 to 6 hours

Inhalation capsules:

• 1 inhalation (200 mcg) orally every 4 to 6 hours
• Maximum dose: 4 inhalations (800 mcg) per day

Nebulizer inhalation solution:

• 2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes

Oral tablets:
Immediate-release tablets:

• Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
• Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day; dosage may be gradually increased up to 8 mg three or four times a day.

Extended-release tablets:

• Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours). In unusual circumstances, such as adults of low body weight, use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

Oral syrup:

• Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
• Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

Uses:

• Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor
• Relief of bronchospasm in patients with reversible obstructive airway disease

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

Inhalation powder:

• 1 or 2 inhalations (90 to 180 mcg) orally every 4 to 6 hours

Inhalation capsules:

• 1 inhalation (200 mcg) orally every 4 to 6 hours
• Maximum dose: 4 inhalations (800 mcg) per day

Nebulizer inhalation solution:

• 2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes

Oral tablets:
Immediate-release tablets:

• Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
• Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day; dosage may be gradually increased up to 8 mg three or four times a day.

Extended-release tablets:

• Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours). In unusual circumstances, such as adults of low body weight, use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

Oral syrup:

• Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
• Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

Uses:

• Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor
• Relief of bronchospasm in patients with reversible obstructive airway disease

Usual Adult Dose for Reversible Airways Disease - Maintenance

Inhalation powder:

• 1 or 2 inhalations (90 to 180 mcg) orally every 4 to 6 hours

Inhalation capsules:

• 1 inhalation (200 mcg) orally every 4 to 6 hours
• Maximum dose: 4 inhalations (800 mcg) per day

Nebulizer inhalation solution:

• 2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes

Oral tablets:
Immediate-release tablets:

• Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
• Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day; dosage may be gradually increased up to 8 mg three or four times a day.

Extended-release tablets:

• Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours). In unusual circumstances, such as adults of low body weight, use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

Oral syrup:

• Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
• Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

Uses:

• Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor
• Relief of bronchospasm in patients with reversible obstructive airway disease

Usual Pediatric Dose for Asthma - Acute

Inhalation powder and capsules:
Less than 4 years: Not indicated

4 years or older:

• Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
• Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated

2 to 12 years:

• Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
• 15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:

• Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes

Use: Relief of bronchospasm in patients with reversible obstructive airway disease and acute attacks of bronchospasm

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease - Acute

Inhalation powder and capsules:
Less than 4 years: Not indicated

4 years or older:

• Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
• Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated

2 to 12 years:

• Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
• 15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:

• Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes

Use: Relief of bronchospasm in patients with reversible obstructive airway disease and acute attacks of bronchospasm

Usual Pediatric Dose for Bronchitis

Inhalation powder and capsules:
Less than 4 years: Not indicated

4 years or older:

• Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
• Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated

2 to 12 years:

• Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
• 15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:

• Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes

Use: Relief of bronchospasm in patients with reversible obstructive airway disease and acute attacks of bronchospasm

Usual Pediatric Dose for Bronchospasm Prophylaxis

Less than 4 years: Not indicated

4 years or older:

• Inhalation powder: 2 inhalations (180 mcg) orally 15 to 30 minutes before exercise
• Inhalation capsule: 1 inhalation (200 mcg) 15 minutes before exercise

Uses: Prevention of exercise-induced bronchospasm

Usual Pediatric Dose for Asthma - Maintenance

Inhalation powder and capsules:
Less than 4 years: Not indicated
4 years or older:

• Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
• Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated
2 to 12 years:

• Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
• 15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:

• Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes.

Oral Tablets:
Less than 6 years: Not indicated
6 to 12 years:

• Immediate-release tablets: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
• Extended-release tablets: Initial dose: 4 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 24 mg/day in divided doses (e.g., every 12 hours).

13 years or older:

• Immediate-release tablets: Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
• Extended-release tablets: Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours).

Oral syrup:

• Less than 2 years: Not indicated
• 2 to 5 years: Initial dose: 0.1 mg/kg (do not exceed 2 mg) orally three times a day. Dosage may be increased stepwise to 0.2 mg/kg three times a day. A maximum dose of 4 mg three times a day should not be exceeded.
• 6 to 14 years: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not exceed 24 mg/day (in divided doses).
• 15 years or older: Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Uses: Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease - Maintenance

Inhalation powder and capsules:
Less than 4 years: Not indicated
4 years or older:

• Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
• Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated
2 to 12 years:

• Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
• 15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:

• Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes.

Oral Tablets:
Less than 6 years: Not indicated
6 to 12 years:

• Immediate-release tablets: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
• Extended-release tablets: Initial dose: 4 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 24 mg/day in divided doses (e.g., every 12 hours).

13 years or older:

• Immediate-release tablets: Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
• Extended-release tablets: Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours).

Oral syrup:

• Less than 2 years: Not indicated
• 2 to 5 years: Initial dose: 0.1 mg/kg (do not exceed 2 mg) orally three times a day. Dosage may be increased stepwise to 0.2 mg/kg three times a day. A maximum dose of 4 mg three times a day should not be exceeded.
• 6 to 14 years: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not exceed 24 mg/day (in divided doses).
• 15 years or older: Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Uses: Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor

Usual Pediatric Dose for Reversible Airways Disease - Maintenance

Inhalation powder and capsules:
Less than 4 years: Not indicated
4 years or older:

• Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
• Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated
2 to 12 years:

• Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
• 15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:

• Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes.

Oral Tablets:
Less than 6 years: Not indicated
6 to 12 years:

• Immediate-release tablets: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
• Extended-release tablets: Initial dose: 4 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 24 mg/day in divided doses (e.g., every 12 hours).

13 years or older:

• Immediate-release tablets: Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
• Extended-release tablets: Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours).

Oral syrup:

• Less than 2 years: Not indicated
• 2 to 5 years: Initial dose: 0.1 mg/kg (do not exceed 2 mg) orally three times a day. Dosage may be increased stepwise to 0.2 mg/kg three times a day. A maximum dose of 4 mg three times a day should not be exceeded.
• 6 to 14 years: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not exceed 24 mg/day (in divided doses).
• 15 years or older: Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Uses: Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Inhalation solution and oral syrup:
Safety and efficacy have not been established in patients younger than 2 years.

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

Immediate and extended release oral tablet:
Safety and efficacy have not been established in patients younger than 6 years.

Intravenous infusion:
Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Inhalation solution, powder, and capsules are for oral inhalation only.
• More frequent administration or a larger number of inhalations are not recommended.
• Oral tablets should not be chewed or crushed; tablets should be swallowed whole with liquids.
• The manufacturer product information should be consulted for instructions of use.

Inhalation powder HFA:

• Prime the inhalation device before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped.
• To prime, release 4 sprays into the air away from the face, shaking well before each spray.
• To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.

Inhalation powder RESPICLICK:

• Inhaler does not require priming.
• Keep the inhaler clean and dry at all times. Never wash or put any part of the inhaler in water.

Switching from oral immediate release to extended release products:

• The administration of one 4 mg extended-release tablet every 12 hours is comparable to one 2 mg immediate tablet every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Patient advice:

• Other inhaled drugs and asthma medications should be taken only as directed by the physician while taking this drug.
• Seek medical advice if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual is required. Do not increase the dose or its frequency of administration.

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