Usual Adult Dose for Asthma - Acute

Subcutaneous: 0.25 mg subcutaneously into the lateral deltoid area. If significant improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg can be administered.
Maximum dose: 0.5 mg within 4 hours

Oral: 2.5 to 5 mg orally three times a day, at approximately six-hour intervals
Maximum dose: 15 mg within 24 hours

Inhalation Powder: 0.5 mg (1 inhalation) orally, as needed. Repeated doses should be taken five minutes apart.
Maximum dose: 3 mg (6 inhalations) in 24 hours

Comments:

• Subcutaneous: Consider other therapeutic measures if there is no clinical improvement within 15 to 30 minutes of the second dose.
• Oral: Therapeutic effect should last up to 6 hours or longer. If side effects are disturbing, reduce to a lower possible dose that provides a clinically significant improvement in pulmonary function.
• Oral inhalation: If severe attack has not been relieved by the second inhalation, higher doses may be required; medical advice should be sought.

Use: Prevention and reversal of bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema

Usual Adult Dose for Asthma - Maintenance

Subcutaneous: 0.25 mg subcutaneously into the lateral deltoid area. If significant improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg can be administered.
Maximum dose: 0.5 mg within 4 hours

Oral: 2.5 to 5 mg orally three times a day, at approximately six-hour intervals
Maximum dose: 15 mg within 24 hours

Inhalation Powder: 0.5 mg (1 inhalation) orally, as needed. Repeated doses should be taken five minutes apart.
Maximum dose: 3 mg (6 inhalations) in 24 hours

Comments:

• Subcutaneous: Consider other therapeutic measures if there is no clinical improvement within 15 to 30 minutes of the second dose.
• Oral: Therapeutic effect should last up to 6 hours or longer. If side effects are disturbing, reduce to a lower possible dose that provides a clinically significant improvement in pulmonary function.
• Oral inhalation: If severe attack has not been relieved by the second inhalation, higher doses may be required; medical advice should be sought.

Use: Prevention and reversal of bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema

Usual Pediatric Dose for Asthma - Acute

6 years or older:

• Inhalation Powder: 0.5 mg (1 inhalation) orally, as needed. Repeated doses should be taken five minutes apart.
• Maximum dose: 3 mg (6 inhalations) in 24 hours

12 to 15 years:

• Oral tablets: 2.5 mg orally three times a day, at approximately six-hour intervals
• Maximum dose: 7.5 mg within 24 hours

12 years or older:

• Subcutaneous: 0.25 mg subcutaneously into the lateral deltoid area. If significant improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg can be administered. Maximum dose: 0.5 mg within 4 hours

Comments:

• Subcutaneous: Consider other therapeutic measures if there is no clinical improvement within 15 to 30 minutes of the second dose.
• Oral: Therapeutic effect should last up to 6 hours or longer. If side effects are disturbing, reduce to a lower possible dose that provides a clinically significant improvement in pulmonary function.
• Oral inhalation: If severe attack has not been relieved by the second dosage, higher doses may be required; medical advice should be sought.

Use: Prevention and reversal of bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema

Usual Pediatric Dose for Asthma - Maintenance

6 years or older:

• Inhalation Powder: 0.5 mg (1 inhalation) orally, as needed. Repeated doses should be taken five minutes apart.
• Maximum dose: 3 mg (6 inhalations) in 24 hours

12 to 15 years:

• Oral tablets: 2.5 mg orally three times a day, at approximately six-hour intervals
• Maximum dose: 7.5 mg within 24 hours

12 years or older:

• Subcutaneous: 0.25 mg subcutaneously into the lateral deltoid area. If significant improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg can be administered. Maximum dose: 0.5 mg within 4 hours

Comments:

• Subcutaneous: Consider other therapeutic measures if there is no clinical improvement within 15 to 30 minutes of the second dose.
• Oral: Therapeutic effect should last up to 6 hours or longer. If side effects are disturbing, reduce to a lower possible dose that provides a clinically significant improvement in pulmonary function.
• Oral inhalation: If severe attack has not been relieved by the second dosage, higher doses may be required; medical advice should be sought.

Use: Prevention and reversal of bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNING:
PROLONGED TOCOLYSIS:
The subcutaneous injection has not been approved for and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, this drug should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of this drug to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. The oral tablet has not been approved and should not be used for acute or maintenance tocolysis.

Safety and efficacy have not been established in patients younger than 12 years (subcutaneous injection, oral tablets), and in patients younger than 6 years (inhalation powder).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Injectable solution: Use only for subcutaneous administration, not for intravenous infusion; discard unused portion after single use; visually inspect for particulate matter and discoloration prior to administration is recommended.
• Inhalation powder: Breathe in forcefully and deeply through the mouthpiece; patient may not taste or feel any medication due to the small amount of drug dispensed; rinse the mouth after each use to minimize unnecessary systemic exposure.
• The manufacturer product information should be consulted for effective and safe use of this drug.

General:

• Oral tablet has not been approved and should not be used for acute or maintenance tocolysis.
• Intravenous solution has not been approved for and should not be used for prolonged tocolysis (beyond 48 to 72 hours), and should not be used for maintenance tocolysis in the outpatient or home setting.

Monitoring:

• Respiratory: Pulmonary function deterioration

Patient advice:

• Do not use more frequently than recommended.
• Do not increase the dose or frequency without medical advice.
• If previously effective dosage regimen fails to provide the usual relief, symptoms become worse, and/or more frequently than usual dose is needed, seek medical advice immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
• Take other inhaled drugs and asthma medications only as directed by the physician while taking this drug.