Usual Adult Dose for Asthma - Maintenance

Administer 20 mg (1 vial) via nebulizer 4 times a day at regular intervals

Prophylaxis of acute bronchospasm due to exercise, exposure to cold dry air, or environmental allergens: 20 mg (1 vial) via nebulizer shortly before anticipated exposure

Comments:

• This drug is a prophylactic agent to be used in patients whose symptoms are sufficiently frequent to require a continuous regimen of medications; the effect is usually evident after several weeks, although some patients show an almost immediate response.
• This drug should not be added to a therapeutic regimen during an acute episode; therapy should be started once asthma is controlled, the airway is cleared, and the patient is able to inhale adequately.

Use: For the management of bronchial asthma

Usual Adult Dose for Systemic Mastocytosis

Initial dose: 200 mg (2 ampules) orally one-half hour before meals and at bedtime

• If satisfactory control is not achieved within 2 to 3 weeks, may increase dose.

Maintenance dose: May reduce dose to the minimum required to maintain adequate control once a therapeutic response has been achieved.
Maximum dose: 40 mg/kg/day

Comment:

• Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

Use: For the management of patients with mastocytosis.

Usual Pediatric Dose for Asthma - Maintenance

Age: 2 years or older:

Administer 20 mg (1 vial) via nebulizer 4 times a day at regular intervals

Prophylaxis of acute bronchospasm due to exercise, exposure to cold dry air, or environmental allergens: 20 mg (1 vial) via nebulizer shortly before anticipated exposure

Comments:

• This drug is a prophylactic agent to be used in patients whose symptoms are sufficiently frequent to require a continuous regimen of medications; the effect is usually evident after several weeks, although some patients show an almost immediate response.
• This drug should not be added to a therapeutic regimen during an acute episode; therapy should be started once asthma is controlled, the airway is cleared, and the patient is able to inhale adequately.

Use: For the management of bronchial asthma

Usual Pediatric Dose for Systemic Mastocytosis

Age: 2 to 12 years old:
Initial dose: 100 mg (1 ampule) orally one-half hour before meals and at bedtime

Age: 13 years or older:
Initial dose: 200 mg (2 ampules) orally one-half hour before meals and at bedtime

• If satisfactory control is not achieved within 2 to 3 weeks, may increase dose to no more than 40 mg/kg/day.

Maintenance dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain adequate control.
Maximum dose: 40 mg/kg/day

Comment:

• Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
• Not recommended for patients less than 2 years of age unless the potential benefits clearly outweigh the risks.

Use: For the management of patients with mastocytosis.

Renal Dose Adjustments

Use with caution; consider decreasing oral dose in patients with renal impairment.

Liver Dose Adjustments

Use with caution; consider decreasing oral dose in patients with hepatic impairment.

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Orally:

• Take orally 30 minutes before meals and at bedtime.
• Oral liquid is supplied in ampules (100 mg/5 mL) for oral use only; not for inhalation or injection.
• At time of use, break open ampule(s) and squeeze contents into a glass of water; drink all liquid.

Nebulizer:

• Administer via nebulization 4 times a day.
• Solution for nebulization is supplied in vials (20 mg/2 mL) for oral inhalation only; not for injection.
• This drug should be administered via a power driven nebulizer at an airflow of 6 to 8 L/min with a suitable face mask; hand-operated nebulizers are not suitable for administration.

Storage requirements:

• Protect from light; store vials/ampules in foil pouches until ready to use
• Do not use if the solution is discolored or contains a precipitate.

• Stability and safety of this drug when mixed with other drugs in a nebulizer have not been established.

General:

• This is a prophylactic agent and has no role in the acute treatment of asthma.
• Effectiveness is dependent upon administration at regular intervals.

Monitoring:

• Monitor for control of symptoms; once symptoms are controlled, dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology.

Patient advice:

• Patients should understand that this drug is a preventative agent, it may take 2 to 4 weeks to see benefit; effectiveness is dependent on regular administration.
• Patients with acute symptoms should seek medical advice promptly.