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Usual doses for long-term asthma controller medications other than inhaled glucocorticoids in children*

Usual doses for long-term asthma controller medications other than inhaled glucocorticoids in children*
Medication Dose form 0 to 4 years 5 to 11 years Comments
Leukotriene receptor antagonists (LTRAs)
Montelukast

4 mg or 5 mg chewable tablet

4 mg granule packets
4 mg once daily at bedtime (1 to 5 years of age). 5 mg once daily at bedtime (6 to 14 years of age). When LTRA treatment is indicated, montelukast is preferred.
Zafirlukast 10 mg tablet Safety and efficacy not established. 10 mg twice per day on empty stomach.

Zafirlukast has potential drug interactions and a small risk of hepatotoxicity.

Food decreases bioavailability of zafirlukast; take at least 1 hour before or 2 hours after meals.
Combined inhaled glucocorticoids and long-acting beta agonists (LABAs)Δ
Fluticasone-salmeterol DPI 100 mcg/50 mcg Safety and efficacy not established. 1 inhalation twice per day.

Most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery of DPI.

Do not exceed dose shown.
MDI 45 mcg/21 mcg 2 puffs twice per day.
Budesonide-formoterol HFA MDI 80 mcg/4.5 mcg Safety and efficacy not established. 1 to 2 puffs twice per day.

Onset of formoterol is similar to albuterol.

There have been no clinical trials in children ≤4 years of age.

Do not exceed dose shown.
Mometasone-formoterol HFA MDI 50 mcg/5 mcg Safety and efficacy not established. 2 puffs twice per day.
Systemic glucocorticoids
Methylprednisolone For detail, refer to Lexicomp drug-specific monographs included with UpToDate 0.25 to 2 mg/kg orally per day or every other day given in the morning. Titrate to the lowest acceptable dose that maintains control. 0.25 to 2 mg/kg orally per day or every other day given in the morning. Titrate to the lowest acceptable dose that maintains control.

(Applies to all 3 glucocorticoids)

Due to their toxic effects, systemic glucocorticoids should be used only rarely for long-term control of asthma (ie, in those few patients with poorly controlled severe persistent asthma despite compliance with maximized ICS and other pharmacologic and preventive therapies). Refer to UpToDate topics on the treatment of persistent asthma in children.

The use and dosing of systemic glucocorticoids for the treatment of acute asthma exacerbations is reviewed elsewhere. Refer to UpToDate topics on acute asthma exacerbations in children in the emergency department and inpatient management.
Prednisolone
Prednisone
Long-acting anticholinergic agents
Tiotropium Soft-mist inhaler 1.25 mcg/actuation Safety and efficacy not established.

2 inhalations once daily.

(Off-label use: 2 inhalations of 2.5 mcg/actuation dose once daily.)

Inhaler is used without a spacer/valved holding chamber.

There have been no clinical trials in children ≤4 years of age.
Chromones
Cromolyn sodium (sodium cromoglycate) 5 mg/puff CFC free MDI (not available in the United States) Safety and efficacy not established 2 puffs 4 times per day.

Less effective than ICS in children. Add-on to ICS is not recommended. Refer to UpToDate topics on the treatment of persistent asthma in children.

4- to 6-week trial may be needed to determine maximum benefit. May cause bronchospasm. Premedication with bronchodilator may be needed.

Use of spacer device may substantially decrease amount of drug delivered.

Once control is achieved, the frequency of dosing may be reduced.
20 mg/ampule solution for nebulization

20 mg 4 times per day.

Safety and efficacy not established in children aged <2 years.
20 mg 4 times per day.
Nedocromil 2 mg/puff CFC free inhaler (not available in the United States) Safety and efficacy not established in children aged <6 years. 2 puffs 4 times per day.
Biologic agents: Refer to separate UpToDate table and topics on biologic therapy for asthma, including omalizumab (anti-IgE) and mepolizumab (anti-IL-5)
Methylxanthines
Theophylline Liquids, sustained-release tablets and capsules

Starting dose for patients without risk factors for decreased theophylline clearance approximately 10 mg/kg per day (initial maximum 300 mg per day).

Usual maximum following titration:
  • <1 year of age: 0.2 × (age in weeks) + 5 = dose in mg/kg per day
  • ≥1 year of age: 16 mg/kg per day (maximum 600 mg per day)

Starting dose for patients without risk factors for decreased theophylline clearance approximately 10 mg/kg/day (initial maximum 300 mg per day).

Usual maximum following titration:
  • 16 mg/kg/day (maximum 600 mg per day)

Due to risk of toxic effects, requirement of frequent serum concentration monitoring, and significant drug-drug interactions, theophylline is infrequently used.

Monitoring and dose adjustment is required to maintain peak serum levels of 5 to 15 mcg/mL at steady-state.

For additional information, including approach to dose adjustment, refer to UpToDate topics on theophylline use in asthma.
LTRA: leukotriene receptor antagonist; LABA: long-acting beta agonist; DPI: dry-powder inhaler; MDI: metered-dose inhaler; HFA: hydrofluoroalkane (inhaler propellant); ICS: inhaled glucocorticoid; CFC: chlorofluorocarbon; IgE: immunoglobulin E; IL: interleukin.
* Doses are provided for those products that have been approved by the US Food and Drug Administration or have sufficient clinical trial safety and efficacy data in the appropriate age ranges to support their use.
¶ Zileuton is available in the United States and some other countries. Its use is not recommended in children.
Δ LABAs should only be used in combination products with inhaled glucocorticoids. Other ICS-LABA combination products are available. Some ICS-LABA combination inhalers may be approved for use in children in countries other than the United States.
Chromone DPI and MDI inhalers with different strengths than those listed in this table are available in some countries other than the United States. Consult local product information.
Data from:
  1. National Heart, Blood, and Lung Institute Expert Panel Report 3 (EPR 3): Guidelines for the Diagnosis and Management of Asthma. NIH Publication no. 08-4051, 2007.
  2. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Updated 2012. Available at www.ginasthma.org.
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