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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
Combined inhaled glucocorticoids and long-acting beta agonists (LABAs)
Budesonide-formoterol MDI 80 mcg/4.5 mcg per actuation Safety and efficacy not established.Δ

Low-dose ICS-LABA: 1 inhalation once or twice per day.

Medium-dose ICS-LABA: 2 inhalations twice per day.
  • Formoterol has a fast onset of action (approximately 5 minutes, similar to albuterol).
  • If used for SMART, do not exceed 36 mcg formoterol per day. Safety and efficacy of SMART has not been established in children <4 years of age.
Mometasone-formoterol MDI 50 mcg/5 mcg per actuation Safety and efficacy not established.Δ

Low- to medium-dose ICS-LABA: 1 inhalation twice per day.

High-dose ICS-LABA: 2 inhalations twice per day.
Fluticasone furoate-vilanterol◊ DPI 50 mcg/25 mcg per actuation Safety and efficacy not established. Low- to medium-dose ICS-LABA: 1 inhalation once per day.
  • Most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery of DPI.
  • Vilanterol and salmeterol have slow onsets of action (approximately 15 minutes and ≥30 minutes, respectively).
  • Do not exceed dose shown.
Fluticasone propionate-salmeterol DPI 100 mcg/50 mcg per actuation Safety and efficacy not established. Medium-dose ICS-LABA: 1 inhalation twice per day (4 to 11 years of age).
MDI 45 mcg/21 mcg per actuation Safety and efficacy not established.Δ§

Low-dose ICS-LABA: 1 inhalation twice per day.

Medium-dose ICS-LABA: 2 inhalations twice per day.
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.
  • Serious neuropsychiatric events, including suicidal thoughts or actions, have been reported with montelukast.
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.
Systemic glucocorticoids

Methylprednisolone

Prednisolone

Prednisone		 For detail, refer to 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 including biologics). 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.
Long-acting anticholinergic agents
Tiotropium Soft-mist inhaler 1.25 mcg/actuation Safety and efficacy not established.

2 inhalations once daily (≥6 years of age).

(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) CFC-free MDI (not available in the United States)†:
  • 1 mg/actuation
  • 5 mg/actuation
 Safety and efficacy not established.

1 mg/actuation: 2 inhalations 4 times per day.

5 mg/actuation: 2 inhalations twice 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.
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.

CFC: chlorofluorocarbon; DPI: dry-powder inhaler; GINA: Global Initiative for Asthma; ICS: inhaled corticosteroid (glucocorticoid); IgE: immunoglobulin E; IL: interleukin; LABA: long-acting beta agonist; LTRA: leukotriene receptor antagonist; MDI: metered-dose inhaler; NAEPP: National Asthma Education and Prevention Program; SMART: single maintenance and reliever therapy.

* Doses are provided for medications with sufficient clinical trial safety and efficacy data in the appropriate age ranges to support their use.[1,2] Some doses may not be approved by regulatory bodies (ie, are used "off label"); refer to local prescribing information for approved uses.

¶ 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. ICS dose range is according to GINA.[2]

Δ The NAEPP expert panel guidelines[1] and UpToDate authors suggest ICS-LABA therapy in patients ≤4 years of age depending on symptom severity; however, dosing has not been established, and safety and efficacy data are limited. For patients in this age range who would benefit from ICS-LABA therapy, may consider doses provided for 5- to 11-year-old patients.

◊ Inhaled fluticasone furoate has a greater antiinflammatory potency per microgram than fluticasone propionate inhalers. Thus, fluticasone furoate is administered at a lower daily dose and used only once daily.

§ Based on efficacy data of the fluticasone MDI in young children and expected lower dose to be delivered with a facemask, fluticasone propionate-salmeterol 45 mcg/21 mcg 2 inhalations twice per day may be categorized as low-dose ICS therapy in patients <4 years of age.[3]

¥ Zileuton is available in the United States and some other countries. Its use is not recommended in children.

‡ Monitoring of transaminases to screen for liver injury has not been shown to be effective in preventing rare hepatic injury due to zafirlukast, and the optimal timing and frequency of testing is not well defined. If liver dysfunction is suspected based on clinical signs or symptoms, immediately discontinue zafirlukast and evaluate for drug-induced liver injury.

† 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.
References:
  1. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. National Heart, Lung, and Blood Institute, 2020. https://www.nhlbi.nih.gov/resources/2020-focused-updates-asthma-management-guidelines (Accessed on February 5, 2023).
  2. 2023 Global Initiative for Asthma (GINA) Report: Global Strategy for Asthma Management and Prevention. www.ginasthma.org/2023-gina-main-report (Accessed on February 5, 2023).
  3. Asthma Care Quick Reference: Diagnosing and Managing asthma. Guidelines from the National Asthma Education and Prevention Program: Expert Panel Report 3. National Heart, Lung, and Blood Institute, 2012. https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf (Accessed on April 17, 2024).
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