Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Montelukast

Generic name
Montelukast
Brand name
ATC Code
R03DC03

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Adjuvant maintenance treatment for asthma in atopic patients
  • Oral
    • 6 months up to 6 years
      • 4 mg/day in 1 dose
      • Directions for administration:

        Take in the evening. Granulate can be used in young children or children who have trouble with the chewable tablet.

      • (Step 1: SABA if necessary)
        (Step 2: start ICS)
        Step 3: double the initial dose of ICS, then add LABA and lower the ICS to the smallest effective dose, in any event down to the initial dose
        LTRA as an alternative to LABA if there are side effects or in children aged < 4-6 years
        Step 4:if LABA has an effect but not enough to control the asthma: continue LABA and double the ICS dose or add LTRA
        If LABA has no effect: stop LABA and double the ICS dose or add LTRA
        Step 5: double the ICS dosage (to 4x the initial dose) and continue LABA and LTRA

        SABA = short-acting beta agonist; LABA = long-acting beta agonist; ICS= inhalation corticosteroids; LTRA = leukotriene receptor antagonist

        Note: Start the treatment at the step that best suits the clinical assessment of the severity

        ...read more
    • 6 years up to 15 years
      • 5 mg/day in 1 dose
      • Directions for administration:

        Take in the evening.

      • (Step 1: SABA if necessary)
        (Step 2: start ICS)
        Step 3: double the initial dose of ICS, then add LABA and lower the ICS to the smallest effective dose, in any event down to the initial dose
        LTRA as an alternative to LABA if there are side effects or in children aged < 4-6 years
        Step 4:if LABA has an effect but not enough to control the asthma: continue LABA and double the ICS dose or add LTRA
        If LABA has no effect: stop LABA and double the ICS dose or add LTRA
        Step 5: double the ICS dosage (to 4x the initial dose) and continue LABA and LTRA

        SABA = short-acting beta agonist; LABA = long-acting beta agonist; ICS= inhalation corticosteroids; LTRA = leukotriene receptor antagonist

        Note: Start the treatment at the step that best suits the clinical assessment of the severity

        ...read more
    • ≥ 15 years
      • 10 mg/day in 1 dose
      • Directions for administration:

        Take in the evening

      • (Step 1: SABA if necessary)
        (Step 2: start ICS)
        Step 3: double the initial dose of ICS, then add LABA and lower the ICS to the smallest effective dose, in any event down to the initial dose
        LTRA as an alternative to LABA if there are side effects or in children aged < 4-6 years
        Step 4:if LABA has an effect but not enough to control the asthma: continue LABA and double the ICS dose or add LTRA
        If LABA has no effect: stop LABA and double the ICS dose or add LTRA
        Step 5: double the ICS dosage (to 4x the initial dose) and continue LABA and LTRA

        SABA = short-acting beta agonist; LABA = long-acting beta agonist; ICS= inhalation corticosteroids; LTRA = leukotriene receptor antagonist

        Note: Start the treatment at the step that best suits the clinical assessment of the severity

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

In children 6-14 years: Headache

In children 2-6 years: stomach ache, thirst

In children 6 months- 2 years: hyperkinesia, diarrhea, eczematous dermatitis, rash. 

Neuropsychiatric side effect like nightmares, aggression and behavioral changes, occur in all paediatric agegroups. Dysphemia has been reported in children, especially in children younger than 5 years of age (CMDh, SmPC). 

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Montelukast granulate can be administered either directly via the mouth or mixed with a spoon into soft food that is cold or at room temperature (for example apple sauce, ice cream, carrots and rice). If mixed with
food montelukast granulate may not be stored for later use. Montelukast granulate is not intended to be administered by dissolution in liquid. But liquids can be drunk after administration.  Montelukast granulate can be administered with or without food.

Be aware of neuropsychiatric side effects (in children, especially stuttering, nightmares, aggression and behavioral changes). When these side effects occur, continuation of treatement with montelukast should be reconsidered. 

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Xanthines
R03DA04
Other systemic drugs for obstructive airway diseases
R03DX09
R03DX05
R03DX11

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References

  1. MSD BV, SPC Singulair granulaat en tablet (RVG 104604 en 25800), www.cbg-meb.nl, Geraadpleegd 10 juni 2010, http://db.cbg-meb.nl/IB-teksten/h104604.pdf
  2. Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), Montelukast: Scientific conclusions and grounds forthe variation to the terms of the Marketing Authorisation(s) , https://www.ema.europa.eu/en/documents/psusa/montelukast-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00002087/201807_en.pdf, 08-05-2019
  3. Ratiopharm, SmPC Montelukast-ratiopharm® 4 mg Granulat (80995.00.00), 08/2016
  4. Ratiopharm, SmPC Montelukast-ratiopharm® mini 4 mg Kautabletten (70602.00.00), 10/2015
  5. Ratiopharm, SmPC Montelukast-ratiopharm® junior 5 mg Kautabletten (70603.00.00), 10/2015
  6. Online GL, Montelukast-ratiopharm® 10 mg Filmtabletten | Gelbe Liste, Accessed March 19, 2018
  7. Ratiopharm, SmPC Montelukast-ratiopharm® 10 mg Filmtabletten (70604.00.00), 08/2016
  8. Online GL, SINGULAIR® 10 mg Filmtabletten | Gelbe Liste, Accessed March 16, 2018
  9. MSD, SmPC Singulair® mini 4 mg Granulat, Singulair®mini 4 mg Kautabletten, Singulair junior®5 mg Kautabletten, Singulair® 10 mg Filmtabletten (42011.00.02, 42011.01.00, 42011.00.00, 42011.00.01), 08/2016
  10. Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), Montelukast: Scientific conclusions and grounds forthe variation to the terms of the Marketing Authorisation(s), https://www.ema.europa.eu/en/documents/psusa/montelukast-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00002087/201807_en.pdf, 08-05-2019
  11. MSD, SmPC Singulair® mini 4 mg Granulat, Singulair®mini 4 mg Kautabletten, Singulair junior®5 mg Kautabletten, Singulair® 10 mg Filmtabletten (42011.00.02, 42011.01.00, 42011.00.00, 42011.00.01), 08/2016

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Changes

Changes