Fexofenadine

Generic name
Fexofenadine
Brand name
ATC Code
R06AX26
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Fexofenadine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In children aged 6 to 11 years, exposure to a one-time dose of 15, 30 or 60 mg fexofenadine is proportional and comparable to a one-time dose of 30, 60 mg or 120 mg respectively in adults. A dose of 30 mg twice daily in children therefore results in a similar AUC and Cmax as in adults on a dose of 120 mg once daily.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Allergic rhinitis and chronic urticaria
  • Oral
    • 6 years up to 12 years
      [1] [2] [3]
      • 60 mg/day in 2 doses.

      • In chronic urticaria, raising the dose can be considered up to a maximum of 4 times the daily dose.

    • 12 years up to 18 years
      [3] [5] [6]
      • 120 mg/day in 1 dose

      • In chronic urticaria, raising the dose can be considered up to max. 4 times the daily dose.

Renal impaiment in children > 3 months

  • GFR ≥50: dose adjustment not needed
  • GFR 30-50: 50% of normal reversal dose, adjustment of dosing interval is not necessary.
  • GFR 10-30: 50% of normal reversal dose, adjustment of dosing interval is not necessary.
  • GFR <10: a general recommendation cannot be given. Weigh up the usage and determine the dosage per patient.
Clinical consequences

With impaired renal function, Cmax and half-life of fexofenadine may increase. This increases the risk of adverse reactions.

Clinical implications:
Prolongation of the QTc interval may occur. Further possible central nervous system side effects.

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

Side effects

No information is present at this moment.

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

No information available on specific warnings and precautions in children.

Interactions

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

ANTIHISTAMINES FOR SYSTEMIC USE

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Piperazine derivatives
R06AE07
R06AE03
Other antihistamines for systemic use
R06AX13

References

  1. sanofi-aventis Netherlands B.V., SPC Telfast 30 mg (RVG 28085) 4 nov 2013, www.cbg-meb.nl
  2. Nederlandse Vereniging voor Dermatologie en Venereologie, Richtlijn Chronische spontane urticaria., www.ndvd.nl, 03-12-2015
  3. Zuberbier T, et al, The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update,, Allergy,, 2014, Jul;69(7), 868-87
  4. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
  5. Opella Healthcare France SAS, SmPC Telfast 180 mg (RVG 21625) 15-07-2023, www.geneesmiddelinformatiebank.nl
  6. Teva B.V. , SmPC Fexofenadine HCl Teva 120 mg (35246) 06-02-2024, www.geneesmiddelinformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose