Desloratadine

Generic name
Desloratadine
Brand name
ATC Code
R06AX27
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Desloratadine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

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 months up to 1 year
      • 1 mg/day in 1 dose

      • CAVE: some formulations contain benzyl alchol. Do not use these solution longer than 1 week. 

    • 1 year up to 6 years
      • 1.25 mg/day in 1 dose
        • In chronic urticaria in children from age 2 upwards, raising the dose can be considered up to a maximum of 4 times the daily dose.
        • For high dosages in urticaria in children weighing < 20 kg , use tablets or orodispersible tablets because of the excessive propylene glycol load if given as the liquid formulation.
        • CAVE: some formulations contain benzylalcohol. Do not use these solution longer than 1 week in children < 3 years.
    • 6 years up to 12 years
      • 2.5 mg/day in 1 dose

      • In chronic urticaria, raising the dose can be considered up to a maximum of 4 times the daily dose. For high dosages in urticaria, use tablets or orodispersible tablets because of the excessive propylene glycol load if given as the liquid formulation.

    • 12 years up to 18 years
      • 5 mg/day in 1 dose

      • In chronic urticaria, raising the dose can be considered up to a maximum of 4 times the daily dose. For high dosages in urticaria, use tablets or orodispersible tablets because of the excessive propylene glycol load if given as the liquid formulation.

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.

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 aged less than two, the following are reported as common (1–10%): diarrhoea, fever and sleeplessness. Other side effects that have been reported in children are QT extension, arrhythmia, bradycardia, abnormal behaviour and aggression.
Increased incidence of new-onset seizures [SmPC Aerius]

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

In children aged less than two, the diagnosis of rhinitis is mostly infectious in nature. Before starting therapy, upper respiratory tract infections or anatomical abnormalities should be ruled out as the cause of rhinitis. [SmPC, Aerius film-coated tablets]

Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, being more susceptible to develop new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment. [SmPC, Aerius film-coated tablets]

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.

Aminoalkyl ethers
R06AA04
R06AA52
R06AA02
Substituted alkylamines
R06AB03
Phenothiazine derivatives
R06AD01
R06AD08
R06AD02
Piperazine derivatives
R06AE07
R06AE03
R06AE09
R06AE05
Other antihistamines for systemic use
R06AX18
R06AX29
R06AX02
R06AX26
R06AX17
R06AX13
R06AX25
R06AX28

References

  1. SP Europe, SPC Aerius (EU/1/00/160/061-069), www.ema.europa.eu, Geraadpleegd 27 mei 2010, http://www.ema.europa.eu/humandocs/PDFs/EPAR/aerius/emea-combined-h313nl.pdf
  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. Schering Corporation, Product Label Clarinex (USA)- feb 2008, www.accessdata.fda.gov
  5. Gupta SK, et al, Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults, Br J Clin Pharmacol, 2007, Aug;64(2), 174-84
  6. de Vries, TW. et al, Adverse drug reactions of systemic antihistamines, Arch Dis Child, 2016;, 101, 968–970.
  7. MSD, SmPC Aerius 5 mg Filmtabletten (EU/1/00/160/061-069 ) 6-3-2020, 11/2017
  8. Aristo, SmPC Desloratadin 0,5 mg/ml (84989.00.00), 02/2018
  9. Heumann, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84586.00.00), 03/2016
  10. Dermapharm, SmPC Desloraderm 0,5 mg/ml Lösung zum Einnehmen (84588.00.00), 11/2017
  11. Hexal, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84366.00.00), 12/2017
  12. MSD, SmPC Aerius 0,5 mg/ml Lösung zum Einnehmen (EU/1/00/160/01 - 069), 11/2017
  13. MSD, SmPC Aerius 2,5 mg/5 mg Schmelztabletten (EU/1/00/160/037 - 048, EU/1/00/160/049 - 060), 11/2017
  14. Actavis, SmPC Desloratadin 5mg Filmtabletten (EU/1/11/745/001-011), 09/2015
  15. Ratiopharm, SmPC Desloratadin 5 mg Filmtabletten (EU/1/11/746/001-011), 11/2017
  16. Online GL, Desloratadin Actavis 5 mg Filmtabletten, Accessed May 18, 2018
  17. Online GL, Desloratadine ratiopharm 5 mg Filmtabletten, Accessed May 18, 2018
  18. Breitkreutz J BJ, Paediatric and geriatric drug delivery. Expert opinion on drug delivery, 2007, 4, 37–45
  19. DAZ.online, Individuell für Kinder: Einige Besonderheiten der paediatrischen Rezeptur, Accessed May 18, 2018
  20. Ratiopharm, SmPC Desloratadin 5 mg Filmtabletten (EU/1/11/746/001-011), 11/2017
  21. MSD, SmPC Aerius 5 mg Filmtabletten (EU/1/00/160/001 - 013; EU/1/00/160/036), 11/2017
  22. Actavis, SmPC Desloratadin 5mg Filmtabletten (EU/1/11/745/001-011), 09/2015
  23. MSD, SmPC Aerius 2,5 mg/5 mg Schmelztabletten (EU/1/00/160/037 - 048, EU/1/00/160/049 - 060), 11/2017
  24. MSD, SmPC Aerius 0,5 mg/ml Lösung zum Einnehmen (EU/1/00/160/01 - 069), 11/2017
  25. Heumann, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84586.00.00), 03/2016
  26. Dermapharm, SmPC Desloraderm 0,5 mg/ml Lösung zum Einnehmen (84588.00.00), 11/2017
  27. Aristo, SmPC Desloratadin 0,5 mg/ml (84989.00.00), 02/2018
  28. Online GL, Desloratadine ratiopharm 5 mg Filmtabletten, Accessed May 18, 2018
  29. Online GL, Desloratadin Actavis 5 mg Filmtabletten, Accessed May 18, 2018
  30. Hexal, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84366.00.00), 12/2017
  31. Dermapharm, SmPC Desloraderm 0,5 mg/ml Lösung zum Einnehmen (84588.00.00), 11/2017
  32. Dermapharm, SmPC Desloraderm 0,5 mg/ml Lösung zum Einnehmen (84588.00.00), 11/2017
  33. Heumann, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84586.00.00), 03/2016
  34. Heumann, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84586.00.00), 03/2016
  35. Ratiopharm, SmPC Desloratadin 5 mg Filmtabletten (EU/1/11/746/001-011), 11/2017
  36. Ratiopharm, SmPC Desloratadin 5 mg Filmtabletten (EU/1/11/746/001-011), 11/2017
  37. Online GL, Desloratadin Actavis 5 mg Filmtabletten, Accessed May 18, 2018
  38. Online GL, Desloratadin Actavis 5 mg Filmtabletten, Accessed May 18, 2018
  39. Online GL, Desloratadine ratiopharm 5 mg Filmtabletten, Accessed May 18, 2018
  40. Aristo, SmPC Desloratadin 0,5 mg/ml (84989.00.00), 02/2018
  41. MSD, SmPC Aerius 0,5 mg/ml Lösung zum Einnehmen (EU/1/00/160/061 – 069), 06/2018
  42. Aristo, SmPC Desloratadin 0,5 mg/ml (84989.00.00), 02/2018
  43. Actavis, SmPC Desloratadin 5mg Filmtabletten (EU/1/11/745/001-011), 09/2015
  44. MSD, SmPC, Aerius 5 mg Filmtabletten (EU/1/00/160/001 - 013; EU/1/00/160/036), 06/2018
  45. MSD, SmPC Aerius 5 mg Filmtabletten (EU/1/00/160/001 - 013; EU/1/00/160/036), 11/2017
  46. Hexal, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84366.00.00), 12/2017
  47. MSD, SmPC Aerius 2,5 mg/5 mg Schmelztabletten (EU/1/00/160/037 - 048, EU/1/00/160/049 - 060), 06/2018
  48. Hexal, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84366.00.00), 12/2017
  49. MSD, SmPC Aerius 2,5 mg/5 mg Schmelztabletten (EU/1/00/160/037 - 048, EU/1/00/160/049 - 060), 11/2017
  50. DAZ.online, Individuell für Kinder: Einige Besonderheiten der paediatrischen Rezeptur, Accessed May 18, 2018
  51. MSD, SmPC Aerius 0,5 mg/ml Lösung zum Einnehmen (EU/1/00/160/01 - 069), 11/2017
  52. Actavis, SmPC Desloratadin 5mg Filmtabletten (EU/1/11/745/001-011), 09/2015
  53. ZorgInstituut Nederland, Farmacotherapeutisch Kompas (Eigenschappen, Contra-Indicaties, Bijwerkingen, Waarschuwingen en Voorzorgen)., Geraadpleegd 19 okt 2014
  54. DAZ.online, Individuell für Kinder: Einige Besonderheiten der paediatrischen Rezeptur, Accessed May 18, 2018
  55. Breitkreutz J BJ, Paediatric and geriatric drug delivery. Expert opinion on drug delivery, 2007, 4, 37–45
  56. Online GL, Desloratadine ratiopharm 5 mg Filmtabletten, Accessed May 18, 2018
  57. Breitkreutz J BJ, Paediatric and geriatric drug delivery. Expert opinion on drug delivery, 2007, 4, 37–45
  58. Informatorium Medicamentorum, (Interacties, Dosis), Geraadpleegd 19 okt 2014
  59. Heumann, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84586.00.00), 03/2016
  60. Aristo, SmPC Desloratadin 0,5 mg/ml (84989.00.00), 02/2018
  61. MSD, SmPC Aerius 5 mg Filmtabletten (EU/1/00/160/001 - 013; EU/1/00/160/036), 11/2017
  62. MSD, SmPC Aerius 2,5 mg/5 mg Schmelztabletten (EU/1/00/160/037 - 048, EU/1/00/160/049 - 060), 11/2017
  63. DAZ.online, Individuell für Kinder: Einige Besonderheiten der paediatrischen Rezeptur, Accessed May 18, 2018
  64. Breitkreutz J BJ, Paediatric and geriatric drug delivery. Expert opinion on drug delivery, 2007, 4, 37–45
  65. Online GL, Desloratadine ratiopharm 5 mg Filmtabletten, Accessed May 18, 2018
  66. Online GL, Desloratadin Actavis 5 mg Filmtabletten, Accessed May 18, 2018
  67. Ratiopharm, SmPC Desloratadin 5 mg Filmtabletten (EU/1/11/746/001-011), 11/2017
  68. Hexal, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84366.00.00), 12/2017
  69. Actavis, SmPC Desloratadin 5mg Filmtabletten (EU/1/11/745/001-011), 09/2015
  70. MSD, SmPC Aerius 0,5 mg/ml Lösung zum Einnehmen (EU/1/00/160/01 - 069), 11/2017
  71. Dermapharm, SmPC Desloraderm 0,5 mg/ml Lösung zum Einnehmen (84588.00.00), 11/2017
  72. Informatorium Medicamentorum, (Interacties, Dosis), Geraadpleegd 19 okt 2014
  73. ZorgInstituut Nederland, Farmacotherapeutisch Kompas (Eigenschappen, Contra-Indicaties, Bijwerkingen, Waarschuwingen en Voorzorgen)., Geraadpleegd 19 okt 2014
  74. Ratiopharm, SmPC Desloratadin 5 mg Filmtabletten (EU/1/11/746/001-011), 11/2017
  75. Heumann, SmPC Desloratadin 0,5 mg/ml Lösung zum Einnehmen (84586.00.00), 03/2016

Changes

Therapeutic Drug Monitoring


Overdose