Rupatadine

Generic name
Rupatadine
Brand name
ATC Code
R06AX28

Rupatadine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In a subgroup of children (average age: 10 years), rupatadine was absorbed quickly after administration of an average dose of 5 mg rupatadine with an average Tmax of 0.5 hours after intake. The average Cmax was 2.5 ng/ml after a single oral dose. With regards to exposure the average total surface was below the curve (AUC) 8.86 ng·hour/ml. All these values are comparable to the values obtained for adults and adolescents.

The average elimination half-life of rupatadine in children was 3.12 hours, which is shorter than that for the tablets in adults and adolescents.

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
    • 2 years up to 12 years and 10 up to 25 kg
      • 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.

    • 2 years up to 12 years and ≥ 25 kg
      • 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.

    • 12 years up to 18 years
      • 10 mg/day in 1 dose
      • In chronic urticaria, raising the dose can be considered up to a maximum of 4 times the daily dose.

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

Liquid formulation:
Common (1–10%): headache, drowsiness.
Occasional (0.1–1%): upper respiratory tract infections, influenza. Dizziness, fatigue. Nausea. Eczema, night sweats. Neutropenia, eosinophilia. against the chikungunya virus

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.

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
R06AX27
R06AX26
R06AX17
R06AX13
R06AX25

References

  1. J. Uriach & Cía., S.A., SmpC Rupafin (RVG 108903) 29-05-14, www.cbg-meb.nl, Geraadpleegd 13 jan 2015
  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

Changes

Therapeutic Drug Monitoring


Overdose