- 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.
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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
| Allergic rhinitis and chronic urticaria |
|---|
|
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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
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
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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
No information available on specific warnings and precautions in children.
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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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| 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 | ||
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References
- J. Uriach & Cía., S.A., SmpC Rupafin (RVG 108903) 29-05-14, www.cbg-meb.nl, Geraadpleegd 13 jan 2015
- Nederlandse Vereniging voor Dermatologie en Venereologie, Richtlijn Chronische spontane urticaria, www.ndvd.nl, 03-12-2015
- 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
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Changes
Changes
