- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
In a phase II study to investigate the pharmacokinetics, pharmacokinetic data were collected in children who received
10 mg bilastine once daily as a melting tablet (31 children aged 4 to 11 years with allergic rhinoconjunctivitis or chronic urticaria). Pharmacokinetic analysis of plasma concentration data showed that paediatric dosing of 10 mg bilastine once daily resulted in comparable systemic exposure to that observed after a 20 mg dose in adults and adolescents (mean AUC 1014 ng × h/ml in children aged 6 to 11 years). [SmPC Allegra]
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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 rhinoconjunctivitis and urticaria |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Common (1-10%): Rhinitis, headache, allergic conjunctivitis, abdominal pain/pain in the upper abdomen
Occasional (0.1-1 %): Dizziness, loss of consciousness, eye irritation, diarrhoea, nausea, swollen lip, eczema, urticaria, fatigue
[SmPC Allegra®]
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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 | ||
| R06AX02 | ||
| R06AX27 | ||
| R06AX26 | ||
| R06AX17 | ||
| R06AX13 | ||
| R06AX25 | ||
| R06AX28 | ||
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References
- A. Nattermann & Cie. GmbH (Sanofi), SmPC Allegra (7004523.00.00) , www.fachinfo.de, 12/2022
- A. Nattermann & Cie. GmbH (Sanofi), SmPC Allegra (7004523.00.00), www.fachinfo.de, 12/2022
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Changes
Changes
