- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| 1-2 years | 6-11 year | Adults | |
| Vd (l/kg) | 0,37 ± 0,06 | - | 0,4 |
| Cmax (ng/ml) | 286 ± 68 | 450 ± 37 | 270 |
| Tmax (hour) | 1 | 1 | 0,9 |
| T1/2 (hour) | 4,1 ± 0,67 | 5,7 ± 0,2 | 7,9 ± 1,9 |
| Cl (ml/min/kg) | 1,05 ± 0,1 | 0,82 ± 0,05 | 0,63 |
SmPC Xyzal
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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
| Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. |
|---|
|
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Renal impaiment in children > 3 months
When the creatinine clearance is > 50 ml/min/1.73m²:
Dose adjustment is not required
When the creatinine clearance is 10-50 ml/min/1.73m²:
< 6 years: 100% of the normal dose each time, dosage interval 24 hours
> 6 years: 50% of the normal dose each time, dosage interval 24 hours.
When the creatinine clearance is < 10 ml/min/1.73m²:
Generalized recommendations cannot be given
| Adjust the dose given each time | Adjust the dosage interval | |
|---|---|---|
| GFR 50-80 ml/min/1.73m² | - | - |
| GFR 30-50 ml/min/1.73m² < 6 yrs ≥ 6 yrs |
- + |
+ - |
| GFR 10-30 ml/min/1.73m² < 6 yrs ≥ 6 yrs |
- + |
+ - |
| GFR <10 ml/min/1.73m² without dialysis | No recommendations | No recommendations |
| GFR <10 ml/min/1.73m² with dialysis | No recommendations | No recommendations |
[Working group on renal dysfunction - Extrapolation of recommendations for adults to children]
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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
Tiredness, headaches, sleepiness, diarrhea, constipation, infection of the upper respiratory tract (pharyngitis, rhinitis), dry mouth, nausea, lower abdominal pain and exacerbation of allergies
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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 in children
In patients with only impaired liver function, no adjustment of the dose is necessary. In patients with both impaired liver function and impaired renal function, adjustment of the dose is necessary
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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 | ||
| R06AE05 | ||
| Other antihistamines for systemic use | ||
|---|---|---|
| R06AX18 | ||
| R06AX29 | ||
| R06AX02 | ||
| R06AX27 | ||
| R06AX26 | ||
| R06AX17 | ||
| R06AX13 | ||
| R06AX25 | ||
| R06AX28 | ||
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References
- Cranswick N, et al, Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile, Int J Clin Pharmacol Ther., 2005, 43, 172-7
- de Blic J, et al, Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial, Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial, 2005, 16, 267-75
- Hussein Z, et al, ETAC Study Group. Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: the ETAC study, Br J Clin Pharmacol., 2005, 59, 28-37
- Simons FE, et al, Early Prevention of Asthma in Atopic Children (EPAAC) Study Group. Safety of levocetirizine treatment in young atopic children: An 18-month study, Pediatr Allergy Immunol., 2007, 18, 535-42
- Simons FE, et al., Population pharmacokinetics of levocetirizine in very young children: the pediatricians\' perspective, Pediatr Allergy Immunol., 2005, 16, 97-103
- Simons FE, et al., Levocetirizine: pharmacokinetics and pharmacodynamics in children age 6 to 11 years, J Allergy Clin Immunol., 2005, 116, 355-61
- Pampura AN, et al, Evidence for clinical safety, efficacy, and parent and physician perceptions of levocetirizine for the treatment of children with allergic disease, Int Arch Allergy Immunol, 2011, 155(4), 367-78
- 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
- UCB, SmPC Xusal akut Tropfen, 49904.00.01, 11/2016
- AVOXA ABDA-Datenbank, Interaktionen (BRD) Levocetirizin, Accessed July 2017
- DAZ.online, Individuell für Kinder, Accessed March 15, 2018
- Breitkreutz J, Boos J, Paediatric and geriatric drug delivery. Expert opinion on drug delivery, 2007
- UCB, SmPC Xusal Tropfen, 49903.00.01, 08/2017
- UCB, SmPC Xusal Saft, 56570.00.00, 06/2017
- UCB, SmPC Xusal 5mg Filmtabletten, 49903.00.00, 08/2017
- Hexal, SmPC Levocetirizin- HEXAL 5mg,73623.00.00, 03/2011
- Ratiopharm, SmPC Levocetirizin- ratiopharm 5mg, 71228.00.00, 05/2016
- MMI, Gelbe Liste Online, Accessed March 15, 2018
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Changes
Changes
