- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The pharmacokinetic data for children is limited, particularly in children younger than 3 years. In the only study so far on children, just nine children under three years of age were given Rapydan; of these, a complete series of pharmacokinetic samples was only taken from 4 and no samples at all were taken from one child. The risk of higher systemic exposure in young children (under three years of age) cannot be excluded. The available pharmacokinetic data suggests that the
lidocaine exposure (AUC and Cmax) is inversely correlated with age. In general, toxicity can be observed at lidocaine values above 5000 ng/ml and even concentrations as low as 1000 ng/ml are already associated with antiarrhythmic activity.
The following table shows the Cmax data that is available for lidocaine and tetracaine by age and treatment group. The limited number of patients exposed means that no firm conclusions can be drawn from the data on safety in children aged under 3 years. (source SPC for Rapydan)
| Cmax lidocaine | Tetracaine | ||
| 4 months to 2 years | 1 plaster |
14.3 (n=2); range: 6.6–22.1 |
< 0.9 (n=2) |
| 2 patches |
141 (n=6); range: 4.6–331 |
0.2 (n=6), range 0-1.33 | |
| 3-6 years | 1 plaster | 13.4 (n=7); range 2.0-63.3 | 0.7 (n=7); range 0-3.97 |
| 2 patches | 16.8 (n=7); range 5.0-33.8 | < 0.9 (n=7) | |
| 7-12 years | 1 plaster | 4.7 (n=9); range 0-12.3 | 7.2 (n=9); range 0-64.9 |
| 2 patches | 2.1 (n=5); range 0-4.9) | <0.9 (n=6) |
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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
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Dosages
| Local anaesthesia |
|---|
|
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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
No information is present at this moment.
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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
Make sure that the plaster stays firmly on the skin to minimise the risk of swallowing or contact with the eyes.
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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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| Amides | ||
|---|---|---|
| N01BB08 | ||
| N01BB01 | ||
| N01BB10 | ||
| N01BB02 | ||
| N01BB52 | ||
| N01BB20 | ||
| N01BB03 | ||
| N01BB04 | ||
| N01BB09 | ||
| Esters of benzoic acid | ||
|---|---|---|
| N01BC01 | ||
| ESTERS OF BENZOIC ACID | ||
|---|---|---|
| N01BC01 | ||
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References
- Eurocept International BV, SPC Rapydan (RVG 100315), ww.cbg-meb.nl, Geraadpleegd 26/11/13, http://db.cbg-meb.nl/IB-teksten/h100315.pdf
- ZorgInstituut Nederland, Farmacotherapeutisch Kompas (Eigenschappen, Contra-Indicaties, Bijwerkingen, Waarschuwingen en Voorzorgen)., Geraadpleegd 04 juli 2024
- Anciaux, B., Safety and feasibility of S-caine patch use in children under the age of three, a pilot study. [Master’s thesis, Vrije Universiteit Brussel]. De Vlaamse Scriptiebank., Available from: https://scriptiebank.be/safety-and-feasibility-s-caine-patch-use-children-under-age-three-pilot-study, 2021
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Changes
Changes
