- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information available about the pharmacokinetic parameters in children.
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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
| Cough |
|---|
|
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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
Primarily in children: Paradoxical stimulation of the central nervous system can also occur, such as nervousness, confusion, irritability, sleeplessness, tremors, tachycardia and increased tendency for convulsions,
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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 in children
Children younger than 2 years because of a possible link with sudden infant death syndrome
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
Do not use in children aged under 2 years because of the risk of sedation and respiratory depression; there is a correlation with sudden infant death syndrome. Be careful in children aged less than 6 years because of the greater risk of neuropsychiatric side effects. Be careful in children with sleep apnoea in their previous history, when sudden infant death syndrome is known in the family, when children wake up spontaneously less easily than normal and in very sick or dehydrated 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 | ||
| R06AD02 | ||
| Piperazine derivatives | ||
|---|---|---|
| R06AE07 | ||
| R06AE03 | ||
| R06AE09 | ||
| R06AE05 | ||
| Other antihistamines for systemic use | ||
|---|---|---|
| R06AX18 | ||
| R06AX29 | ||
| R06AX02 | ||
| R06AX27 | ||
| R06AX26 | ||
| R06AX17 | ||
| R06AX13 | ||
| R06AX25 | ||
| R06AX28 | ||
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Reference
- sanofi-aventis Netherlands B.V., SPC Toplexil (RVG 05706)15 nov 2013, www.cbg-meb.nl
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Changes
Changes
