- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Acute promyelocytic leukaemia |
|---|
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Renal impaiment in children > 3 months
In reduced renal function in children (10-50 ml/min):
oral: 25 mg/m² BSA per day in 2 doses.
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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
There have been some reports of increased toxicity in children treated with tretinoin, in particular an increase in pseudotumor cerebri.
A higher frequency of intracranial hypertension has been observed in children and adolescents; the incidence decreased with the use of lower doses of tretinoin.
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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
Pseudotumor cerebri occurs more often in paediatric patients than in adults. Data from clinical studies shows a reduced incidence of pseudotumor cerebri, without compromising results, when low doses of tretinoin are used. Dose reduction to 25 mg/m² should therefore be considered for children with symptoms of toxicity, such as persistent headaches.
Rare cases of depression, worsening of anxiety and affective disorders are reported in patients using oral retinoids.(DHPC). Care must be taken when used in patients with a history of depression.
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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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| Methylhydrazines | ||
|---|---|---|
| L01XB01 | ||
| MONOKLONALE ANTILICHAMEN | ||
|---|---|---|
| L01XC11 | ||
| L01XC18 | ||
| L01XC18 | ||
| Other antineoplastic agents | ||
|---|---|---|
| L01XX01 | ||
| L01XX02 | ||
| L01XX05 | ||
| L01XX23 | ||
| L01XX24 | ||
| Proteasome inhibitors | ||
|---|---|---|
| L01XG01 | ||
| Antineoplastic cell and gene therapy | ||
|---|---|---|
| L01XL04 | ||
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References
- Cheplapharm Arzneimittel GmbH, SmPC Vesanoid (RVG 20455) 16-05-2017, www.geneesmiddeleninformatiebank.nl
- College ter Beoordeling van Geneesmiddelen, DHPC Retinoiden 05-12-2019, www.cbg-meb.nl
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Changes
Changes
