Tretinoin, oral

Generic name
Tretinoin, oral
Brand name
ATC Code
L01XX14
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Tretinoin, oral

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.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Acute promyelocytic leukaemia
  • Oral
    • 1 month up to 18 years
      • 45 mg/m²/day in 2 doses.
      • Duration of treatment:

        Continue the treatment until complete remission has been achieved, but only for a maximum of 90 days.

      • In children with persistent headaches, consider dose reduction (25 mg/m²/day).

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.

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.

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

OTHER ANTINEOPLASTIC AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Methylhydrazines
L01XB01
MONOKLONALE ANTILICHAMEN
L01XC11
L01XC18
L01XC18
Other antineoplastic agents
L01XX01
L01XX02
L01XX05
L01XX23
L01XX24
Proteasome inhibitors
L01XG01
Antineoplastic cell and gene therapy
L01XL04

References

  1. Cheplapharm Arzneimittel GmbH, SmPC Vesanoid (RVG 20455) 16-05-2017, www.geneesmiddeleninformatiebank.nl
  2. College ter Beoordeling van Geneesmiddelen, DHPC Retinoiden 05-12-2019, www.cbg-meb.nl

Changes

Therapeutic Drug Monitoring


Overdose