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Vesanoid (Tretinoin Oral) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug-Drug Interactions

In 13 patients who had received daily doses of tretinoin for 4 consecutive weeks, administration of ketoconazole (400 to 1200 mg oral dose) 1 hour prior to the administration of the tretinoin dose on day 29 led to a 72% increase (218 ± 224 vs 375 ± 285 ng∙h/mL) in tretinoin mean plasma AUC. The precise cytochrome P450 enzymes involved in these interactions have not been specified; CYP 3A4, 2C8 and 2E have been implicated in various preliminary reports.

OVERDOSAGE

In case of overdose with VESANOID, reversible signs of hypervitaminosis A (headache, nausea, vomiting, mucocutaneous symptoms) can appear. The maximal tolerated dose in patients with myelodysplastic syndrome or solid tumors was 195 mg/m2/day. The maximal tolerated dose in pediatric patients was lower at 60 mg/m2/day. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia. These symptoms have quickly resolved without apparent residual effects.

There is no specific treatment in the case of an overdose; however, it is important that the patient be treated in a special hematological unit.

CONTRAINDICATIONS

VESANOID is contraindicated in patients with a known hypersensitivity to VESANOID, any of its components, or other retinoids. VESANOID should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.

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