<p><strong>Pediatric Use</strong>: There are limited clinical data on the pediatric use of Tretinoin. Of 15 pediatric patients (age range: 1 to 16 years) treated with Tretinoin, the incidence of complete remission was 67%. Safety and effectiveness in pediatric patients below the age of 1 year have not been established. Some pediatric patients experience severe headache and pseudotumor cerebri, requiring analgesic treatment and lumbar puncture for relief. Increased caution is recommended in the treatment of pediatric patients. Dose reduction may be considered for pediatric patients experiencing serious and/or intolerable toxicity; however, the efficacy and safety of Tretinoin at doses lower than 45 mg/m2 /day have not been evaluated in the pediatric population.<br />
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<strong>Geriatric Use</strong>: Of the total number of subjects in clinical studies of Tretinoin, 21.4% were 60 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.</p>