The US FDA has approved an improved aripiprazole oral film for the treatment of schizophrenia in adults and pediatric patients aged 13 years and above. Clinical evidence Clinical trials demonstrated that aripiprazole oral film was superior to placebo in improving Positive and Negative Syndrome Scale scores over four and six weeks in adult and pediatric patients.
Additionally, in a long-term clinical trial involving 310 patients, aripiprazole oral film achieved a significantly longer time to relapse over 26 weeks compared to placebo. Dosage and administration Administer once daily with or without food Starting dosage: Adults – 10 to 15 mg/day; pediatric patients (13-17 years) – 2 mg/day Contraindications Known hypersensitivity to aripiprazole Warnings and precautions Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis Neuroleptic malignant syndrome…
