OPIPZA

Aripiprazole oral film activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D 2 receptors similar to the parent drug and represents 40% of the parent drug exposure in plasma.

AbsorptionFollowing administration of aripiprazole oral film, the median (range) time to reach peak plasma concentrations (T max ) occurs at of 1.5 (1, 6) hours. In two studies comparing the ...

14.1 Overview of the Clinical Studies The efficacy of OPIPZA for the treatment of schizophrenia in patients ages 13 to 17 years, adjunctive treatment of adults with MDD, treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, and treatment of Tourette's disorder in pediatric patients 6 years and older is based on the following adequate and well-controlled studies of another oral aripiprazole product (referred to as "aripiprazole" in this section): Four short-term trials and one maintenance trial in adult patients and one short-term trial in pediatri...

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neu...

OPIPZA is contraindicated in patients with a history of a hypersensitivity to aripiprazole. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see Adverse Reactions (6.1) ] . Known hypersensitivity to aripiprazole ( 4 )

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ) Tardive Dyskinesia : Discontinue if clinically appropriate ( 5.5 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain ( 5.6 ) Pathological Gam...

7 DRUG INTERACTIONS Dosage adjustments for patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers ( 7.1 ): Factors Dosage Recommendations CYP2D6 Poor Metabolizers taking strong CYP3A4 inhibitors ( 7.1 ) Administer a quarter of recommended dosage ( 2.6 ) Strong CYP2D6 or CYP3A4 inhibitors ( 7.1 ) Administer half of recommended dosage ( 2.6 ) Strong CYP2D6 and CYP3A4 inhibitors ( 7...