Olanzapine

Product manufactured by Tya Pharmaceuticals

Application Nr Approved Date Route Status External Links
ANDA201741 2012-03-20 Intramuscular RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Olanzapine For Injection Is An Atypical Antipsychotic Indicated For The: Treatment Of Acute Agitation Associated With Schizophrenia And Bipolar I Mania. ( ) 1.4 Efficacy Was Established In Three 1-Day Trials In Adults. ( ) 14.3 1.4 Agitation Associated With Schizophrenia And Bipolar I Mania Olanzapine For Injection Is Indicated For The Treatment Of Acute Agitation Associated With Schizophrenia And Bipolar I Mania. Efficacy Was Demonstrated In 3 Short-Term (24 Hours Of Im Treatment) Placebo-Controlled Trials In Agitated Adult Inpatients With: Schizophrenia Or Bipolar I Disorder (manic Or Mixed Episodes) [see ]. Clinical Studies ( 14.3 ) “psychomotor Agitation” Is Defined In Dsm-Iv As “excessive Motor Activity Associated With A Feeling Of Inner Tension.” Patients Experiencing Agitation Often Manifest Behaviors That Interfere With Their Diagnosis And Care, E.g., Threatening Behaviors, Escalating Or Urgently Distressing Behavior, Or Self-Exhausting Behavior, Leading Clinicians To The Use Of Intramuscular Antipsychotic Medications To Achieve Immediate Control Of The Agitation.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Olanzapine OLANZAPINE ZINC52957434

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