Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

FDA Approves Long-Acting Olanzapine Intramuscular Injection for Schizophrenia NEW YORK -- December 14, 2009 -- The US Food and Drug Administration (FDA) has approved olanzapine (ZYPREXA RELPREVV) as an extended release injectable suspension form for the treatment of schizophrenia in adults. The approval is based on data involving 2,054 patients, in which intramuscular olanzapine injection was found to be effective in controlling symptoms of schizophrenia, including hallucinations, delusions, apathy, and social withdrawal. Efficacy was shown without the need for oral supplementation. Data showed that the olanzapine intramuscular injection at doses of 150, 210, 300, and 405 mg provides therapeutic exposure for 2 or 4 weeks depending on the dose. The intramuscular injection was found to have a similar safety profile as oral olanzapine, with the exception of injection-related events, including post-injection delirium/sedation syndrome (PDSS). As of November 30, 2009, across all clinical trials, PDSS events have occurred in < 0.1% of injections and approximately 2% of patients. The potential for onset of an event is greatest within the first hour after injection. The majority of cases have occurred within the first 3 hours after injection; however cases have occurred after 3 hours. All patients largely recovered within 72 hours and the majority of these patients have chosen to continue treatment. Labeling for olanzapine intramuscular injection includes a requirement for the patient to be observed at a healthcare facility with ready access to emergency response services for at least 3 hours following each injection and to be accompanied to his or her destination upon leaving the facility. The manufacturer, Eli Lilly, has worked with the FDA to develop a Risk Evaluation and Mitigation Strategy, which includes a communication plan, a patient medication guide, and a mandatory Patient Care Program, which restricts distribution of olanzapine intramuscular injection to prescribers, healthcare facilities, pharmacy service providers and patients enrolled in the program. SOURCE: Eli Lilly and Company E-mail this page to a friend or colleague! To print, use this version