Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine succinate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f ] [1,4]oxazepine. It is present as the succinate salt.
Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine capsules in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Media Articles Related to Loxapine
Scientists identify schizophrenia's "Rosetta Stone" gene
Source: Mental Health News From Medical News Today [2015.07.24]
Scientists have identified a critical function of what they believe to be schizophrenia's "Rosetta Stone" gene that could hold the key to decoding the function of all genes involved in the disease.
High blood levels of growth factor correlate with smaller brain areas in patients with schizophrenia
Source: Schizophrenia News From Medical News Today [2015.07.16]
High blood levels of a growth factor known to enable new blood vessel development and brain cell protection correlate with a smaller size of brain areas key to complex thought, emotion and behavior...
Rexulti Approved for Schizophrenia, Depression
Source: MedicineNet Schizophrenia Specialty [2015.07.14]
Title: Rexulti Approved for Schizophrenia, Depression
Category: Health News
Created: 7/13/2015 12:00:00 AM
Last Editorial Review: 7/14/2015 12:00:00 AM
FDA approves REXULTI as adjunctive treatment for adults with major depressive disorder and as a treatment for adults with schizophrenia
Source: Schizophrenia News From Medical News Today [2015.07.13]
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) have announced that the U.S.
Smoking Linked to Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2015.07.13]
Title: Smoking Linked to Schizophrenia
Category: Health News
Created: 7/11/2015 12:00:00 AM
Last Editorial Review: 7/13/2015 12:00:00 AM
Published Studies Related to Loxapine
Rapid acute treatment of agitation in patients with bipolar I disorder: a
multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. 
of agitation in patients with bipolar I disorder... CONCLUSIONS: Inhaled loxapine provided a rapid, non-injection, well-tolerated
Off-label medication use. 
Prescribing medications for off-label uses is not illegal. Off-label prescribing
includes using medications for unapproved indications; using a drug outside of
the recommended dosage range or duration of use; using a drug in certain
unapproved patient populations, such as those defined by age, sex, or particular
clinical parameters; or intentionally using a medication in a patient who has a
Efficacy and safety of loxapine for inhalation in the treatment of agitation in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial. [2011.10]
CONCLUSIONS: Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00369577. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. [2011.01]
CONCLUSIONS: Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.
Efficacy and safety of loxapine for inhalation in the treatment of agitation in
patients with schizophrenia: a randomized, double-blind, placebo-controlled
CONCLUSIONS: Inhaled loxapine was generally safe and well tolerated and produced
Clinical Trials Related to Loxapine
Multidose PK Study of Staccato Loxapine [Completed]
StaccatoŽ Loxapine Treatment of Schizophrenic Patients With Agitation [Completed]
Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning [Recruiting]
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming
patients down in a situation of restlessness during mechanical ventilation weaning. This
drug is used for several years to quieten restless patients. Its purpose is to restore
spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical
Fasting Study of Loxapine Succinate Capsules 25 mg and LoxitaneŽ Capsules 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan loxapine succinate
25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg)
dose administration under fasting conditions.
StaccatoŽ Loxapine for Inhalation in Schizophrenia [Completed]
Staccato Loxapine is being developed for the treatment of acute agitation in patients with
schizophrenia. A 50 patient, dose escalation Phase I clinical trial was completed in November
Reports of Suspected Loxapine Side Effects
Cardiogenic Shock (25),
Disseminated Intravascular Coagulation (17),
Neuroleptic Malignant Syndrome (16),
Extremity Necrosis (13),
Toxicity TO Various Agents (11),
Blood Pressure Decreased (7),
Multiple Drug Overdose (6),
Blood Glucose Increased (6), more >>
Page last updated: 2015-07-24