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 cases of death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, Sudden death) or infections (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 is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
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LOXAPINE SUMMARY
Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines.
Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine succinate capsules in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
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NEWS HIGHLIGHTSMedia Articles Related to Loxapine
ADUSAVE (loxapine) Inhalation Powder Approved For Schizophrenia Or Bipolar Agitation
Source: Bipolar News From Medical News Today [2012.12.27]
ADASUVE (loxapine) Inhalation Powder has just been approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation resulting from schizophrenia or bipolar I disorder. They anticipate that the treatment will be available around the third quarter of 2013...
Schizophrenia 'Guideline of Guidelines' Released
Source: Medscape Psychiatry & Mental Health Headlines [2013.05.16]
New "meta-guidelines" combining recommendations from several expert organizations on the management and treatment of schizophrenia have been released.
Medscape Medical News
Model Cell System Offers Insights Into Epilepsy, Schizophrenia, Other Neuropsych Disorders
Source: Autism News From Medical News Today [2013.05.06]
Medical researchers have manipulated human stem cells into producing types of brain cells known to play important roles in neurodevelopmental disorders such as epilepsy, schizophrenia and autism...
Neurons In The Nose Could Be The Key To Early, Fast, And Accurate Diagnosis Of Schizophrenia
Source: Schizophrenia News From Medical News Today [2013.05.01]
A debilitating mental illness, schizophrenia can be difficult to diagnose. Because physiological evidence confirming the disease can only be gathered from the brain during an autopsy, mental health professionals have had to rely on a battery of psychological evaluations to diagnose their patients. Now, Dr. Noam Shomron and Prof...
Schizophrenia May Be Diagnosed By Testing Nerve Cells From The Nose
Source: Schizophrenia News From Medical News Today [2013.05.01]
Collecting neurons from the nose could be a fast way to test for schizophrenia, a debilitating mental illness that is often difficult to diagnose. This was the finding of a new study led by researchers from Tel Aviv University (TAU) in Israel...
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. [2012]
of agitation in patients with bipolar I disorder... CONCLUSIONS: Inhaled loxapine provided a rapid, non-injection, well-tolerated
Off-label medication use. [2012]
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
known contraindication.
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
trial. [2011]
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
ventilation.
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
2005.
Reports of Suspected Loxapine Side Effects
Cardiogenic Shock (25),
Disseminated Intravascular Coagulation (17),
Neuroleptic Malignant Syndrome (16),
Extremity Necrosis (13),
Hypoglycaemia (11),
Toxicity TO Various Agents (11),
Blood Pressure Decreased (7),
Overdose (6),
Multiple Drug Overdose (6),
Blood Glucose Increased (6), more >>
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Page last updated: 2013-05-16
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