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Loxapine (Loxapine) - Summary


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).



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.

See all Loxapine indications & dosage >>


Media Articles Related to Loxapine

Finger lengths may indicate risk of schizophrenia in males
Source: Endocrinology News From Medical News Today [2015.03.19]
Research suggests that the ratio of the lengths of the index finger and the ring finger in males may be predictive of a variety of disorders related to disturbed hormonal balance.

Rat brains point to lead's role in schizophrenia
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2015.03.16]
A study of the brains of rats exposed to lead has uncovered striking similarities with what is known about the brains of human schizophrenia patients, adding compelling evidence that lead is a factor...

Abnormal brain rhythms tied to problems with thinking in schizophrenia
Source: Anxiety / Stress News From Medical News Today [2015.03.09]
Study of unique mouse model shows cognitive deficits may be reversibleBy studying specially bred mice with specific developmental and cognitive traits resembling those seen in schizophrenia, UC...

Medicare and patients with schizophrenia could save $150 million on Part D plans
Source: Health Insurance / Medical Insurance News From Medical News Today [2015.03.02]
Using an "intelligent," rather than random, method for assigning people with schizophrenia to Medicare Part D prescription drug coverage plans could save Medicare and patients a combined $150...

An evolutionary approach reveals new clues toward understanding the roots of schizophrenia
Source: Autism News From Medical News Today [2015.02.26]
Is mental illness simply the evolutionary toll humans have to pay in return for our unique and superior cognitive abilities when compared to all other species?

more news >>

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

more studies >>

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.

more trials >>

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 >>

Page last updated: 2015-03-19

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