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Loxapine (Loxapine) - Summary

 
 



WARNING

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 SUMMARY

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.


See all Loxapine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Loxapine

Siblings of Schizophrenia Patients at Greater Risk for Same Diagnosis: Study
Source: MedicineNet Schizophrenia Specialty [2016.09.21]
Title: Siblings of Schizophrenia Patients at Greater Risk for Same Diagnosis: Study
Category: Health News
Created: 9/21/2016 12:00:00 AM
Last Editorial Review: 9/21/2016 12:00:00 AM

Medication against schizophrenia inhibits pancreatic cancer
Source: Schizophrenia News From Medical News Today [2016.09.09]
A receptor for the dopamine neurotransmitter promotes growth and spread of pancreatic cancer - and schizophrenia drugs, which block the function of this receptor, slowed tumor growth and metastatic...

Sleep apnoea blamed for schizophrenia complications
Source: Schizophrenia News From Medical News Today [2016.08.29]
Undiagnosed sleep apnoea is being blamed for high rates of cardiovascular disease and memory loss among people with schizophrenia.

Schizophrenia: Symptoms, Types, Causes, and Treatment
Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2016.08.26]
Title: Schizophrenia: Symptoms, Types, Causes, and Treatment
Category: Slideshows
Created: 9/27/2010 9:31:00 AM
Last Editorial Review: 8/26/2016 12:00:00 AM

Schizophrenia symptoms eased with aerobic exercise
Source: Schizophrenia News From Medical News Today [2016.08.12]
Around 12 weeks of aerobic exercise was found to significantly improve the cognitive functioning of individuals with schizophrenia in a new study.

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

Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients [Terminated]
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication. However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam. The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

Staccato Loxapine Multidose PK [Completed]

QT/QTc Study of 2 Doses of ADASUVEļæ½ [Completed]
It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers. The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec

Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning [Completed]
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.

Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting [Not yet recruiting]
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVEĀ® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVEĀ® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.

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: 2016-09-21

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