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Latuda (Lurasidone Hydrochloride) - Summary

 
 



WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions ].
  • LATUDA is not approved for use in patients with dementia-related psychosis [see Warnings and Precautions].
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ].
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions].
 

LATUDA SUMMARY

LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives.

Schizophrenia

LATUDA is indicated for the treatment of patients with schizophrenia.

The efficacy of LATUDA in schizophrenia was established in five 6-week controlled studies of adult patients with schizophrenia [see Clinical Studies ].

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2)].

Depressive Episodes Associated with Bipolar I Disorder

Monotherapy: LATUDA is indicated as monotherapy for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of LATUDA was established in a 6-week monotherapy study in adult patients with bipolar depression [see Clinical Studies ].

Adjunctive Therapy with Lithium or Valproate: LATUDA is indicated as adjunctive therapy with either lithium or valproate for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of LATUDA as adjunctive therapy was established in a 6-week study in adult patients with bipolar depression who were treated with lithium or valproate [see Clinical Studies].

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration].

The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established.


See all Latuda indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Latuda (Lurasidone)

Annual cost of relapses and relapse-related hospitalizations in adults with schizophrenia: results from a 12-month, double-blind, comparative study of lurasidone vs quetiapine extended-release. [2013]
quetiapine extended-release (XR)... CONCLUSION: Adults treated for schizophrenia with lurasidone are predicted to

Lurasidone in schizophrenia: new information about dosage and place in therapy. [2012]
Lurasidone is a newer "atypical" or "secondgeneration" antipsychotic that has received regulatory approval in the US and Canada for the treatment of schizophrenia. Recent changes in lurasidone product labeling include an expansion of the recommended dose range from 40-80 mg/day to 40-160 mg/day, administered once-daily with food.

Performance and interview-based assessments of cognitive change in a randomized, double-blind comparison of lurasidone vs. ziprasidone. [2011]
changes... CONCLUSIONS: These data suggest that interview-based cognitive measures such as

Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. [2009]
CONCLUSIONS: The results of this study suggest that the novel psychotropic agent

Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. [2014]
treatment outcomes in patients with an acute exacerbation of schizophrenia... CONCLUSION: In this 6-week double-blind study, treatment with lurasidone 80 mg or

more studies >>

Clinical Trials Related to Latuda (Lurasidone)

Lurasidone Low-Dose - High-Dose Study Study [Completed]
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.

Lurasidone Effects on Tissue Glutamate in Schizophrenia [Recruiting]
24 individuals with schizophrenia or schizoaffective disorders, who are currently considered stable, will be recruited, screened for entry criteria into a blinded study with a 4-week randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related outcomes with lurasidone as compared to haloperidol and perphenazine.

Lurasidone Pediatric Autism Study [Completed]
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects [Completed]

Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old [Not yet recruiting]
This study is an 8-week open-label trial testing Lurasidone (LatudaŽ) as a treatment for mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders. We hypothesize that Lurasidone will be safe, tolerable, and effective in improving the core symptoms of bipolar disorders in children and adolescents ages 6-17.

more trials >>

Reports of Suspected Latuda (Lurasidone) Side Effects

Insomnia (12)Paranoia (9)Hallucination, Auditory (8)Dyspnoea (8)Psychiatric Decompensation (8)Aggression (8)Anxiety (8)Urticaria (7)Convulsion (7)Confusional State (6)more >>


Page last updated: 2014-12-01

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