LURASIDONE HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)

Tilgjengelig fra:

Dr. Reddys Laboratories Inc

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Lurasidone Hydrochloride tablets are indicated for: • Treatment of adult and adolescent patients (13 to 17 years) patients with schizophrenia [see Clinical Studies ( 14.1)] . • Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)]. • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)]. • Known hypersensitivity to lurasidone HCl or any components in the formulation.  Angioedema has been observed with lurasidone [see Adverse Reactions ( 6.1)] . • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1)]. • Stron

Produkt oppsummering:

Lurasidone hydrochloride tablets 120 mg are white to off white coloured, oval shaped, film coated tablets plain on one side and debossed "465" on other side.  Bottles of 30                                                                    NDC 43598-355-30 Storage Store lurasidone hydrochloride tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature] .

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

LURASIDONE HYDROCHLORIDE- LURASIDONE HYDROCHLORIDE TABLET, FILM COATED
Dr. Reddys Laboratories Inc
----------
SPL MEDGUIDE
MEDICATION GUIDE
Lurasidone Hydrochloride (loo-RAS-i-done HYE-droe-KLOR-ide) Tablets
What is the most important information I should know about lurasidone
hydrochloride tablets?
Lurasidone hydrochloride tablets may cause serious side effects,
including:
• Increased risk of death in elderly people with dementia-related
psychosis. Medicines like lurasidone
hydrochloride tablets can raise the risk of death in elderly people
who have lost touch with reality (psychosis)
due to confusion and memory loss (dementia). Lurasidone hydrochloride
tablets are not approved for the
treatment of people with dementia-related psychosis.
• Increased risk of suicidal thoughts or actions in children and
young adults. Antidepressant medicines may
increase suicidal thoughts or actions in some children and young
adults within the first few months of
treatment and when the dose is changed.
o Depression and other serious mental illnesses are the most important
causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These include
people who have (or have a family history of) depression, bipolar
illness (also called manic-depressive
illness), or a history of suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
o Pay close attention to any changes, especially sudden changes in
mood, behaviors, thoughts, or feelings.
This is very important when an antidepressant medicine is started or
when the dose is changed.
o Call the healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts, or
feelings.
o Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider between
visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has
any of the

Preparatomtale

LURASIDONE HYDROCHLORIDE- LURASIDONE HYDROCHLORIDE TABLET, FILM COATED
DR. REDDYS LABORATORIES INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LURASIDONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LURASIDONE HYDROCHLORIDE TABLETS.
LURASIDONE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH. LURASIDONE HYDROCHLORIDE IS NOT
APPROVED FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. ( 5.1).
• ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND
BEHAVIORS IN PEDIATRIC
AND YOUNG ADULT PATIENTS. CLOSELY MONITOR FOR CLINICAL WORSENING AND
EMERGENCE OF
SUICIDAL THOUGHTS AND BEHAVIORS. ( 5.2).
INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are an atypical antipsychotic
indicated for the treatment of:
• Schizophrenia in adults and adolescents (13 to 17 years) ( 1,
14.1)
• Depressive episode associated with Bipolar I Disorder (bipolar
depression) in adults and pediatric
patients (10 to 17 years) as monotherapy ( 1, 14.2). • Depressive
episode associated with Bipolar I
Disorder (bipolar depression) in adults as adjunctive therapy with
lithium or valproate ( 1, 14.2).
DOSAGE AND ADMINISTRATION
Lurasidone hydrochloride tablets should be taken with food (at least
350 calories). Administration with food substantially increases the
absorption of Lurasidone hydrochloride
tablets ( 2.3, 12.3).
INDICATION
STARTING DOSE RECOMMENDED DOSE
Schizophrenia – adults ( 2.1)
40 mg per day 40 mg to 160 mg per day
Schizophrenia-adolescent(13 to 17) ( 2.1)
40 mg per day 40 mg to 80 mg per day
Bipolar Depression – adults ( 2.2)
20 mg per day 20 mg to 120 mg per day
Bipolar Depression –