LATUDA- lurasidone hydrochloride tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

lurasidone hydrochloride (UNII: O0P4I5851I) (lurasidone - UNII:22IC88528T)

Fáanlegur frá:

Sumitomo Pharma America, Inc.

INN (Alþjóðlegt nafn):

lurasidone hydrochloride

Samsetning:

lurasidone hydrochloride 20 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

LATUDA is indicated for: - Treatment of adult and adolescent patients (13 to 17 years) 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)]. - Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposu

Vörulýsing:

LATUDA tablets are white to off-white, round (20 mg or 40 mg), white to off-white, oblong (60 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L20” (20 mg), “L40” (40 mg), “L80” (80 mg) or “L120” (120 mg). Tablets are supplied in the following strengths and package configurations (Table 39). Storage Store LATUDA tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature] .

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

Sumitomo Pharma America, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 5/2022
MEDICATION GUIDE
LATUDA (luh-TOO-duh)
(lurasidone hydrochloride)
tablets
What is the most important information I should know about LATUDA?
LATUDA may cause serious side effects, including:
•
Increased risk of death in elderly people with dementia-related
psychosis. Medicines like LATUDA
can raise the risk of death in elderly people who have lost touch with
reality (psychosis) due to
confusion and memory loss (dementia). LATUDA is 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.
•
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?
•
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.
•
Call a healthcare provider right away to report new or sudden changes
in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call a 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 following
symptoms, especially if they are new, worse, or worry you:
•
thoughts about suicide o

Vara einkenni

LATUDA- LURASIDONE HYDROCHLORIDE TABLET, FILM COATED
SUMITOMO PHARMA AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LATUDA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LATUDA.
LATUDA (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. LATUDA IS NOT APPROVED FOR THE
TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (5.1).
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR
IN PEDIATRIC
AND YOUNG ADULT PATIENTS. CLOSELY MONITOR FOR CLINICAL WORSENING AND
EMERGENCE OF
SUICIDAL THOUGHTS AND BEHAVIORS (5.2).
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes, Hyperprolactinemia (5.6,
5.7)
12/2019
INDICATIONS AND USAGE
LATUDA is 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
LATUDA should be taken with food (at least 350 calories).
Administration with food substantially increases
the absorption of LATUDA (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 –adolescents (13 to 17
years) (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 –pediatric patients
(10 to 17 years) (2.2)
20 mg per day
20 mg to 80 mg per da