LATUDA- lurasidone hydrochloride tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

REMEDYREPACK INC.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.)

Produktu pārskats:

LATUDA tablets are white to off-white oval (80 mg) “L80” Tablets are supplied in the following NDC: 70518-3010-00 NDC: 70518-3010-01 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Storage Store LATUDA tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

REMEDYREPACK INC.
----------
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
[phone]
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 3/2018
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
followin

Produkta apraksts

LATUDA- LURASIDONE HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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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).
INDIC ATIO N
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