LURASIDONE HYDROCHLORIDE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Macleods Pharmaceuticals Limited

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Lurasidone hydrochloride 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 (other indication) [see Clinical Studies (14.2)]. • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (other indication) [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 pregna

Vörulýsing:

Lurasidone hydrochloride tablets are white to off-white, round (20 mg or 40 mg), white to off-white, capsule (60 mg), light yellow, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “F3” (20 mg), “F4” (40 mg), “F5” (60 mg), “F6” (80 mg)  or “F7” (120 mg). Tablets are supplied in the following strengths and package configurations (Table 39). Table 39: Package Configuration for Lurasidone Hydrochloride Tablets                                                                                              Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Macleods Pharmaceuticals Limited
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MEDICATION GUIDE
Lurasidone Hydrochloride Tablets
(loo RAS I done)
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 following symptoms,
especially if they are new, worse, or worry you:
•
thoughts about suicide

Vara einkenni

LURASIDONE HYDROCHLORIDE - LURASIDONE HYDROCHLORIDE TABLET, FILM
COATED
MACLEODS PHARMACEUTICALS LIMITED
----------
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
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
Lurasidone hydrochloride 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 (other
indication) in adults as monotherapy (1,
14.2)
• Depressive episode associated with Bipolar I Disorder (other
indication) in adults as adjunctive therapy
with lithium or valproate (1, 14.2)
DOSAGE AND ADMINISTRATION
• Lurasidone hydrochloride should be taken with food (at least 350
calories). Administration with food
substantially increases the absorption of lurasidone hydrochloride
(2.3, 12.3).
• Moderate and Severe Renal Impairment: Recommended starting dose is
20 mg per day, and the
maximum recommended dose is 80 mg per day (2.4, 8.6).
INDICATION
STARTING DOSE
RECOMMENDED DOSE
Schizophrenia – adults (2.1)
40 mg per day
40 mg to 160 mg p