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:

Ascend Laboratories, LLC

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Lurasidone hydrochloride tablets are indicated for: • 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 exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride ta

Vörulýsing:

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

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LURASIDONE HYDROCHLORIDE - LURASIDONE HYDROCHLORIDE TABLET, FILM
COATED
ASCEND LABORATORIES, LLC
----------
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 TABLETS
ARE 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).
INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are an atypical antipsychotic
indicated for the treatment of:
• 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
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 day
• 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).
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