Rx Item-Lurasidone Generic Latuda 40Mg Tab 30 By Novadoz Pharma

Clinical Information
Gen. Code and Des.
66932 lurasidone HCl ORAL TABLET 40 MG
GCN and Des.
29366 lurasidone HCl ORAL TABLET 40 MG
Strength
40MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28160804 ATYPICAL ANTIPSYCHOTICS
Active Ingredients
13607 lurasidone HCl 367514883
Inactive Ingredients
2272 mannitol 69658
2432 lactose 64044515
2537 povidone 9003398

LATUDA- lurasidone hydrochloride tablet, film coated
Sunovion Pharmaceuticals Inc.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

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 [see Warnings and Precautions (5.1 )].



Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients from clinical worsening, and for emergence of suicidal thoughts and behaviors. LATUDA is not approved for use in pediatric patients with depression [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

?LATUDA is indicated for:

?Treatment of adult and adolescent patients age 13 to 17 years with schizophrenia [see Clinical Studies (14.1)].
?Monotherapy treatment of adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
?Adjunctive treatment with lithium or valproate in adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
2 DOSAGE AND ADMINISTRATION

2.1 Schizophrenia
Adults

The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 160 mg per day [see Clinical Studies (14.1)]. The maximum recommended dose is 160 mg per day.

? Adolescents

?The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 80 mg per day [see Clinical Studies (14.1)]. The maximum recommended dose is 80 mg per day.

2.2 Depressive Episodes Associated with Bipolar I Disorder
The recommended starting dose of LATUDA in adults is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2)]. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) [see Clinical Studies (14.2)].

?The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established. DOSAGE FORMS AND STRENGTHS

LATUDA tablets are available in the following shape and color (Table 1) with respective one-sided debossing.

Table 1: LATUDA Tablet Presentations
Tablet Strength Tablet Color/Shape Tablet Markings
20 mg white to off-white round L20
40 mg white to off-white round L40
60 mg white to off-white oblong L60
80 mg pale green oval L80
120 mg white to off-white oval L120

Lurasidone Generic Latuda 40Mg
Lurasidone Generic Latuda 40Mg Item No.:RX750704 750704 NDC No.72205-0208-30 72205-208-30 72205020830 72205203-72205-20830-8 UPC No.:3-72205-20830-8 372205208308 372205208308 MPN 020830

x Item-Lurasidone 20mg Novadoz
Item No.:RX750700 750700 NDC No.72205-0207-30 72205-207-30 72205020730 72205020730 UPC No.:3-72205-20730-1 3-72205-20730-1 3-72205-20730-1 MPN 020730

LURASIDONE HCL ORAL TABLE
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Drug info from dailymed
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RX ITEM-Latuda 20Mg Tab 30 By Sunovion P
Item No.:RX154664 NDC No.63402030230 63402-302-30 6340230230 UPC No.:363402302302 NDC No. 63402-0302-30 UPC/GTIN No. 3-63402-30230-2 MPN 30230

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Latuda 20Mg Tab 30 By Sunovion Pharma
Item No.:RX154664 NDC No.63402030230 63402-302-30 6340230230 UPC No.:363402302302 NDC No. 63402-0302-30 UPC/GTIN No. 3-63402-30230-2 MPN 30230

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