Rx Item-Lurasidone Generic Latuda 60Mg Tab 30 By Accod Pharma

Brand
Brand
Latuda
Manufacturer
ACCORD HEALTHCARE
Strength
60MG
Size
30.0
Color
WHITE TO OFF WHITE
Shape
OBLONG


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

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