";s:4:"text";s:6132:"Tablets are supplied in the following strengths and package configurations (Table 33).Store LATUDA tablets at 25°C (77°F); excursions permitted to 15° -30°C (59° -86°F) [See USP Controlled Room Temperature].Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA. The long half-life (time it takes to metabolize 50% of the drug) has been referenced as the reason once daily dosing with levothyroxine …
Change in weight from baseline for olanzapine was +4.15 kg and for quetiapine extended-release was +2.09 kg in Studies 3 and 5 [see In the uncontrolled, longer-term schizophrenia studies (primarily open-label extension studies), LATUDA was associated with a mean change in weight of -0.69 kg at week 24 (n=755), -0.59 kg at week 36 (n=443) and -0.73 kg at week 52 (n=377).Data from the short-term, placebo-controlled adolescent schizophrenia study are presented in Table 10. In the clinical studies, LATUDA was administered with food The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. It is advisable that a total daily dose of more than 50 mg … Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients.
LATUDA has been shown to be effective in a dose range of 40 mg per day to 80 mg per day [see The recommended starting dose of LATUDA in adults is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. The median change from baseline to endpoint for males was +1.5 ng/mL and for females was +3.1 ng/mL.
Incidence of EPS is provided in Table 24.In the short-term, placebo-controlled schizophrenia and bipolar depression studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (BAS) for akathisia and the Abnormal The mean change from baseline for LATUDA-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients, with the exception of the Barnes Akathisia Scale global score (LATUDA, 0.1; placebo, 0.0). It is unknown whether dose adjustment is necessary on the basis of age alone.Elderly patients with dementia-related psychosis treated with LATUDA are at an increased risk of death compared to placebo. Daily Dose Average Daily Drug Cost ($) Annual Drug Cost ($) Lurasidone (Latuda) 40 mg 80 mg 120 mg tab XXXXXXa 40 mg to 120 mg daily XXXXXX XXXXXX Asenapine (Saphris) 5 mg 10 mg tab 1.5516b 5 mg twice daily 3.10 1,133 Aripiprazole (Abilify) 2 mg 5 mg 10 mg 15 mg 20 mg 30 mg tab 3.0970 3.4867 4.1337 4.7827 5.4317 6.7277 10 mg to 15 mg daily In schizophrenia, dosing usually starts at 40 mg/daily, but for bipolar depression treatment, 20 mg/daily is recommended.