LATUDA is indicated for the treatment of patients with schizophrenia.
The efficacy of LATUDA in schizophrenia was established in five 6-week controlled studies of adult patients with schizophrenia [see Clinical Studies].
The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. 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 DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATION
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/day to 160 mg/day [see Clinical Studies]. The maximum recommended dose is 160 mg/day.
LATUDA should be taken with food (at least 350 calories) [see CLINICAL PHARMACOLOGY].
Dose Modifications in Special Populations
Dose adjustment is recommended in moderate (creatinine clearance: 30 to < 50 mL/min) and severe renal impairment (creatinine clearance < 30 mL/min) patients. The recommended starting dose is 20 mg. The dose in these patients should not exceed 80 mg/day [see Use in Specific Populations].
Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. The recommended starting dose is 20 mg. The dose in moderate hepatic impairment patients should not exceed 80 mg/day and the dose in severe hepatic impairment patients should not exceed 40 mg/day [see Use in Specific Populations].
Dose Modifications Due to Drug Interactions
Concomitant Use with Potential CYP3A4 Inhibitors
The recommended starting dose is 20 mg/day. The dose of LATUDA should not exceed 80 mg/day in combination with a moderate CYP3A4 inhibitor such as diltiazem. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole) [see CONTRAINDICATIONS; DRUG INTERACTIONS].
Concomitant Use with Potential CYP3A4 Inducers
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|
|80 mg||pale green oval||L80|
|120 mg||white to off-white oval||L120|
Storage And Handling
LATUDA tablets are white to off-white, round (20 mg or 40 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L20” (20 mg), “L40” (40 mg), “L80” (80 mg) or “L120” (120 mg). Tablets are supplied in the following strengths and package configurations (Table 9):
Table 9: Package
Configuration for LATUDA Tablets
|Tablet Strength||Package Configuration||NDC Code|
|20 mg||Bottles of 30||63402-302-30|
|Bottles of 90||63402-302-90|
|Bottles of 500||63402-302-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-302-10 Carton 63402-302-01 Blister|
|40 mg||Bottles of 30||63402-304-30|
|Bottles of 90||63402-304-90|
|Bottles of 500||63402-304-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-304-10 Carton 63402-304-01 Blister|
|80 mg||Bottles of 30||63402-308-30|
|Bottles of 90||63402-308-90|
|Bottles of 500||63402-308-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-308-10 Carton 63402-308-01 Blister|
|120 mg||Bottles of 30||63402-312-30|
|Bottles of 90||63402-312-90|
|Bottles of 500||63402-312-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-312-10 Carton 63402-312-01 Blister|
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. Revised: December 2012
Last reviewed on RxList: 2/4/2013
This monograph has been modified to include the generic and brand name in many instances.
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