Lurasidone hydrochloride
Tablet, Film Coated · Oral
Uses
Lurasidone hydrochloride is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . 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 )] . Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) 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 ( 2.3 , 12.3 ). Indication Starting Dose Recommended Dose Schizophrenia–adults ( 2.1 ) 40 mg per day 40 mg to 160 mg per day Schizophrenia – adolescents (13 to 17 years) ( 2.1 ) 40 mg per day 40 mg to 80 mg per day 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 ). Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment ( 2.5 , 8.7 ). Concomitant Use of a Moderate CYP3A4 inhibitor (e.g., diltiazem): Lurasidone hydrochloride tablets dose should be reduced to half of the original dose level. Recommended starting dose is 20 mg per day. Maximum recommended dose is 80 mg per day ( 2.6 , 7.1 ) Concomitant Use of a Moderate CYP3A4 Inducer: It may be necessary to increase the dose of lurasidone hydrochloride tablets ( 2.6 , 7.1 ) 2.1 Schizophrenia Adults The recommended starting dose of lurasidone hydrochloride tablets is 40 mg once daily. Initial dose titration is not required. Lurasidone hydrochloride tablets have 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 (13 to 17 years) The recommended starting dose of lurasidone hydrochloride tablets is 40 mg once daily. Initial dose titration is not required. Lurasidone hydrochloride tablets have 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 Adults The recommended starting dose of lurasidone hydrochloride tablets is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Lurasidone hydrochloride tablets have 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 mg to 60 mg per day) [see Clinical Studies ( 14.2 )] . Pediatric Patients (10 – 17 years) The recommended starting dose of lurasidone hydrochloride is 20 mg given once daily as monotherapy. Initial dose titration is not required. The dose may be increased after one week based on clinical response. Lurasidone hydrochloride has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. At the end of the clinical study, most of the patients (67%) received 20 mg or 40 mg once daily [see Clinical Studies ( 14.2 )] . The maximum recommended dose is 80 mg per day. The efficacy of lurasidone hydrochloride in the treatment of mania associated with bipolar disorder has not been established. 2.3 Administration Information Lurasidone hydrochloride tablets should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of lurasidone hydrochloride. Administration with food increases the AUC approximately 2-fold and increases the C max approximately 3-fold. In the clinical studies, lurasidone hydrochloride tablets were administered with food [see Clinical Pharmacology ( 12.3 )] . The effectiveness of lurasidone hydrochloride tablets 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 lurasidone hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration ( 2.1 and 2.2 )] . 2.4 Dose Modifications for Renal Impairment Dose adjustment is recommended in moderate (creatinine clearance: 30 mL/min to < 50 mL/min) and severe renal impairment (creatinine clearance < 30 mL/min) patients. The recommended starting dose is 20 mg per day. The dose in these patients should not exceed 80 mg per day [see Use in Specific Populations ( 8.6 )]. 2.5 Dose Modifications for Hepatic Impairment 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 per day. The dose in moderate hepatic impairment patients should not exceed 80 mg per day and the dose in severe hepatic impairment patients should not exceed 40 mg per day [see Use in Specific Populations ( 8.7 )]. 2.6 Dose Modifications Due to Drug Interactions of CYP3A4 Inhibitors and CYP3A4 Inducers Concomitant Use with CYP3A4 Inhibitors Lurasidone hydrochloride should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Contraindications ( 4 )] . If lurasidone hydrochloride is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the lurasidone hydrochloride tablets dose should be reduced to half of the original dose level.
Dosage forms and strengths
Tablets: 20 mg, 40 mg, 60 mg, 80 mg and 120 mg ( 3 ) Lurasidone hydrochloride tablets are available in the following shape and color with respective one-sided debossing: 20 mg lurasidone hydrochloride tablets are yellow to light yellow, round shaped, coated tablets, debossed with "C31" on one side and plain on the other side. 40 mg lurasidone hydrochloride tablets are white to off white, round shaped, coated tablets, debossed with "C32" on one side and plain on the other side. 60 mg lurasidone hydrochloride tablets are white to off white, modified capsule shaped, coated tablets, debossed with "C33" on one side and plain on the other side. 80 mg lurasidone hydrochloride tablets are yellow to light yellow, oval shaped, coated tablets, debossed with "C34" on one side and plain on the other side. 120 mg lurasidone hydrochloride tablets are white to off white, oval shaped, coated tablets, debossed with "C35" on one side and plain on the other side.
Contraindications
Known hypersensitivity to lurasidone hydrochloride or any components in the formulation ( 4 ). Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole) ( 2.6 , 4 , 7.1 ). Concomitant use with a strong CYP3A4 inducer (e.g., rifampin) ( 2.6 , 4 , 7.1 ). Known hypersensitivity to lurasidone hydrochloride 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 )].
Warnings and precautions
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) ( 5.3 ). Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ). Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ). Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.6 ). Hyperprolactinemia: Prolactin elevations may occur ( 5.7 ). Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing lurasidone hydrochloride if a clinically significant decline in WBC occurs in the absence of other causative factors ( 5.8 ). Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.9 ). 5.1 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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6-times to 1.7-times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [ see Boxed Warning , Warnings and Precautions ( 5.3 )] . 5.2 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 2. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 2 Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated 1.2 Increases Compared to Placebo < 18 14 additional patients 18 to 24 5 additional patients 1.2 Decreases Compared to Placebo 25 to 64 1 fewer patient ≥ 65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression. 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. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing lurasidone hydrochloride, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.3 Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, compared to placebo-treated subjects. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions ( 5.1 )]. 5.4 Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including lurasidone hydrochloride. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue lurasidone hydrochloride and provide intensive symptomatic treatment and monitoring. 5.5 Tardive Dyskinesia Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
Side effects
Commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) were ( 6.1 ): Adult patients with schizophrenia: somnolence, akathisia, extrapyramidal symptoms, and nausea Adolescent patients (13 to 17 years) with schizophrenia: somnolence, nausea, akathisia, EPS (non-akathisia), rhinitis (80mg only), and vomiting Adult patients with bipolar depression: akathisia, extrapyramidal symptoms, and somnolence Pediatric patients (10-17 years) with bipolar depression: nausea, weight increase, and insomnia. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions ( 5.2 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.13 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warnings and Precautions ( 5.15 )] Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies [see Warnings and Precautions ( 5.16 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults The information below is derived from an integrated clinical study database for lurasidone hydrochloride consisting of 3,799 adult patients exposed to one or more doses of lurasidone hydrochloride for the treatment of schizophrenia and bipolar depression in placebo-controlled studies. This experience corresponds with a total experience of 1,250.9 patient-years. A total of 1,106 lurasidone hydrochloride-treated patients had at least 24 weeks and 371 lurasidone hydrochloride-treated patients had at least 52 weeks of exposure. Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology. Schizophrenia The following findings are based on the short-term, placebo-controlled premarketing adult studies for schizophrenia in which lurasidone hydrochloride tablets was administered at daily doses ranging from 20 mg to 160 mg (n=1,508). Commonly Observed Adverse Reactions: The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with lurasidone hydrochloride were somnolence, akathisia, extrapyramidal symptoms, and nausea. Adverse Reactions Associated with Discontinuation of Treatment: A total of 9.5% (143/1,508) lurasidone hydrochloride-treated patients and 9.3% (66/708) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with lurasidone hydrochloride that were at least 2% and at least twice the placebo rate. Adverse Reactions Occurring at an Incidence of 2% or More in lurasidone hydrochloride-treated Patients: Adverse reactions associated with the use of lurasidone hydrochloride (incidence of 2% or greater, rounded to the nearest percent and lurasidone hydrochloride incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 19.
Drug interactions
7.1 Drugs Having Clinically Important Interactions with Lurasidone Hydrochloride Table 34 Clinically Important Drug Interactions with Lurasidone Hydrochloride Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride should not be used concomitantly with strong CYP3A4 inhibitors [ see Contraindications ( 4 ) ]. Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 [ see Dosage and Administration ( 2.6 ) ]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil Strong CYP3A4 Inducers Clinical Impact: Concomitant use of lurasidone hydrochloride with strong CYP3A4 inducers decreased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride should not be used concomitantly with strong CYP3A4 inducers [ see Contraindications ( 4 ) ]. Examples: Rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of lurasidone hydrochloride with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride dose should be increased when used concomitantly with moderate inducers of CYP3A4 [ see Dosage and Administration ( 2.6 ) ]. Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin 7.2 Drugs Having No Clinically Important Interactions with Lurasidone Hydrochloride Based on pharmacokinetic studies, no dosage adjustment of Lurasidone hydrochloride is required when administered concomitantly with lithium, valproate, or substrates of P-gp or CYP3A4 [see Clinical Pharmacology ( 12.3 )] .
Use in specific populations
Pregnancy: May cause extrapyramidal and or/withdrawal symptoms in neonates with third trimester exposure ( 8.1 ). 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-andresearchprograms/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see Clinical Considerations] . There are no studies of lurasidone hydrochloride use in pregnant women. The limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. In animal reproduction studies, no teratogenic effects were seen in pregnant rats and rabbits given lurasidone during the period of organogenesis at doses approximately 1.5-times and 6-times, the maximum recommended human dose (MRHD) of 160 mg/day, respectively based on mg/m 2 body surface area [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Data Animal Data Pregnant rats were treated with oral lurasidone at doses of 3 mg/kg/day, 10 mg/kg/day, and 25 mg/kg/day during the period of organogenesis. These doses are 0.2 times, 0.6 times, and 1.5 times the MRHD of 160 mg/day based on mg/m 2 body surface area. No teratogenic or embryo-fetal effects were observed up to 1.5 times the MRHD of 160 mg/day, based on mg/m 2 . Pregnant rabbits were treated with oral lurasidone at doses of 2 mg/kg/day, 10 mg/kg/day, and 50 mg/kg/day during the period of organogenesis. These doses are 0.2 times, 1.2 times and 6 times the MRHD of 160 mg/day based on mg/m 2 . No teratogenic or embryo-fetal effects were observed up to 6 times the MRHD of 160 mg/day based on mg/m 2 . Pregnant rats were treated with oral lurasidone at doses of 0.4 mg/kg/day, 2 mg/kg/day, and 10 mg/kg/day during the periods of organogenesis and lactation. These doses are 0.02 times, 0.1 times and 0.6 times the MRHD of 160 mg/day based on mg/m 2 . No pre- and postnatal developmental effects were observed up to 0.6 times the MRHD of 160 mg/day, based on mg/m 2 . 8.2 Lactation Risk Summary Lactation studies have not been conducted to assess the presence of lurasidone in human milk, the effects on the breastfed infant, or the effects on milk production. Lurasidone is present in rat milk. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for lurasidone hydrochloride and any potential adverse effects on the breastfed infant from lurasidone hydrochloride or from the underlying maternal condition. 8.4 Pediatric Use Schizophrenia The safety and effectiveness of lurasidone hydrochloride tablets 40-mg/day and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.1 )] . The safety and effectiveness of lurasidone hydrochloride has not been established in pediatric patients less than 13 years of age with schizophrenia. Bipolar Depression The safety and effectiveness of lurasidone hydrochloride tablets 20 to 80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17 years) was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients [ see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 )]. The safety and effectiveness of lurasidone hydrochloride has not been established in pediatric patients less than 10 years of age with bipolar depression. Irritability Associated with Autistic Disorder The effectiveness of lurasidone hydrochloride in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. Efficacy was not demonstrated in a 6-week study evaluating lurasidone hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 years to 17 years of age with irritability associated with autistic disorder diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria. The primary objective of the study as measured by improvement from Baseline in the irritability subscale of the Aberrant Behavior Checklist (ABC) at Endpoint (Week 6) was not met. A total of 149 patients were randomized to lurasidone hydrochloride or placebo. Vomiting occurred at a higher rate than reported in other lurasidone hydrochloride studies (4/49 or 8% for 20 mg, 14/51 or 27% for 60 mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on lurasidone hydrochloride with vomiting).
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-andresearchprograms/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see Clinical Considerations] . There are no studies of lurasidone hydrochloride use in pregnant women. The limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. In animal reproduction studies, no teratogenic effects were seen in pregnant rats and rabbits given lurasidone during the period of organogenesis at doses approximately 1.5-times and 6-times, the maximum recommended human dose (MRHD) of 160 mg/day, respectively based on mg/m 2 body surface area [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Data Animal Data Pregnant rats were treated with oral lurasidone at doses of 3 mg/kg/day, 10 mg/kg/day, and 25 mg/kg/day during the period of organogenesis. These doses are 0.2 times, 0.6 times, and 1.5 times the MRHD of 160 mg/day based on mg/m 2 body surface area. No teratogenic or embryo-fetal effects were observed up to 1.5 times the MRHD of 160 mg/day, based on mg/m 2 . Pregnant rabbits were treated with oral lurasidone at doses of 2 mg/kg/day, 10 mg/kg/day, and 50 mg/kg/day during the period of organogenesis. These doses are 0.2 times, 1.2 times and 6 times the MRHD of 160 mg/day based on mg/m 2 . No teratogenic or embryo-fetal effects were observed up to 6 times the MRHD of 160 mg/day based on mg/m 2 . Pregnant rats were treated with oral lurasidone at doses of 0.4 mg/kg/day, 2 mg/kg/day, and 10 mg/kg/day during the periods of organogenesis and lactation. These doses are 0.02 times, 0.1 times and 0.6 times the MRHD of 160 mg/day based on mg/m 2 . No pre- and postnatal developmental effects were observed up to 0.6 times the MRHD of 160 mg/day, based on mg/m 2 .
Pediatric use
8.4 Pediatric Use Schizophrenia The safety and effectiveness of lurasidone hydrochloride tablets 40-mg/day and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.1 )] . The safety and effectiveness of lurasidone hydrochloride has not been established in pediatric patients less than 13 years of age with schizophrenia. Bipolar Depression The safety and effectiveness of lurasidone hydrochloride tablets 20 to 80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17 years) was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients [ see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 )]. The safety and effectiveness of lurasidone hydrochloride has not been established in pediatric patients less than 10 years of age with bipolar depression. Irritability Associated with Autistic Disorder The effectiveness of lurasidone hydrochloride in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. Efficacy was not demonstrated in a 6-week study evaluating lurasidone hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 years to 17 years of age with irritability associated with autistic disorder diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria. The primary objective of the study as measured by improvement from Baseline in the irritability subscale of the Aberrant Behavior Checklist (ABC) at Endpoint (Week 6) was not met. A total of 149 patients were randomized to lurasidone hydrochloride or placebo. Vomiting occurred at a higher rate than reported in other lurasidone hydrochloride studies (4/49 or 8% for 20 mg, 14/51 or 27% for 60 mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on lurasidone hydrochloride with vomiting). In a long-term, open-label study that enrolled pediatric patients (age 6 to 17 years) with schizophrenia, bipolar depression, or autistic disorder from three short-term, placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. There was one adverse event in this trial that was considered possibly drug-related and has not been reported in adults receiving lurasidone: a 10 year old male experienced a prolonged, painful erection, consistent with priapism, that led to treatment discontinuation. In this trial, the mean increase in height from open-label baseline to Week 104 was 4.94 cm. To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]), which normalize for the natural growth of children and adolescents by comparisons to age- and sex-matched population standards. A z-score change <0.5 SD is considered not clinically significant. In this trial, the mean change in height z-score from open-label baseline to Week 104 was +0.05 SD, indicating minimal deviation from the normal growth curve. Juvenile animal studies Adverse effects were seen on growth, physical and neurobehavioral development at doses as low as 0.2 times the MRHD based on mg/m 2 . Lurasidone was orally administered to rats from postnatal days 21 through 91 (this period corresponds to childhood, adolescence, and young adulthood in humans) at doses of 3 mg/kg/day, 30 mg/kg/day, and 150 (males) mg/kg/day or 300 (females) mg/kg/day which are 0.2 times to 10 times (males) and 20 times (females) the maximum recommended adult human dose (MRHD) of 160 mg/day based on mg/m 2 . The adverse effects included dose-dependent decreases in femoral length, bone mineral content, body and brain weights at 2 times the MRHD in both sexes, and motor hyperactivity at 0.2 times and 2 times the MRHD in both sexes based on mg/m 2 . In females, there was a delay in attainment of sexual maturity at 2 times the MRHD, associated with decreased serum estradiol. Mortality occurred in both sexes during early post-weaning period and some of the male weanlings died after only 4 treatments at doses as low as 2 times the MRHD based on mg/m 2 . Histopathological findings included increased colloid in the thyroids and inflammation of the prostate in males at 10 times MRHD based on mg/m 2 and mammary gland hyperplasia, increased vaginal mucification, and increased ovarian atretic follicles at doses as low as 0.2 times the MRHD based on mg/m 2 . Some of these findings were attributed to transiently elevated serum prolactin which was seen in both sexes at all doses. However, there were no changes at any dose level in reproductive parameters (fertility, conception indices, spermatogenesis, estrous cycle, gestation length, parturition, number of pups born). The no effect dose for neurobehavioral changes in males is 0.2 times the MRHD based on mg/m 2 and could not be determined in females. The no effect dose for growth and physical development in both sexes is 0.2 times the MRHD based on mg/m 2 .
Geriatric use
8.5 Geriatric Use Clinical studies with lurasidone hydrochloride did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. In elderly patients with psychosis (65 to 85), lurasidone hydrochloride concentrations (20 mg/day) were similar to those in young subjects. It is unknown whether dose adjustment is necessary on the basis of age alone. Elderly patients with dementia-related psychosis treated with lurasidone hydrochloride are at an increased risk of death compared to placebo. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [ see Boxed Warning , Warnings and Precautions ( 5.1 , 5.3 )] .
Overdosage
10.1 Human Experience In premarketing clinical studies, accidental or intentional overdosage of lurasidone hydrochloride tablets was identified in one patient who ingested an estimated 560 mg of lurasidone hydrochloride. This patient recovered without sequelae. This patient resumed lurasidone hydrochloride treatment for an additional two months. 10.2 Management of Overdosage No specific antidotes for lurasidone hydrochloride are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an overdose occurs, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org). Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with an acute overdose of lurasidone hydrochloride. Similarly, the alpha-blocking properties of bretylium might be additive to those of lurasidone hydrochloride, resulting in problematic hypote nsion. Hypotension and circulatory collapse should be treated with appropriate measures. Epinephrine and dopamine should not be used, or other sympathomimetics with beta-agonist activity, since beta stimulation may worsen hypotension in the setting of lurasidone hydrochloride-induced alpha blockade. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Gastric lavage (after intubation if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis.
Description
Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R ,4 S ,7 R ,7a S )-2-{(1 R ,2 R )-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1- ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H -isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S·HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white solid. It is slightly soluble in methanol. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are citric acid monohydrate, croscarmellose sodium, hypromellose, iron oxide yellow (only for 20 mg and 80 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, pregelatinised starch, poloxamer, titanium dioxide and talc. Lurasidone hydrochloride tablets
Mechanism of action
12.1 Mechanism of Action The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D 2 and serotonin Type 2 (5HT 2A ) receptor antagonism.
How supplied
20 mg lurasidone hydrochloride tablets are yellow to light yellow, round shaped, coated tablets, debossed with "C31" on one side and plain on the other side and are supplied as: NDC 68382-965-06 in bottle of 30 tablets with child-resistant closure NDC 68382-965-16 in bottle of 90 tablets with child-resistant closure NDC 68382-965-01 in bottle of 100 tablets NDC 68382-965-05 in bottle of 500 tablets NDC 68382-965-77 in cartons of 100 tablets (10 x 10 unit-dose) 40 mg lurasidone hydrochloride tablets are white to off white, round shaped, coated tablets, debossed with "C32" on one side and plain on the other side and are supplied as: NDC 68382-966-06 in bottle of 30 tablets with child-resistant closure NDC 68382-966-16 in bottle of 90 tablets with child-resistant closure NDC 68382-966-01 in bottle of 100 tablets NDC 68382-966-05 in bottle of 500 tablets NDC 68382-966-77 in cartons of 100 tablets (10 x 10 unit-dose) 60 mg lurasidone hydrochloride tablets are white to off white, modified capsule shaped, coated tablets, debossed with "C33" on one side and plain on the other side and are supplied as: NDC 68382-859-06 in bottle of 30 tablets with child-resistant closure NDC 68382-859-16 in bottle of 90 tablets with child-resistant closure NDC 68382-859-01 in bottle of 100 tablets NDC 68382-859-05 in bottle of 500 tablets NDC 68382-859-77 in cartons of 100 tablets (10 x 10 unit-dose) 80 mg lurasidone hydrochloride tablets are yellow to light yellow, oval shaped, coated tablets, debossed with "C34" on one side and plain on the other side and are supplied as: NDC 68382-967-06 in bottle of 30 tablets with child-resistant closure NDC 68382-967-16 in bottle of 90 tablets with child-resistant closure NDC 68382-967-01 in bottle of 100 tablets NDC 68382-967-05 in bottle of 500 tablets NDC 68382-967-77 in cartons of 100 tablets (10 x 10 unit-dose) 120 mg lurasidone hydrochloride tablets are white to off white, oval shaped, coated tablets, debossed with "C35" on one side and plain on the other side and are supplied as: NDC 68382-968-06 in bottle of 30 tablets with child-resistant closure NDC 68382-968-16 in bottle of 90 tablets with child-resistant closure NDC 68382-968-01 in bottle of 100 tablets NDC 68382-968-05 in bottle of 500 tablets NDC 68382-968-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage Store lurasidone hydrochloride tablets at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide) Suicidal Thoughts and Behavior Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [ see Boxed Warning , Warnings and Precautions ( 5.2 ) ]. Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction referred to as Neuroleptic Malignant Syndrome (NMS). Advise patients, family members, or caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS [ see Warnings and Precautions ( 5.4 ) ]. Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [ see Warnings and Precautions ( 5.5 ) ]. Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [ see Warnings and Precautions ( 5.6 ) ]. Hyperprolactinemia Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of lurasidone hydrochloride. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females, erectile dysfunction or gynecomastia in males [ see Warnings and Precautions ( 5.7 ) ]. Leukopenia/Neutropenia Advise patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia that they should have their CBC monitored while taking lurasidone hydrochloride [ s ee Warnings and Precautions ( 5.8 )] . Orthostatic Hypotension Educate patients about the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [ see Warnings and Precautions ( 5.9 ) ]. Interference with Cognitive and Motor Performance Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that lurasidone hydrochloride therapy does not affect them adversely [ see Warnings and Precautions ( 5.12 ) ]. Heat Exposure and Dehydration Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions ( 5.13 )] . Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania [ see Warnings and Precautions ( 5.14 ) ]. Concomitant Medication Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, because there is a potential for drug interactions [see Drug Interactions ( 7 )] . Pregnancy Advise patients that lurasidone hydrochloride may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )] . Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy [see Use in Specific Populations ( 8.1 )] . Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.
Label text from the FDA structured product label by Zydus Pharmaceuticals USA Inc. (revised Jul 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Lurasidone Hydrochloride in 132 products
Lurasidone hydrochloride NDC products (132)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7170 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7078 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6438 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 16729-350 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-349 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-348 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-347 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-346 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 62332-495 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-498 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-497 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-496 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-494 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-496 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-497 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-498 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-494 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-495 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 60687-780 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-769 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-758 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-747 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 65162-879 | Lurasidone Hydrochloride 20 mg/1 Tablet, Coated | Amneal Pharmaceuticals LLC | ANDA |
| 65162-880 | Lurasidone Hydrochloride 40 mg/1 Tablet, Coated | Amneal Pharmaceuticals LLC | ANDA |
| 65162-881 | Lurasidone Hydrochloride 80 mg/1 Tablet, Coated | Amneal Pharmaceuticals LLC | ANDA |
| 65162-882 | Lurasidone Hydrochloride 120 mg/1 Tablet, Coated | Amneal Pharmaceuticals LLC | ANDA |
| 65162-082 | Lurasidone Hydrochloride 60 mg/1 Tablet, Coated | Amneal Pharmaceuticals LLC | ANDA |
| 53746-082 | Lurasidone Hydrochloride 60 mg/1 Tablet, Coated | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-879 | Lurasidone Hydrochloride 20 mg/1 Tablet, Coated | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-880 | Lurasidone Hydrochloride 40 mg/1 Tablet, Coated | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-881 | Lurasidone Hydrochloride 80 mg/1 Tablet, Coated | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-882 | Lurasidone Hydrochloride 120 mg/1 Tablet, Coated | Amneal Pharmaceuticals of New York LLC | ANDA |
| 67877-639 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-638 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-640 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-642 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-641 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 65862-955 | Lurasidone Hydrochloride 60 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-956 | Lurasidone Hydrochloride 80 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-954 | Lurasidone Hydrochloride 40 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-953 | Lurasidone Hydrochloride 20 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-957 | Lurasidone Hydrochloride 120 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 31722-081 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-084 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-083 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-082 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-080 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 69097-937 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Cipla USA, Inc. | ANDA |
| 69097-938 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Cipla USA, Inc. | ANDA |
| 69097-939 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Cipla USA, Inc. | ANDA |
| 69097-941 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Cipla USA, Inc. | ANDA |
| 69097-942 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Cipla USA, Inc. | ANDA |
| 67046-1659 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1637 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1654 | Lurasidone Hydrochloride 60 mg/1 Tablet | Coupler LLC | ANDA |
| 43598-355 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Dr. Reddys Laboratories Inc | ANDA |
| 43598-354 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Dr. Reddys Laboratories Inc | ANDA |
| 43598-353 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Dr. Reddys Laboratories Inc | ANDA |
| 43598-352 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Dr. Reddys Laboratories Inc | ANDA |
| 43598-351 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Dr. Reddys Laboratories Inc | ANDA |
| 76282-522 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-523 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-524 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-534 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-525 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Exelan Pharmaceuticals Inc. | ANDA |
| 51407-836 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-833 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-832 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-838 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-837 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 23155-891 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-887 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-888 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-889 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-890 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 68180-670 | Lurasidone Hydrochloride 20 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-671 | Lurasidone Hydrochloride 40 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-672 | Lurasidone Hydrochloride 60 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-673 | Lurasidone Hydrochloride 80 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-674 | Lurasidone Hydrochloride 120 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-419 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-420 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-421 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-422 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-423 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 0904-7356 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7422 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | MAJOR PHARMACEUTICALS | ANDA |
| 0904-7423 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | MAJOR PHARMACEUTICALS | ANDA |
| 0904-7424 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | MAJOR PHARMACEUTICALS | ANDA |
| 0904-7425 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | MAJOR PHARMACEUTICALS | ANDA |
| 0904-7421 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | MAJOR PHARMACEUTICALS | ANDA |
| 0904-7359 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7358 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7357 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7355 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 72603-624 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-623 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-622 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-621 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72205-211 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-210 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-209 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-208 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-207 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 82804-215 | Lurasidone Hydrochloride 20 mg/1 Tablet | Proficient Rx LP | ANDA |
| 70518-4427 | Lurasidone Hydrochloride 40 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4563 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4491 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4260 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4241 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4117 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 47335-685 | Lurasidone Hydrochloride 80 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 47335-684 | Lurasidone Hydrochloride 40 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 47335-639 | Lurasidone Hydrochloride 60 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 47335-579 | Lurasidone Hydrochloride 120 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 47335-578 | Lurasidone Hydrochloride 20 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 13668-464 | Lurasidone Hydrochloride 20 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-465 | Lurasidone Hydrochloride 40 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-466 | Lurasidone Hydrochloride 80 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-467 | Lurasidone Hydrochloride 120 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-509 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-737 | Lurasidone Hydrochloride 60 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 70771-1738 | Lurasidone Hydrochloride 120 mg/1 Tablet, Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1737 | Lurasidone Hydrochloride 80 mg/1 Tablet, Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1736 | Lurasidone Hydrochloride 60 mg/1 Tablet, Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1735 | Lurasidone Hydrochloride 40 mg/1 Tablet, Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1734 | Lurasidone Hydrochloride 20 mg/1 Tablet, Coated | Zydus Lifesciences Limited | ANDA |
| 68382-968 | Lurasidone Hydrochloride 120 mg/1 Tablet, Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-967 | Lurasidone Hydrochloride 80 mg/1 Tablet, Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-966 | Lurasidone Hydrochloride 40 mg/1 Tablet, Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-965 | Lurasidone Hydrochloride 20 mg/1 Tablet, Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-859 | Lurasidone Hydrochloride 60 mg/1 Tablet, Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
Lurasidone hydrochloride recalls
- D-0266-2024 Jan 31, 2024 · Class II · Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. - D-0267-2024 Jan 31, 2024 · Class II · Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Frequently asked questions
What is Lurasidone hydrochloride used for?
Lurasidone hydrochloride is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . 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…
What are the side effects of Lurasidone hydrochloride?
Commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) were ( 6.1 ): Adult patients with schizophrenia: somnolence, akathisia, extrapyramidal symptoms, and nausea Adolescent patients (13 to 17 years) with schizophrenia: somnolence, nausea, akathisia, EPS (non-akathisia), rhinitis (80mg only), and vomiting Adult patients with bipolar depression: akathisia,… See the full label for the complete list.
Who makes Lurasidone hydrochloride?
Lurasidone hydrochloride is listed by 28 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Lurasidone hydrochloride been recalled?
The FDA enforcement database lists 2 recalls for Lurasidone hydrochloride, most recently D-0266-2024 (class ii): CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.