Drugplain

LURASIDONE HYDROCHLORIDE 40 mg/1

LURASIDONE HYDROCHLORIDE · TABLET · Aurobindo Pharma Limited

2 Recalls on Record
Plain English

LURASIDONE HYDROCHLORIDE is a tablet containing lurasidone hydrochloride at 40 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name
LURASIDONE HYDROCHLORIDE
Generic Name
LURASIDONE HYDROCHLORIDE
NDC Code (Product)
65862-954
Manufacturer
Aurobindo Pharma Limited
Strength
40 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA208045
Marketing Start
03/10/2023

Recall History

2 Recalls on Record
Class II01/18/2024

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

CompletedVoluntary: Firm initiated
Class II01/18/2024

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

CompletedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective348 reports
suicide attempt236 reports
condition aggravated160 reports
sedation153 reports
dyskinesia152 reports
dystonia143 reports
anosognosia140 reports
blood prolactin abnormal140 reports
sexual dysfunction140 reports
blood glucose increased138 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Lurasidone hydrochloride tablets are 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 & Administration

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 tablets ( 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 recommend…

Contraindications

4 CONTRAINDICATIONS • Known hypersensitivity to lurasidone HCl 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 )]. • Known hypersensitivity to lurasidone hydrochloride tablets 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 ).

Drug Interactions

7 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…

Adverse Reactions

6 ADVERSE REACTIONS 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 Warnin…

Frequently Asked Questions

What is LURASIDONE HYDROCHLORIDE used for?

LURASIDONE HYDROCHLORIDE contains LURASIDONE HYDROCHLORIDE. It is a tablet taken oral. Consult your doctor for specific uses.

Is LURASIDONE HYDROCHLORIDE a controlled substance?

LURASIDONE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for LURASIDONE HYDROCHLORIDE?

The generic name for LURASIDONE HYDROCHLORIDE is LURASIDONE HYDROCHLORIDE. There are 11 other brand versions of LURASIDONE HYDROCHLORIDE.

What is the NDC code for LURASIDONE HYDROCHLORIDE 40 mg/1?

The NDC (National Drug Code) for LURASIDONE HYDROCHLORIDE 40 mg/1 is 65862-954, listed by Aurobindo Pharma Limited.

Product NDC

65862-954

Package NDC

65862-954-05

Other LURASIDONE HYDROCHLORIDE Dosages

Other Lurasidone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)