Lurasidone HCL 40 mg/1
Lurasidone HCL · TABLET · Direct_rx
Lurasidone HCL is a tablet containing lurasidone hcl at 40 mg/1, taken oral. Manufactured by Direct_rx.
Key Facts
- Brand Name
- Lurasidone HCL
- Generic Name
- Lurasidone HCL
- NDC Code (Product)
72189-598- Manufacturer
- Direct_rx
- Strength
- 40 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208045
- Marketing Start
- 12/16/2024
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.
Full Prescribing Information
Indications & 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)].
Dosage & Administration
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 do…
Contraindications
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)].
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…
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 Warnings and Precautions (5.14)] Dysphagia [see Warnings and Precautions (5.15)]…
Frequently Asked Questions
What is Lurasidone HCL used for?
Lurasidone HCL contains Lurasidone HCL. It is a tablet taken oral. Consult your doctor for specific uses.
Is Lurasidone HCL a controlled substance?
Lurasidone HCL is not classified as a controlled substance by the DEA.
What is the generic name for Lurasidone HCL?
The generic name for Lurasidone HCL is Lurasidone HCL. There are no other listed brand versions of Lurasidone HCL.
What is the NDC code for Lurasidone HCL 40 mg/1?
The NDC (National Drug Code) for Lurasidone HCL 40 mg/1 is 72189-598, listed by Direct_rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)