Lurasidone Hydrochloride 20 mg/1
Lurasidone Hydrochloride · TABLET, FILM COATED · American Health Packaging
Lurasidone Hydrochloride is a tablet, film coated containing lurasidone hydrochloride at 20 mg/1, taken oral. Manufactured by American Health Packaging.
Key Facts
- Brand Name
- Lurasidone Hydrochloride
- Generic Name
- Lurasidone Hydrochloride
- NDC Code (Product)
60687-747- Manufacturer
- American Health Packaging
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212244
- Marketing Start
- 06/05/2023
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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, film coated 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 6 other brand versions of Lurasidone Hydrochloride.
What is the NDC code for Lurasidone Hydrochloride 20 mg/1?
The NDC (National Drug Code) for Lurasidone Hydrochloride 20 mg/1 is 60687-747, listed by American Health Packaging.