Lurasidone is an atypical antipsychotic sold in the U.S. under 2 brand and generic names, for bipolar disorder, major depressive disorder and schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Latuda (application NDA200603). Other lurasidone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA ( 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): LATUDA 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 LATUDA ( 2.6 , 7.1 ). 2.1 Schizophrenia Adults The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA…
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 )] Commonly observed adverse…
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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| 1 | Not yet rated | Prescription | Tablet | Generic | $9 | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 578 | 20 mg | white | round | — |
| 684 | 40 mg | white | round | — |
| 639 | 60 mg | white | capsule | — |
| 685 | 80 mg | green | oval | — |
| 579 | 120 mg | white | oval | — |
| F3 | 20 mg | white |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Lurasidone Hydrochloride Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Lurasidone Hydrochloride Tablets 120mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 LATUDA 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 ).
Drugs Having Clinically Important Interactions with LATUDA Table 34: Clinically Important Drug Interactions with LATUDA Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA 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 LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA 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 LATUDA with strong CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA should not be used concomitantly with strong CYP3A4 inducers [see Contraindications ( 4 )] . Examples: Rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine Moderate CYP3A4 Inducers…
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| F5 | 60 mg | white | capsule | — |
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| F6 | 80 mg | yellow | oval | — |
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| F7 | 120 mg | white | oval | — |
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| 64 | 20 mg | white | round | — |
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| 65 | 40 mg | white | round | — |
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| 509 | 60 mg | white | capsule | — |
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