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Dosage of Lurasidone in details
The recommended starting dose of Lurasidone is 40 mg once daily. Initial dose titration is not required. Lurasidone has been shown to be effective in a dose range of 40 mg per day to 160 mg per day. The maximum recommended dose is 160 mg per day.
Depressive Episodes Associated with Bipolar I Disorder
The recommended starting dose of Lurasidone is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Lurasidone has 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. 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 to 60 mg per day).
Lurasidone should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Lurasidone. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, Lurasidone was administered with food.
Dose Modifications in Special Populations
Dose adjustment is recommended in moderate (creatinine clearance: 30 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.
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/day.
Dose Modifications Due to Drug Interactions
Concomitant Use with CYP3A4 Inhibitors
Lurasidone should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).
If Lurasidone is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the Lurasidone dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and Lurasidone is added to the therapy, the recommended starting dose of Lurasidone is 20 mg per day, and the maximum recommended dose of Lurasidone is 80 mg per day.
Grapefruit and grapefruit juice should be avoided in patients taking Lurasidone, since these may inhibit CYP3A4 and alter Lurasidone concentrations.
Concomitant Use with CYP3A4 Inducers
Lurasidone should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If Lurasidone is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurasidone dose after chronic treatment (7 days or more) with the CYP3A4 inducer.
Dosage Forms And Strengths
Lurasidone tablets are available in the following shape and color (Table 1) with respective one-sided debossing:
Table 1: Lurasidone Tablet Presentations
|Tablet Strength||Tablet Color/Shape||Tablet Markings|
|20 mg||white to off-white round||L20|
|40 mg||white to off-white round||L40|
|60 mg||white to off white oblong||L60|
|80 mg||pale green oval||L80|
|120 mg||white to off-white oval||L120|
Storage And Handling
Lurasidone tablets are white to off-white, round (20 mg or 40 mg), white to off-white, oblong (60 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L20” (20 mg), “L40” (40 mg), “L80” (80 mg) or “L120” (120 mg). Tablets are supplied in the following strengths and package configurations (Table 26):
Table 26: Package Configuration for Lurasidone Tablets
|Tablet Strength||Package Configuration||NDC Code|
|20 mg||Bottles of 30||63402-302-30|
|Bottles of 90||63402-302-90|
|Bottles of 500||63402-302-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-302-10 Carton 63402-302-01 Blister|
|40 mg||Bottles of 30||63402-304-30|
|Bottles of 90||63402-304-90|
|Bottles of 500||63402-304-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-304-10 Carton 63402-304-01 Blister|
|60 mg||Bottles of 30||63402-306-30|
|Bottles of 90||63402-306-90|
|Bottles of 500||63402-306-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-306-10 Carton 63402-306-01 Blister|
|80 mg||Bottles of 30||63402-308-30|
|Bottles of 90||63402-308-90|
|Bottles of 500||63402-308-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-308-10 Carton 63402-308-01 Blister|
|120 mg||Bottles of 30||63402-312-30|
|Bottles of 90||63402-312-90|
|Bottles of 500||63402-312-50|
|Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each||63402-312-10 Carton 63402-312-01 Blister|
Store Lurasidone tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).
Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA. Issued: July/2013
What other drugs will affect Lurasidone?
Before you take Lurasidone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Lurasidone.
Many drugs can interact with Lurasidone. Below is just a partial list. Tell your doctor if you are using:
- bosentan (Tracleer);
- conivaptan (Vaprisol);
- dexamethasone (Decadron, Hexadrol);
- imatinib (Gleevec);
- isoniazid (for treating tuberculosis);
- St. John's wort;
- an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifapentine (Priftin), or telithromycin (Ketek);
- antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);
- an antidepressant such as nefazodone;
- heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
- HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);
- medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil); or
- seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Solfoton), phenytoin (Dilantin), or primidone (Mysoline).
This list is not complete and other drugs may interact with Lurasidone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Potential for Other Drugs to Affect Lurasidone
Lurasidone is predominantly metabolized by CYP3A4. Lurasidone should not be used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). The Lurasidone dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil, etc.). If Lurasidone is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurasidone dose.
Lithium: It is not necessary to adjust the Lurasidone dose when used concomitantly with lithium (Figure 1).
Valproate: It is not necessary to adjust the Lurasidone dose when used concomitantly with valproate. A dedicated drug-drug interaction study has not been conducted with valproate and Lurasidone. Based on pharmacokinetic data from the bipolar depression studies valproate levels were not affected by Lurasidone, and Lurasidone concentrations were not affected by valproate.
Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Lurasidone, since these may inhibit CYP3A4 and alter Lurasidone concentrations.
Figure 1: Impact of Other Drugs on Lurasidone Pharmacokinetics
Potential for Lurasidone to Affect Other Drugs
No dose adjustment is needed for lithium, substrates of P-gp, CYP3A4 (Figure 2) or valproate when coadministered with Lurasidone. ).
Figure 2: Impact of Lurasidone on Other Drugs
Drug Abuse And Dependence
Lurasidone is not a controlled substance.
Lurasidone has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with Lurasidone did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of Lurasidone misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).
- DailyMed. "LURASIDONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "22IC88528T: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Antipsychotic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Lurasidone are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lurasidone. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported frequency of useNo survey data has been collected yet
Consumer reported dosesNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology