• Dosage of Tablura in details
• Tablura interactions
• Tablura reviews

Dosage of Tablura in details

Tablura Dosage

Generic name: Tablura hydrochloride 20mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Schizophrenia

The recommended starting dose of Tablura is 40 mg once daily. Initial dose titration is not required. Tablura 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 Tablura is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Tablura 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) [see Clinical Studies (14.2).

Administration Instructions

Tablura should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Tablura. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, Tablura was administered with food.

Dose Modifications in Special Populations

Renal Impairment

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.

Hepatic Impairment

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

Tablura should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).

If Tablura is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the Tablura dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and Tablura is added to the therapy, the recommended starting dose of Tablura is 20 mg per day, and the maximum recommended dose of Tablura is 80 mg per day.

Grapefruit and grapefruit juice should be avoided in patients taking Tablura, since these may inhibit CYP3A4 and alter Tablura concentrations.

Concomitant Use with CYP3A4 Inducers

Tablura should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If Tablura is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Tablura dose after chronic treatment (7 days or more) with the CYP3A4 inducer.

More about Tablura (Tablura)

• Side Effects
• During Pregnancy or Breastfeeding
• Dosage Information
• Drug Images
• Drug Interactions
• Support Group
• Pricing & Coupons
• En Espanol
• 356 Reviews - Add your own review/rating

Consumer resources

• Tablura
• Tablura (Advanced Reading)

Professional resources

• Tablura (AHFS Monograph)
• Tablura (FDA)

Related treatment guides

• Bipolar Disorder
• Schizophrenia

What other drugs will affect Tablura?

Before you take Tablura, 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 Tablura.

Many drugs can interact with Tablura. 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 Tablura. 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.

Tablura interactions

Potential for Other Drugs to Affect Tablura

Tablura is predominantly metabolized by CYP3A4. Tablura 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 Tablura 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 Tablura is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Tablura dose.

Lithium: It is not necessary to adjust the Tablura dose when used concomitantly with lithium (Figure 1).

Valproate: It is not necessary to adjust the Tablura dose when used concomitantly with valproate. A dedicated drug-drug interaction study has not been conducted with valproate and Tablura. Based on pharmacokinetic data from the bipolar depression studies valproate levels were not affected by Tablura, and Tablura concentrations were not affected by valproate.

Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Tablura, since these may inhibit CYP3A4 and alter Tablura concentrations.

Figure 1: Impact of Other Drugs on Tablura Pharmacokinetics

Potential for Tablura to Affect Other Drugs

No dose adjustment is needed for lithium, substrates of P-gp, CYP3A4 (Figure 2) or valproate when coadministered with Tablura. ).

Figure 2: Impact of Tablura on Other Drugs

Drug Abuse And Dependence

Controlled Substance

Tablura is not a controlled substance.

Abuse

Tablura 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 Tablura 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 Tablura misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).

References

1. 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).
2. 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).
3. MeSH. "Antipsychotic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Tablura 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 Tablura. 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.

User reports

Consumer reviews

There are no reviews yet. Be the first to write one!

Your name:  Email:  Spam protection:  < Type 25 here

Information checked by Dr. Sachin Kumar, MD Pharmacology