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Lurastar Dosage |
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Generic name: Lurastar 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.
The recommended starting dose of Lurastar is 40 mg once daily. Initial dose titration is not required. Lurastar 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.
The recommended starting dose of Lurastar is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Lurastar 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).
Lurastar should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Lurastar. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, Lurastar was administered with food.
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.
Concomitant Use with CYP3A4 Inhibitors
Lurastar should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).
If Lurastar is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the Lurastar dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and Lurastar is added to the therapy, the recommended starting dose of Lurastar is 20 mg per day, and the maximum recommended dose of Lurastar is 80 mg per day.
Grapefruit and grapefruit juice should be avoided in patients taking Lurastar, since these may inhibit CYP3A4 and alter Lurastar concentrations.
Concomitant Use with CYP3A4 Inducers
Lurastar should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If Lurastar is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurastar dose after chronic treatment (7 days or more) with the CYP3A4 inducer.
Before you take Lurastar, 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 Lurastar.
Many drugs can interact with Lurastar. Below is just a partial list. Tell your doctor if you are using:
This list is not complete and other drugs may interact with Lurastar. 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.
Lurastar is predominantly metabolized by CYP3A4. Lurastar 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 Lurastar 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 Lurastar is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurastar dose.
Lithium: It is not necessary to adjust the Lurastar dose when used concomitantly with lithium (Figure 1).
Valproate: It is not necessary to adjust the Lurastar dose when used concomitantly with valproate. A dedicated drug-drug interaction study has not been conducted with valproate and Lurastar. Based on pharmacokinetic data from the bipolar depression studies valproate levels were not affected by Lurastar, and Lurastar concentrations were not affected by valproate.
Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Lurastar, since these may inhibit CYP3A4 and alter Lurastar concentrations.
Figure 1: Impact of Other Drugs on Lurastar Pharmacokinetics
No dose adjustment is needed for lithium, substrates of P-gp, CYP3A4 (Figure 2) or valproate when coadministered with Lurastar. ).
Figure 2: Impact of Lurastar on Other Drugs
Lurastar is not a controlled substance.
Lurastar 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 Lurastar 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 Lurastar misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).
Users | % | ||
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6-10mg | 2 | 100.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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