RVP

Drug Catalog - Product Detail

ARIPIPRAZOLE TB 10MG 90

NDC Mfr Size Str Form
13668-0218-90 TORRENT PHARMACEUTICALS 90 10MG TABLET
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Description
11 DESCRIPTION Aripiprazole, USP is a psychotropic drug that is available as aripiprazole tablets, USP. Aripiprazole, USP is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23 H 27 Cl 2 N 3 O 2 and its molecular weight is 448.39. The chemical structure is: Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, mannitol and microcrystalline cellulose. Additionally, 2 mg tablets contain ferric oxide yellow. description image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Aripiprazole tablets, USP 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Bottles of 30 NDC 13668-216-30 Bottles of 90 NDC 13668-216-90 Bottles of 100 NDC 13668-216-01 Bottles of 500 NDC 13668-216-05 Bottles of 6250 NDC 13668-216-69 100 Unit dose Tablets NDC 13668-216-74 Aripiprazole tablets, USP 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side. Bottles of 30 NDC 13668-217-30 Bottles of 90 NDC 13668-217-90 Bottles of 100 NDC 13668-217-01 Bottles of 500 NDC 13668-217-05 Bottles of 6250 NDC 13668-217-69 100 Unit dose Tablets NDC 13668-217-74 Aripiprazole tablets, USP 10 mg are white to off-white, round, uncoated tablets, debossed with "10" on one side and "18" on other side. Bottles of 30 NDC 13668-218-30 Bottles of 90 NDC 13668-218-90 Bottles of 100 NDC 13668-218-01 Bottles of 500 NDC 13668-218-05 Bottles of 7000 NDC 13668-218-52 100 Unit dose Tablets NDC 13668-218-74 Aripiprazole tablets, USP 15 mg are white to off-white, round, uncoated tablets, debossed with "15" on one side and "19" on other side. Bottles of 30 NDC 13668-219-30 Bottles of 90 NDC 13668-219-90 Bottles of 100 NDC 13668-219-01 Bottles of 500 NDC 13668-219-05 Bottles of 5000 NDC 13668-219-51 100 Unit dose Tablets NDC 13668-219-74 Aripiprazole tablets, USP 20 mg are white to off-white, round, uncoated tablets, debossed with "20" on both sides. Bottles of 30 NDC 13668-220-30 Bottles of 90 NDC 13668-220-90 Bottles of 100 NDC 13668-220-01 Bottles of 500 NDC 13668-220-05 Bottles of 3400 NDC 13668-220-68 100 Unit dose Tablets NDC 13668-220-74 Aripiprazole tablets, USP 30 mg are white to off-white, round, uncoated tablets, debossed with "30" on one side and "21" on other side. Bottles of 30 NDC 13668-221-30 Bottles of 90 NDC 13668-221-90 Bottles of 100 NDC 13668-221-01 Bottles of 500 NDC 13668-221-05 Bottles of 2500 NDC 13668-221-31 100 Unit dose Tablets NDC 13668-221-74 16.2 Storage Tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia ( 14.1 ) Aripiprazole Oral Tablets are indicated for the treatment of: Schizophrenia [see CLINICAL STUDIES (14.1) ] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults ( 2.1 ) 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents ( 2.1 ) 2 mg/day 10 mg/day 30 mg/day Oral formulations: Administer once daily without regard to meals ( 2 ) Known CYP2D6 poor metabolizers: Half of the usual dose ( 2.7) 2.1 Schizophrenia Adults The recommended starting and target dose for aripiprazole is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see CLINICAL STUDIES (14.1) ] . Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either aripiprazole 15 mg/day or placebo, and observed for relapse [see CLINICAL STUDIES (14.1 )] . Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adolescents The recommended target dose of aripiprazole is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. Aripiprazole can be administered without regard to meals [see CLINICAL STUDIES (14.1) ] . Patients should be periodically reassessed to determine the continued need for maintenance treatment. Switching from Other Antipsychotics There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to aripiprazole or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. 2.7 Dosage Adjustments for Cytochrome P450 Considerations Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 2). When the coadministered drug is withdrawn from the combination therapy, aripiprazole dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, aripiprazole dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response. Table 2: Dose Adjustments for Aripiprazole in Patients who are known CYP2D6 Poor Metabolizers and Patients Taking Concomitant CYP2D6 Inhibitors, 3A4 Inhibitors, and/or CYP3A4 Inducers Factors Dosage Adjustments for Aripiprazole Known CYP2D6 Poor Metabolizers Administer half of usual dose Known CYP2D6 Poor Metabolizers taking concomitant strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) Administer a quarter of usual dose Strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) Administer half of usual dose Strong CYP2D6 and CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP3A4 inducers (e.g., carbamazepine, rifampin) Double usual dose over 1 to 2 weeks 2.8 Dosing of Oral Solution The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see CLINICAL PHARMACOLOGY (12.3) ]. 2.9 Dosing of Orally Disintegrating Tablets The dosing for Aripiprazole Orally Disintegrating Tablets is the same as for the oral tablets [see DOSAGE AND ADMINISTRATION (2.1) ].